Introduction: Heart Failure (HF) is a common cause of hospitalization in older adults, and gaps in transitional care can increase the risk of readmission. Informed by the results of our network meta-analysis, we designed a transitional care model - Patient-Centered Care Transitions in HF (PACT-HF) - to improve outcomes in HF. Adopting a pragmatic study design and an integrated Knowledge Translation (iKT) research approach, we implement and test the effectiveness of PACT-HF across 10 large hospitals in a publicly funded health care system.
Hypothesis: PACT-HF will improve event-free survival and patient-reported quality of care following hospitalization for HF.
Methods: We use a stepped wedge cluster randomized trial design to introduce PACT-HF to hospitals in a randomized sequence until all hospitals initiate the intervention. The intervention goal is for all patients hospitalized with HF to receive self-care education and multidisciplinary care; and in addition, for high-risk patients to receive nurse-led home visits and Disease Management Clinic care following discharge. Thus, the intervention requires integration of care across hospitals, home care agencies, and outpatient clinics. While hospitals are the unit of recruitment and randomization, patients (estimated sample size of 4200) are the unit of analysis. Primary outcomes are hierarchically ordered as time to composite readmissions / emergency department (ED) visits / death, and time to composite readmissions / ED visits. In a nested study of 8 hospitals, we measure the patient-centered outcomes of Discharge Preparedness, Care Transitions Quality, and Quality Adjusted Life Years (QALY); and the 6-month health care resource use and costs. We obtain all clinical and cost outcomes via linkages to provincial administrative databases.
Conclusions: This protocol describes the implementation and testing of a transitional care model that comprises services informed by high-level evidence. The study adopts an iKT and pragmatic approach, uses a robust study design, links clinical trial data with outcomes held in administrative databases, and includes patient-reported outcomes. Findings will have implications on clinical practice, health care policy, and KT research methodology.