Recruiting

I-TRANSFER-HF

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06118983

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

I-TRANSFER-HF

Study Details

Brief 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.

Conditions

Heart Failure

Study ID

NCT06118983

Start date

Jul 28, 2026

Status verified date

Aug, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

1094 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: I-TRANSFER-HF

This is a 1-year long intervention period when I-TRANSFER-HF is in operation.

no intervention: Standard of Care (usual care)

This is a baseline period of usual care (UC) with no intervention.

Interventions

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.

Primary outcome measure

  • All-cause 30-day hospital readmission [ Time Frame: 30 days following post-Index HF Hospitalization ]
  • Number of Eligible patients [ Time Frame: 12 months ]
  • Number of Eligible Patients Who Received Protocol Components [ Time Frame: 12 months ]
  • Modality of outpatient follow-up [ Time Frame: 12 months ]
  • Timeliness of Post-Hospital Discharge Home Health Nursing Evaluation [ Time Frame: 12 months ]
  • Timeliness of Post-Hospital Outpatient Follow-Up [ Time Frame: 12 months ]
  • Feasibility of implementing I-TRANSFER-HF (Qualitative Interviews) [ Time Frame: 30 days after intervention (year of intervention) ]
  • Feasibility of implementing I-TRANSFER-HF (Surveys) [ Time Frame: 30 days after intervention (year of intervention) ]

Central Contacts and Locations

Central contacts

Madeline R Sterling, MD, MPH, MS

6469625029mrs9012@med.cornell.edu

Locations

VNS Health Partners in Care

Recruiting

New York, New York, United States, 10017

Contacts

Kathy Bowles, PhD, RN,FAAN

bowles@nursing.upenn.edu

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Madeline R Sterling, MD, MPH, MS

646-962-5029mrs9012@med.cornell.edu

Principal Investigator:

Madeline R Sterling, MD, MPH, MS

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • home health care
  • hospital-to-home transition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-08-21.