Trial Outcomes & Findings for Nurse-Led Heart Failure Care Transition Intervention for African Americans: The Navigator Program (NCT NCT01141907)

NCT ID: NCT01141907

Last Updated: 2019-02-19

Results Overview

Rehospitalization with primary diagnosis of heart failure

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 3 months post enrollment
• Results posted on: 2019-02-19

Participant Flow

Participant milestones

Measure	Heart Failure Self Care Support Navigator Team Intervention: The intervention is aimed at controlling heart failure (HF) and preventing exacerbations and hospitalizations by improving self management behaviors with the support of the Home Automated Telemonitoring (HAT) system. The intervention will be 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 will be initiated during the index hospitalization or as soon as possible after randomization. The RN-CHN team will collaborate with the participants, their caregivers, and their usual source of HF care. Intervention strategies include tracking of weight and HF symptoms to provide automated feedback regarding self management and plan of care, enhancing medication and symptom self management, promoting HF care follow up, and using a patient centered record to promote communication with providers.	Usual Heart Failure Care 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.
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Heart Failure Self Care Support n=6 Participants 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.	Usual Heart Failure Care n=5 Participants 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.	Total n=11 Participants Total of all reporting groups
Age, Continuous	63.7 years STANDARD_DEVIATION 7.4 • n=5 Participants	56.8 years STANDARD_DEVIATION 18.83 • n=7 Participants	60.55 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post enrollment

Rehospitalization with primary diagnosis of heart failure

Outcome measures

Measure	Heart Failure Self Care Support n=6 Participants 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.	Usual Heart Failure Care n=5 Participants 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.
Rehospitalization	2 hospital readmisions	6 hospital readmisions

Adverse Events

Heart Failure Self Care Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Heart Failure Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cheryl Dennison

Johns Hopkins University

Phone: 443-287-4174

Email: cdennis4@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place