RecruitingRecruiting
Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF)
NCT06118983 · Weill Medical College of Cornell University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF): A Type 1 Hybrid Effectiveness- Implementation Trial
About this study
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).
Eligibility criteria
Aim 1, Inclusion Criteria:
* Adults hospitalized for HF who transition from participating hospitals to their partner HHC agency during the study period.
Aim 1, Exclusion Criteria:
* Patients hospitalized for HF and discharged: home without HHC, or to an inpatient rehabilitation facility, skilled nursing facility, or hospice; patients with end stage 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
Enrollment target: 1094 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-07-01
Estimated completion: 2028-07-01
Last updated: 2026-05-05
Interventions
Other: I-TRANSFER-HF
Primary outcomes
- • All-cause 30-day hospital readmission (30 days following post-Index HF Hospitalization)
- • Number of Eligible patients (12 months)
- • Number of Eligible Patients Who Received Protocol Components (12 months)
Sponsor
Weill Medical College of Cornell University · other
With: National Heart, Lung, and Blood Institute (NHLBI), Johns Hopkins University, University of Colorado, Denver, NYU Langone Health, University of California, San Diego
Contacts & investigators
ContactMadeline R Sterling, MD, MPH, MS · contact · mrs9012@med.cornell.edu · 6469625029
InvestigatorMadeline R Sterling, MD, MPH, MS · principal_investigator, Weill Medical College of Cornell University
All locations (2)
VNS Health Partners in CareRecruiting
New York, New York, United States
Weill Cornell MedicineRecruiting
New York, New York, United States