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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • I-TRANSFER-HF

    Other intervention

    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.

Treatment groups

1,094 Participants
are divided into 2 treatment groups
Group A: I-TRANSFER-HFExperimental treatment 1 intervention
Group B: Standard of Care (usual care)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
30 days following post-Index HF Hospitalization
2

Number of Eligible patients

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

Time frame
12 months
3

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

Time frame
12 months
4

Modality of outpatient follow-up

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

Time frame
12 months

Secondary outcomes

1

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

Time frame
30 days following post-Index heart failure Hospitalization.
2

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.

Time frame
During a 12-month period (year of intervention)
3

Acceptability of I-TRANSFER-HF - Qualitative Interviews

Acceptability will be assessed through qualitative interviews.

Time frame
30 days after intervention (year of intervention)
4

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.

Time frame
30 days after intervention (year of intervention)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Johns Hopkins University

Collaborator

University of Colorado, Denver

Collaborator

NYU Langone Health

Collaborator

University of California, San Diego

Collaborator