Heart Failure
Conditions
Keywords
home health care, hospital-to-home transition
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).
Interventions
OTHERI-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.
Sponsors
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
University of Colorado, Denver
NYU Langone Health
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Eligible patients | 12 months | Number of heart failure patients eligible to receive I-TRANSFER-HF as assessed by Medicare claims data |
| Number of Eligible Patients Who Received Protocol Components | 12 months | Number of heart failure patients who received both components of I-TRANSFER-HF (front-loaded home health nurse visits and early outpatient medical follow-up), one, or none as assessed by Medicare claims data |
| Modality of outpatient follow-up | 12 months | The modality of outpatient follow-up received (in-person vs. virtual visit) as assessed by Medicare claims data |
| Timeliness of Post-Hospital Discharge Home Health Nursing Evaluation | 12 months | The timeliness of first-week nursing visits within 2 days of hospital discharge as assessed by Medicare claims data |
| Timeliness of Post-Hospital Outpatient Follow-Up | 12 months | The timeliness of outpatient visits within 7 days of hospital discharge as assessed by Medicare claims data |
| Feasibility of implementing I-TRANSFER-HF (Qualitative Interviews) | 30 days after intervention (year of intervention) | Feasibility will be assessed through qualitative interviews with site stakeholders |
| Feasibility of implementing I-TRANSFER-HF (Surveys) | 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. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived feasibility of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause 30-day ED visits | 30 days following post-Index heart failure Hospitalization. | 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 |
| 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 - Qualitative Interviews | 30 days after intervention (year of intervention) | Acceptability will be assessed through qualitative interviews. |
| Acceptability of Intervention Measure for the I-TRANSFER-HF Study - Survey | 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. The scale for this measure ranges from 4-20 with higher scores indicating greater perceived acceptability of the intervention. |
| Fidelity of I-TRANSFER-HF (Participant-Completed) | 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 (Observational Ratings) | 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. |
Countries
United States
Contacts
CONTACTMadeline R Sterling, MD, MPH, MS
PRINCIPAL_INVESTIGATORMadeline R Sterling, MD, MPH, MS
Weill Medical College of Cornell University
Outcome results
None listed