I-TRANSFER-HF: Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe: A Type 1 Hybrid Effectiveness Implementation Trial

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ABSTRACT. Heart failure (HF) affects 6.2 million people in the US, costs $30 billion dollars per year, and results in 1 million hospitalizations per year. Readmission within 30 days occurs in 25% of Medicare beneficiaries hospitalized for HF, and previous interventions to reduce readmissions have had limited success. One of the most promising strategies to reduce readmissions and improve outcomes in HF is through home health care (HHC), which is delivered by Medicare certified HHC agencies, and provides skilled nurse home visits to monitor and manage patients during the post-acute period. Annually, 34% of Medicare beneficiaries hospitalized for HF receive HHC. Our prior AHRQ-funded national, observational, comparative effectiveness study (R01HS020257) found that HF patients had an 8% lower 30-day readmission rate (40% relative reduction) when they received two evidence-based practices: a) early and intensive HHC nurse visits (defined as a first HHC nursing visit within 2 days of hospital discharge with a total of three or more nursing visits within the first week) and b) an outpatient medical visit within the first week of discharge, compared to those who did not receive this timely follow-up. However, nationwide, only 12% of Medicare beneficiaries receive this early visit protocol, representing a major implementation gap. To advance the science and improve outcomes in HF, we will test an intervention called Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF), comprised of early and intensive HHC nurse visits and an outpatient visit within 7 days of discharge. Using a Hybrid Type 1, stepped wedge randomized trial design, we will test the effectiveness and implementation of I-TRANSFER-HF in partnership with 4 geographically diverse dyads of hospitals and HHC agencies (“hospital-HHC agency” dyads) across the US. Aim 1 will test the effectiveness of I-TRANSFER-HF to reduce 30-day readmissions (primary outcome) and ED visits (secondary outcome) and increase days at home (secondary outcome) among HF patients who receive timely follow-up compared to usual care. Hospital-HHC agency dyads will be randomized to cross over from a baseline period of no intervention to the intervention at different points in time. Medicare claims data from each dyad will be used to ascertain outcomes; these data will be supplemented with national claims data for external controls not in the trial, weighted to produce covariate balance. Hypotheses will be tested with generalized mixed models. Aim 2 will assess the determinants of I-TRANSFER-HF’s implementation using a multi-method approach and guided by the Consolidated Framework for Implementation Research (CFIR). Qualitative interviews will be conducted with key stakeholders across the hospital-HHC agency dyads to assess acceptability, barriers, and facilitators of implementation; feasibility and process measures will be assessed with Medicare claims data. As the first pragmatic trial of HHC in HF, this study has the potential to dramatically improve care and outcomes for HF patients and produce novel insights for the dissemination and implementation of HHC nationally.