1094 Participants Needed

Home Care Improvement Intervention for Heart Failure

(I-TRANSFER-HF Trial)

Recruiting at 1 trial location
MR
Overseen ByMadeline R Sterling, MD, MPH, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Weill Medical College of Cornell University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with heart failure transition smoothly from hospital to home care. Named I-TRANSFER-HF, it combines early visits from home health nurses with outpatient medical appointments to determine if it can reduce hospital readmissions within 30 days. The study aims to assess the effectiveness and practicality of this plan in real-life settings. Suitable participants are those currently hospitalized for heart failure who will receive home health care after discharge. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance transitions from hospital to home.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on improving care transitions rather than changing medication regimens.

What prior data suggests that I-TRANSFER-HF is safe for heart failure patients?

Research shows that the I-TRANSFER-HF treatment aims to ease the transition from hospital to home for people with heart failure. Nurses visit patients at home early and schedule prompt follow-up medical appointments.

Specific data on the safety of I-TRANSFER-HF is not available because it focuses on better care organization, not a new drug or device. Generally, programs like this aim to improve care delivery and are considered low-risk. Since the study evaluates I-TRANSFER-HF in everyday settings, it suggests minimal safety concerns.

The trial setup indicates likely safety, as it employs existing healthcare practices rather than introducing new medical treatments.12345

Why are researchers excited about this trial?

Researchers are excited about the I-TRANSFER-HF intervention because it offers a novel approach to managing heart failure at home. Unlike traditional treatments that primarily involve regular hospital visits and medication management, I-TRANSFER-HF leverages digital health tools and personalized care plans to improve patient outcomes right from their homes. This innovative method aims to enhance patient engagement and adherence to treatment protocols by providing real-time health monitoring and tailored support. By shifting the focus to home-based care, I-TRANSFER-HF may reduce hospital readmissions and improve the quality of life for heart failure patients, making it a promising development in heart failure management.

What evidence suggests that I-TRANSFER-HF is effective for improving the hospital-to-home transition for heart failure patients?

Research has shown that early visits from home health nurses and timely follow-up doctor appointments can reduce hospital readmissions for heart failure patients. In this trial, the I-TRANSFER-HF program, which participants may receive, combines these steps to ease the transition from hospital to home. Studies have found that similar programs lower the chances of patients returning to the hospital within 30 days. By improving coordination between hospitals and home care services, I-TRANSFER-HF aims to keep heart failure patients healthier at home. Early results suggest this approach could be more effective than standard care, another arm of this trial, in preventing early readmissions.13456

Who Is on the Research Team?

MR

Madeline R Sterling, MD, MPH, MS

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults hospitalized with heart failure transitioning from certain hospitals to home health care (HHC) services. It includes healthcare professionals involved in this transition process at participating hospital-HHC pairs. Excluded are patients discharged elsewhere, on dialysis, or with left ventricular devices.

Inclusion Criteria

I am a healthcare professional working on transitioning heart failure patients from hospital to home care.
Adults who are hospitalized for heart failure and are moved from the hospital to a partnering home health care agency during the study.

Exclusion Criteria

I am not a healthcare professional managing heart failure patient transitions from hospital to home care.
I was hospitalized for heart failure and have been discharged to a facility or home without home health care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of I-TRANSFER-HF, combining early home health nurse visits and outpatient medical appointments

12 months
Regular visits as per intervention protocol

Follow-up

Participants are monitored for safety and effectiveness after intervention

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • I-TRANSFER-HF
Trial Overview The I-TRANSFER-HF intervention aims to improve the transition from hospital to home care for heart failure patients. The study compares outcomes before and after its implementation and assesses how well it works in real-world settings by preventing rehospitalization within 30 days.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: I-TRANSFER-HFExperimental Treatment1 Intervention
Group II: Standard of Care (usual care)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

University of Colorado, Denver

Collaborator

Trials
1,842
Recruited
3,028,000+

NYU Langone Health

Collaborator

Trials
1,431
Recruited
838,000+

University of California, San Diego

Collaborator

Trials
1,215
Recruited
1,593,000+

Published Research Related to This Trial

The CareNavRN™ intervention, involving specialized home health nurse visits for 4 weeks, showed a reduction in 30-day hospital readmission rates for heart failure patients, with 16% in the intervention group compared to 29% in the control group, although the results were not statistically significant due to small sample size.
Participants in the intervention group demonstrated significant improvements in heart failure knowledge, self-care confidence, and quality of life, indicating that CareNavRN™ may enhance patient outcomes during the transition from hospital to home.
Testing the Effect of a Home Health Heart Failure Intervention on Hospital Readmissions, Heart Failure Knowledge, Self-Care, and Quality of Life.Leavitt, MA., Hain, DJ., Keller, KB., et al.[2021]
Nurse home visits were found to be the most effective transitional care service in reducing all-cause mortality and readmissions after hospitalization for heart failure, with a relative risk of 0.78 for mortality and an incident rate ratio of 0.65 for readmissions based on a meta-analysis of 53 randomized controlled trials involving 12,356 patients.
Disease management clinics (DMCs) also contributed to decreased mortality and readmissions, but nurse home visits provided the greatest cost savings, amounting to approximately $3,810, indicating that effective transitional care can also be economically beneficial.
Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure: a systematic review and network meta-analysis.Van Spall, HGC., Rahman, T., Mytton, O., et al.[2022]
Nurse-led transitional care interventions (TCIs) significantly reduced all-cause readmissions by 9% and HF-specific readmissions by 29% among 8422 heart failure patients, compared to usual care.
These interventions also shortened hospital stays by an average of 2.37 days, but did not significantly decrease emergency department visits, indicating a targeted effectiveness in reducing hospital readmissions rather than overall healthcare utilization.
Effects of nurse-led transitional care interventions for patients with heart failure on healthcare utilization: A meta-analysis of randomized controlled trials.Li, M., Li, Y., Meng, Q., et al.[2022]

Citations

Improving TRansitions ANd outcomeS for heart FailurE ...This study will use a Hybrid Type 1, stepped wedge randomized trial design, to test the effectiveness and implementation of I-TRANSFER-HF.
RePORT RePORTERTo advance the science and improve outcomes in HF, we will test an intervention called Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39354472/
a type 1 hybrid effectiveness-implementation trial: study protocolThis study will use a Hybrid Type 1, stepped wedge randomized trial design, to test the effectiveness and implementation of I-TRANSFER-HF.
Improving TRansitions ANd outcomeS for heart FailurE ...To advance the science and improve outcomes in HF, we will test the effectiveness and implementation of an intervention called Improving TRansitions ANd ...
Improving TRansitions ANd OutcomeS for Heart FailurE ...This study is trying to improve the hospital-to-home transition for people with heart failure who receive home care services.
Improving TRansitions ANd OutcomeS for Heart FailurE Patients ...Aim 1 will test the effectiveness of I-TRANSFER-HF to reduce 30-day readmissions (primary outcome) and ED visits (secondary outcome) and increase days at home ( ...
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