NCT06118983

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. 1.Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days?
  2. 2.Are there parts of I-TRANSFER-HF that are easy or hard to implement in the real world?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,094

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
24mo left

Started Jul 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2.6 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

October 31, 2023

Last Update Submit

April 30, 2026

Conditions

Heart Failure

Keywords

home health carehospital-to-home transition

Outcome Measures

Primary Outcomes (8)

  • All-cause 30-day hospital readmission

    All-cause 30-day hospital readmission among adults hospitalized for heart failure who receive home health care after discharge and receive the I-TRANSFER-HF protocol compared to usual care, as assessed by Medicare claims

    30 days following post-Index HF Hospitalization

  • Number of Eligible patients

    Number of heart failure patients eligible to receive I-TRANSFER-HF as assessed by Medicare claims data

    12 months

  • Number of Eligible Patients Who Received Protocol Components

    Number of heart failure patients who received both components of I-TRANSFER-HF (front-loaded home health nurse visits and early outpatient medical follow-up), one, or none as assessed by Medicare claims data

    12 months

  • Modality of outpatient follow-up

    The modality of outpatient follow-up received (in-person vs. virtual visit) as assessed by Medicare claims data

    12 months

  • Timeliness of Post-Hospital Discharge Home Health Nursing Evaluation

    The timeliness of first-week nursing visits within 2 days of hospital discharge as assessed by Medicare claims data

    12 months

  • Timeliness of Post-Hospital Outpatient Follow-Up

    The timeliness of outpatient visits within 7 days of hospital discharge as assessed by Medicare claims data

    12 months

  • Feasibility of implementing I-TRANSFER-HF (Qualitative Interviews)

    Feasibility will be assessed through qualitative interviews with site stakeholders

    30 days after intervention (year of intervention)

  • Feasibility of implementing I-TRANSFER-HF (Surveys)

    Feasibility will be measured through the completion of the validated, 4-item, Feasibility of Intervention Measure (FIM). Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). The score is calculated as the mean. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived feasibility of the intervention.

    30 days after intervention (year of intervention)

Secondary Outcomes (7)

  • All-cause 30-day ED visits

    30 days following post-Index heart failure Hospitalization.

  • Days at home among adults hospitalized for heart failure who receive home health care after discharge and receive the I-TRANSFER-HF protocol compared to usual care, as assessed by Medicare claims

    During a 12-month period (year of intervention)

  • Acceptability of I-TRANSFER-HF - Qualitative Interviews

    30 days after intervention (year of intervention)

  • Acceptability of Intervention Measure for the I-TRANSFER-HF Study - Survey

    30 days after intervention (year of intervention)

  • Fidelity of I-TRANSFER-HF (Participant-Completed)

    30 days after intervention (year of intervention)

  • +2 more secondary outcomes

Study Arms (2)

I-TRANSFER-HF

EXPERIMENTAL

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

Other: I-TRANSFER-HF

Standard of Care (usual care)

NO INTERVENTION

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

Interventions

I-TRANSFER-HFOTHER

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.

I-TRANSFER-HF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • \- 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.
  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VNS Health Partners in Care

New York, New York, 10017, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Related Publications (1)

  • Sterling MR, Espinosa CG, Spertus D, Shum M, McDonald MV, Ryvicker MB, Barron Y, Tobin JN, Kern LM, Safford MM, Banerjee S, Goyal P, Ringel JB, Rajan M, Arbaje AI, Jones CD, Dodson JA, Cene C, Bowles KH. Improving TRansitions ANd outcomeS for heart FailurE patients in home health CaRe (I-TRANSFER-HF): a type 1 hybrid effectiveness-implementation trial: study protocol. BMC Health Serv Res. 2024 Oct 1;24(1):1160. doi: 10.1186/s12913-024-11584-x.

    PMID: 39354472DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Madeline R Sterling, MD, MPH, MS

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline R Sterling, MD, MPH, MS

CONTACT

6469625029mrs9012@med.cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 7, 2023

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)