Introduction to the Project
The problem of sickle cell disease (SCD) has been developing at an exponentially high rate, causing multiple fatal outcomes in patients, as well as making them vulnerable to numerous infectious diseases (Badawy et al., 2017). The issue must be addressed as a global concern that affects vulnerable and disadvantaged groups in remote areas. Applying hydroxyurea-based therapy (HU therapy) combined with the use of a pill packaging system and a mobile application to instances of SCD provides one approach to treating the disease and preventing the further spread of SCD, at the same time catering to the needs of people that have been affected by SCD.
In this context, a pill packaging system is associated with the use of pill boxes, blisters, packs of blisters, unit-dose systems, or blended systems to organize taking a required dose of medications regularly (Conn et al., 2015; Lorenzini & Hellström, 2017). The application of these systems during HU therapy is viewed as a beneficial intervention for patients with SCD.
To understand the gravity of the problem, it is important to consider the nature of the malady. The development of SCD is linked to decreased levels of hemoglobin in red cells. Thus, SCD is “a group of inherited red blood cell disorders” when “red blood cells become hard and sticky and … die early, which causes a constant shortage of red blood cells” (Centers for Disease Control and Prevention, 2017, para. 1). When red blood cells move through small and narrow blood vessels, they become stuck and prevent a normal blood flow, causing pain as well as other health problems (Adams-Graves & Bronte-Jordan, 2016).
Therefore, it is important to ensure that SCD patients adhere to their medication to relieve their state. The project is aimed at analyzing the outcomes that the combination of applying HU along with a pill packaging system and a mobile application has on medication adherence in SCD patients.
Numerous approaches toward managing SCD exist, and HU therapy is among them. HU is defined as an antimetabolite drug that increases the amount of important fetal hemoglobin (Hb F) in individuals’ red blood cells. Furthermore, HU inhibits ribonucleoside diphosphate reductase, preventing changes in the red blood cells (Hosseini et al., 2016; Keikhaei, Yousefi, & Bahadoram, 2016).
As a result of HU effects, the red blood cells do not change their shape and form and remain flexible not to affect the blood flow in vessels (Keikhaei et al., 2016). This effect leads to preventing the development of the pain syndrome in patients with SCD, but to observe positive outcomes, it is necessary to take HU for several weeks (Araujo et al., 2016; Wilson & Nelson, 2015). Therefore, patients’ adherence to this medication is of critical importance to prevent or relieve pain and improve their quality of life (Badawy et al., 2017).
When designing a treatment method based on the use of HU, it is vital to keep in mind that adhering to HU is a complex therapy that requires proper patient perceptions (Badawy et al., 2017). Since HU therapy implies direct collaboration between medical professionals and the patient and active education of the patient, designing a communication channel that will enable a nurse to administer HU-based treatment is essential.
HU-based therapy will assist patients with SCD in managing a pain crisis because of preventing clots in blood vessels that cause pain (McGann et al., 2016). Patient outcomes can also be improved by the utilization of a pill packaging system that implies the arrangement of the necessary pills in boxes for each intake for patients’ convenience (Conn et al., 2015). It is noteworthy that the effectiveness of HU-based therapy supported by the employment of a pill packaging system when treating SCD has not received much attention among researchers.
Chapter One includes a synopsis of the background of this project and the problem statement. The purpose of the current project and the clinical question will be further provided in this chapter. Chapter One also overviews the potential advancement of scientific knowledge this project can offer, the project’s significance, and the rationale for the chosen methodology. This chapter describes the project design and methodology and provides the definitions of the employed terms and concepts. Chapter One outlines the project’s assumptions, limitations, and delimitations.
Background of the Project
The problem of SCD has been studied in depth, yet no treatment that can remove all symptoms and cure patients completely has been found to date. In the United States, at least 100,000 people currently suffer from SCD (Centers for Disease Control and Prevention, 2017). While on a global scale, the problem might not seem drastic, in some areas, including most of the African continent, the rates of SCD reach as high as 30% of the population (Badawy et al., 2017; Kutlar et al., 2019). Studies show that the cause of SCD lies in the genetic mutation of hemoglobin (Badawy et al., 2017; Kutlar et al., 2019). Addressing the problem of SCD and curing the disease completely would necessitate performing a meticulous genome study, which is currently impossible (Badawy et al., 2017).
In the present and past, SCD is primarily treated with hydroxyurea as the main approved drug to address this state. To support the HU-based therapy, supportive care measures were proposed to patients (Adams-Graves & Bronte-Jordan, 2016). Furthermore, for the past two decades, patients with SCD received such options as chronic blood transfusions as well as the stem cell transplantation that are rather costly in comparison to taking HU (Badawy et al., 2017).
Therefore currently, it is important to focus on how to improve HU therapy in order to increase the degree of pain control for patients (McGann et al., 2016). The use of pill packaging systems and mobile applications as reminders is viewed as important to contribute to adherence to hydroxyurea in patients (Huang, 2000; McGann et al., 2016; Telen, 2016). The reason is that those patients, who take hydroxyurea regularly, suffer from pain crises rarely (Badawy et al., 2017; Hosseini et al., 2016; Huang, 2000).
Problem Statement
It is not known whether a combination of HU facilitated by the use of a pill packaging system as an approach to organizing patients’ medications and the use of a mobile application can have a positive impact on the adherence to hydroxyurea for patients with SCD. Although SCD might seem a minor concern on a global scale, especially when compared to other disorders and diseases, its scope is significant for the United States because SCD is diagnosed in 1 from every 365 African-American births (Badawy et al., 2017). Developing an intervention for managing SCD is a necessary step in meeting the needs of SCD patients.
Although numerous strategies have been designed to address SCD, little progress has been made so far in terms of SCD prevention and control. Furthermore, the use of such pill packaging systems as pill organizers to simplify the process of taking drugs and increase adherence to minimize pain episodes also needs examination in the context of HU therapy (Badawy et al., 2017; Conn et al., 2015).
HU is one of a few therapies that have delivered promising outcomes to date, suggesting that its effects on SCD patients and populations vulnerable to SCD should be explored in depth. It is believed that the application of HU will allow for alleviating the painful experiences typical of SCD patients (Badawy et al., 2017). A lack of information on the positive and negative aspects of using HU presents an additional obstacle to managing the problem and makes the further study of HU an urgent measure (Lê et al., 2015). The use of pill packaging systems needs detailed investigation since only some aspects of pill intake management were previously examined by researchers including Huang (2000) and Kopelowicz et al. (2015).
The need for this project is in the fact that is necessary to determine the potential of taking hydroxyurea in combination with using pill packaging systems and a mobile application for reminders for increasing medication adherence and addressing pain crises. Sufficient studies have not been conducted regarding the effects of taking HU with the help of pill packaging systems or mobile applications on patients’ medication adherence and possible pain experiences (Badawy et al., 2017; McGann et al., 2016). It is essential to evaluate the combination of the HU-based therapy and a pill packaging system, as well as using a mobile application in order to identify the relationship between this approach and medication adherence affecting the quality of patients’ life.
This project will contribute to solving the problem of patients’ pain episodes providing information on opportunities for improving the well-being of people with SCD with the help of affecting their adherence to HU. The limited amount of evidence supporting the positive effects of HU combined with the use of a pill packaging system and facilitated by using a mobile app signifies the need for immediate research. A recent article has indicated that the application of HU deserves scrutiny as a potential strategy to ameliorate the conditions of current SCD patients (Badawy et al., 2017).
Purpose of the Project
The purpose of this quantitative descriptive project was to determine to what degree HU therapy combined with using a pill packaging system and a mobile application could affect possible changes in the adherence of SCD patients to their medication. The use of a pill packaging system and a mobile application as an independent variable will be measured with reference to the application or not of this intervention by patients with SCD.
The medication adherence as a dependent variable will be measured with reference to the regularity of taking HU. The discussion of positive and negative outcomes of the proposed therapy combined with the pill packaging intervention contributes to creating strategies that may help to address pain episodes associated with the disease in question. The project explores the opportunities for the management of SCD in patients, especially African Americans (Lê et al., 2015). The examination of interventions, such as the combination of HU therapy with pill packaging systems and a mobile application oriented toward improving the adherence to HU is important to determine the effectiveness of these interventions to decrease such effects of SCD as pain crises.
The problem of low quality of life and the physical discomfort afflicting SCD patients and associated with pain must be managed as an evident concern. The application of an approach based on HU may lead to vast improvements among people with SCD when coupled with using convenient pill packaging systems and a mobile application (Badawy et al., 2017). The opportunities that HU combined with a pill packaging system provides must be examined to enhance the current quality of nursing care and ensure that the level of awareness rises among SCD patients, their parents, at-risk groups, and general audiences.
To address the problem, it is necessary to explore the nature of SCD and the effects that HU therapy facilitated by a pill packaging system and a mobile app produces on patients. The current approach to the effort to cure SCD associated with blood transfusions and transplantations allows for helping only a small group of patients due to the high costs of procedures (Wilson & Nelson, 2015). An analysis of the advantages and disadvantages of the HU-based pill packaging system contributes to solving and problem and provides an opportunity to design a framework for managing the need of any SCD patient or a group of patients.
Clinical Question
The project in question strives to determine whether HU therapy enhanced by a pill packaging system and a mobile application can be associated with the higher levels of medication adherence to prevent pain episodes in patients with SCD. Therefore, this project determined how the specified strategy contributes to increasing medication adherence among patients and enables nurses to increase their competency levels. The opportunity for using pill packaging systems and a mobile application can also serve as a method of sustaining the high quality of life in SCD patients because of addressing pain.
The following clinical question guides this quantitative project:
Q1: In patients with SCD, how does the use of HU therapy combined with utilizing a pill packaging system and a mobile application allow for increased medication adherence?
In this question, HU therapy based on using pill packaging systems and a mobile app as an independent variable is defined by following the intervention by SCD patients. Thus, possible changes in medication adherence in patients with SCD are the dependent variable, and the data on it were collected with the help of a questionnaire. It is important to determine whether the intervention, such as the use of HU therapy with pill packaging systems and a mobile application can promote medication adherence in patients with SCD.
Advancing Scientific Knowledge
It is critical to encourage the advancement of scientific knowledge associated with the management of SCD to address and prevent pain episodes or crises that are observed when HU is taken irregularly and medication adherence is low.
When considering the rationale for the project, it is important to mention the lack of studies that handle the topic of HU in combination with pill packaging and other systems to increase medication adherence as a possible solution to SCD-related pain. Currently, a significant gap exists in the scientific knowledge of HU as a tool for improving the quality of SCD patients’ lives by increasing their adherence to HU and relieving their pain, as well as promoting patient education concerning the use of mobile applications as reminders (Kopelowicz et al., 2015; Lê et al., 2015).
The findings of the studies that are currently available provide reasons to believe that the application of HU therapy can facilitate patient control, which will lead to a drop in the levels of pain common in SCD patients (Centers for Disease Control and Prevention, 2017). The focus must be on the need to study the opportunities that HU and pill packaging systems, as well as mobile app reminders, provide for SCD patients.
The application of the proposed strategy based on HU, pill packaging systems, and a mobile app is likely to lead to a change in medication adherence and pain cycles observed in SCD patients (Badawy, Thompson, & Liem, 2016; Badawy et al., 2017). According to Wilson and Nelson (2015), HU therapy provides a relatively cheap and possibly effective alternative to existing approaches, most of which are quite costly.
Stettler, McKiernan, Adejoro, and Walczak (2015) made the following specific claim: “Despite evidence demonstrating the benefits of hydroxyurea in patients with SCD and frequent pain crises, this analysis suggests that more than 3 of 4 patients who might benefit were not treated with this safe and inexpensive drug” (p. 1671). The current barriers to treatment include the refusal to acknowledge that HU therapy delivers impressive results and that significant outcomes can be achieved through high-level medication adherence (Badawy et al., 2017).
The few studies that explore the link between HU and the quality of SCD patients’ lives prove that HU can potentially benefit people suffering from SCD. The opportunities under consideration occur due to the presence of elements that help to address the vaso‐occlusive crisis (VOC) in HU (Centers for Disease Control and Prevention, 2017). A few studies that do serve to tackle the problem of pain management in patients having SCD with the help of HU and delve into the mechanics of the process have proven HU’s efficacy (Badawy et al., 2017).
These studies have provided reasons to believe that the adherence to HU can help to reduce the pain experienced by patients with SCD. HU can counteract the activation of platelets in SCD patients that typically leads to inflammation and further aggravation of the SCD condition (Kutlar et al., 2019). The use of HU, in turn, will help to reduce inflammation and alleviate negative experiences (Lorenzini & Hellström, 2017; Zhang, Xu, Manwani, & Frenett, 2016). The described intervention with a focus on combining HU therapy with a pill packaging system and a mobile app can allow for improving medication adherence and addressing pain (Badawy et al., 2017).
Although the impact of the provision of HU therapy facilitated by a pill packaging system is unknown, recent research on the effects of pill packaging systems in treating similar conditions suggests improved patient outcomes (Lorenzini & Hellström, 2017). The use of a pill packaging system and mobile reminders in apps in HU-based therapy is expected to improve the quality of patients’ lives through increasing the adherence to HU.
The theory of planned behavior is a theoretical model that supports the project and tends to explain how the usage of pill packaging systems can lead to changes in medication adherence in patients. This theory was developed by Icek Ajzen, who determined particular factors affecting changes in people’s individual behaviors. Ajzen (1985) claimed that people’s attitudes, behavioral control, and subjective norms should be viewed as predictors of an individual’s decision to choose a behavior.
The process of decision making and selecting a behavior (in this project, the behavior is adherence or not to medications) is based on a person’s evaluation influenced by the mentioned predictors. The project adds to explaining how this theoretical model can be applied to the topic of taking medications regularly to improve health outcomes and advances the approach to modeling patients’ behavior with the help of proposing some instruments, like pill packaging or a mobile app (Rich, Brandes, Mullan, & Hagger, 2015).
Significance of the Project
The project has practical significance for improving medication adherence in patients with SCD who need to take hydroxyurea regularly, following their specific regimen, in order to guarantee the prevention of pain episodes. This project provides new insights into the realization of HU therapy with reference to using pill packaging systems and a mobile application (Mango Health) in order to ensure patients do not forget to take pills regularly. Therefore, the project provides numerous significant issues to address, as well as the opportunity for improving the well-being and life conditions of SCD patients with reference to affecting their adherence to medications.
Indeed, the analysis of the effects that the HU therapy supported by the pill packaging technique produces, especially the effects that it has on pain management and adherence to the medication, will allow improving the current services for HU patients. As a result, if the combination of HU therapy with using pill packaging systems and a mobile app leads to increasing medication adherence, it is possible to expect the decrease in pain episodes in patients with SCD.
The application of the HU therapy enhanced by a pill packaging system and a mobile app may prompt the design of a new effective intervention to be used with SCD patients (Kutlar et al., 2019). This project promises great potential to provide a path to creating a more comfortable setting for addressing SCD-related concerns and helping patients to manage their condition while adding to both theory and practice.
There is a gap in research associated with the lack of literature on how pill packaging systems and mobile applications can relate to medication adherence (Haywood et al., 2014). However, this project contributes to addressing this gap, providing answers to the question of whether the application of pill packaging systems and mobile apps as reminders in patients with SCD can lead to increased medication adherence (Conn et al., 2015; Rich et al., 2015).
Furthermore, the project completion is significant for clinicians and practitioners working with SCD patients because the project provides an important opportunity to advance not only the understanding of the intervention but also practice of taking pills by patients (Huang, 2000; Nevitt, Jones, & Howard, 2017). The results of this project will be significant for professionals who work with patients with SCD who take hydroxyurea as there were no other studies on the relationship between HU therapy, pill packaging, using a mobile app and medication adherence (Lin et al., 2016). Therefore, it will be possible to improve the practice of providing HU therapy to guarantee taking pills regularly.
Rationale for Methodology
A quantitative methodology was chosen for the project to address the clinical question and determine the effects of applying HU therapy combined with pill packaging systems and the use of a mobile application on medication adherence in SCD patients. Thus, a quantitative methodology is more appropriate for conducting this project when comparing to a qualitative methodology and mixed methods because quantitative tools add to finding the relationships between independent and dependent variables (Trochim, Donnelly, & Arora, 2015).
A quantitative methodology allows for focusing on data provided in a numerical form, applying statistical tests to analyzing these data to make results more objective (Cokley & Awad, 2013). Finally, a quantitative methodology is effective to be applied when findings need to be generalized for a wider population, as it is typical in clinical practice (LibGuides, 2018; Trochim et al., 2015). As a result of using this methodology, the effects of the proposed intervention were analyzed thoroughly, causing possible changes in patients’ medication adherence to become evident.
The collection of quantitative data regarding the use of pill packaging systems in patients with SCD, as well as further statistical analysis of data, allows for concluding about the effectiveness of the combined intervention. Badawy et al. (2017) and Lê et al. (2015) among other researchers applied a quantitative method in order to examine different outcomes and effects of various interventions, including HU therapy, in patients with SCD.
Since the nature of the project is quantitative, it was possible to use a large sample size that allows for representing all target groups and embracing as many members of the SCD population as possible (Adesina, Brunson, Keegan, & Wun, 2017; Cokley & Awad, 2013). The proposed methodology helps find the relationship between applying HU therapy and pill packing systems, a mobile app, and adherence to the medication in SCD patients.
Nature of the Project Design
The design selected for this project is descriptive one to answer the clinical question on how the use of HU therapy combined with utilizing a pill packaging system and a mobile application can lead to increased medication adherence in patients with SCD. A descriptive approach was selected because it was necessary to apply the intervention (HU therapy combined with a pill packaging system and a mobile app) and describe how the intervention could be related to possible changes in patients’ medication adherence (Trochim et al., 2015).
Thus, a descriptive approach is effective to answer “what-questions,” therefore, it is appropriate to determine the outcomes of the intervention based on HU therapy and using pill packaging and a mobile app for medication adherence (Bell, Bryman, & Harley, 2018). In comparison to correlational or experimental designs, it requires the minimal involvement of an author and more time-efficient; it is the best choice to address the problem of using effective HU-based interventions for increasing medication adherence and addressing the pain crises (Bell et al., 2018; Cokley & Awad, 2013).
A descriptive design effectively supports the developed intervention based on using pill packaging and a mobile app as a solution to the practice problem of low medication adherence associated with pain episodes in SCD patients. The sample for this project included 75 patients with SCD who were asked to take hydroxyurea with the help of pill packaging systems and utilize the Mango Health mobile application for reminders. The data on the sample were collected with the help of a questionnaire developed by Huang (2000) in order to determine possible changes in patients’ medication adherence as a result of applying the intervention.
Definition of Terms
The following terms are used operationally in this project:
SCD
Sickle cell disease (SCD) is defined as a genetic red blood cell disorder caused by an autosomal recessive mutation that is likely to cause anemia unless appropriate measures are taken (Kutlar et al., 2019).
Hydroxyurea (Hydroxycaramide, HU)
It is a medication that allows for decreasing the number of pain episodes in patients with SCD due to affecting the red blood cells to make them round and rather flexible through increasing fetal hemoglobin and preventing blockages of blood vessels (Kutlar et al., 2019).
- Pill packaging systems. A pill package system implies the use of some packages (such as blister packs or pill boxes) to help patients arrange their regular intake of medication (Conn et al., 2015).
- Mango Health mobile application. Mango Health is a mobile application that offers users the information on their medication schedules and regimens and provides reminders (Kutty, 2020; Singh et al., 2016). Users of the app receive different types of rewards for taking their pills regularly (Haase, Farris, & Dorsch, 2017).
- Medication adherence. Adherence to the medication is an extent to which patients take pills correctly, regularly, or according to a prescribed regimen with a focus on following directions strictly and taking pills on time (Badawy et al., 2017).
Assumptions, Limitations, Delimitations
The project has several limitations, most of which are linked directly to the methodology to be employed. The first limitation is associated with examining the results related to participants only in Charlotte, North Carolina. The second limitation is associated with the quantitative methodology and a descriptive design as incomplete records and questionnaire answers can affect the quality of statistical analysis, and incomplete data should be excluded.
Furthermore, due to the focus on obtaining complete and valid quantitative results, an important piece of information might be lacking. The limitations of the quantitative methodology do not allow for exploring qualitative changes in patients’ adherence to medication. The specified issues may be reviewed in a follow-up project addressing qualitative aspects of using a combination of HU and a pill packaging system, as well as using a mobile application. The timeframe in one month can also influence the results of the project, and further studies can be longer to receive more detailed information.
The key assumption that can be made at this point is that the adoption of the proposed intervention can have a positive outcome on medication adherence, consequently improving the quality of patients’ lives. Due to the changes in patients’ perception of taking pill regularly, individuals can have the likelihood of significantly changing their adherence to the medication. The integration of the specified pill packaging systems and a mobile application can facilitate reducing the levels of discomfort that SCD patients experience on a daily basis. As delimitations, the strategies for making the samples as diverse as possible and introducing methods for generalizing the end results should be used. It is believed that the selected approach leads to creating a comprehensive intervention for improving medication adherence in SCD patients.
Summary and Organization of the Remainder of the Project
The problem of SCD remains an unceasing threat to the well-being of people all over the world, including the population in the United States. The specific problem identified for this project is that it is not known whether a combination of HU therapy with a pill packaging system and a mobile application can have a positive impact on the adherence to hydroxyurea in patients with SCD. The reason is that the scope of SCD is large in the United States as this condition is diagnosed in 1 from every 365 African-American births (Badawy et al., 2017).
The purpose of this quantitative descriptive project is to determine to what degree HU therapy combined with pill packaging and a mobile application can affect changes in the medication adherence of SCD patients, where the use of a pill packaging system and a mobile application is an independent variable, and medication adherence is a dependent variable. The clinical question formulated for this project is following: in patients with SCD, how does the use of HU therapy combined with utilizing a pill packaging system and a mobile application allow for increased medication adherence?
The project has theoretical and practical significance for improving medication adherence in patients with SCD because of addressing the gaps in research and imporving clinical practice (Kutlar et al., 2019). A quantitative methodology and a descriptive design were chosen for the project to address the clinical question and the purpose and to determine the effects of applying the intervention on medication adherence in SCD patients. The enhancement of the intervention will enable the ability of patients to control their regular taking of hydroxyurea to improve their state and achieve positive results in addressing pain (Zhang et al., 2016).
This project is organized in a way to facilitate investigating the problem in depth by progressing from an overview of the issue with an analysis of the latest studies on the topic to a detailed consideration of the project methodology. Chapter Two will provide an overview of the current literature on the use of HU when in SCD patient treatment. Chapter Three will present the methodology that will be employed to address the set clinical question.
Chapter Four will include the graphic and written presentation of the results of this project. Chapter Five outlines the assessment of the findings along with discussion. Finally, the evaluation of the project results, recommendations for the implementation of SCD management practice, and considerations for further projects will be added. The layout of the chapters will be provided in the natural progression from the discussion of the problem to the assessment of the suggested solutions to the implications of the project results.
Literature Review
Sickle cell disease (SCD) affects a vast number of people, reducing the quality of their lives and increasing mortality rates drastically (Badawy et al., 2017; Hosseini et al., 2016). The problem of managing the disorder is fraught with numerous challenges that range from the necessity to address severe pain experienced by patients to the need of managing possible complications (Hosseini et al., 2016). Among the methods of managing the problem of SCD, taking hydroxyurea (HU) should be mentioned as a method of improving patients’ life quality by introducing a more elaborate pain management approach. Implementing an HU-based approach toward the management of SCD requires focusing on several aspects of the disease management simultaneously (McGann et al., 2016).
One of these aspects is adherence to the medication in SCD patients that can depend on a variety of factors, including the type of pill packaging systems used. The purpose of this quantitative descriptive project was to determine to what degree HU therapy combined with using a pill packaging system and a mobile application could affect possible changes in the adherence of SCD patients to their medication. This chapter presents a review of the literature to determine the role of pill packaging and mobile applications in treating SCD with the help of HU to improve medication adherence.
Recent studies on the topic have been searched in such databases as PubMed, Cochrane, Google Scholar, and ProQuest with the help of the following keywords: “sickle cell disease,” “hydroxyurea,” “pill packaging,” “Mango Health” “medication adherence.” Consequently, 218 articles were retrieved, and 37 articles were selected for further review.
The need for conducting this project is supported by the review of articles that indicate the absence of studies on the relationship between the use of pill packaging in SCD patients and their adherence to hydroxyurea. Past and current studies represent only the findings on the application of HU in SCD patients (Hosseini et al., 2016; McGann et al., 2016; Telen, 2016), or only the results of research on the relationship between pill-taking systems and medication adherence (Haywood et al., 2014; Huang, 2000; Smaldone et al., 2016).
It is necessary to identify further gaps in researching the role of using pill packaging in treating SCD patients taking HU. This chapter provides a review of the literature organized according to two large themes, such as hydroxyurea for treating SCD and pill packaging systems for medication adherence and related subtopics. These subtopics include hydroxyurea among other SCD therapies, pain management, complications and comorbid issues, pill packaging systems, patient education on taking medications, and medication adherence.
Theoretical Foundations
The theoretical model that can support the current DPI project oriented toward identifying how the usage of pill packaging systems can be associated with changes in medication adherence is the theory of planned behavior. This theoretical framework was proposed and developed by Icek Ajzen, who concentrated on specific factors and conditions that can influence changes in people’s behaviors. According to Ajzen’s (1985) seminal work, people’s attitudes, behavioral control, and subjective norms are the key predictors of an individual’s decision to demonstrate or not a certain behavior. After evaluating the behavior from the personal perspective (attitude), from other people’s positions (norms), and from the analysis of resources to be able to perform in a certain way (control), individuals make decisions regarding this or that behavior.
This theory can be applied to this project directly in order to provide the background for understanding how patients’ medication adherence is formed with reference to the above-mentioned assumptions. Thus, patients make decisions on taking pills regularly when assess their attitude to this practice and available pill packaging systems, refer to prescribed regimens as norms, and try to adhere to medication in terms of their control over their behavior.
Patients choose to use medications according to a certain schedule or a prescribed regimen when they assess the outcomes of their behavior from several perspectives. Some people have positive attitudes toward the practice of taking drugs regularly, but other people can perceive this practice as ineffective to help them cope with their health condition (Kopelowicz et al., 2015; Lin, Updegraff, & Pakpour, 2016).
Research on patients’ adherence to medications by Kopelowicz et al. (2015), who applied the theory of planned behavior to improve medication adherence in patients with schizophrenia, and Lin et al. (2016), who studied the theory of planned behavior in relation to adherence in patients with epilepsy, among other studies, is based on Ajzen’s theory. This aspect supports the idea regarding the appropriateness of this model for being used in the current project.
The decision regarding the application of the theory of planned behavior to this project is based on the analysis of previous studies on the topic. Researchers referred to this model in order to explain why some patients chose to take medications regularly, and other groups of patients ignored their regimens (Lin et al., 2016; Rich, Brandes, Mullan, & Hagger, 2015). In this context, the focus is on analyzing the motivation and intentions of patients that are influenced by their attitudes, subjective norms, and behavioral control that can be effective or ineffective in this case. Therefore, this theory provides a framework for addressing the clinical question on the outcomes of applying the intervention for medication adherence in patients with SCD.
Review of the Literature
In this section, two wide topic areas related to this project, such as the use of hydroxyurea for treating SCD and the use of pill packaging systems to affect medication adherence, are discussed in detail. These themes have been identified after reviewing the relevant literature on the problem. In this section, a review of recent studies on the topics is provided along with the analysis of gaps in the current research on the problem.
Hydroxyurea in treating SCD
In SCD patients, HU is actively applied among other therapies to treat the condition because it can contribute to improving patient outcomes though minimizing the possibility of pain episodes. Specifics of using this medication in SCD patients have been studied by researchers, and they are actively analyzed in the reviewed articles (Savage et al., 2015; Zhang et al., 2016). The following subtopics are identified in this context: the use of HU among other SCD therapies, HU in pain management, and SCD complications.
Hydroxyurea among other SCD therapies
It is critical to provide SCD patients with an opportunity for pain alleviation since red blood cells in these patients have a specific shape that interrupts a blood flow in vessels causing pain episodes. The comparison between the available approaches toward the management of pain and the reduction of unpleasant experiences with a focus on HU has to be incorporated into the analysis (Sins, Mager, Davis, & Biemond, 2017).
The results of the assessment have to be integrated into the creation of a patient-specific treatment approach to improve the overall quality of their lives and build a more comfortable environment for them (Benenson & Porter, 2018). An HU-based strategy will help to avoid painful experiences due to its effects on the hemoglobin levels in the target population through making red blood cells round and flexible to avoid blockages in vessels.
In their quantitative study, Stettler et al. (2015) presented an analysis of effects that hydroxyurea can have on SCD patients. The clinical question was to find the effects of HU on the treatment of SCD in adult patients because of extremely painful experiences. The hypothesis stated that HU allows for reducing pain in SCD patients. The authors used the term “pain crisis” and provided a very brief overview of the literature.
The sample included 2086 adult SCD patients, and the database search was used to retrieve the data with no supplementary procedures included. The researchers found that HU can improve patient outcomes significantly (18.2% (95% CI, 15.0%-21.8%)), leading to overcoming pain crises. The research supported the idea that HU is required for pain alleviation and improvement of outcomes in SCD patients. Future research may be needed to address the problems of the HU application.
Keikhaei et al. (2016) conducted a cohort study aimed at exploring different aspects of the HU therapy’s impact on SCD patients. The researchers focused on evaluating both clinical, such as pain alleviation, and hematological, such as HbF levels change, alterations in patients with SCD. The sample of the research included 48 adult patients with SCD. The drastic effect of poor pain management in the target population was the key rationale for the research to be undertaken. The hypothesis stated that HU has a positive effect on clinical and hematological changes in patients. The key concepts of the study include HbF levels, MCV, MCH. Forty-eight participants were enrolled in the research.
The cohort study involved obtaining data with the help of questionnaires. In addition, basic demographic data such as patients’ sex, age, and the duration of their SCD were collected. The outcomes of the research indicate that there is a direct connection between the application of HU treatment and the extent of pain alleviation in SCD patients. Specifically, the article supports the hypothesis that 10 mg/kg/day can help patients to reduce painful experiences due to a rise in hemoglobin levels (Keikhaei et al., 2016). The article results indicate that the application of the HU-based therapy allows for reducing pain in patients with SCD. The integration of HU-based treatment strategies into the management of SCD patients’ needs should be seen as necessary.
Nevitt et al. (2017) studied the contrast between the application of HU and a placebo to manage pain in SCD patients. The authors intended to compare the application of the HU-based therapy for managing pain to the use of a placebo. The reason for the review study was the concern regarding the low quality of SCD patients’ lives due to poor management of their condition. The notion of HU is rendered in the course of the analysis. The authors offered a profound review of the literature, and 74 samples were selected for the analysis. The study represented a large review of the literature concerning the management of SCD-related pain with HU and with the help of a placebo.
The outcomes of the study supported the idea that the adoption of HU is beneficial to the needs of patients compared to a placebo. The data were collected via the database search and organized in multiple tables. The analysis results stated that HU provides more opportunities for pain management than a placebo (Nevitt et al., 2017). The study shows that the use of HU helps to reduce pain and improve the physical and psychological state in SCD patients. The outcomes of the study point to the further research question, which may include the methods of administering HU to patients.
In their quantitative research, Hosseini et al. (2016) also formulated the clinical question to examine the mechanisms of HU effects on patients with SCD. The hypothesis of the research was that there are specific cellular biophysical properties that can be determined at the normoxia level. The authors did not specify the sample, yet mentioned that the required information was gathered with the help of the Excess Human Material Protocol.
The study findings showed that the biophysical properties of SCD patients can be identified can be determined at the normoxia level. The analysis of the data supported the initially stated hypothesis. The study aimed at determining common patterns in SCD patients to enhance the efficacy of HU, and the results of the research supported the view that these characteristics are visible at the normoxia level. This study also demonstrates the specifics of using HU in patients with SCD in order to improve the quality of their life.
The adoption of an HU-based intervention as the method for reducing pain is critical for patients that suffer from SCD. The integration of the proposed tool leads to a successful prevention of numerous infections and, thus, helps patients to avoid multiple threats to which they become vulnerable after the development of SCD (Keikhaei et al., 2016; Smith et al., 2015). Indeed, since the use of the tool in question leads to the reduction of inflammations and a drop in the negative effects thereof on a patient, the threat of acquiring an infection is reduced (Zempsky et al., 2017).
The possibility of a hospital-acquired infection (HAI) can, in turn, be lowered with the adoption of a strategy aimed at improving nurses’ schedule and removing the threat of a workplace burnout that can cause a medical error and a subsequent HAI in SCD patients (Nevitt et al., 2017). A strategy that involves several approaches is required in the case under analysis.
Pain management
The problem of pain management in patients suffering from SCD remains a concern for most medical workers and nurses. Due to the drop in hemoglobin levels and the consequent changes in a patient’s tissue, blood clots and ruptures become very common, thus, causing intense pain and reducing the quality of life extensively (Stettler et al., 2015). Strategies for managing pain in SCD patients are a critical step toward handling the problem of SCD on an epidemiological level (Savage et al., 2015). When considering the opportunities for pain management in patients with SCD, one should mention that the application of HU does not allow for alleviating it completely. The analysis of recent articles on the topic is required to examine this area in detail and identify possible gaps.
In their case study, Brandow, Zappia, and Stucky (2017) examined the effects of a natural pain management model applied for children with SCD. Although the article was aimed at studying the underlying mechanisms of pain development in teenage patients based on a case study of a 19-year-old patient, its findings are important to contribute to the analysis. The research was restricted to a single case, with the hypothesis concerning the cause of pain and the intensity thereof.
The researchers viewed the target patient as the study population, the sample being one. The analysis of the patient’s records was the key data collection tool. Other procedures included a general analysis of recent SCD cases. The results of the analysis supported the assumption that the intensity and extent of pain could rise with a patient’s age, the progression of the SCD, and the increase in the opioid dosage (40% of children experience chronic pain, and 35% report everyday pain). The study indicates that pain increases as SCD progresses, with opioids enhancing negative experiences of SCD patients. What tools can be used for pain alleviation is the question for future research.
Savage et al. (2015) discussed the current lack of information for building a comprehensive SCD management strategy in the study, with a summary of essential findings and a commentary on them with reference to 22 trials. From this point, the study focused on addressing the existing knowledge gaps, so that a more elaborate approach toward addressing SCD issues could be designed, and improved strategies could be introduced. The authors hypothesized that health maintenance currently remains a grey area, mentioning the terms such as “alloimmunization” (Savage et al., 2015). Since the data collection tool used in the study was a qualitative review, no participants were included in the study.
The authors concluded that the existing guidelines for SCD management are often based on rather scarce data; therefore, the creation of coordinated databases was suggested. The study supported the view that there are significant gaps in the research of SCD management. As a result, a thorough analysis of the existing databases is required. What trends these databases will show is the key question for future research, although this topic was actively discussed in other articles.
Karafin et al. (2018) conducted a cross-sectional cohort study on the effects of opioids on pain management in patients with sickle cell disease. The purpose of the research was to analyze the effects that opioids produce on SCD patients’ health-related quality of life (HRQOL). The scope of the study was restricted to the analysis of the effects that opioids as the means of pain management could produce on people with SCD. The rationale for the study included the need to alleviate pain experienced by SCD patients and the assessment of opioids as a pain management medication. The authors asserted that the increase in the opioid dose leads to the aggravation of patients’ condition.
The authors selected the population including 99 adults with SCD and a median age of 30. HRQOL questionnaires were incorporated for effective data collection. Additional procedures included counting the amount of morphine administered to patients daily. The results of the analysis indicated that the use of opioids affects patients’ perception of pain in the long term by intensifying it. From this perspective, the analysis of data supported the view that there was a correlation between pain perception and the opioid dose in SCD patients (Karafin et al. 2018). The study can be summarized as a research that identified the link between the intensity of pain and the opioid dose administered to SCD patients. The main question for future research is what options for pain alleviation except opioids can be used for SCD.
Not all authors primarily referred to HU-related therapies as the major approach to overcoming pain in SCD patients. Sins et al. (2017) explored pain management techniques outside the use of the HU therapy. The authors of the research sought to understand how pain can be alleviated in patients suffering from SCD aside from using the HU technique. Having conducted the literature review of 63 sources, they found that other strategies that may include changes in dietary supplements and the introduction of the gardos channel blocker senicapoc may reduce the threat of painful experiences in the target demographic. Zempsky et al. (2017) explored the influence of phenotype as a factor defining SCD patients’ propensity toward experiencing severe pain.
The goal of the research was to define whether the experience of pain associated with SCD was linked to a specific phenotype in SCD patients. The scope of the paper was limited to the study of child patients. It was found that the extent of pain experienced by a SCD patient is not linked directly to their WSP phenotype. The research supported the idea that the WSP phenotype of patients with SCD did not define the extent of pain that they suffer.
In addition, Benenson and Porter (2018) provided an overview of the types of pain experienced by SCD patients. The goal of their research was to represent the nature and causes of pain that SCD patients could feel. The scope of the study allowed the authors to embrace the notion of SCD in general. The paper represented a review of literature focused on the concepts of HU and pain management. Since the research implied a literature review, no samples were included.
The data collection was based on the analysis of the recent studies and cases of SCD pain management. The findings show that the nature of pain experienced by SCD patients stems from bone demineralization. The analysis of the data supported the idea that positive changes can be introduced into SCD management. The study also indicates that pain is an inevitable aspect of SCD due to bone demineralization.
HU used to manage pain in SCD patients is viewed by researchers as an effective tool. The propensity among SCD patients to experience severe pain is in inverse proportion toward their hemoglobin levels (Savage et al., 2015). Strategies for increasing the levels of hemoglobin in patients should be regarded as a valid approach toward managing pain intensity and levels in SCD patients (Telen, 2016). On the other hand, the incorporation of other treatment options, including opioid medications, is often suggested (Brandow et al., 2017). The studies show that HU is not the only solution to the problem of pain management in SCD patients; thus, this aspect needs to be examined in detail.
Due to the detrimental side effects that opioids have on patients suffering from pain, one may need to reconsider the application of opioids and, instead, view a combination of HU and medicinal marijuana as a possible method of handling the concern (Karafin et al., 2018). The integration of the specified strategy will increase the chances for bettering the lives of patients, at the same time maintaining their response to pain alleviation strategies and preventing the situations that will require a consistent increase in the dose of the medication.
Complications and comorbid issues
In order to understand the significance of using an HU-based therapy when meeting the needs of SCD patients as opposed to deploying traditional approaches, one will need to consider the phenomenon of a painful crisis in SCD patients. The specified notion, which is also known as the vaso-occlusive crisis, implies highly unpleasant experiences caused by sickle-shaped red blood cells in patients’ bloodstream (Hernigou et al., 2018). The specified process requires the introduction of the approach that will help to reduce the inflammation caused by sickle-shaped cells and increase the amount and effects of positive acute-phase proteins in patients (McGann et al., 2016). A thorough analysis of the available evidence is critical.
McGann et al. (2016) conducted a clinical trial to point at the lack of awareness about CD in certain areas, which could lead to numerous complications, including infections, thus, reducing patients’ chances for survival. The researchers focused on the sample from sub-Saharan Africa, formulating the hypothesis that HU can lead to significant improvements as long as gaps in knowledge are remedied. The concepts such as hematological toxicities and other infection-associated terms were studied in detail. Six hundred children were enrolled in the clinical trial, with a sample amounting to 120 people.
The data were gathered by inspecting the records of clinical events, and other procedures included interviews with patients. The outcomes of the analysis were in the fact that the use of an HU-based treatment could reduce the probability of an infection-related complication in patients. Patient education is strongly encouraged to reduce the threat even more. Preventing infections in SCD patients becomes possible with a combination of HU and patient education. The researchers concluded that patient education and staff training coupled with HU produces impressive results.
Hankins et al. (2016) in their quantitative study analyzed the propensity among SCD children toward the Parvovirus B19 infection, as well as provided the description of strategies for its prevention. The purpose of the study was to evaluate the possibility of children with SCD having a natural parvovirus B19 infection during the HU therapy. The researchers assumed that there was a link between B19 and HU, introducing the notion of a myelosupressive agent. Accordingly, 120 patients were sampled for a clinical trial. The analysis of medical records was used as the key data collection tool, with no other methods mentioned.
The research outcomes indicated that SCD patients have higher risks of acquiring the parvovirus B19 based on the outcomes of the record analysis used as a data collection tool. The authors noted that the application of HU could reduce the threat of B19, which affected SCD patients’ lives significantly. The use of the HU-based therapy helps to avoid the contraction of B19. For that reason, HU should be incorporated into the treatment framework.
The purpose of the research performed by Hernigou et al. (2018) was to determine the probability of different health complications associated with osteoporosis occurring in SCD patients with specific levels of Tetrahydroaminoacridine (THA) in the target population. The quantitative study was limited to the analysis of 312 arthroplastiesm, and the authors sought to answer the question of whether the levels of THA in patients could define their propensity toward osteoporosis and, therefore, increased levels of pain. The sample was represented by 244 patients, and THA is the key term used in the study.
The information for the study was collected by analyzing the medical records of the patients involved in the case. Personal interviews were also utilized as the methods for retrieving critical data. Medical complications were observed after 27% of operations. The research results proved that there was a direct link between the levels of THA and the levels of pain experienced by SCD patients. Controlling TRA can be seen as an important step in addressing SCD patients’ needs. A connection between THA rates and the propensity toward pain in SCD patients has been identified, which means that the specified complication has to be addressed.
It is also important to focus on alternative views presented in the literature regarding the topic. Guery et al. (2018) conducted a chart review and set expectations for the analysis of the threats that Non-typhoidal salmonellosis (NTS) contains for SCD patients and focused on covering the challenges associated with diagnosing the disease in SCD patients. The authors limited the scope of the study to the assessment of NTS in adult patients. The research hypothesized that the clinical presentation of NTS is unnoticeable in adult SCD patients. The data collection primarily involved a chart review, with the historical data from 2006 to 2016 having been gathered (3500 individuals).
The researchers determined significant challenges associated with the diagnosis of NTS in adult SCD patients. The study outcomes suggested that the current approach toward managing the NTS issue should be improved. The analysis of the information implies the need to incorporate tools for preventing and addressing NTS in SCD patients. Patients with SCD are exposed to the threat of an NTS due to the drop in the levels of the immune system. As a result, the study indicates that nurses should be particularly aware of the comorbidities associated with NTS.
Lee et al. (2018) went further and explained the effects that the development of asthma had on patients with SCD, as well as the methods for avoiding and managing the specified comorbidity. They defined the impact that the use of HU has on SCD child patients with respiratory infections such as asthma being their comorbid disease with reference to the results related to 200 patients aged 2-20 years old.
To gather the required information, the researchers used patients’ records that were taken during the clinical trial and referred to a questionnaire. According to the findings of the research analysis, young patients with SCD were particularly exposed to the threat of a respiratory infection in case of vitamin D deficiency. These results indicate that respiratory infections remain a threat to SCD patients aged 2-20 years old. Ogu and Billett (2018) provided a general overview of the key comorbidities that may occur in SCD patients. The weakness of the study is its broad scope with a focus on the research question being geared toward the study of SCD comorbidities, in general. Providing a general review of the existing literature, the study did not include any samples.
According to the key findings, several comorbidities are associated with SCD. These include musculoskeletal deformation, vaso-occlusive episodes, hyperuricaemia, and other health issues that require a combined therapy. The researchers stated that, in order to address SCD patients’ needs, one has to combine several strategies to manage comorbid issues along with basic SCD-related concerns (Lee et al., 2018).
In their turn, Adesina et al. (2017), in their quantitative study, determined the degree of risk that SCD patients could face regarding the development of osteonecrosis. The scope of the research was limited to the assessment of patients with SCD and the ONFH diagnosis, who have recently undergone a hip replacement surgery. The sample included 1356 participants, and patient records were scrutinized closely. The results of the study indicated that ONFH affects patients with SCD significantly, with the surgery changing the quality of their lives drastically.
DeBaun and Kirkham (2016) also hypothesized that HU could improve the treatment of SCD-related central nervous system complications. The authors offered a general review of the recent studies as the only data collection tool, and the results of the analysis supported the idea that the use of HU reduces the propensity among patients to develop CNS-related issues. The possibility of CNS-related problems in SCD patients was observed, and the application of HU as a prevention tool was recommended.
Given the nature of the HU-based treatment, the researchers considered utilizing it as the method of managing inflammation and the related concerns in SCD patients. Since the use of HU leads to a reduction in the number of white blood cells and the rise in the levels of mean hemoglobin in SCD patients, the specified approach has to be tested as a plausible solution to the pain crisis and the increase in the levels of comfort among SCD patients (Hankins et al., 2016; DeBaun & Kirkham, 2016).
Managing the needs of SCD patients implies building a pain management strategy based on a detailed analysis of the nature of painful crises and their development. Because of the increase in white cell count and the drop in hemoglobin levels, a pain crisis during a SCD requires the application of an HU-based intervention that leads to an increase in the number of red blood cells and, thus alleviates the pain caused by vessel and tissue rupture in SCD patients (Minniti & Kato, 2016). The adoption of an HU-based approach is highly recommended as the solution to the pain crisis in HU patients and associated complications.
The problem of SCD and its comorbidities needs to be studied in depth in terms of the outcomes that the latter has on patients’ well-being and the increase in the quality of their lives. In most SCD patients, comorbid health issues are inevitable due to the nature of the disorder (Guery et al., 2018). With the application of specific management techniques, the negative impact of comorbidities o patients with SCD can be minimized.
It is crucial to inspect different ways in which SCD affects functions of a patient’s organism. While the impact that SCD has on the propensity toward acquiring infections and the associated comorbidities is necessary to study, other systems apart from immune and nervous ones require an analysis (Lee et al., 2016).
For instance, the effects that SCD produces on patients’ musculoskeletal system also needs a profound analysis with the assessment of HU as a possible treatment method. It is worth noting that the negative impact of SCD on the musculoskeletal system also contributes to an increased level of discomfort and pain experienced by SCD patients, which means that appropriate tools for minimizing the painful experiences have to be incorporated into the treatment process (Ogu & Billett, 2018). Patients will have their quality of life improved systematically with the help of regular HU therapy sessions.
Other impacts also need to be explored to sustain the efficacy of an HU-based therapy and integrate new components into it. Opportunities for a comprehensive model to be designed will appear. For instance, it is important to know that certain comorbidities add to the risk of developing a stroke in adult SCD patients (Adesina et al., 2017). Creating an environment in which patients are shielded from as many negative factors as possible should be the goal of a health management strategy.
The introduction of an HU-based therapy is expected to reduce the specified risks, including the risk of a stroke, yet, in many cases, additional resources such as the provision of vitamin D are required (Adams-Graves & Bronte-Jordan, 2016). It is imperative for a nurse to compose a comprehensive treatment plan based on a combination of HU and other treatment methods.
Pill packaging systems and medication adherence
In addition to reviewing the literature on the use of HU is SCD patients, it is also important to examine the information presented in studies regarding the application of pill packaging systems and the connection of this approach to medication adherence in patients. The reason is that, if medication adherence is inadequate, it is more problematic to cope with complications of SCD (Conn et al., 2015; Hughes, Cadogan, Patton, & Ryan, 2016). On the one hand, the use of pill packing systems and special boxes is highly recommended by healthcare professionals. On the other hand, there is limited research on the topic (Lorenzini & Hellström, 2017). Subtopics that have been identified after reviewing the literature on the problem are pill packaging systems, education of patients, and medication adherence.
Pill packaging systems
In healthcare organizations, nurses often propose SCD patients to use special pill boxes in order to organize their taking of medications. Researchers focused on different types of packaging interventions in their studies while examining the correlation of using these systems and expected patient outcomes (Boeni, Spinatsch, Suter, Hersberger, & Arnet, 2014; Lorenzini & Hellström, 2017). In spite of the fact the examined studies do not present the information on packaging systems to be used in SCD patients in relation to the HU therapy, the reviewed sources are still important to be analyzed to identify potential gaps in research.
Telen (2016) concentrated on schedules and systems in using pills when comparing HU to traditional and innovative methods of SCD treatment. The main aim of the article was to compare the efficacy of different methods of SCD treatment, including the HU approach. The researcher assumed that HU and new drugs could improve the well-being of patients compared to traditional medications.
The qualitative research allowed for examining effects of different treatment methods in SCD patients with reference to the results of eight studies. The research results indicated that the adoption of HU and innovative treatment strategies helped to reduce the number of negative experiences in patients and raise the quality of their lives significantly, and the use of a certain system in taking pills contributed to that. The current management of SCD patients’ needs is quite poor in regard to the alleviation of pain when drugs are used inappropriately.
Conn et al. (2015) studied the specifics of applying pill packaging interventions in order to increase medication adherence in patients. The researchers used a systematic review and meta-analysis for testing their assumptions (52 reports). The overall mean in effect size was 0.593, which is related to the mean of 71% adherence for treatment subjects in contrast to 63% in control subjects. The findings demonstrated that different packaging interventions can effectively increase the adherence of adult patients to drugs, especially if pill boxes and simple blister packs are applied. This study supports the view that, utilizing certain packing systems, it is possible to improve patient outcomes associated with the well-organized medication therapy.
In their systematic review, Lorenzini and Hellström (2017) examined how older patients can appropriately use pill packaging. The study was focused on finding a relationship between the application of senior‐friendly medication packaging and positive outcomes for older people. The search of sources for analysis was conducted in such databases as Scopus, Medline, Web of Science, and Engineering Village. The authors selected 34 articles, and their review indicated that the application of specific pill packing devices and systems is beneficial for patients, especially for older ones, because they can easily use these devices and follow a schedule of taking their drugs.
The review of the articles on the topic of using pill packing in patients indicates that there are no studies to examine the experience of SCD patients, and this gap needs to be addressed with the help of the current project. The researchers of reviewed articles are concentrated on finding the relationship between using different packing systems and changes in patients’ medication adherence (Lorenzini & Hellström, 2017; Telen, 2016). Additional research is required in the field in order to study the relationship with a focus on SCD patients taking HU and using pill packaging systems in order to improve their drug adherence.
Patient education on taking medications
When it comes to addressing the needs of patients with SCD and the related comorbidities with the help of the HU therapy, one must keep in mind that the specified process implies the direct and consistent communication between a patient and a nurse, as well as other healthcare staff members, regarding their medication therapy (Brennan-Cook, Bonnabeau, Aponte, Augustin, & Tanabe, 2018). In addition, the integration of strategies that allow for improving communication between a patient and a nurse suggests a significant rise in the quality of patient education.
Although the specified issue is often taken for granted during the provision of HU treatment for SCD patients, it is critical to ensure that the target demographic is aware of the means of maintaining positive health levels with the help of adhering to taking drugs (HU) (Sinha, Bakshi, Ross, & Krishnamurti, 2018). Patient education and the promotion of patient agency and independence are critical components of the HU therapy and the process of patient care (Badawy et al., 2016). With the help of a consistent process of patient education, SCD patients will learn how to take HU appropriately.
Brennan-Cook et al. (2018) conducted a descriptive study and tested certain patient education techniques to provide SCD patients with opportunities to overcome negative outcomes of their condition. The goal of the research was to study the available SCD patient education tools with a focus on the scope embracing 200 SCD patients. The research hypothesis concerned the integration of nurse-patient communication to improve their approach to applying the medication therapy.
The authors found out that communication is critical for SCD patients’ education, and patient education is critical in SCD cases, with further studies for education techniques being required. Smaldone et al. (2016) received similar results when they aimed at showing that the incorporation of patient education approaches that involve transformative nursing leadership could contribute to faster patient education. Transformative leadership was recommended to improve patient education.
Sinha et al. (2018) studied the use of HU in adult SCD patients and found out that the promotion of patient education through nurse-patient communication is essential for successful pain management. The researchers supported the idea regarding the importance of patient-nurse communication during SCD management with reference to the sample of 95 patients. Earlier, Hsu et al. (2016) defined the opportunities for SCD patients’ education regarding the use of different interventions, including pill packing. The study showed that patients’ lack of awareness about SCD may lead to lethal outcomes, which necessitates the introduction of a program for patient awareness.
Record analysis was used to collect the data, and it was concluded that creating an awareness program is the key toward improving SCD patients’ education. There is a significant lack of awareness among SCD patients, which needs to be managed with the help of an improved communication strategy to inform about the rules of the medication therapy.
Nagalla and Ballas (2016) represented the methods of reducing painful experiences in SCD patients with reference to using different interventions, including medication therapies. A sample of three studies out of 51 selected ones was included in the analysis. The results of the research demonstrated that the current strategies for changing red cell parameters lack consistency. Despite improved approaches toward managing the needs of SCD, the nature of change in red cells count is still vague, which does not allow modifying the pain management framework successfully.
Little attention can be paid to educating patients regarding the specifics of their condition to improve their living. In their turn, Minniti and Kato (2016) discussed patient education and medication therapies when focusing on strategies for managing and preventing the cases of leg ulcers in SCD patients. The scope of the research allowed for embracing the needs of the global community since the analysis of separate cases is provided.
The hypothesis of the research was that a combination of HU and supportive care, as well as patient education, could reduce the probability of leg ulcers or the aggravation of an already existing issue. The authors introduced the terms such as “chronic transfusions” and provided a short literature review in the introduction section. The authors reduced the sample to five clinical cases. It is possible to state that the study provided an analysis of several clinical cases as the main data collection tool. According to the findings of the analysis, the adoption of HU helps to reduce the threat of leg ulcers development, as well as manage the ones that already exist.
In this case, much attention is also paid to patients’ adherence to medication and regimens (Minniti & Kato, 2016). Leg ulcers are a common complication observed in SCD patients due to disruptions in the functioning of blood vessels. As a part of a larger therapy, HU should be seen as a method of managing leg ulcers and preventing them from occurring at earlier stages of SCD.
The reviewed articles demonstrate that the lack of a patient-nurse dialogue in regard to the management of SCD and medication therapies is especially common in the setting that involves either severe overstaffing or patients living in remote areas that cannot be accessed by healthcare providers (Hsu et al., 2016). A strategy for encouraging a patient-nurse dialogue in unfavorable conditions is required. The specified issue can be addressed by utilizing digital tools for maintaining the dialogue consistent to ensure effective patient education. In addition, monitoring tools that allow nurses to concentrate on the needs of outpatients, as well as address the concerns of SCD inpatients in an understaffed environment, are needed.
There are also several gaps in the contemporary literature that addresses the effects of HU on SCD patients in alleviating their pain with reference to taking such pills as HU. Specifically, the opportunities for combining the HU approach with a framework that encourages communication between a patient and a healthcare expert or a nurse are examined in studies. The specified issue is particularly important for SCD patients, who require the assistance and support of nurses and healthcare experts throughout their life (Smaldone et al., 2016).
The lack of insight into communication and patient education that can be used to create the platform for successful pain management is a reason for concern (Nagalla & Ballas, 2016). With the insight gained from the studies mentioned above, one can construct the patient education strategy and the communication framework for nurses to utilize when administering HU therapy to SCD patients. As a result, a drop in the instances of medical errors and a rise in the efficacy of pain management are expected.
Medication adherence
There are indications that the application of HU and pill packaging systems can assist in managing most of the instances of pain crisis in SCD patients by addressing some of the changes within their bloodstream and the opportunities for managing the issues associated with the patients’ musculoskeletal system (Checchi, Huybrechts, Avorn, & Kesselheim, 2014). The existing studies support the view that the integration of the proposed approaches will introduce opportunities for alleviating pain based on a process of healing in a patient’s tissue, and medication adherence will increase (Adams-Graves & Bronte-Jordan, 2016; Smith et al., 2015).
New mechanisms in managing painful sensations in SCD patients can be introduced successfully (Zempsky et al., 2017). Currently, the use of opioids is being regarded as important, yet the increase in dosage and the propensity toward developing dependency in SCD patients are rather troubling signs signaling that there is a necessity to change the treatment approach and use appropriate regimens (Boeni et al., 2014; Hosseini et al., 2016; Zhang et al., 2016). The researchers pay much attention to studying the relationship between regimens, medication therapy, and medication adherence leading to positive patient outcomes.
Smith et al. (2015) conducted a quantitative study and assessed the effects that HU has on the alleviation of pain in SCD patients in general and with the focus on the aspect of medication adherence. The goals of the article were to determine the connection between the use of an HU approach and the extent of pain experienced by people with SCD depending on their adherence to the regimen. The rationale for the research was to reduce painful experiences in SCD patients, the key concepts being analgesics and HU.
A sample of 134 patients was used in the research, and it was found that the use of HU has an analgesic effect on the pain experienced by SCD patients when applied appropriately. The study set in a clinical environment was expected to prove that HU has a positive effect on pain management in patients. The initial hypothesis was supported with future studies having to focus on how patient-nurse communication can be enhanced. This communication is reported to play an important role in influencing medication adherence in patients.
In a cross‐sectional survey, Badawy et al. (2016) studied how the use of technologies can contribute to medication adherence in patients with SCD. They discussed modern devices and technologies along with education techniques in SCD patients. The research involved 107 participants and indicated that patient-nurse communication along with the application of certain apps should be supported with innovative solutions for better training. IT and ICT tools are believed to be essential in enhancing the quality of care for SCD patients when the focus is on patients’ adherence to the regimen of taking drugs, including HU.
It was concluded that innovative communication tools should be integrated into the promotion of patient education. Hoppe et al. (2017) analyzed the effects of Simvastatin on VOC in SCD patients experiencing vasoocclusive pain. The rationale behind the study was that the assessment of the drug in question would allow for alleviating pain more actively and effectively. The researchers found out the management of pain in SCD patients should be improved by introducing Simvastatin as the primary medication and incorporating it into the pain management strategy, but the focus is also on controlling how patients adhere to using their drugs.
In their review research, Adams-Graves and Bronte-Jordan (2016) discussed the issues associated with access to care for SCD patients. The goal of the study was to inspect the factors that impede patients with SCD from accessing healthcare services. The rationale for the study was to provide people with SCD with access to care and improve the quality thereof. The research question was how to improve the existing strategies with the help of an HU-based framework. In addition to that, the researchers also discussed the role of medication adherence in influencing the quality of treatment for SCD patients.
The Registry and Surveillance System for Hemoglobinopathies (RuSH) program was used to collect data, and the results of the research proved that there are significant impediments in access to care for SCD patients. Due to the lack of access to healthcare, patients with SCD and comorbidities suffer extensively because of the impossibility to get prescriptions and take pills appropriately. There are many factors that can prevent SCD patients from taking their drugs regularly in order to improve their physical state.
Zhang et al. (2016) reviewed cellular and molecular factors that define the success of a pain management intervention. The purpose of the research was to review the factors that could lead to vaso-occlusive crises (VOC) and define the approaches that may help in improving patients’ well-being and quality of life. In this context, much attention should be paid to following regimens. The scope of the study was rather broad, with the rationale being the need to address diverse cases of SCD and pain management.
The key concepts reviewed were VOC, pain management in SCD patients, and medication adherence. Since the entire study was an overview of the existing factors, it can be regarded as a comprehensive literature review. The findings indicate that the factors that contribute to a rise in pain levels in SCD patients include nemolysis that causes inflammation and the following rise in pain intensity. Patients need to adhere to their medications in order to overcome VOC successfully. In other cases, it is possible to experience significant pain and negative effects on the everyday life.
The review of the literature indicates that there are a limited number of studies that cover the problem of the medication adherence with reference to the sample of SCD patients taking HU. The studies discussed in this section seem to only indirectly address the question of adherence to drugs, such as HU, in order to overcome SCD symptoms and associated pain (Badawy et al., 2016). As a method of inhibiting pain and restoring some of the functions of a SCD patient’s body, the HU therapy should be regarded as one of the most promising frameworks for improving the quality of SCD patients’ lives (Nagalla & Ballas, 2016).
Combined with an elaborate somatosensory system for identifying the causes of pain and reducing the impact thereof, HU will serve as an innovative approach toward addressing the needs of people with SCD (Boeni et al., 2014; Haywood et al., 2014). From this perspective, more research is required in order to determine how certain strategies in taking pills (the use of pill packaging systems, for example) can contribute to increasing the adherence to medications in SCD patients.
Summary
The purpose of this project was to determine whether applying specific pill packaging systems in patients with SCD can lead to increasing their adherence to medications in comparison to patients who do not use such systems. In this chapter, available literature on this topic has been discussed, and two major themes and six related subtopics have been identified: hydroxyurea among other SCD therapies, pain management, complications and comorbid issues, pill packaging systems, patient education on taking medications, and medication adherence..
It has been found that researchers are inclined to actively discuss the effectiveness of using HU in patients with SCD, but the limited research is available on using packaging systems in patients with SCD or patients taking HU. Many studies describe the results of testing the relationship between taking pills and using different regimens and adherence to medications to influence patients’ outcomes.
There is a gap in the literature on the topic concerning possible relations between the application of pill packaging systems for patients taking HU and their medication adherence. The review of the literature indicates the necessity of conducting the current project in order to provide evidence regarding the possible relationship between applying packaging pills and changes in medication adherence in a specific group of SCD patients taking HU.
In addition to synthesizing and analyzing the articles on the problem of using HU in patients with SCD with the focus on their adherence to medications, the chapter also includes the information on the theoretical model to be applied in this project. The suitable theoretical model to use is Ajzen’s theory of planned behavior that can explain what factors influence patients’ adherence to medications. The analysis of retrieved articles indicates that the focus on in-depth reviews of records provided by hospitals and other healthcare organizations regarding SCD patients’ regimens and adherence to medications is appropriate for this current project.
As a result, after performing this DPI project, it is possible to expect that effective evidence of using pill packing for increasing adherence to medications will appear to be used by healthcare providers in their practice. In this case, the focus is on improving experiences of patients with SCD taking HU and using certain pill packaging systems. In Chapter Three, the methodology applied to this project will be described in order to explain what procedures will be followed to determine how the use of pill packaging systems and a mobile application can affect changes in the adherence to medications in patients with SCD who take HU.
Methodology
The purpose of this project was to examine medication adherence related to hydroxyurea-based (HU) therapy in patients with sickle cell disease (SCD). The focus of this project is on determining the outcomes of using pill compliance packaging and a mobile application on HU therapy for SCD patients in the context when non-compliance packaging approaches proved to be ineffective. As a result, it is important to examine how the application of pill packaging systems along with mobile apps can contribute to improving medication adherence.
The methodology described in this chapter is proposed to address the question of how HU therapy combined with applying pill packaging systems and a mobile app can affect medication adherence in patients with SCD. In this chapter, the problem, clinical question, appropriate methodology and design, as well as the population and sample, are described in detail. The chapter presents the applied instruments with a focus on their validity and reliability and the description of data collection and analysis procedures, ethical considerations, and limitations.
Statement of the Problem
It is not known whether a combination of HU facilitated by the use of a pill packaging system as an approach to organizing patients’ medications and the use of a mobile application can have a positive impact on the adherence to hydroxyurea for patients with SCD. According to researchers, the application of HU and pill packaging systems, as well as appropriate mobile applications, can potentially prevent the development of complications associated with SCD, but the research on the role of this therapy in increasing medication adherence is still limited (Badawy et al., 2017; Wang, 2016). Taking hydroxyurea is discussed as one of the most effective therapies in patients with SCD, but there is still a high occurrence of non-adherence to this medication and the lack of research on the problem.
The specific problem investigated in this project is that, although HU is actively used to treat SCD, healthcare providers had a difficult time finding alternatives to increase medication adherence in patients. The use of pill packaging systems in SCD patients requires more detailed investigation because only limited aspects of pill intake management were researched previously (Telen, 2016). A lack of data on applying pill packaging systems and mobile apps in combination with HU therapy illustrates the necessity of more research in the field to examine all potential outcomes of using HU and pill packaging systems for SCD patients in terms of their medication adherence.
Clinical Question
The clinical question appropriate for this project is formulated to address the problem and purpose that were determined for this project. In this chapter, the described methodology will work to provide answers to the following question: In patients with SCD, how does the use of HU therapy combined with utilizing a pill packaging system and a mobile application allow for increased medication adherence?
In this question, the independent variable is HU therapy based on using pill packaging systems and a mobile application that was measured with reference to the presence or absence of the intervention. The dependent variable includes changes in medication adherence in patients with SCD, the data on which were collected with the help of a survey and measured referring to the provided figures. The focus on the relationship between these variables accentuates the necessity of selecting the quantitative methodology for this project.
Project Methodology
A quantitative methodology is viewed as the most appropriate option for conducting this project in comparison to a qualitative methodology and mixed methods. The reason is that a quantitative methodology applies surveys and statistical tests for finding the relationships between variables with reference to collecting numerical data, and these tests include chi-square tests, t-tests, Pearson correlation coefficient and regression tests among others (Bell et al., 2018; Trochim et al., 2015).
A qualitative methodology helps a clinician understand specific details regarding the phenomenon, concentrate on subjects’ visions, and formulate the theory referring to collected data (Trochim et al., 2015). This approach cannot lead to addressing the set clinical question in this project. On the contrary, a quantitative method can be viewed as appropriate to apply the selected theory to explain the studied relationship and test hypotheses.
For the purpose of this project, a quantitative methodology covers the questions asked, and the application of mixed methods can seem unrequired. Applying a survey (questionnaire) proposed in the context of quantitative methods, it was possible to collect data regarding the use of compliance pill packaging and a mobile app in patients with SCD in the numerical form and analyze them to further conclude about the effectiveness of the combined intervention for individuals with SCD (Bell et al., 2018). Referring to the existing literature on the problem where a quantitative method was applied, it is possible to predict positive outcomes of using the intervention in persons with SCD (Badawy et al., 2017; Lê et al., 2015). From this perspective, a quantitative methodology is selected as appropriate to examine the efficacy of pill packaging systems and a mobile application for the improvement of medication adherence in patients with SCD.
Project Design
The project design applied in this project was descriptive in order to answer the clinical question on how the use of HU therapy combined with utilizing a pill packaging system and a mobile application could lead to increased medication adherence in patients with SCD. The reason for selecting a descriptive approach was the necessity of applying the intervention (HU therapy combined with a pill packaging system and a mobile app) and then describe how the intervention could be related to possible changes in patients’ medication adherence (Trochim et al., 2015).
A descriptive approach is viewed in the academic literature as effective to answer specific “what-questions.” This design is appropriate to assist in determining the outcomes of the intervention based on HU therapy and using pill packaging and a mobile app for medication adherence (Bell et al., 2018; Trochim et al., 2015). In comparison to correlational, case study, phenomenological or experimental designs, this approach requires the minimal involvement of an investigator. It is also more time-efficient, and it can be regarded as the best choice to address the problem of using effective HU-based interventions for increasing medication adherence and addressing the pain crises (Bell et al., 2018; Cokley & Awad, 2013).
A descriptive design effectively supports the offered intervention based on using pill packaging systems and a mobile app as a solution to the practice problem of low medication adherence in SCD patients. The sample for this project included 75 patients with SCD who were asked to take hydroxyurea with the help of pill packaging systems and utilize the Mango Health mobile application. Thus, the independent variable was the use of pill packaging systems with a mobile app in the context of HU therapy, and the dependent variable was medication adherence. The data on the sample were collected with the help of a questionnaire that was developed by Huang (2000) in order to determine possible changes in patients’ medication adherence as a result of applying the intervention.
Population and Sample Selection
For the purpose of this project, the setting is extended to include a medical center and a pharmacy located in Charlotte, North Carolina. The authorities of these settings have agreed to provide the information on patients with SCD who received HU therapy supported by using pill packaging systems and without these systems. The following inclusion criteria were formulated for participants: living in Charlotte, NC, being diagnosed with SCD, taking HU, and having a smartphone to use applications. Exclusion criteria included taking other medications in addition to hydroxyurea and using other therapies. The population was attained referring to Premier Pharmacy and Wellness Center data bases: potential participants were selected depending on being prescribed to receive hydroxyurea.
The total population for this project covers all individuals with SCD treated by HU in Charlotte (1,018 individuals), and the project population covers those patients having SCD who received medications in Premier Pharmacy and Wellness Center (512 individuals). Thus, the total population size is 1,018 individuals, among which 512 individuals represent the project population, and they were contacted in the context of the purposive sampling procedure with the help of managers of Premier Pharmacy and Wellness Center to be invited to participate in the project.
The project sample size (out of more than 1,000 people with SCD in Charlotte, NC, reported for the period of 10 years) is 75 male and female participants who are aged 18-30 years old. This project sample size is determined after completing the power analysis with the help of G*Power software where the power value was set as 0.8 and the type I error rate was set as 5%.
To receive access to records on patients with SCD and medications they take, the authorities of the selected pharmacies were contacted, and their approval and supervision were required to gather all required data for analysis in this project. The clinician did not participate in selecting medical records for analysis as the Premier Pharmacy and Wellness Center managers selected and provided the information about patients who agreed to participate in the project; therefore, this approach allows for the randomization of data.
At the stage of recruiting, the participants addressing inclusion criteria were provided with the details regarding the project and an informed consent form, in which it was stated that their confidentiality would be guaranteed. Those participants who agreed to participate in the project provided their signed informed consent forms before starting the data collection procedures.
Instrumentation or Sources of Data
The main source of data for this project is the questionnaire completed as the participants’ reaction to the following intervention: the application of HU therapy combined with using pill packaging systems and a mobile application (Mango Health).
Pill packaging systems
Some patients using the services of Premier Pharmacy and Wellness Center use bottles for keeping their medication, and others use pill packaging systems, such as labelled blisters, unit-dose and multi-dose organizers and pill boxes with dates. According to Huang (2000) and Boeni et al. (2014), the type of containers for organizing pills can influence medication adherence.
Those participants who agreed to join the project were asked whether they used a pill packaging system (a free option) referring to the information from the records on SCD patients’ prescription fill history and pill pack counts from Premier Pharmacy in Charlotte, North Carolina, as well as medical records from Wellness Center. Similar records were also used by Wickson-Griffiths, Kaasalainen, Ploeg, and McAiney (2014) and Van Melle et al. (2018) in their studies.
The Mango Health mobile application
The participants were asked to use Mango Health, a specific application for supporting the management of taken medications (Kutty, 2020). This app provides patients with regular reminders regarding the number of pills to take, as well as with refill alerts and information on drug side effects (Haase et al., 2017). This application contributes to increasing adherence to medications in patients with chronic illnesses who need to take pills regularly (Kutty, 2020; Singh et al., 2016). The application is free, and it can be downloaded to be used with Android and iOS. The participants were asked to use this application when receiving their HU therapy regardless of the type of pill organizers they utilize.
Medication adherence questionnaire
The freely available medication adherence questionnaire developed for patients using pill packaging systems was adapted for this project (Appendix A). The questionnaire was designed for the study by Huang (2000) with reference to the data self-reported by participants. The questionnaire includes eight main items on patients’ adherence to pill taking, as well as additional questions to collect demographic data on patients. Huang (2000) reported that this tool was effective to determine patterns of pill taking in patients to further conclude regarding possible differences in their medication adherence.
Validity
Validity of data collected after applying pill packaging systems and a mobile application, as well as using a survey, is measured with reference to the validity coefficient using the SPSS software. According to Huang (2000), the desired degree of validity for the instrument measuring medication adherence is.30 -.40, this value is regarded as high. In this case, the application of the interventions and the further survey allows for assessing accurately the concept of medication adherence specified for the project (Conn et al., 2015; Jácome & Ferreira, 2018).
Reliability
The reliability of the data collected is measured with reference to Cohen’s kappa applied for determining interrater reliability and Cronbach’s alpha used for identifying the degree of internal consistency. For the interventions used in this project and the applied questionnaire developed by Huang (2000), validity statistics are presented by Cohen’s kappa that is 0.7 (95% CI 0.5–0.9, p <0.001) and Cronbach’s alpha that is 0.79-0.89.
These statistics allow for concluding about the high reliability of the selected data source to determine how the use of special pill packaging systems and a mobile app can be related to medication adherence in patients with SCD (Conn et al., 2015; Singh et al., 2016).
Data Collection Procedures
During the first stage, the authorities of Premier Pharmacy and Wellness Center were contacted to receive access to their databases including information on patients with SCD receiving HU-based treatment and pill packaging. After obtaining the approval of authorities (Appendix B), the issue of receiving the consent from patients was addressed (Appendix C) (Trochim et al., 2015).
At the second stage, after accessing medical records and protocols, 512 records including all the data on patients’ SCD, their prescription fill history, and adherence to the medication were selected, and patients were contacted to participate in the project. Those SCD patients of Wellness Center who were not prescribed any type of HU were regarded as not meeting inclusion criteria for this project, and the related data were not collected. Seventy-five patients with SCD agreed to join the project and provided their consent.
The use of a pill packaging system and the Mango Health mobile application for assisting patients in taking their HU pills regularly was the main intervention developed for this project. All the patients were provided with the information regarding the Mango Health application and pill packaging systems. In a month after the intervention, the participants were given a questionnaire to complete in order to retrieve information on the participants’ use of pill packaging systems and regularity of taking medicines. Demographics data related to patients were also collected, and they include individuals’ age, gender, race, and employment. All the data gathered for this project are stored using the web cloud application and protected by passwords. It is important to note that the retrieved files will be destroyed after completing this quantitative project.
Data Analysis Procedures
The clinical question that guided the data analysis procedures was how the use of HU therapy combined with utilizing a pill packaging system and a mobile application can allow for increased medication adherence in patients with SCD. For the independent variable of using a pill packaging system and a mobile application, the categorical data were collected after conducting the intervention with reference to the participants’ medical records and their answers to the questionnaire items. For collecting data on the dependent variable of medication adherence, the same questionnaire was used.
The collected categorical data (raw data) were converted into figures for inferential analysis with the help of a chi-square test. Thus, a chi-square test was utilized to accentuate the changes in medication adherence (a dependent variable) depending on the presence of HU therapy with or without pill packaging systems supported by the use of a mobile application (an independent variable).
The focus was on finding a statistically significant difference in the level of medication adherence reported depending on the application of HU using or no specific pill organizers and a mobile application (p < 0.05). A chi-square test was selected for this project as a tool applied typically in a quantitative methodology (Trochim et al., 2015). The rationale for selecting a chi-square test is that the results of this test allow for concluding about a potential relationship between the application of HU using pill packaging and the regularity of taking pills in patients with SCD.
SPSS (Statistical Package for Social Sciences) software was used for conducting a chi-square test to evaluate the assumptions formulated for this project. The participants’ answers (Yes/No) were converted into figures (1/0) organized in tables to be used in SPSS for a chi-square test.
Descriptive analysis was applied to demographic data and descriptive data that were also collected with the help of the questionnaire. The following data were collected and measured with reference to the percentage: the regularity of taking HU, the use of Mango Health, problems with remembering taking HU, and the interest in pill packaging systems. Percentages can be viewed as the most recognized variant of descriptive statistics for quantitative projects with reference to analyzing collected data. Percentages for the collected data were calculated by dividing the frequency in categories by the total number of participants. Then, the results were multiplied by 100%.
Ethical Considerations
The ethical issue related to the project is associated with retrieving medical records on patients with SCD from Premier Pharmacy and Wellness Center. The reason is that they include protected health information according to the Health Insurance Portability and Accountability Act (HIPAA) and the protection of received data. To guarantee that all the ethical issues are addressed, it is necessary to ask for and receive the permission of the authorities regarding access to clinical data for the purpose of this project (Trochim et al., 2015).
The ethical issues related to the population and sample are the confidentiality and anonymity of the participants. It was obligatory to receive the consent from patients of the selected settings as potential participants in this project to fill in the questionnaire with reference to the provided informed consent forms. Any personal data presented in project records and filled-in questionnaires were labeled with ID for each participant to guarantee the protection of patients’ confidentiality.
According to the Belmont Report, beneficence, respect, and justice were guaranteed through protecting patients’ confidentiality when disclosing project results. Beneficence was guaranteed at the stages of data collection and analysis when risks of disclosing personal information were minimized for the participants. Respect was guaranteed at the stages of recruiting participants and collecting data as they were able to withdraw from the project at any stage. Justice was ensured through the ethical process of selecting participants according to inclusion criteria without biasing potential respondents. The approval for conducting such type of project should be received from the Institutional Review Board (Appendix D).
Limitations
One of the major limitations is the necessity to limit the project scope to the settings located in Charlotte, North Carolina, that makes the project more specific. The other key limitations in this project are associated with the use of the quantitative methodology, and a descriptive design. Depending on the specifics of available medical records and answers to questionnaires, one of the limitations is the lack of access to accurate records presenting all the required information.
It is important to note that, if the documentation and participants’ answers to questionnaires are incomplete, it is almost impossible to receive statistically significant results when conducting certain analyses to test hypotheses and assumptions. In the project, this limitation was addressed while selecting only those patients, whose medical records included all the required data, and questionnaires were checked for providing the answers to all questions.
One more limitation was associated with the application of a quantitative method. It was almost impossible to examine the trends in the sphere of treating patients with SCD with reference to the figures that were gathered for this quantitative project because of its descriptive nature (Trochim et al., 2015). Further research on the topic is recommended to be based on a qualitative methodology to examine patient outcomes after receiving HU therapy in detail to support the findings of this project. The reason is that the quantitative methodology does not allow for exploring qualitative changes in patients’ adherence to medication. The timeframe in one month could also influence the results of the project. This limitation was addressed during the analysis of the results to avoid potentially inaccurate generalizations and interpretations.
Summary
This chapter has presented detailed and comprehensive information on the methodology that was selected for examining how the application of HU therapy combined with pill packaging and a mobile app in individuals with SCD can predict changes in medication adherence. For this project, a quantitative method has been selected as more suitable to address the purpose of the project than a qualitative method or mixed methods.
A descriptive design was proposed as a specific research design that allows for conducting analysis with reference to the description of data on a certain condition using chi-square tests among other statistical tests to examine medication adherence in patients. The project sample included 75 patients with SCD receiving services in Premier Pharmacy and Wellness Center in Charlotte, North Carolina.
Data collection and analysis procedures typical for a descriptive project were described in this chapter with much detail to present the steps to be made by the author to realize the purpose of this project. A questionnaire was used to collect data on the application of the intervention based on HU therapy and using pill packaging and a mobile app. A chi-square statistical test was chosen to examine the differences in medication adherence of patients after the application of the intervention.
In addition, the chapter also includes the information on the validity and reliability of using instruments, and it was stated the proposed instruments were reliable and valid. Finally, the ethical issues and limitations associated with this project were also described in this chapter to inform the reader about all the details related to conducting this quantitative project. The results associated with applying a review and a questionnaire to address the clinical question set for this project will be presented in Chapter 4.
Data Analysis and Results
The problem to be addressed in this project is that it is not known whether a combination of hydroxyurea (HU), a pill packaging system (boxes, blisters, unit-dose and multi-dose systems), and a mobile application can have a positive impact on the adherence to medications for patients with sickle cell disease (SCD). Therefore, the purpose of this project was to examine the specifics of medication adherence to hydroxyurea-based therapy in patients with SCD depending on the use of a pill package and a mobile application. The clinical question that came from this problem and purpose statements was formulated in the following way: In patients with SCD, how does the use of HU therapy combined with utilizing a pill packaging system and a mobile application allow for increased medication adherence?
The methodology selected for this project to address the clinical question is quantitative, with a focus on applying a descriptive research design and data analysis based on a chi-square test. The purpose of this chapter is to summarize the information collected during the project, describe the data analysis procedure, and present actual results. Therefore, in this chapter, descriptive data related to the project results, data analysis procedures, findings, and the summary will be provided in detail.
Descriptive Data
For the purpose of this project, the records and answers to the questionnaire of 75 male and female individuals with SCD receiving HU-based therapy and visiting Premier Pharmacy and Wellness Center in Charlotte, North Carolina, were reviewed and analyzed. Table 1 presents descriptive demographic data related to the selected sample of the participants in this project. The focus was on determining the participants’ age, gender, race, and employment. Percentages were calculated for each category.
Table 1. Descriptive Demographic Data.
All the participants addressed the following inclusion criteria: living in Charlotte, NC, being diagnosed with SCD, taking HU, and having a smartphone to use applications. The demographic data indicate that 64% of the participants with SCD and taking HU, who are aged 18-30 years, are men. All the participants involved in the project are African Americans. Furthermore, 77% of the participants are employed. These percentages were calculated dividing the frequency in age, gender, race, and employment categories by the total number of participants; the results were multiplied by 100%.
Data Analysis Procedures
The following data were collected with the help of a questionnaire to be used in a chi-square test: adherence to taking pills by patients in comparison to a prescribed number of pills per day and problems in taking pills regularly in addition to using a mobile application. A chi-square independence test was conducted with the help of the SPSS software to determine possible statistically significant differences for the variables in both determined groups (those using pill packaging and those not using pill packaging). Thus, a chi-square independence test was conducted for groups to determine the presence of any statistically significant difference in the level of medication adherence self-reported by participants depending on the application of HU with or without using pill packaging systems and a mobile application, where p < 0.05.
The conducted chi-square independence test helped to provide the data significant for answering the set clinical question on finding a possible difference between the application of HU supported by pill packaging systems and a mobile app and medication adherence in patients with SCD. Thus, the selected data analysis is aligned with the set clinical question, and it is appropriate to be used in a quantitative descriptive project. The sources of error in this case were associated with the self-reported level of medication adherence. To ensure the levels of medication adherence were reported by patients rather accurately, these data were compared with the number of pills taken by patients per day in comparison to a prescribed number according to medical records.
Referring to reliability and validity issues, the collected data were checked several times to minimize errors; Cohen’s kappa is 0.7, and Cronbach’s alpha equals 0.79-0.89 (Conn et al., 2015; Singh et al., 2016). The reliability and validity of data related to a chi-square test were checked with the help of SPSS, and they were also determined to be high. Descriptive data were analyzed with the help of calculating the percentages for the collected data by dividing the frequency in categories by the total number of participants and multiplying the results by 100%.
Results
This section presents the findings of the project with a focus on descriptive statistics and inferential statistics related to a chi-square test. Descriptive statistical data are important to describe the variables in quantitative terms with a focus on the measures of central tendency as well as the measures of variability (Trochim et al., 2015). In this project, inferential statistics results indicated the presence of any differences between the examined samples of data. The presented data will be used and analyzed in the next chapter to answer the following clinical question:
- Q1: In patients with SCD, how does the use of HU therapy combined with utilizing a pill packaging system and a mobile application allow for increased medication adherence?
Descriptive statistical data related to the percentages associated with the variables in this project were summarized in Table 2.
Table 2. Descriptive Statistics.
According to Table 2, all the participants used the Mango Health application in order to take pills regularly. Among the participants using a pill packaging system, 94% were adherent to their medication in contrast to 36% in the group of patients not using a pill packaging system. In addition, all the patients also reported having problems and difficulties with remembering when to take a pill.
The results of a chi-square test to determine the presence of differences between outcomes for intervention and control groups were summarized in Table 3 and Table 4. Table 3 presents the information regarding the cross-tabulation for groups and categories for 75 participants.
Table 3. Chi-Square Cross-tabulation for Groups and Categories.
According to Table 3, 16 participants from the intervention group reported to be adherent to their medication, when one participant reported taking HU irregularly. In the group of patients who did not use a pill packaging system, 37 participants stated that they did not take HU regularly. The total number of the cases of adherence to medication was 37 for two groups, and the total number of non-adherence in the sample was 38. Table 4 represents the chi-square statistic at p < 0.05.
Table 4. Chi-Square Test Results.
The purpose of a chi-square test was to determine whether there is a statistically significant difference in medication adherence between those patients who used a pill packaging system and those who did not use such a system. According to the test results, X2 (1, N = 75) = 17.6389, p =.000027. The test result is significant at p <.05; thus, it is possible to state that there is a statistically significant difference in adherence to HU between the two groups of participants.
Summary
In this chapter, the results of examining the relationship between the variables to address the clinical question were provided. The purpose of analyzing data from a questionnaire and a chi-square test was to determine how the use of HU-based therapy supported by a pill packaging system and a mobile application could influence outcomes for patients with SCD while referring to the data collected after one month of applying the intervention.
The chi-square test results (X2 (1, N = 75) = 17.6389, p =.000027, at p <.05) indicated there was a statistically significant difference in medication adherence between those patients who used a pill packaging system and those who did not use it. In Chapter 5, the interpretation and analysis of the received findings will be presented with reference to stating how the obtained results are effective to address the set clinical question and how these findings are correlated with the previous findings on the problem and topic.
Summary, Conclusions, and Recommendations
Chapter 5 provides the summary of the project with a focus on the interpretation of the received findings, conclusions and implications for theory and practice, as well as recommendations. The completion of the project to examine how the use of pill packaging systems along with HU-based therapy and a mobile application in individuals with SCD can affect their medication adherence has important implications for both theorists and practitioners. The reason is that the results of the project helped to determine what interventions can be regarded as beneficial for patients with SCD.
It was found out that there was a statistically significant difference (p <.05) in medication adherence between the participants who used a pill packaging system in combination with a mobile application and those who did not use a pill packaging system. Thus, the detailed interpretation of the results presented in this chapter and supported by the discussion of implications and recommendations will inform health care providers and theorists regarding the effectiveness of applying pill packaging systems for patients with SCD who use HU-based therapy in order to improve their adherence to medications.
Summary of the Project
The purpose of this project was to examine the potential effects of hydroxyurea-based therapy combined with the use of a pill packaging system and the use of a mobile application on medication adherence in patients with SCD. This purpose was determined as a result of identifying the following problem area in research and practice regarding the medication adherence of patients with SCD. Thus, it was identified that there was a lack of knowledge on how the use of different types of pill packaging systems can influence the effectiveness of treatment of sickle cell disease in patients with reference to their adherence to the prescribed medication (Badawy et al., 2017).
In order to achieve the set purpose of this project and find more evidence in relation to the discussed problem, a specific clinical question was formulated. It was important to formulate a clinical question and find out how the application of HU therapy along with a pill packaging system and the use of a mobile application in individuals with SCD could lead to increased medication adherence in comparison to the absence of such an intervention.
To find the answers to the formulated clinical question, it was necessary to refer to the theoretical framework based on the discussion of Icek Ajzen’s theory of planned behavior. According to the theory assumptions, people’s specific attitudes, their ability for behavioral control, and their knowledge of subjective norms can predict their decision to demonstrate or not certain behaviors in different situations (Rich et al., 2015). This theory can explain why patients with SCD can choose to adhere or not to their medication regimens. The theory can also explain how the use of additional tools like pill packaging systems and a mobile application can affect or not patients’ decisions regarding the regular consumption of hydroxyurea, whether they can change their attitude to taking pills and view this behavior as a routine.
To achieve the project goals, it was necessary to select a quantitative methodology based on the application of a questionnaire as a specific approach in order to collect various clinical data on a large sample of respondents using pill packaging systems and a mobile application. Thus, 75 patients of Premier Pharmacy and Wellness Center in Charlotte, North Carolina, were selected for this project depending on their medical records out of more than 1,000 records of patients with SCD in North Carolina. The focus was only on the adult population (18-30-year-old females and males) who took hydroxyurea to cope with their SCD.
The information on participants’ use of pill packaging systems and medication adherence levels were retrieved to be used in the project data analysis. The analysis of this information was conducted with the help of a chi-square test to determine possible differences in medication adherence of these patients. Following the project results, it was found out that there was a significant difference (X2 (1, N = 75) = 17.6389, p =.000027) in medication adherence between the participants using pill packaging in combination with a mobile application and those participants did not use these tools. The project is of great importance as it helps healthcare providers determine what interventions can lead to positive changes in medication adherence in patients with SCD.
Summary of Findings and Conclusion
In patients with SCD, how does the use of HU therapy combined with utilizing a pill packaging system and a mobile application allow for increased medication adherence?
In this section, the findings of the project are summarized and interpreted to address the clinical question and provide a conclusion regarding the achievement of the project purpose. The main theme to discuss in this section in detail is associated with the potential connection between the use of pill packaging systems and a mobile application (Mango Health) in patients with SCD taking HU and changes in their medication adherence after the intervention.
It was found that there was a statistically significant difference (X2 (1, N = 75) = 17.6389, p =.000027) in medication adherence between the patients with SCD who used pill packaging in combination with a mobile application and those patients who did not use pill packaging. These results are supported by the findings of Conn et al. (2015) and Lorenzini and Hellström (2017), who stated that pill packaging systems are helpful to stimulate patients’ medication adherence. These findings were also in line with the results of studies by Boeni et al. (2014), Huang (2000), and Haywood et al. (2014), who found the positive correlation and relationship between using different types of pill packaging systems and similar interventions and medication adherence in patients.
According to descriptive data, all the individuals experienced difficulties with remembering when to take HU, but 94% of those participants who used pill packaging took their medicine regularly and demonstrated adherence to their medication in comparison to only 36% among the participants who did not use pill packaging. The use of the mobile application was not an influential factor in this case as all the participants reported using the application.
Similar results were reported by Boeni et al. (2014), who noted that drug reminder packaging is effective to help patients remember about taking pills, and their adherence to medications increases. These results allow for concluding that the use of pill packaging systems can be somehow related to stimulating medication adherence in patients. However, the results regarding the ineffective use of a mobile application to remind patients to take drugs oppose the findings of Badawy et al. (2016), who accentuated the effectiveness of smartphone apps for stimulating medication adherence.
Implications
It is important to discuss the contribution of the results of this project to theoretical discussion of medication adherence in the context of applying hydroxyurea in patients with SCD and to clinical practice of treating individuals with this disease. Therefore, this section presents the theoretical implications of conducting this project and important practical implications to understand how the findings can change the process of treating patients with SCD with the help of HU-based therapy. In addition, future implications are also described in this section to demonstrate how this project can contribute to the development of further projects on the problem.
Theoretical implications
Implications of this project for theory and research are numerous because studies and other clinical projects on the connection between the application of pill packaging systems and mobile apps in patients with SCD and their medication adherence are almost absent or rare. Thus, there is a gap in theory and research associated with the lack of knowledge of how pill packaging systems and mobile applications can relate to medication adherence that was addressed with the help of the findings in this project. The strength of this project is that it provided the answer to the question of whether the application of pill packaging systems in patients with SCD who take HU could lead to increased medication adherence.
The previous research on related topics and problems did not provide the answers to these questions (Conn et al., 2015; Rich et al., 2015). However, there are also weaknesses of this project that are associated with the limitations of discussing these results in the context of theory and research because of the application of a questionnaire and a descriptive approach as a methodological design. Thus, there are possibilities that the findings of the project could be different depending on the application of other research designs or the experimental methodology.
The results can be effectively discussed in the context of Ajzen’s (1985) theory of planned behavior chosen as a basis for a theoretical framework in this project. Thus, individual beliefs of patients with SCD regarding the usefulness of pill packaging and their assessment of their personal ability to follow a medication regimen could influence and explain their results in this project, as well as certain social pressure they felt or not after receiving patient education on this aspect.
Furthermore, patients’ perceptions of their ability to control their behavior and adhere to the regimen could also explain their further results after using pill packaging. From this perspective, participants’ changes in medication adherence could significantly depend on their attitude to using pill packaging systems and a mobile application explained with reference to the theory of planned behavior. However, the limitations of this project do not allow for analyzing this aspect in detail, and qualitative projects can be required. Still, the conclusions are credible depending on the appropriate application of the quantitative descriptive methodology based on using a chi-square test for measuring categorical data.
Practical implications
The completed project has many implications for clinicians and practitioners in the sphere of health care. Thus, it is possible to note that the results of this project can be easily applied by professionals who work with patients with SCD if these patients take hydroxyurea in the context of their basic therapy. There were no similar projects or studies reported in the existing literature on the topic, that is why, the results of this project are important in terms of their implications for practice to be actively used by practitioners (Lin et al., 2016). Healthcare professionals can promote the use of pill packaging systems and mobile applications in order to improve patients’ adherence to medications depending on the results of this project.
Future implications
There are also implications for further development of projects on the topic of a relationship between using pill packaging systems, specific mobile applications, and changes in adherence to the medication typical of patients with SCD. The findings of the project indicated that there is a statistically significant difference in medication adherence between the participants using pill packaging and the participants who do not use this method. Thus, further examination is necessary in order to understand how the type of SCD and the type of pill packaging systems could influence the results in order to determine whether the current findings can be easily applied to a wider range of situations associated with HU-based therapy.
Another type of future implications is associated with the results that were not achieved or identified with the help of the project. In the context of future projects, it is possible to refer to the examination of patients with SCD who take medications other than hydroxyurea in order to understand whether the use of pill packaging and medication adherence can depend on the type of drugs to take. Moreover, it is also possible to apply other methodologies, with a focus on detailed qualitative projects to determine patients’ views on the problem and select other settings.
Recommendations
This section presents the summary of the recommendations that should be viewed as resulting from the completed project and discussed implications for theory and practice, as well as future implications. Therefore, in this section, recommendations for future projects on a similar topic and problem are presented in detail. Additionally, the chapter ends with the provision of critical implications for practice to implement the change in a facility where practitioners work with patients having SCD and taking hydroxyurea.
Recommendations for future projects
When referring to the results of the project and discussed implications, it is possible to formulate four recommendations for future projects. Firstly, it is necessary to examine how the use of a mobile application (for example, Mango Health) can stimulate or not medication adherence because the results of this project were not illustrative for this aspect. Secondly, it is important to test how the use of pill packaging systems can be related to medication adherence with the help of correlation and regression tests as this project results indicated only the significant difference in findings. Thirdly, it is necessary to investigate patients’ feedback regarding the use of pill packaging systems and outcomes.
Finally, it is important to examine the relationship between the use of pill packaging and medication adherence in comparison to other systems, such as calendar-based organizers for pills. The proposed recommendations contribute to making the next steps in the clinical research and practice on medication adherence to address the needs of patients with SCD in terms of preventing their pain episodes.
Recommendations for practice
It is also important to identify three recommendations for future practice in the field of treating patients with SCD in order to influence their adherence to such medication as hydroxyurea and health outcomes. Firstly, it is critical for practitioners to integrate the use of pill packaging systems supported by the use of mobile applications in their daily practice. Healthcare providers and nurses will be able to educate patients with SCD on how to adhere to their regimen easily. Secondly, it is necessary to promote the use of different pill organizers for patients to analyze their effectiveness depending on patients’ feedback (Smaldone et al., 2016).
Healthcare providers will be able to choose pill packaging systems depending on their patients’ needs. Thirdly, it is essential to promote the use of pill packaging and other systems if they are free and safe for patients to improve medication adherence and make the process of taking HU easier and regular for patients. If healthcare providers encourage the use of convenient pill packaging among patients, it is possible to increase their medication adherence, referring to the project results.
The benefits associated with implementing the results of this project in practice will be received by both health care practitioners and patients with SCD. The reason is that health care providers can decide on whether to educate patients with SCD taking HU on using pill packaging systems in order to improve their medication adherence if some problems with following a regimen are observed. Patients taking hydroxyurea also receive an opportunity to change their health outcomes when deciding on whether or not to use blisters of pills or other packaging systems for organizing their prescribed hydroxyurea pills.
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Appendix A
Questionnaire
Please circle correct answer or give short answers where applies.
- Age: 18-30 years old/Other (Specify).
- Gender: Male/Female.
- Race: White/Non-White.
- Employment: YES/NO.
- Do you take your HU everyday as prescribed? YES/NO.
- Do you have difficulty remembering to take your HU? YES/NO.
- Do you skip pills? YES/NO.
- Do you take more pills than assigned? YES/NO.
- Do you mistake pills due to carelessness? YES/NO.
- Is your HU filled in pill bottles? YES/NO. Is your HU filled in a pill packaging system? YES/NO.
- Are you interested in using pill packaging systems?
- Do you use a mobile application for reminders (Mango Health)?