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

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118983
• Other study ID #: 23-06026204
• Secondary ID: R01HL169312
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2024
• Est. completion date: January 2028

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: Madeline R Sterling, MD, MPH, MS
• Phone: 6469625029
• Email: mrs9012[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1154
• Est. completion date: January 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	VNS Health Partners in Care	New York	New York
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of heart failure patients eligible to receive I-TRANSFER-HF as assessed by Medicare claims data		12 months
Primary	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
Primary	The modality of outpatient follow-up received (in-person vs. virtual visit) as assessed by Medicare claims data		12 months
Primary	The timeliness of first-week nursing visits within 2 days of hospital discharge as assessed by Medicare claims data		12 months
Primary	The timeliness of outpatient visits within 7 days of hospital discharge as assessed by Medicare claims data		12 months
Primary	Feasibility of implementing I-TRANSFER-HF	Feasibility will be assessed through qualitative interviews with site stakeholders	30 days after intervention (year of intervention)
Primary	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	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.
Secondary	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)
Secondary	Acceptability of I-TRANSFER-HF	Acceptability will be assessed through qualitative interviews.	30 days after intervention (year of intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)