Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF): A Type 1 Hybrid Effectiveness- Implementation Trial

Study Overview
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Brief Summary
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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: Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days? 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.

Official Title
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Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF): A Type 1 Hybrid Effectiveness- Implementation Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Other: I-TRANSFER-HF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 heart failure patients eligible to receive I-TRANSFER-HF as assessed by Medicare claims data |  | 12 months | 
| Number of heart failure patients who received both components of I-TRANSFER-HF (frontloaded home health nurse visits and early outpatient medical follow-up), one, or none as assessed by Medicare claims data |  | 12 months | 
| The modality of outpatient follow-up received (in-person vs. virtual visit) as assessed by Medicare claims data |  | 12 months | 
| The timeliness of first-week nursing visits within 2 days of hospital discharge as assessed by Medicare claims data |  | 12 months | 
| 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 | Feasibility will be assessed through qualitative interviews with site stakeholders | 30 days after intervention (year of intervention) | 
| Feasibility of implementing I-TRANSFER-HF | 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 |
| --- | --- | --- |
| 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. | 
| 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) | 
| Acceptability of I-TRANSFER-HF | Acceptability will be assessed through qualitative interviews. | 30 days after intervention (year of intervention) | 
| Acceptability of I-TRANSFER-HF | 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) | 
| Fidelity of I-TRANSFER-HF | 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 | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home health care, hospital-to-home transition