The research project aims at addressing the following clinical question: In patients with heart failure receiving regular education (P), how does the use of management program regarding diet adherence, exercise, early warning signs of a worsening condition, and close medical monitoring (I) compared to a group of regular educational sessions (C) decrease the hospitalization rate (O) in six months (T)?
Study Design
Based on the clinical question under consideration, an experimental study is the most appropriate choice for addressing the problem relevantly. Although no medication will be prescribed, there is still an opportunity to modify the intervention and control the quality and volume of information communicated in educational lectures. At the same time, the study aims at recording and measuring intervention outcomes and comparing them with baseline data. All of these features are common for experimental interventions (Howick, 2017).
Setting and Sample
In order to find a relevant answer to the clinical question, the intervention will be conducted as hospital-based due to the necessity of accessing patients as well as monitoring them. Therefore, one of the local hospitals is a setting for the intervention. The sample will not be large. It will include 60 patients divided into two groups – intervention and control. The intervention group will become the subject of the new educational program and medical monitoring, while the control group patients will attend conventional education sessions. This choice can be explained by the necessity to pay special attention to each patient, as well as the limited timeframe of the intervention – six months. More than that, it is associated with the choice of the study design – a mixed approach that is more complicated to conduct in case of large samples (Creswell, 2014). The patients will be chosen randomly among those with the increased risks of heart failure (e.g., those with a history of heart failure).
Confidentiality Issues
Privacy is one of the central problems in research. That is why addressing confidentiality issues is the foundation of the practical implementation of the planned intervention. To cope with the potential challenges, developing informed consent forms, as well as patient information sheets, is essential (Webster & Sell, 2014). In this way, patients will be asked to sign informed consent once they are acquainted with project objectives, and all of their questions are correctly answered. Moreover, these forms will guarantee that personal information will not be revealed or shared with third persons. Moreover, personal patient data will be stored in password-protected files so that the risks of information loss are minimal.
Procedures and Interventions
A heart failure education program is a planned intervention. The objective of the initiative is to educate patients on the criticality of exercising and adhering to a healthy diet (including reduction of sugar and salt intake and avoiding products with high cholesterol) as well as make them aware of the early signs of heart failure. Another aspect of the planned intervention is close medical monitoring aimed at assessing patients’ physical health conditions. The abovementioned combination of intervention techniques is efficient for reducing hospitalization rates and decreasing risks of heart failure (Agrinier et al., 2013). The planned intervention is inseparable from several types of procedures, such as developing educational frameworks for launching the program, identifying the most relevant dieting and exercise patterns by conducting a comprehensive literature review and developing frameworks for medical monitoring. It is essential to state that different materials – audio, video, and photos – will be incorporated to increase the potential efficiency of the intervention and foster patient involvement in education.
Instruments, Scales, and Measurements of Outcomes
The outcomes will be measured by using a mixed research design. The rationale for this choice is the desire to estimate both the quality of patients’ lifestyles (qualitative aspect) and the changes in their physical health determinants (quantitative measurement). It contributes to a better understanding of the investigated issue (Mertens & Hesse-Biber, 2012). In this way, improved physical health and exercise and dieting behaviors, as well as a better understanding of heart failure signs, will be perceived as positive outcomes of the intervention. Still, guaranteeing conclusions validity is critical. To achieve his objective, simple triangulation will be used. In particular, a focus will be made on comparing and contrasting research findings with those of previous studies (e.g., studies mentioned in the evidence research section) (Petto, 2017).
Data Collection: Methods of Collection and Testing Frequency
Two methods of data collection will be deployed – surveys and physical assessment data. It can be explained by the specificities of the study design as well as the necessity to collect both qualitative and quantitative data. That said, qualitative data will be obtained from questionnaires. They will be developed in a way to address both patients’ knowledge of heart failure risks and the connection between heart failure and lifestyle as well as their dieting and exercise patterns. On the other hand, quantitative data will be collected during medical monitoring. The idea is to measure main physical health determinants (including blood pressure, bodyweight, etc.). Moreover, data will be collected in two stages – before and after the intervention – due to the desire to measure its outcomes. It is valid for both intervention and control groups because measuring the effectiveness of conventional education sessions is as well Imperative. Therefore, medical pre-and post-tests are necessary, as the information collected before the beginning of the intervention will constitute baseline data – the foundation for comparing intervention outcomes with and drawing research conclusions.
References
Agrinier, N., Altieri, C., Alla, F., Jay, N., Dobre, D., Thilly, N., & Zannad, F. (2013). Effectiveness of a multidimensional home nurse-led heart failure disease management program – a French nationwide time-series comparison. International Journal of Cardiology, 168(4), 3652-3658. Web.
Cresswell, J. W. (2014). Research design: Qualitative, quantitative, and mixed methods approach (4th ed.). Thousand Oaks, CA: SAGE Publications.
Howick, J. (2017). Justification of evidence-based medicine epistemology. In J. A. Marcum (ed.), The Bloomsbury companion to contemporary philosophy of medicine (pp. 113-146). New York, NY: Bloomsbury Academic.
Mertens, D. M., & Hesse-Biber, S. (2012). Triangulation and mixed methods research: Provocative positions. Journal of Mixed Methods Research, 6(2), 75-79. Web.
Petto, P. J. (2017). Mixed methods in ethnographic research: Historical perspectives (developing qualitative inquiry). New York, NY: Routledge.
Webster, M., & Sell, J. (2014). Laboratory experiments in the social sciences (2nd ed.). Waltham, MA: Elsevier.