Clinical trial NCT06118983: Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF)
Official title: Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF): A Type 1 Hybrid Effectiveness- Implementation Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: home health care
hospital-to-home transition
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Johns Hopkins University
name: University of Colorado, Denver
name: NYU Langone Health
name: University of California, San Diego
First posted: 2023-11-07
Enrollment: 1154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause 30-day hospital readmission
timeFrame: 30 days following post-Index HF Hospitalization
measure: Number of Eligible patients
timeFrame: 12 months
measure: Number of Eligible Patients Who Received Protocol Components
timeFrame: 12 months
measure: Modality of outpatient follow-up
timeFrame: 12 months
measure: Timeliness of Post-Hospital Discharge Home Health Nursing Evaluation
timeFrame: 12 months
measure: Timeliness of Post-Hospital Outpatient Follow-Up
timeFrame: 12 months
measure: Feasibility of implementing I-TRANSFER-HF (Qualitative Interviews)
timeFrame: 30 days after intervention (year of intervention)
measure: Feasibility of implementing I-TRANSFER-HF (Surveys)
timeFrame: 30 days after intervention (year of intervention)
Secondary outcomes:
measure: All-cause 30-day ED visits
timeFrame: 30 days following post-Index heart failure Hospitalization.
measure: 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
timeFrame: During a 12-month period (year of intervention)
measure: Acceptability of I-TRANSFER-HF (Qualitative Interviews)
timeFrame: 30 days after intervention (year of intervention)
measure: Acceptability of I-TRANSFER-HF (Surveys)
timeFrame: 30 days after intervention (year of intervention)
measure: Fidelity of I-TRANSFER-HF (Participant-Completed)
timeFrame: 30 days after intervention (year of intervention)
measure: Fidelity of I-TRANSFER-HF (Observational Ratings)
timeFrame: 30 days after intervention (year of intervention)
measure: Adaptation of I-TRANSFER-HF
timeFrame: 30 days after intervention (year of intervention)
Other outcomes:
Locations:
city: New York
country: United States
facility: VNS Health Partners in Care
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Madeline R Sterling, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References: