150 Participants Needed

Transitions of Care for Heart Failure

AB
TW
Overseen ByTina Wismar, MSN, FNP-BC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Hackensack Meridian Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The transition period from hospital to home is a time of heightened risk for patients to experience adverse events, medication errors, and readmission to the hospital. Patients at the highest risk include older adults and patients with low health literacy, socioeconomic disadvantages, and/or multiple comorbidities. This project proposes to expand the existing Transitions of Care Clinic (TOCC) which was recently introduced in our institution in 2024, to bridge the gap in care between hospital discharge to home and connect discharged patients to their outpatient providers with a focus on patients with heart failure (HF). The existing TOCC, a multidisciplinary team composed of a pharmacist and a nurse practitioner, seeks to improve the services that are currently being provided to patients and enhance the transitions of care process by providing patients with education, tools, and resources to help manage their chronic disease. With this study, we propose to expand TOCC by offering extensive education to patients via iPad videos and providing them with HF tool kits prior to their discharge. We will also assist with scheduling follow appointments with their outpatient providers and follow up with patients after the appointment takes place to re-evaluate their needs and reinforce self management of heart failure. By targeting patients being treated for acute exacerbation of heart failure with preserved ejection fraction (HFpEF), this study aims to facilitate the transition of care, reduce hospital readmissions and improve patients' quality of life and satisfaction. Patients with HFpEF represent a majority of the HF patients that are readmitted at OUMC. HFpEF patients have fewer guideline recommended treatments and represent a vulnerable patient population. The HF tool kits will provide these patients with the essential tools, resources, and log sheets for self-management such as monitoring daily weights, monitoring blood pressure and heart rate. Patients provided with a kit will receive an initial phone call from TOCC within 1 to 3 days of discharge and a second phone call within 21-24-days post discharge.

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 focuses on providing education and resources for managing heart failure after hospital discharge.

What data supports the effectiveness of the HF Kit treatment for heart failure?

The research highlights that effective transitional care interventions, such as early symptom identification and follow-up appointments, improve quality of life and reduce hospitalizations for heart failure patients. Additionally, participation in performance improvement registries has been associated with better use of recommended therapies and improved outcomes for heart failure patients.12345

Is the HF Kit treatment generally safe for humans?

Research shows that heart failure treatments can have serious adverse events (unwanted side effects), especially in older adults, but specific safety data for the HF Kit is not detailed in the available studies.678910

What makes the HF Kit treatment unique for heart failure?

The HF Kit treatment is unique because it focuses on improving the transition of care from hospital to home for heart failure patients, which is a high-risk period for re-hospitalization and death. It combines healthcare services and interventions, such as early symptom identification and follow-up care, to enhance patient understanding and management of their condition, unlike standard treatments that may not emphasize transitional care.13111213

Research Team

AB

Alexandria Berns, PharmD

Principal Investigator

Hackensack Meridian Health

Eligibility Criteria

The TOCC program is designed for patients with heart failure who are transitioning from hospital to home. It's especially aimed at older adults and those with low health literacy, socioeconomic challenges, or multiple health conditions. The goal is to help these individuals manage their condition better after they leave the hospital.

Inclusion Criteria

Patient discharged home
I was hospitalized for worsening heart failure with normal heart pumping function.

Exclusion Criteria

Leave against medical advice (AMA)
I was discharged to a care facility.
I was discharged from the hospital with homecare support.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Education and Discharge Preparation

Participants receive extensive education via iPad videos and are provided with HF tool kits prior to discharge

During hospital stay
In-hospital education session

Initial Follow-up

Participants receive an initial phone call from TOCC within 1 to 3 days of discharge to assess needs and reinforce self-management

1-3 days post discharge
1 phone call

Secondary Follow-up

Participants receive a second phone call from TOCC within 21-24 days post discharge to re-evaluate needs and reinforce self-management

21-24 days post discharge
1 phone call

Follow-up

Participants are monitored for satisfaction and readmission rates, with a focus on reducing hospital readmissions and improving quality of life

31-45 days post discharge

Treatment Details

Interventions

  • HF Kit
Trial Overview This trial tests an expanded Transitions of Care Clinic (TOCC) approach that includes providing heart failure kits and follow-up calls to patients. Education via iPad videos and tools for self-management like weight scales and fluid intake monitors are part of the kit.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Active Cohort - Heart Failure (HF) KitExperimental Treatment1 Intervention
Extensive education to patients via iPad videos and providing them with HF kits prior to their discharge. Structured follow up post discharge and linkage to care.
Group II: Historical controlsActive Control1 Intervention
Standard of care education and follow up

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials
141
Recruited
42,900+

New Jersey Health Foundation

Collaborator

Trials
3
Recruited
220+

New Jersey Health Foundation

Collaborator

Findings from Research

Participation in heart failure (HF) performance improvement registries, such as ADHERE and OPTIMIZE-HF, has led to significant enhancements in the use of guideline-recommended therapies for HF, improving patient care in both hospital and outpatient settings.
These registries have not only improved adherence to quality measures but have also resulted in better clinical outcomes for patients with HF, helping to reduce disparities in care.
Improving quality of care and outcomes for heart failure. -Role of registries-.Fonarow, GC.[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.
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]
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.
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]

References

Heart Failure: Priorities for Transition to Home. [2023]
Improving quality of care and outcomes for heart failure. -Role of registries-. [2022]
Knowledge to action: Rationale and design of the Patient-Centered Care Transitions in Heart Failure (PACT-HF) stepped wedge cluster randomized trial. [2019]
Variability in Implementation of Interventions Aimed at Reducing Readmissions Among Patients With Heart Failure: A Survey of Teaching Hospitals. [2018]
Trends in quality of care among patients with incident heart failure in Denmark 2003-2010: a nationwide cohort study. [2022]
Characterization and prediction of adverse events from intensive chronic heart failure management and effect on quality of life: results from the pro-B-type natriuretic peptide outpatient-tailored chronic heart failure therapy (PROTECT) study. [2015]
Evolving therapies for the management of chronic and acute decompensated heart failure. [2021]
Can medications be safely withdrawn in patients with stable chronic heart failure? systematic review and meta-analysis. [2022]
Adverse drug events and associated factors in heart failure therapy among the very elderly. [2021]
Adverse drug reaction-related hospitalisations among patients with heart failure at two hospitals in the United Arab Emirates. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Care transitions in elderly heart failure patients: current practices and the pharmacist's role. [2016]
12.United Statespubmed.ncbi.nlm.nih.gov
Effect of Nurse-Implemented Transitional Care for Chinese Individuals with Chronic Heart Failure in Hong Kong: A Randomized Controlled Trial. [2015]
13.United Statespubmed.ncbi.nlm.nih.gov
Transitions of care in heart failure: a scientific statement from the American Heart Association. [2022]
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