Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial

Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial

Trials, January 2015

25622823

Penny H Feldman, Margaret V McDonald, Melissa A Trachtenberg, Antoinette Schoenthaler, Noreen Coyne, Jeanne Teresi

BackgroundRacial and ethnic disparities persist in stroke occurrence, recurrence, morbidity and mortality. Uncontrolled hypertension (HTN) is the most important modifiable risk factor for stroke risk. Home health care organizations care for many patients with uncontrolled HTN and history of stroke; however, recurrent stroke prevention has not been a home care priority. We are conducting a randomized controlled trial (RCT) to compare the effectiveness, relative to usual home care (UHC), of two Community Transitions Interventions (CTIs). The CTIs aim to reduce recurrent stroke risk among post-stroke patients via home-based transitional care focused on better HTN management.Methods/DesignThis 3-arm trial will randomly assign 495 black and Hispanic post-stroke home care patients with uncontrolled systolic blood pressure (SBP) to one of three arms: UHC, UHC complemented by nurse practitioner-delivered transitional care (UHC¿+¿NP) or UHC complemented by an NP plus health coach (UHC¿+¿NP¿+¿HC). Both intervention arms emphasize: 1) linking patients to continuous, responsive preventive and primary care, 2) increasing patients¿/caregivers¿ ability to manage a culturally and individually tailored BP reduction plan, and 3) facilitating the patient¿s reintegration into the community after home health care discharge. The primary hypothesis is that both NP-only and NP¿+¿HC transitional care will be more effective than UHC alone in achieving a SBP reduction. The primary outcome is change in SPB at 3 and 12 months. The study also will examine cost-effectiveness, quality of life and moderators (for example, race/ethnicity) and mediators (for example, changes in health behaviors) that may affect treatment outcomes. All outcome data are collected by staff blinded to group assignment.DiscussionThis study targets care gaps affecting a particularly vulnerable black/Hispanic population characterized by persistent stroke disparities. It focuses on care transitions, a juncture when patients are particularly susceptible to adverse events. The CTI is innovative in adapting for stroke patients an established transitional care model shown to be effective for HF patients, pairing the professional NP with a HC, implementing a culturally tailored intervention, and placing primary emphasis on longer-term risk factor reduction and community reintegration rather than shorter-term transitional care outcomes.Trial registrationClinicalTrials.gov NCT01918891; Registered 5 August 2013.