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 volunteersQualifiers
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
Sequential
Treatments tested in this trial
I-TRANSFER-HF
Other interventionI-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
Trial outcomes
Primary outcomes
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
Number of Eligible patients
Number of heart failure patients eligible to receive I-TRANSFER-HF as assessed by Medicare claims data
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
Modality of outpatient follow-up
The modality of outpatient follow-up received (in-person vs. virtual visit) as assessed by Medicare claims data
Secondary outcomes
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
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.
Acceptability of I-TRANSFER-HF - Qualitative Interviews
Acceptability will be assessed through qualitative interviews.
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.
Sponsors and contacts
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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