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

Johns Hopkins University

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Heart Failure Self Care Support; Other: Usual heart failure care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01141907

R21NR011056 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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11 participants in 2 patient groups

Heart Failure Self Care Support

Experimental group

Description:

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.

Treatment:

Behavioral: Heart Failure Self Care Support

Usual Heart Failure Care

Active Comparator group

Description:

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.

Treatment:

Other: Usual heart failure care