Group medical visits after heart failure hospitalization: Study protocol for a randomized-controlled trial

A primary goal of this research project is to better understand how shared medical appointments (SMAs) can improve the health status and decrease hospitalization and death for patients recently discharged with heart failure (HF) by providing education, disease state monitoring, medication titration, and social support to patients and their caregivers. We propose a 3-site randomized-controlled efficacy trial with mixed methods to test a SMA intervention, versus usual care. Patients within 12 weeks of a HF hospitalization will be randomized to receive either HF-SMA (intervention arm) with optional co-participation with their caregivers, versus usual care (control arm). The HF-SMA will be provided by a non-physician team composed of a nurse, a nutritionist, a health psychologist, a nurse practitioner and/or a clinical pharmacist and will consist of four sessions of 2-h duration that occur every other week for 8 weeks. Each session will start with an assessment of patient needs followed by theme-based disease self-management education, followed by patient-initiated disease management discussion, and conclude with break-out sessions of individualized disease monitoring and medication case management. The study duration will be 180 days for all patients from the day of randomization. The primary study hypothesis is that, compared with usual care, patients randomized to HF-SMA will experience better cardiac health status at 90 and 180 days follow-up. The secondary hypotheses are that, compared to usual care, patients randomized to HF-SMA will experience better overall health status, a combined endpoint of hospitalization and death, better HF self-care behavior, and lower B-type natriuretic peptide levels.