The GENICA project - a prospective cohort of heart failure patients with a comprehensive ambulatory approach aiming better outcomes: study protocol.

Abstract

Introduction: Heart failure (HF) is a syndrome increasing worldwide, and literature shows that the hospitalizations are associated with greater mortality rates. A patient-centered method combined with optimized medical treatment and palliative care may improve HF outcomes, and some advocate a multifaceted approach to achieve a perfect management of chronic HF (CHF).

Objective: The objective of this study was to present the study protocol of GENICA project which aims to optimize the ambulatory approach of CHF patients, and reduce their re-hospitalization, emergency readmission, and global death rate.

Design: Prospective cohort including patients referred to HF consultation and collecting sociodemographic, clinical, and analytical variables among others. The outcomes will be mortality, re-hospitalization, and emergency readmission rates. The association between the independent variables and outcomes will be assessed by logistic regression. Comparison between GENICA patients and controls will be made by χ² test. Significance at p level of less than 0.05.

Results: GENICA will offer a wide range of longitudinal data with evidence that will influence future healthcare of CHF patients at an ambulatory basis.

Discussion: GENICA will provide practical evidence of real HF patient's profile and develop workable decision algorithms, which will influence future ambulatory care of CHF. HF patients will be safer at home and will keep stability for longer periods, consuming less health resources and slow the progression of the disease. Being a matched cohort, GENICA benefits from an accuracy similar to that of randomized controlled trials, without the need to perform a rigorous allocation of the intervention. Being prospective there's no problem about response bias.

Conclusion: CHF should be approached with a multidisciplinary and multifaceted strategy privileging the outpatient setting, including home monitoring, and GENICA is the paramount protocol enabling this. GENICA may come to show health policy makers that the asset is not to divide and rule, but to converge strategies, therapies, and knowledge.