Randomized controlled trial of a coordinated care intervention to improve risk factor control after stroke or transient ischemic attack in the safety net: Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities (SUCCEED).
BACKGROUND
Recurrent strokes are preventable through awareness and control of risk factors such as hypertension, and through lifestyle changes such as healthier diets, greater physical activity, and smoking cessation. However, vascular risk factor control is frequently poor among stroke survivors, particularly among socio-economically disadvantaged blacks, Latinos and other people of color. The Chronic Care Model (CCM) is an effective framework for multi-component interventions aimed at improving care processes and outcomes for individuals with chronic disease. In addition, community health workers (CHWs) have played an integral role in reducing health disparities; however, their effectiveness in reducing vascular risk among stroke survivors remains unknown. Our objectives are to develop, test, and assess the economic value of a CCM-based intervention using an Advanced Practice Clinician (APC)-CHW team to improve risk factor control after stroke in an under-resourced, racially/ethnically diverse population.


METHODS
In this single-blind randomized controlled trial, 516 adults (≥40 years) with an ischemic stroke, transient ischemic attack or intracerebral hemorrhage within the prior 90 days are being enrolled at five sites within the Los Angeles County safety-net setting and randomized 1:1 to intervention vs usual care. Participants are excluded if they do not speak English, Spanish, Cantonese, Mandarin, or Korean or if they are unable to consent. The intervention includes a minimum of three clinic visits in the healthcare setting, three home visits, and Chronic Disease Self-Management Program group workshops in community venues. The primary outcome is blood pressure (BP) control (systolic BP <130 mmHg) at 1 year. Secondary outcomes include: (1) mean change in systolic BP; (2) control of other vascular risk factors including lipids and hemoglobin A1c, (3) inflammation (C reactive protein [CRP]), (4) medication adherence, (5) lifestyle factors (smoking, diet, and physical activity), (6) estimated relative reduction in risk for recurrent stroke or myocardial infarction (MI), and (7) cost-effectiveness of the intervention versus usual care.


CONCLUSIONS
If this multi-component interdisciplinary intervention is shown to be effective in improving risk factor control after stroke, it may serve as a model that can be used internationally to reduce race/ethnic and socioeconomic disparities in stroke in resource-constrained settings.


BACKGROUND
ClinicalTrials.gov Identifier NCT01763203 .
Los Angeles County Department of Health Services, Los Angeles, California, USA. towfighi@usc.edu.|University of Southern California, Los Angeles, California, USA. towfighi@usc.edu.|Rancho Los Amigos National Rehabilitation Center, Downey, California, USA. towfighi@usc.edu.
Amytis
http://orcid.org/0000-0002-9565-6787
A
Towfighi
University of California, Los Angeles (UCLA), Los Angeles, California, USA.
Eric M
EM
Cheng
Rancho Los Amigos National Rehabilitation Center, Downey, California, USA.|University of California, Los Angeles (UCLA), Los Angeles, California, USA.
Monica
M
Ayala-Rivera
University of California, Los Angeles (UCLA), Los Angeles, California, USA.
Heather
H
McCreath
University of Southern California, Los Angeles, California, USA.|Los Angeles County-University of Southern California (USC) Medical Center, Los Angeles, California, USA.
Nerses
N
Sanossian
Rancho Los Amigos National Rehabilitation Center, Downey, California, USA.|Kaiser Permanente, Sacramento, California, USA.
Tara
T
Dutta
University of California, Los Angeles (UCLA), Los Angeles, California, USA.|Harbor-UCLA Medical Center, Torrance, California, USA.
Bijal
B
Mehta
University of California, Los Angeles (UCLA), Los Angeles, California, USA.|Olive View-UCLA Medical Center, Sylmar, California, USA.
Robert
R
Bryg
University of California, Los Angeles (UCLA), Los Angeles, California, USA.|Olive View-UCLA Medical Center, Sylmar, California, USA.
Neal
N
Rao
Cedars Sinai Medical Center, Los Angeles, California, USA.
Shlee
S
Song
Rancho Los Amigos National Rehabilitation Center, Downey, California, USA.|Kaiser Permanente, Irvine, California, USA.
Ali
A
Razmara
Fielding School of Public Health, Department of Health Policy and Management, University of California, Los Angeles, Los Angeles, California, USA.
Magaly
M
Ramirez
University of Southern California, Los Angeles, California, USA.|Rancho Los Amigos National Rehabilitation Center, Downey, California, USA.
Theresa
T
Sivers-Teixeira
Harbor-UCLA Medical Center, Torrance, California, USA.
Jamie
J
Tran
Rancho Los Amigos National Rehabilitation Center, Downey, California, USA.|Los Angeles County-University of Southern California (USC) Medical Center, Los Angeles, California, USA.
Elizabeth
E
Mojarro-Huang
Rancho Los Amigos National Rehabilitation Center, Downey, California, USA.|Harbor-UCLA Medical Center, Torrance, California, USA.|Olive View-UCLA Medical Center, Sylmar, California, USA.
Ana
A
Montoya
Los Angeles County Department of Health Services, Los Angeles, California, USA.|Rancho Los Amigos National Rehabilitation Center, Downey, California, USA.
Marilyn
M
Corrales
Rancho Los Amigos National Rehabilitation Center, Downey, California, USA.|Harbor-UCLA Medical Center, Torrance, California, USA.
Beatrice
B
Martinez
Watts Labor Community Action Committee, Watts, California, USA.
Phyllis
P
Willis
Worker Education and Resource Center, Los Angeles, California, USA.
Mireya
M
Macias
Esperanza Community Housing, Los Angeles, California, USA.
Nancy
N
Ibrahim
School of Social Work, Edward R. Roybal Institute on Aging, and Daniel J. Epstein Department of Industrial and Systems Engineering, University of Southern California, Los Angeles, California, USA.|RAND Corporation, Santa Monica, California, USA.
Shinyi
S
Wu
Dimagi, Inc., Cambridge, Massachusetts, USA.
Jeremy
J
Wacksman
Dimagi, Inc., Cambridge, Massachusetts, USA.
Hilary
H
Haber
University of California, Los Angeles (UCLA), Los Angeles, California, USA.
Adam
A
Richards
University of California, Los Angeles (UCLA), Los Angeles, California, USA.
Frances
F
Barry
Rancho Los Amigos National Rehabilitation Center, Downey, California, USA.
Valerie
V
Hill
Department of Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA.
Brian
B
Mittman
University of California, Los Angeles (UCLA), Los Angeles, California, USA.
William
W
Cunningham
University of California, Los Angeles (UCLA), Los Angeles, California, USA.
Honghu
H
Liu
University of California, Los Angeles (UCLA), Los Angeles, California, USA.|RAND Corporation, Santa Monica, California, USA.|Department of Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, USA.
David A
DA
Ganz
Worker Education and Resource Center, Los Angeles, California, USA.
Diane
D
Factor
University of California, Los Angeles (UCLA), Los Angeles, California, USA.|Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Barbara G
BG
Vickrey
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002543:Cerebral Hemorrhage / Q000517:prevention & control*; D003153:Community Health Services / Q000379:methods*; D054625:Healthcare Disparities; D006801:Humans; D002546:Ischemic Attack, Transient / Q000517:prevention & control*; D015141:Los Angeles; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D012307:Risk Factors; D064876:Safety-net Providers / Q000379:methods*; D055502:Secondary Prevention / Q000379:methods*; D016037:Single-Blind Method; D020521:Stroke / Q000517:prevention & control*
Biomarkers; Blood pressure; Community health worker; Coordinated care; Disparities; Intracerebral hemorrhage; NINDS Common Data Elements; Stroke; Transient ischemic attack; Vascular risk