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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: I-TRANSFER-HF

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).

• Study Type: Interventional
• Enrollment (Estimated): 1094
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madeline R Sterling, MD, MPH, MS; Phone Number: 6469625029; Email: mrs9012@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Madeline R Sterling, MD, MPH, MS; Phone Number: 646-962-5029; Email: mrs9012@med.cornell.edu
      • Principal Investigator: Madeline R Sterling, MD, MPH, MS
    • New York, New York, United States, 10017
      • Recruiting
      • VNS Health Partners in Care
      • Contact: Kathy Bowles, PhD, RN,FAAN; Email: bowles@nursing.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I-TRANSFER-HF; This is a 1-year long intervention period when I-TRANSFER-HF is in operation.	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.
No Intervention: Standard of Care (usual care); This is a baseline period of usual care (UC) with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Days at home will be calculated as 365 days minus the number of inpatient days in an acute care facility, an inpatient rehabilitation facility, a skilled nursing facility, or an inpatient hospice unit.	During a 12-month period (year of intervention)
Adaptation of I-TRANSFER-HF	Adaptation will be assessed with qualitative interviews to document how the intervention was modified and refined during the study period.	30 days after intervention (year of intervention)
All-cause 30-day ED visits	All-cause 30-day emergency department visits 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 data	30 days following post-Index heart failure Hospitalization.
Fidelity of I-TRANSFER-HF (Participant-Completed)	Fidelity will be assessed by extent to which I-TRANSFER-HF is implemented by the study site teams. Fidelity will be measured using participant-completed fidelity checklists. These checklists will be developed during the implementation process.	30 days after intervention (year of intervention)
Fidelity of I-TRANSFER-HF (Observational Ratings)	Fidelity will be assessed by extent to which I-TRANSFER-HF is implemented by the study site teams. Fidelity will be measured using observational fidelity ratings conducted by site champions. These checklists will be developed during the implementation process.	30 days after intervention (year of intervention)
Acceptability of I-TRANSFER-HF - Qualitative Interviews	Acceptability will be assessed through qualitative interviews.	30 days after intervention (year of intervention)
Acceptability of Intervention Measure for the I-TRANSFER-HF Study - Survey	Acceptability will be assessed through the 4-item, validated, Acceptability of Intervention Measure (AIM). 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 acceptability of the intervention.	30 days after intervention (year of intervention)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Johns Hopkins University; University of Colorado, Denver; University of California, San Diego; National Heart, Lung, and Blood Institute (NHLBI); NYU Langone Health
• Investigators: Principal Investigator: Madeline R Sterling, MD, MPH, MS, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: home health care; hospital-to-home transition
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 23-06026204; R01HL169312 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No