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

Overview

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).

Interventions

• 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.

Primary outcome measures

• All-cause 30-day hospital readmission [Time frame: 30 days following post-Index HF Hospitalization]
• Number of Eligible patients [Time frame: 12 months]
• Number of Eligible Patients Who Received Protocol Components [Time frame: 12 months]
• Modality of outpatient follow-up [Time frame: 12 months]
• Timeliness of Post-Hospital Discharge Home Health Nursing Evaluation [Time frame: 12 months]
• Timeliness of Post-Hospital Outpatient Follow-Up [Time frame: 12 months]
• Feasibility of implementing I-TRANSFER-HF (Qualitative Interviews) [Time frame: 30 days after intervention (year of intervention)]
• Feasibility of implementing I-TRANSFER-HF (Surveys) [Time frame: 30 days after intervention (year of intervention)]

Secondary outcome measures (7)

• All-cause 30-day ED visits [Time frame: 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 [Time frame: During a 12-month period (year of intervention)]
• Acceptability of I-TRANSFER-HF - Qualitative Interviews [Time frame: 30 days after intervention (year of intervention)]
• Acceptability of Intervention Measure for the I-TRANSFER-HF Study - Survey [Time frame: 30 days after intervention (year of intervention)]
• Fidelity of I-TRANSFER-HF (Participant-Completed) [Time frame: 30 days after intervention (year of intervention)]
• Fidelity of I-TRANSFER-HF (Observational Ratings) [Time frame: 30 days after intervention (year of intervention)]
• Adaptation of I-TRANSFER-HF [Time frame: 30 days after intervention (year of intervention)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 2 centers

• VNS Health Partners in Care — New York
• Weill Cornell Medicine — New York

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 PMID 39354472

Identifiers

NCT: NCT06118983 · 23-06026204 · R01HL169312

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗