Heart failure commonly abbreviated as HF is a clinical syndrome that is a result of structural and/or functional disorders impairing the heart’s cardiac pump to support physiological blood circulations (Blanche, Fumeaux, & Polikar, 2010). While treatment pharmaceutical treatment is available for HF, other programs such as the continuous quality improvement programs are effective in improving the clinical outcomes for such patients. The purpose of this study is to make an evaluation of the clinical outcomes inherent in heart failures. Therefore, a prospective cohort study design will be employed. In a prospective cohort study, the population to be studied is identified at the beginning of the study and they are accompanied over time. The study begins at a similar time as the first exposure to the cohort status (Hulley, Cummings‎, Browner, Grady, & Newman, 2011). The group characteristics are first identified and the present case status of the study population/sample is determined, and the selected individuals are followed forward in time with the exposure status being established at the start of the study.

The prospective study will be done over a period of 12 months and will include all the patients admitted to the local community hospital. The participants will be selected for inclusion in the project study on the basis of a medical review that confirms a diagnosis of HF upon discharge that is based on code 248 of the International Classification of Diseases. The physician attending to the specific patients should determine the primary diagnosis upon discharge as being HF. The threats to internal and external validity in this study would include a significant loss to follow-up of the sample population, the existence of a potential bias in the analysis and assessment of data, the lack of a proper medical team at the hospital level, and an error in the selection of the sample population and these will be handled in a variety of ways including the generalizability of the findings.

To ensure that there is no time loss in the following up of the population sample, the researcher will engage in periodic reviews and these will be done after every two months. In addition, the medical team at the local hospital will be carefully selected and required to make their follow-up reviews after every two months as part of their compulsory job description. In addition, to ensure that the proper medical team is involved from the hospital level, the preferred primary care providers comprising of five physicians, five internists, a registered nurse and clinical assistant to will be competitively interviewed and compensated. The selection will be founded on the level of dedication to undertaking clinical projects and abilities to monitor and measure clinical outcomes. This will not only ensure professionalism hence the acquisition of accurate data but also ensure that no time is lost in following-up. The selected team will also be required to develop guidelines for HF on the basis of a review of the literature and the already existing local and national systems and health plans to ensure uniformity, selection of the appropriate sample population, and collection of the relevant data.

Furthermore, the entire medical team will be provided adequate time to read and understand the developed and endorsed guidelines and plan and make any amendments. This will ensure that external validity is promoted as the guidelines and plan if found useful could be applied to the larger population as they were obtained and endorsed through consensus. These will also be taken through quality improvement meetings after every two months to improve the reliability and validity of the final results. Moreover, to ensure the selection of the most appropriate sample population, an inclusion criterion that will require only the first 100 patients aged 40 years and above and diagnosed with HF to be part of the study. They should be also in close to the area or hospital to ensure they can be easily followed up. Finally, standardized inpatient admission orders will be developed to act as a parallel check to the existing guideline on HF treatment to ensure every decision point is addressed.

Analysis Plan

The commercially available SPSS software will be used for data analysis where comparisons of the outcomes will be made between patients with HF who enrolled in the continuous quality improvement program and those who did not enroll. The ANOVA one-way test for continuous variables and the chi-test for analysis of categorical variables will be used for the comparative analysis (Hulley, Cummings‎, Browner, Grady, & Newman, 2011). The improvement in outcomes, survival and hospitalization-free survival will be used to make comparisons and the Kaplan-Meier curves together with the log-rank test will employ to make the comparisons. Regression analyses will also be conducted for the purposes of evaluating the variables that determined improvement in treatment outcomes, survival, and hospitalization-free survival (Hulley, Cummings‎, Browner, Grady, & Newman, 2011). To achieve this, the Multivariate cox regression analyses will be used. The multivariate analysis will evaluate clinical parameters, for instance, age, hypertension, hyperlipidemia, fibrillation of the arteries, serum sodium, gender, urea, and hemoglobin. The other model in the Cox analysis will evaluate the medication taken such as beta blockers, furosemide, angiotensin-converting enzyme (ACE) and spironolactone. A statistically significant level (P<0.05) will be considered.

 

References

Blanche, C., Fumeaux, T., & Polikar, R. (2010). Heart Failure with Normal Ejection Fraction: is it worth considering? Swiss Med Weekly, 139, pp. 66-72.

Hulley, S. B., Cummings, S. R., Browner, W. S., Grady, D. G., & Newman, T. B. (2011). Designing Clinical Research. Philadelphia: Lippincott Williams & Wilkins.