Nurse-Led Heart Failure Care Transition Intervention for African Americans: The Navigator Program

January 30, 2019 updated by: Johns Hopkins University

Nurse-Led Heart Failure Care Transition Intervention for African Americans

Heart failure (HF) affects over 5 million Americans with HF morbidity reaching epidemic proportions. Annual rates of new and recurrent HF events including hospitalization and mortality are higher among African Americans. In this study, the investigators are testing an interdisciplinary model for heart failure care, with focus on enhancing self management and use of telehealth, which has significant potential to improve self management and outcomes.

The main purpose of this study is to learn how to help African Americans with heart failure care for themselves at home. We hope to find out if a team including a nurse and community health navigator using a computer telehealth device can help people with heart failure stay healthier. The team will help people with heart failure to manage their medication, monitor their symptoms and weigh themselves every day after they leave the hospital. The team will also help people with heart failure learn to solve problems that may keep them from following their treatment plan.

Study Overview

Status

Completed

Conditions

Heart Failure

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

hospitalized with admitting diagnosis of heart failure in prior 8 weeks
self-identified as African American
community-dwelling (i.e., not in a long-term care facility)
residence within a predefined radius in Baltimore City
working telephone in their home
provide signed informed consent

Exclusion Criteria:

cannot speak or understand English
severe renal insufficiency requiring dialysis
acute myocardial infarction within preceding 30 days
receiving home care services for HF post discharge
legally blind or have major hearing loss
screen positive for cognitive impairment on the Mini-cog at baseline
unable to stand independently on a weight scale (limited ability to participate in HAT system)
weigh more than 325 pounds (exceed scale capacity)
serious or terminal condition such as psychosis or cancer (actively receiving chemo or radiation)
pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Heart Failure Self Care Support The goal of the Heart Failure Self Care Support Intervention (Navigator Program), delivered by a nurse and community health navigator team over 3 months post discharge from the index hospitalization, was to improve care transitions by providing patients with tools and support that promote knowledge and skills for HF self care as they transition from hospital to home. The multifaceted Navigator Intervention included the following intervention components: HF home automated telemonitoring support, medication and symptom self management, patient-centered record, HF care follow up, and activation of key supporter.	Behavioral: Heart Failure Self Care Support The intervention is aimed at preventing HF exacerbations and hospitalizations by improving self management with the support of the Home Automated Telemonitoring (HAT) system. The intervention was delivered by a RN-community health navigator (CHN) team over three months to HF patients and their caregivers in their home and via telephone and HAT system. The intervention was initiated during the index hospitalization. The RN-CHN team collaborated with participants, caregivers, and their usual source of HF care. Intervention strategies included tracking of weight and HF symptoms to provide feedback regarding self management and plan of care, enhancing medication and symptom self management, promoting HF care follow up, and promoting communication with providers.
ACTIVE_COMPARATOR: Usual Heart Failure Care Usual care for HF patients included the following: 1) Referral to HF clinic if the patient has no usual source of HF outpatient care, 2) HF patient education by HF care coordinator (advanced practice nurse), and 3) HF self care guide. All participants were treated by their usual source of HF care in the usual manner.	Other: Usual heart failure care Participants assigned to usual care are treated by their usual source of HF care in the usual manner and in accordance with the American College of Cardiology/American Heart Association Guidelines for the management of HF. Usual care for HF patients admitted to Johns Hopkins Hospital also includes the following: 1) Referral to HF clinic if the patient has no usual source of care and 2) HF patient education booklet.

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Heart Failure Self Care Support

The goal of the Heart Failure Self Care Support Intervention (Navigator Program), delivered by a nurse and community health navigator team over 3 months post discharge from the index hospitalization, was to improve care transitions by providing patients with tools and support that promote knowledge and skills for HF self care as they transition from hospital to home. The multifaceted Navigator Intervention included the following intervention components: HF home automated telemonitoring support, medication and symptom self management, patient-centered record, HF care follow up, and activation of key supporter.

Behavioral: Heart Failure Self Care Support

The intervention is aimed at preventing HF exacerbations and hospitalizations by improving self management with the support of the Home Automated Telemonitoring (HAT) system. The intervention was delivered by a RN-community health navigator (CHN) team over three months to HF patients and their caregivers in their home and via telephone and HAT system. The intervention was initiated during the index hospitalization. The RN-CHN team collaborated with participants, caregivers, and their usual source of HF care. Intervention strategies included tracking of weight and HF symptoms to provide feedback regarding self management and plan of care, enhancing medication and symptom self management, promoting HF care follow up, and promoting communication with providers.

ACTIVE_COMPARATOR: Usual Heart Failure Care

Usual care for HF patients included the following: 1) Referral to HF clinic if the patient has no usual source of HF outpatient care, 2) HF patient education by HF care coordinator (advanced practice nurse), and 3) HF self care guide. All participants were treated by their usual source of HF care in the usual manner.

Other: Usual heart failure care

Participants assigned to usual care are treated by their usual source of HF care in the usual manner and in accordance with the American College of Cardiology/American Heart Association Guidelines for the management of HF. Usual care for HF patients admitted to Johns Hopkins Hospital also includes the following: 1) Referral to HF clinic if the patient has no usual source of care and 2) HF patient education booklet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehospitalization Time Frame: 3 months post enrollment	Rehospitalization with primary diagnosis of heart failure	3 months post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

Principal Investigator: Cheryl R Dennison, PhD, Johns Hopkins University School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (ESTIMATE)

June 11, 2010

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

R21NR011056 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Nurse-Led Heart Failure Care Transition Intervention for African Americans: The Navigator Program