Transitions of Care for Heart Failure

Overseen By Tina Wismar, MSN, FNP-BC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hackensack Meridian Health

Disqualifiers: Dementia, Hemodialysis, Hospice, others

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

Compensation: Varies

Number of Visits: 2

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the transition from hospital to home for patients with heart failure, specifically those with HFpEF (a type of heart failure where the heart can't properly fill with blood). The study provides patients with educational videos on iPads, heart failure tool kits for self-care, and organized follow-ups to reduce hospital readmissions and enhance quality of life. Patients hospitalized for heart failure at Ocean University Medical Center and returning home may qualify. As an unphased trial, this study offers patients the opportunity to actively participate in improving heart failure care and potentially enhance their own recovery experience.

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 prior data suggests that this protocol is safe for heart failure patients?

Research has shown that adding tools and education for patients in heart failure care is safe and well-received. One study found that managing heart failure at home led to benefits such as shorter hospital stays and high patient satisfaction, with no major safety issues. Another study demonstrated that using digital tools in heart failure care is both safe and effective. These findings suggest that providing heart failure kits, which include educational resources and tools for self-care, safely helps patients manage their condition after leaving the hospital. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HF Kit because it offers a fresh approach to managing heart failure after hospital discharge. Unlike the standard of care, which typically involves basic education and follow-up, the HF Kit provides patients with extensive educational support through engaging iPad videos and equips them with a comprehensive kit designed to aid in their recovery. This method aims to improve transitions of care by ensuring patients have the tools and knowledge they need right from the start, potentially reducing readmission rates and improving outcomes.

What evidence suggests that the HF Kit is effective for heart failure?

Research has shown that certain care programs can reduce hospital visits and the risk of death for heart failure patients. In this trial, participants in the active cohort will receive thorough education and support through the HF Kit, which studies have shown leads to better health outcomes. These kits provide tools and resources for managing health, such as tracking daily weight and blood pressure, crucial for patients with heart failure with preserved ejection fraction (HFpEF). Other studies have demonstrated that organized follow-up care after hospital discharge can significantly reduce the likelihood of readmission. This approach empowers patients to manage their condition, potentially improving their quality of life. ^{2 4 6 7 8}

Who Is on the Research Team?

Alexandria Berns, PharmD

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Active Cohort - Heart Failure (HF) Kit Experimental Treatment 1 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 controls Active Control 1 Intervention

Standard of care education and follow up

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

Published Research Related to This Trial

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]

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]

Sacubitril-valsartan has been shown to significantly reduce cardiovascular mortality and hospitalizations related to heart failure, highlighting its efficacy as a new treatment option.

Other emerging therapies like ivabradine and ferric carboxymaltose have also proven effective in reducing hospitalizations for heart failure, indicating a promising expansion of treatment options for managing chronic heart failure and acute decompensated heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving therapies for the management of chronic and acute decompensated heart failure. Cook, JC., Tran, RH., Patterson, JH., et al.[2021]

Among 511 heart failure patient admissions, 6.7% were due to adverse drug reactions (ADRs), with over one-third of these hospitalizations deemed preventable.

The study found that the number of medications taken by heart failure patients was a significant predictor of ADR-related hospitalizations, with diuretics being the most common drugs involved, leading to issues like volume depletion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reaction-related hospitalisations among patients with heart failure at two hospitals in the United Arab Emirates. Saheb Sharif-Askari, N., Syed Sulaiman, SA., Saheb Sharif-Askari, F., 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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving quality of care and outcomes for heart failure. -Role of registries-. Fonarow, GC.[2022]

From 2003 to 2010, the use of recommended care processes for heart failure patients in Denmark significantly increased, including echocardiography and beta-blocker prescriptions, which are crucial for managing the condition.

During the same period, the 1-year mortality rate for heart failure patients decreased from 20.5% to 12.8%, suggesting that improved adherence to care guidelines may have contributed to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in quality of care among patients with incident heart failure in Denmark 2003-2010: a nationwide cohort study. Nakano, A., Johnsen, SP., Frederiksen, BL., et al.[2022]

Adverse drug events (ADEs) are common in older adults (over 75 years) receiving heart failure therapy, with 57% of studies reporting such events, particularly with beta blockers and spironolactone.

Factors like advanced age, poor left ventricular function, and higher New York Heart Association Class are associated with increased ADEs, indicating a need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events and associated factors in heart failure therapy among the very elderly. Sztramko, R., Chau, V., Wong, R.[2021]

In a study of 151 patients with systolic heart failure followed for about 10 months, treatment-related serious adverse events (SAEs) were common, but there was no significant difference in SAEs between those receiving NT-proBNP-guided care and standard care.

Patients who experienced SAEs had poorer quality of life and less improvement in heart function, and a risk score was developed to help predict which patients might be at higher risk for these adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Gandhi, PU., Szymonifka, J., Motiwala, SR., et al.[2015]

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