In this paper, the description of a randomized controlled trial will be given to clarify if it is possible to reduce the incidence of hospital-acquired pressure ulcers on day 3 of hospitalization if patients with a high risk of developing a pressure ulcer are provided with a treatment plan that is based on a pressure ulcer protocol initiated in the emergency department. In addition, this study compares the outcomes of two different interventions offered to two groups of patients with similar signs and diseases. A systematic review is used as the method of gathering information about the disease. Evidence-based literature is taken from the Cochrane Database with several original articles properly described and synthesized. It is expected to prove the effectiveness of the protocol-based treatment and use the intervention in local hospitals to help patients and their families prevent the risks of pressure ulcers.
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Many adult patients and the patients with chronic illnesses and injured traumas are at risk of having pressure ulcers. Pressure ulcers (PU), also known as bedsores, are skin injuries that may be caused by pressure and different shearing forces (Ham, Schoonhoven, Schuurmans, Veugelers, & Leenen, 2015). In the United States, this problem affects 1.3-3 million people of different age (Smith et al., 2013). The evidence-based literature shows that pressure ulcers’ risk factors are old age, cognitive/physical impairments, and multiple comorbid conditions that may affect the condition of skin (Chou et al., 2013).
Nurses and doctors take numerous steps to prevent the development of this health condition and develop new interventions that are based on the reduction of its severity. Many attempts to reduce the incidence of pressure ulcers are taken in hospital settings, as well as in emergencies, including HAPU prevention programs (Swafford, Culpepper, & Dunn, 2016), specific dressing (Santamaria et al., 2015), and wearing masks (Schallom et al., 2015). Regarding such variety of options and the inability to predict all outcomes, it is necessary to clarify the effectiveness of each approach or think about the creation of new combined strategies. In this paper, the implementation of a specially developed PU protocol will be evaluated to understand if hospital pressure ulcers can be prevented.
In patients that are identified as high risk for developing a pressure ulcer (P), does the implementation of a pressure ulcer protocol initiated in the emergency department (I) as compared to patients who receive usual care (C), reduce the incidence of hospital-acquired pressure ulcers (O) on day 3 of hospitalization (T)?
Evidence Review and Synthesis
The search process began with the use of the “GoogleScholar” engine. “Pressure ulcer” was the main keyword, and such terms as “treatment”, “patients”, “hospital”, and “prevention” were used randomly. The only requirement of this search strategy was the choice of the time period. Not to gather old material, the sources were sorted by date since 2013. The next step was the choice of a database. The Cochrane Database of Systematic Reviews was used to gather the articles with different levels of evidence, including Level I, Level II, and Level III (see Appendix A). The presence of peer-reviewed articles and evidence-based literature considerably improved the results of this research. All important aspects were identified and used to formulate a clear PICOT question and review the material needed.
Critical Appraisal of the Evidence
The evaluation table (see Appendix A) and evidence synthesis table (see Appendix B) were used to compare the results of the chosen studies and prove their validity and reliability. Each study was a serious contribution to the development of independent research and intervention for pressure ulcer patients. For example, Santamaria et al. (2015) focused on the prevention of sacral and heel pressure ulcers with the help of silicon multi-layered foam dressings and used the Level I type of evidence relying on the results of a randomized controlled trial. In terms of this study, certain benefits of special dressings were identified and could be used in further projects. The project by Bus et al. (2016) focused on the use of footwear interventions for patients who may have pressure ulcers because of diabetes as the main risk factor. Several medical databases, including Cochrane, PubMed, and EMBASE, promoted access to strong original articles where controlled and non-controlled studies were reviewed.
Level I and II evidence improved the current project demonstrating the effectiveness of ulcer treatment with footwear and offloading interventions. The study developed by Schallom et al. (2015) was used as evidence for invasive ventilation masks therapies for patients with pressure ulcers. Mask alternatives introduced an effective approach to the treatment of the chosen disease. The investigations of Chou et al. (2013) and Smith et al. (2013) gave a general picture of the disease, its risk assessment, and prevention. The evaluation of PU treatment strategies using Medline, Cochrane, and Embase databases can be used as a solid background of this research to identify what aspects of PU treatment have already been discovered, and what new methods can be offered to present doctors, nurses, and patients.
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The choice of the above-mentioned sources can be explained through several reasons. First, all authors used similar methods of data gathering and analysis to investigate different aspects of the same health problem. Second, a variety of interventions is introduced to prove that pressure ulcer is a treatable and preventive disease in case certain steps and strategies are taken in time (Sullivan & Schoelles, 2013). Finally, the chosen sources help to understand that PU treatment is a complex process that includes different people. The results of PU treatment depend on how well patients, nurses, and doctors comprehend their roles and possible contribution. Though people believe that pressure ulcers may create certain threats to adult patients only, the evidence-based literature tells that all patients who suffer from chronic diseases or cannot frequently move because of injuries and traumas are exposed to having this health problem. Therefore, the recognition of pressure ulcers at the early stage and the development of numerous preventive steps cannot be ignored in the intentions to save human lives and improve the quality of life.
Purpose of the Project
As an APRN, I am going to develop this project with the purpose to compare the effectiveness of the use of a pressure ulcer protocol in the emergency department and the choice of usual care in hospitals to reduce the cases of pressure ulcers on the third day of hospitalization. The desired outcome is to come to one conclusion and identify what preventive steps can be helpful to patients with different stages of pressure ulcers.
The plan for this research will be based on the evidence-based literature found in the Cochrane Database. It is necessary to integrate evidence with clinical expertise and patient preferences to inform about final decision and implemented change. The implementation process should begin with the identification of a sample group. 40 patients of different age and both genders with a high risk of developing a pressure ulcer will be invited. The main inclusion criteria will be a PU diagnosis or PU risks, hospitalization, and the ability to stay in a hospital for the next 3-5 days.
The study design will be a randomized controlled trial where the participants should be divided into two groups (a controlled group includes 20 patients who should be treated in regards to a pressure ulcer protocol initiated in the emergency department, and another group of 20 patients should receive usual care). Two nurses have to be chosen and asked to communicate with patients and their families, check on the patients’ conditions, and report on any change that occurs during the next three days after hospitalization. The cooperation of nurses, patients, and researchers can be used to create an effective treatment plan for patients with pressure ulcers. Pre- and post-intervention conditions of patients need to be evaluated and noted to make sure that all participants chose this study voluntary after being informed about all possible outcomes. A written agreement protocol should be offered to all participants of the study.
First, statistical analysis can be used to compare the already identified results and outcomes of the chosen treatment plan. Subgroup analysis with the identification of p-value is an integral step at this stage. It is important to identify if treatment was effective, if there are the differences between old and young patients, and if the stages of pressure ulcers are critical. The main changes in patients’ conditions regarding the chosen treatment plan have to be described and properly explained. The opinions of the patients and nurses have to be added to the analysis.
All 40 participants need to pass a 3-day examination after the chosen protocol or another treatment plan for pressure ulcer is used. The evaluation should be based on the opinions of direct participants, as well as on the results of the intervention. Patients can share their personal attitudes and physical conditions after they had been offered a PU protocol in the emergency department. Then, these opinions should be compared to the opinions of patients who are provided with usual care in hospitals. It is expected to conclude that a PU protocol in the emergency department is a promising intervention that can be used for the reduction of hospital-acquired pressure ulcers on the third day of hospitalization.
Bus, S. A., Deursen, R. W., Armstrong, D. G., Lewis, J. E. A., Caravaggi, C. F., & Cavanagh, P. R. (2016). Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: A systematic review. Diabetes/Metabolism Research and Reviews, 32(1), 99-118.
Chou, R., Dana, T., Bougatsos, C., Blazina, I., Starmer, A. J., Reitel, K., & Buckley, D. (2013). Pressure ulcer risk assessment and prevention: A systematic comparative effectiveness review. Annals of Internal Medicine, 159(1), 28-38.
Ham, W.H., Schoonhoven, L., Schuurmans, M.J., Veugelers, R., & Leenen, L.P. (2015). Pressure ulcer education improves interrater reliability, identification, and classification skills by emergency nurses and physicians. Journal of Emergency Nursing, 41(1), 43-51.
Santamaria, N., Gerdtz, M., Sage, S., McCann, J., Freeman, A., Vassiliou, T.,… Knott, J. (2015). A randomised controlled trial of the effectiveness of soft silicone multi‐layered foam dressings in the prevention of sacral and heel pressure ulcers in trauma and critically ill patients: The border trial. International Wound Journal, 12(3), 302-308.
Schallom, M., Cracchiolo, L., Falker, A., Foster, J., Hager, J., Morehouse, T.,… Kollef, M. (2015). Pressure ulcer incidence in patients wearing nasal-oral versus full-face noninvasive ventilation masks. American Journal of Critical Care, 24(4), 349-356.
Smith, M. B., Totten, A., Hickam, D. H., Fu, R., Wasson, N., Rahman, B.,… Saha, S. (2013). Pressure ulcer treatment strategies: A systematic comparative effectiveness review. Annals of Internal Medicine, 159(1), 39-50.
Sullivan, N., & Schoelles, K. M. (2013). Preventing in-facility pressure ulcers as a patient safety strategy: A systematic review. Annals of Internal Medicine, 158(5), 410-416.
Swafford, K., Culpepper, R., & Dunn, C. (2016). Use of a comprehensive program to reduce the incidence of hospital-acquired pressure ulcers in an intensive care unit. American Journal of Critical Care, 25(2), 152-155.
Appendix A: Evaluation Table
|Citation||Design||Sample size||Major Variables||Study findings||Level of evidence||Evidence synthesis|
|Study 1 (Santamaria et al., 2015)||Randomised controlled trial||The sample size is adequate.440 critically ill patients in intensive therapy units.||The population and interventions are independent variables. |
The outcomes are dependent variables.
the findings demonstrate benefits for the application of multi-layered soft silicone foam dressings.
results cannot be generalized to other patient populations
|Strong level of evidence that is obtained from a randomized controlled trial||The use of multi-layered soft silicone foam dressings is an effective preventive approach for sacral and heel pressure ulcers|
|Study 2 (Bus et al., 2016)||Randomized controlled trial||The sample size is adequate. 1171 for footwear 6639 for offloading interventions||The population and interventions are independent variables. |
The outcomes are dependent variables.
the application of neuropathic footwear demonstrated the reduction in plantar pressure
the possible selection bias in the current literature.
|Strong level of evidence that is obtained from a randomized controlled trial||The use of therapeutic footwear demonstrates the reduction in plantar pressure.|
|Study 3 (Schallom et al., 2015)||Comparison study||The sample size is adequate. 1204 patients with orders for noninvasive ventilation||The population and interventions are independent variables. |
The outcomes are dependent variables.
the findings demonstrate abundant benefits for the use of a full-face mask
missed enrollment opportunities could have led to bias sampling.
|Moderate level of evidence that is obtained from comparison study without randomization||No patients who had pressure ulcers that had developed due to the use of nasal-oral masks had pressure ulcers while using full-face masks.|
|Study 4 (Chou et al., 2013)||Nonrandomized controlled trial||The sample size is adequate. 1231 randomly assigned patients||The population and interventions are independent variables. |
The outcomes are dependent variables.
advanced static mattress, repositioning, and additional skin care are associated with low risk for the development of pressure ulcers
an inadequate description of randomization
|Moderate level of evidence that is obtained from a nonrandomized controlled trial||Repositioning, additional skin care, and advanced static support surfaces are effective for preventing ulcers.|
|Study 5 (Smith et al., 2013)||Comparative observational study||The sample size is adequate.50 clinical trials||The population and interventions are independent variables. |
The outcomes are dependent variables.
Study findings can be generalized to the population
inadequate description of randomization
|Moderate level of evidence that is obtained from controlled trials without randomization||The use of |
air-fluidized beds, protein, supplementation, radiant heat dressings reduce the number of patients with pressure ulcers.
Appendix B: Evidence Synthesis
|(database) ex: Cochran||Study 1||Study 2||Study 3||Study 4||Study 5||Synthesis|
|(p) Population||Critically ill people in the intensive therapy unit who acquired pressure ulcers. These patients include the unconscious and artificially ventilated. The patient’s pelvic areas, heels, and sacrum are exposed to direct pressure||Participants with diabetes type one and two. These patients include those with neuropathic plantar forefoot ulcers who were at high risk of infection or amputation||Patients who underwent non- invasive ventilation in 5 intensive therapy units. All patients were divided into two groups. Patients in the first group used nasal-oral masks, and patients in the second group used full-faced masks||Patients from different settings that include acute therapy hospitals, long-term care facilities, rehabilitation facilities, operating rooms, and home care who are at risk for pressure ulcers. Another specific population included patients who used wheelchairs||Adults with pressure ulcers at different stages. These injuries range from the first stage with relatively healthy skin in which there are no breaks or abnormal openings to the fourth stage with exposed bones or muscles.||The resulting samples represent people who suffer pressure ulcers at different stages. The studies unite various cases that include patients in intensive therapy units, long-term care facilities, operating rooms, patients with diabetes. Also, the studies focus on patients who are at high risk of developing pressure ulcers.|
|The medical interventions involved the use of multi-layered soft silicone foam antiseptic dressings during admission to the emergency department. These interventions included all-in-one three-layered |
foam dressing for heels and five-layered sacrum dressing that was fixed using Tubifast tubular elastic bandage
|The medical interventions involved the use of four types of interventions. These interventions included non-removable offloading, orthopedic footwear with demonstrated pressure relief, cast shoes, and surgical interventions like Achilles tendon lengthening and silicone injections.||The medical interventions involved the use of special nasal pillows for nasal-oral masks. Such pillows are made of soft silicone material.||The medical interventions involved the use of static and dynamic support surfaces like special mattresses, integrated bed systems, coverings, and pillows. Another type of interventions included repositioning and skin care.||The medical interventions involved the application of air-fluidized support surfaces that circulate filtered air through ceramic beads covered with silicone. Other interventions included||The studies review different types of medical interventions that depend on the severity of symptoms, personal characteristics of patients and settings. These interventions include special dressings, footwear, ventilation masks, support surfaces, additional nutrition, and other types of therapy aimed at improving healing processes.|
|This study presents a comparative analysis of the group of patients who received standard medical care and the intervention group. Standard care included reduction of pressure, infection control, and meticulous wound treatment. These measures were implemented by means of special mattresses, ointments, and heat lamps.||The researchers conducted a comparative analysis of the intervention group and the group that received standard medical care. The second group included patients who received conservative offloading treatment and worn their own non-orthopedic, canvas shoes. The comparative analysis also focused on insoles with removable plugs and arch support and simple flat insoles.||The researchers conducted a comparative analysis of the group of patients who used standard full-face ventilation masks and another group that received special treatment that involved the use of nasal-oral masks with soft silicone pillows.||This research demonstrates a comparative analysis of the group of patients who received regular medical care and another group that received special treatment that included preventive interventions. These interventions depended on the level of the risk of the development of pressure ulcers and patient characteristics.||This work offers a comparative analysis of patients who received special treatment that included the use of air-fluidized beds, gauze dressings, Collagen application and patients who received standard medical care that included hydrocolloid dressings and alternative pressure surfaces.||These studies focus on various comparison groups that are divided into two main categories. The first category of participants received special medical treatment that included additional procedures and non-standard approaches. Meanwhile, the second category received usual medical care.|
|This study revealed that there were much fewer patients with pressure ulcers in the intervention group. The results showed four times fewer cases with sacral and pressure ulcers, and three times fewer cases with pressure injuries.||The results showed abundant evidence that non-removable offloading and neuropathic footwear prevented foot ulcer recurrence. However, there is not enough evidence other types of offloading interventions are effective. In addition, there is no evidence that any type of interventions can heal proximal foot ulcers.||This study demonstrated that the use of nasal-oral masks did not reduce chances of the development of pressure ulcers. 20 percent of patients who used nasal-oral masks suffered from pressure ulcers, whereas such injuries developed only in 2 percent of patients who used full-face masks.||This study revealed that the use of special support surfaces is associated with lower risk of pressure ulcers by 30 percent compared to regular mattresses. Repositioning reduced the risk of such injuries by 8 percent. Interventions that included additional skin care reduced the risk of pressure ulcers by 10 percent.||This study proved that medical interventions that combined the use of air-fluidized beds, protein, supplementation, radiant heat dressings, and electrical therapy led to complete wound healing in approximately 40 percent cases. Also, such interventions caused the reduction in wound size and rates of complications.||The studies showed different results, though not all types of interventions were effective. Pressure ulcers developed more often in patients to whom nasal-oral masks were applied. In addition, neither type of intervention could heal proximal foot ulcers. However, most approaches were effective.|
|25 days||30-120 days||1.5-72 hours||28 days||6 weeks||Observing periods varied from 1.5 hour to 120 days depending on several factors: severity of symptoms, medical settings, and a type of intervention.|