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

Phase

N/A

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

I-TRANSFER-HF

Clinical Study ID

NCT06118983

23-06026204

R01HL169312

Ages > 18
All Genders
Accepts Healthy Volunteers

Study 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:

Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days?
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.

Eligibility Criteria

Inclusion

Aim 1, Inclusion Criteria:

Adults hospitalized for HF who transition from participating hospitals to theirpartner HHC agency during the study period.

Exclusion

Aim 1, Exclusion Criteria:

Patients hospitalized for HF and discharged: home without HHC, or to an inpatientrehabilitation facility, skilled nursing facility, or hospice; patients with endstage renal disease on dialysis and those with left ventricular devices.

Aim 2, Inclusion Criteria:

Healthcare professional involved in the transition of heart failure patients from the acute care setting (hospital) to HHC (home health care) agencies, and the implementation of the I-TRANSFER-HF at one of the four participating hospital-HHC dyads.

Aim 2, Exclusion Criteria:

Healthcare professional not involved in the transition of heart failure patients from the acute care setting (hospital) to HHC (home health care) agencies, and the implementation of the I-TRANSFER-HF at one of the four participating hospital-HHC dyads.

Study Design

I-TRANSFER-HF

July 28, 2026

July 01, 2028

Study 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).

Connect with a study center

VNS Health Partners in Care
New York, New York 10017
United States
Active - Recruiting
Weill Cornell Medicine
New York, New York 10021
United States
Active - Recruiting

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