Home Care Improvement Intervention for Heart Failure

(I-TRANSFER-HF Trial)

Recruiting at 1 trial location

Overseen By Madeline R Sterling, MD, MPH, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: End stage renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1154 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment I-TRANSFER-HF for heart failure patients?

Research shows that home health interventions, like CareNavRN, can improve heart failure patients' knowledge, self-care, and quality of life, and may reduce hospital readmissions. Although the results were not statistically significant, they suggest that such interventions could be beneficial during the transition from hospital to home. ^{1 2 3 4 5}

Is the Home Care Improvement Intervention for Heart Failure safe for humans?

The available research focuses on the effectiveness of transitional care services for heart failure patients but does not provide specific safety data for the Home Care Improvement Intervention or its related programs. ^{2 5 6 7 8}

What makes the I-TRANSFER-HF treatment unique for heart failure patients?

The I-TRANSFER-HF treatment is unique because it focuses on improving the transition from hospital to home for heart failure patients by using specially trained home health nurses who visit patients weekly for four weeks. This approach aims to reduce hospital readmissions and improve patients' knowledge, self-care, and quality of life, which is different from standard treatments that may not provide such personalized, ongoing support at home. ^{2 3 6 9 10}

Research Team

Madeline R Sterling, MD, MPH, MS

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: I-TRANSFER-HF Experimental Treatment 1 Intervention

This is a 1-year long intervention period when I-TRANSFER-HF is in operation.

Group II: Standard of Care (usual care) Active Control 1 Intervention

This is a baseline period of usual care (UC) with no intervention.

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+

Findings from Research

In a study involving 2494 adults hospitalized for heart failure, a patient-centered transitional care model did not significantly reduce hospital readmissions or emergency department visits compared to usual care.

However, the intervention improved patients' preparedness for discharge and quality of transition, indicating benefits in patient experience despite no change in clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure: The PACT-HF Randomized Clinical Trial. Van Spall, HGC., Lee, SF., Xie, F., et al.[2020]

A project in a São Paulo cardiology hospital showed that compliance with best practices for transitional care in heart failure patients improved significantly after implementing targeted strategies, including nurse training and revised discharge procedures.

Before the intervention, compliance was zero for five out of six criteria, but after the intervention, compliance reached 100% for those criteria, demonstrating the effectiveness of the implemented strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitional care from the hospital to the home in heart failure: implementation of best practices. Nakahara-Melo, M., Conceição, APD., Cruz, DALMD., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The PRADO-IC transition care programme aims to reduce heart failure readmissions by 30% through administrative assistance and nurse follow-up for 2 to 6 months, with a study involving 404 patients planned to assess its cost-effectiveness and clinical outcomes.

This mixed-method study design combines quantitative and qualitative analyses to evaluate the implementation of the programme across six centers, providing valuable insights for decision-makers on improving care coordination for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRADOC: a trial on the efficiency of a transition care management plan for hospitalized patients with heart failure in France. Duflos, C., Labarre, JP., Ologeanu, R., et al.[2022]

The PACT-HF transitional care model aims to improve outcomes for heart failure patients by providing comprehensive self-care education, multidisciplinary care, and early follow-up, with a focus on high-risk patients receiving additional nurse-led home visits.

This study will analyze data from approximately 3200 patients across 10 hospitals to assess the effectiveness of the intervention on reducing hospital readmissions and improving patient-centered outcomes, linking clinical data with administrative databases for a thorough evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge to action: Rationale and design of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) stepped wedge cluster randomized trial. Van Spall, HGC., Lee, SF., Xie, F., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Transitional care programs for heart failure patients aim to improve the shift from hospital to home, but current research shows a lot of variability in how these programs are designed and evaluated, making it hard to determine their effectiveness.

There is a need for more focused research on specific transitional care interventions to identify best practices that are both clinically effective and economically feasible for managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitions of care in heart failure: a scientific statement from the American Heart Association. Albert, NM., Barnason, S., Deswal, A., et al.[2022]

Heart failure is a serious and progressive condition that leads to high mortality and frequent hospitalizations, highlighting the need for effective management strategies.

Implementing best practices in clinical care, self-management support, and care transitions can significantly improve patient outcomes and reduce healthcare costs for heart failure patients in home care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best practices for heart failure: a focused review. Suter, PM., Gorski, LA., Hennessey, B., et al.[2016]

A survey of 17 teaching hospitals revealed that 94% responded, showing a wide range of interventions aimed at reducing heart failure patient readmissions, with an average of 10.9 interventions at an advanced implementation stage.

Predischarge interventions were more commonly implemented than bridging or postdischarge interventions, indicating a focus on improving care transitions before patients leave the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in Implementation of Interventions Aimed at Reducing Readmissions Among Patients With Heart Failure: A Survey of Teaching Hospitals. Vasilevskis, EE., Kripalani, S., Ong, MK., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Patient-Centered Transitional Care Services on Clinical Outcomes in Patients Hospitalized for Heart Failure: The PACT-HF Randomized Clinical Trial. [2020]

2. Brazil pubmed.ncbi.nlm.nih.gov

Transitional care from the hospital to the home in heart failure: implementation of best practices. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Testing the Effect of a Home Health Heart Failure Intervention on Hospital Readmissions, Heart Failure Knowledge, Self-Care, and Quality of Life. [2021]

4. England pubmed.ncbi.nlm.nih.gov

PRADOC: a trial on the efficiency of a transition care management plan for hospitalized patients with heart failure in France. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Knowledge to action: Rationale and design of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) stepped wedge cluster randomized trial. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of transitional care services in patients discharged from the hospital with heart failure: a systematic review and network meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Transitions of care in heart failure: a scientific statement from the American Heart Association. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Best practices for heart failure: a focused review. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Variability in Implementation of Interventions Aimed at Reducing Readmissions Among Patients With Heart Failure: A Survey of Teaching Hospitals. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of nurse-led transitional care interventions for patients with heart failure on healthcare utilization: A meta-analysis of randomized controlled trials. [2022]