NCT06118983

Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,094 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is trying to improve the hospital-to-home transition for people with heart failure who receive home care services. The study will test an intervention called I-TRANSFER-HF, which differs from usual care by combining early home health nurse visits and outpatient medical appointments. The study is interested in two questions: 1. Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days? 2. Are there parts of I-TRANSFER-HF that are easy or hard to implement in the real world? The researchers will answer these questions by testing the intervention among pairs of hospitals and home health agencies across the country. During the study, the hospital-agency pairs will be asked to implement I-TRANSFER-HF. The researchers will then compare the results from before and after I-TRANSFER-HF was adopted. They will also interview people from these hospitals and agencies to see how I-TRANSFER-HF is being implemented under real-world conditions.

Detailed description

The investigators' will test two hypotheses: Hypothesis 1 (H1): Compared to usual care, adults with heart failure who receive the I-TRANSFER-HF intervention will have fewer 30-day readmissions, ED visits, and greater days at home. The four hospital-agency pairs will all begin the study with a baseline period of no intervention and then randomly selected to start the intervention phase at different points in time. Medicare claims data from each hospital-agency pair will be used to determine outcomes, and these data will be supplemented with national claims data for external controls not in the study to test the effectiveness of the I-TRANSFER-HF intervention. Hypothesis 2 (H2): Compared to usual care, heart failure patients who receive I-TRANSFER-HF will have a higher proportion of timely first week HHC nursing visits (within 2 days of hospital discharge, plus 2 more) and outpatient visits (within 7-days of discharge). Given the rise of telemedicine, the study will test the association between the type of outpatient visit (in-person vs. virtual), its timing, and its association with outcomes. H2 requires conducting qualitative interviews with key stakeholders across the 4 hospital-agency pairs to identify barriers and facilitators that influence I-TRANSFER-HF's implementation. The study will assess the intervention's acceptability, feasibility, fidelity, and adaptation with interviews and Medicare claims data using a multi-methods approach and guided by the updated Consolidated Framework for Implementation Research (CFIR 2.0).

Conditions

• Heart Failure

Interventions

Type	Name	Description
OTHER	I-TRANSFER-HF	I-TRANSFER-HF is 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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-01-01
• Completion: 2028-07-01
• First posted: 2023-11-07
• Last updated: 2025-08-06

Locations

2 sites across 1 country: United States