In the paper, the implementation phase of a randomized controlled trial will be described. The randomized controlled trial aims to research whether telephone-based and online care are more effective compared to standard nursing home visits in patients who are 36 years old or older and who undergo post-acute care.
The sample for the research will be recruited from three local hospitals that specialize in acute care. Nurses and physicians at the selected healthcare facilities will be approached to collect data on eligible participants. Before that, the researcher will contact the hospital administration to obtain their agreement on the research and inclusion of patients in the research.
The researcher also aims to approach families and patients with an explanation of the research aim. Those patients and their families who will agree to participate in the project will be asked to provide contact details for future discussion of their inclusion. If the individuals who agreed to participate will meet the inclusion criteria, the author will provide them with an informed consent document that they will need to sign to take part in the research.
As it is a randomized controlled trial, there is a need to recruit enough participates to ensure that there will be control and intervention groups. The research aims to recruit at least 20 participants. The expected number of participants is approximately 200 individuals.
Recruitment of Professionals
Nurses and physicians working in the chosen facilities will be contacted by the researcher to obtain their agreement to participate in the project. The project will involve part-time participation from nursing professionals and physicians. Depending on the eventual sampling, the author expects to recruit from twenty to fifty medical professionals who will take part in web-based and phone-based education or home visits. All selected professionals who will agree to participate are to be provided with an informed consent document that will include a detailed description of the project, its time frame, and aims. Researchers with experience in conducting randomized controlled trials will also be recruited for the project. This is necessary to provide unbiased analysis of collected data and results.
The patients will be randomly assigned to the control and intervention group, using specialized software (for example, GraphPad). Participants will be asked to use web-based technologies and telephone instruction to educate themselves and report any issues, as well as receive preventive care. Participants from the other group will converse with the healthcare provider face-to-face during the visits of nursing professionals or follow other standard protocols that are used in post-acute transitional care. As it is impossible for nursing professionals and physicians not to determine to which group patients belong, they will be asked to provide patients with surveys and questionnaires that will be used to evaluate the effectiveness of care and its ability to prevent adverse health events in the post-acute care at the end of the intervention. The researcher assumes that not all participants will take part in interviews. Quantitative data, such as the number of readmissions and adverse events, will also be provided by physicians to data analysts. This data will be collected from all participants (the whole sample). However, no indication of the group to which the patient belongs will be given to data analysts to ensure unbiased analysis.
The collection of data on readmissions during post-acute care will also take part at the end of the research. Using this data, the researcher together with data analysis will be able to analyze whether the readmission rates in both groups have changed and how they have changed. Furthermore, at the end of the project, interviews with participants who agree to be interviewed will also be analyzed to understand how patients perceived the quality of care and its effectiveness. As Kieft, de Brouwer, Francke, and Delnoij (2014) point out, various factors, including the environment and nurses’ experience and social skills, affect the perceived quality of care. This study aims to find out how digital tools such as online technologies and phone-based consultation affect patients’ perception of their treatment.
The project will take twelve months and be implemented step-by-step. The specified timeframe of the project can be found below (see Figure 1):
|Contact with hospital administration, nurses, physicians, patients, and their families||One to two months|
|Recruitment of data analysts||One month|
|Preparation for the project (patient education, education of medical personnel, etc.)||One month|
|Implementation of the project||Twelve months|
|Interviewing of participants||One month (at the end of the twelve months)|
|Data analysis||Up to three months|
|Final analysis||Two-four weeks|
|Article completion||One month|
Figure 1. Project timeframe.
As can be seen from the approximate timeframe of the project, the research together with preparations and post-research analysis will take more than one year, while the study itself will be completed in twelve months to ensure the high fidelity of results.
Although it might seem that low-cost randomized controlled trials are difficult to conduct, there is evidence that various projects, including relatively large randomized controlled trials, were conducted without exceeding $100,000 or even $50,000 budget. Important factors here are the limited size of personnel taking part in the study and data available for the researcher to measure baseline results (it can be provided by hospitals where participants had surgeries or other urgent care). RCTs are usually more expensive than other types of studies (Zandniapour & Vicinanza, 2013). To decrease the expense of an RCT, White, Sabarwal, and de Hoop (2014) suggest ensuring that the chosen study design corresponds with its aims. The author’s approximate calculations revealed that up to $25,000 will be spent on medical personnel and data analysts’ financial reward for participation, $5,000-$6,000 on data collection of patients and their recruitment, $15,000 on the implementation of the study during the twelve months, and up to $5,000 on data analysis and final analysis of collected results. Thus, the budget for the RCT is approximately $51,000.
Various statistical tools can be used in RCTs. For example, randomization is a common method used in RCTs as it ensures unbiased allocation of treatment (Egbewale, 2015). However, others suggest that providing baseline characteristics of study participants is more reliable and it is also more frequently used in new RCTs. Baseline tests of significance are the most common method used by researchers and statisticians in large studies published in respected journals; in this case, “study groups are compared in a wide range of baseline variables; those with a statistically significant difference between groups are automatically accounted for in the analysis” (Egbewale, 2015, p. 356). Subgroup analysis is also an option as the author will compare two groups where patients’ characteristics or methods are different. As such, various tools can be used, but the subgroup analysis seems to be the most fitting one.
The RCT will take twelve months to complete, whereas the recruitment processes and data analysis will also take up to six months. The author plans to recruit at least twenty and up to two hundred participants, as well as from twenty to fifty nursing professionals and physicians. Subgroup analysis is preferred as the statistical tool that best fits the study’s aim.
Egbewale, B. E. (2015). Statistical issues in randomised controlled trials: A narrative synthesis. Asian Pacific Journal of Tropical Biomedicine, 5(5), 354-359.
Kieft, R. A., de Brouwer, B. B., Francke, A. L., & Delnoij, D. M. (2014). How nurses and their work environment affect patient experiences of the quality of care: A qualitative study. BMC Health Services Research, 14(1), 249-258.
White, H., Sabarwal, S., & de Hoop, T. (2014). Randomized controlled trials (RCTs). Web.
Zandniapour, L., & Vicinanza, N. (2013). Budgeting for rigorous evaluation: Insights from the social innovation fund. Web.