Prolonged impact of home versus clinic-based management of chronic heart failure: Extended follow-up of a pragmatic, multicentre randomized trial cohort
Introduction
Since the mid-to-late 1990s [1], [2], [3], [4] chronic heart failure management programs [CHF-MPs] have revolutionized the post-discharge management of the syndrome. Most CHF-MPs are nurse-led but multidisciplinary in application. Randomized trials comparing these to usual care typically included older individuals with complex co-morbidity, a relatively equal gender-balance and those with preserved systolic function in whom evidence-based treatments are scarce [5]. A meta-analysis of published trials confirmed significant reductions in all-cause readmissions and prolonged survival relative to usual care [6]. Multidisciplinary CHF-MPs now form part of gold-standard care of the syndrome [7], [8]. Translation into clinical practice, however, has not been easy. Contemporary debate has focused on essential components of care and mechanisms of benefit [9] including the role of home visits as part of a transitional care approach to post-discharge management [10]. Building on compelling data that a face-to-face approach to CHF management is superior to that delivered remotely [11], there are potential advantages in applying home visits to provide a more comprehensive profile of the individual, identifying physical and socio-cultural factors that influence health outcomes and developing a more personal therapeutic relationship [12]. A home-based, nurse-led program of care was the basis for the first randomized trial of any form of CHF-MP to report prolonged all-cause survival and reduced readmissions relative to usual care [3]. In the Which Intervention Is most cost-effective and Consumer friendly in reducing heart failure Hospital stay (WHICH?) Trial we prospectively tested whether a home-based intervention was superior to the same principles of CHF management but applied via a specialist outpatient clinic intervention [13]. This head-to-head, multicentre randomized study showed that there was no difference in the primary composite endpoint of event-free survival from an all-cause, unplanned hospitalization or death during initial 12–18 month follow-up. However, home-based intervention was associated with significantly reduced all-cause hospital stay and health care costs accompanied by a non-significant trend toward prolonged survival [14].
Section snippets
Study hypothesis
Based on our initial findings and previous studies of the prolonged benefits of a home-based approach [15], [16], we hypothesized that during extended follow-up (minimum 3 years) we would observe the following: 1) no difference between the two groups with respect to event-free survival from all-cause death or recurrent unplanned hospitalization (our initial primary endpoint); 2) a significant difference in all-cause mortality in favor of home-based intervention (tested in the null form) and; 3)
Methods
The study design and primary end-point analyses at 12–18 month follow-up of the WHICH? Trial have been previously reported [13], [14]. This was a multi-center randomized controlled trial, undertaken in 3 Australian tertiary hospitals, with blinded endpoint acquisition and adjudication that adhered to guidelines for pragmatic studies [17]. Conforming to the principles outlined in the Declaration of Helsinki, approval for the original and extended follow-up components of the study was provided by
Statistical analyses
The study was originally sized (two sided alpha 0.05 with > 80% power) to detect a 15% absolute difference in the primary endpoint at 12–18 months between the two groups. The same power was retained with respect to examining the primary endpoint and the constituent endpoints of any unplanned hospitalization and all-cause death during longer-term follow-up; based on statistical advice, an intention-to-treat, two-sided p value of < 0.05 was retained. Continuous data are presented as a mean ± standard
Results
Table 1 summarizes the baseline profile of the study cohort according to group allocation and initial post-discharge management. This was a typically older cohort of patients with CHF; the majority being male, having LVSD and complex presentations with significant co-morbidity. Most were also prescribed a combination of a loop-diuretic therapy, ACE inhibitor/ARB antagonist, beta blocker and/or an aldosterone inhibitor. Groups were well matched with the exception of home-based intervention
Discussion
During extended follow-up of this typically older patient cohort with CHF, we re-confirmed minimal differences between groups in the primary endpoint of event-free survival from unplanned hospitalization or death. Over the longer-term, however, favorable survival trends toward home-based intervention strengthened; 16% fewer deaths on an absolute basis and a greater than one-third reduction in all-cause mortality on an adjusted basis relative to clinic-based management. Contrasting with the
Acknowledgments
We thank all the cardiac nurses, health care professionals and patients who participated, Alicia Calderone, and staff at Baker IDI who contributed to data management. The WHICH? Trial (Grant number 418967) and SS and MC are supported by the National Health and Medical Research Council (NHMRC) of Australia.
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