Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF): A Type 1 Hybrid Effectiveness- Implementation Trial
Study Details
Study Description
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:
-
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: I-TRANSFER-HF This is a 1-year long intervention period when I-TRANSFER-HF is in operation. |
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.
|
| No Intervention: Standard of Care (usual care) This is a baseline period of usual care (UC) with no intervention. |
Outcome Measures
Primary Outcome Measures
- All-cause 30-day hospital readmission [30 days following post-Index HF Hospitalization]
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 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 [30 days after intervention (year of intervention)]
Feasibility will be assessed through qualitative interviews with site stakeholders
- Feasibility of implementing I-TRANSFER-HF [30 days after intervention (year of intervention)]
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.
Secondary Outcome Measures
- 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 [During a 12-month period (year of intervention)]
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 [30 days after intervention (year of intervention)]
Acceptability will be assessed through qualitative interviews.
- Acceptability of I-TRANSFER-HF [30 days after intervention (year of intervention)]
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.
- Fidelity of I-TRANSFER-HF [30 days after intervention (year of intervention)]
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.
- Fidelity of I-TRANSFER-HF [30 days after intervention (year of intervention)]
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.
- Adaptation of I-TRANSFER-HF [30 days after intervention (year of intervention)]
Adaptation will be assessed with qualitative interviews to document how the intervention was modified and refined during the study period.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VNS Health Partners in Care | New York | New York | United States | 10017 |
| 2 | Weill Cornell Medicine | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Madeline R Sterling, MD, MPH, MS, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-06026204
- R01HL169312