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.
