Clinical trial NCT01763203: The SUCCEED Trial of Secondary Stroke Prevention
Official title: Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities: the SUCCEED Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Secondary Stroke Prevention
Keywords: Self-management
Chronic Care Model
Community health worker
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: Rancho Los Amigos National Rehabilitation Center
name: Olive View-UCLA Education & Research Institute
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: California Community Foundation
name: Cedars-Sinai Medical Center
First posted: 2013-01-08
Enrollment: 487
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to test a newly-developed outpatient clinic and community-based care intervention called SUCCEED (Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities) for improving control of stroke risk factors among stroke patients in the Los Angeles County "safety net", and to measure the costs of running such an intervention, relative to usual care.

Detailed description: Individuals randomized to the intervention arm will receive care from a team that consists of a care manager(CM) who is either a nurse practitioner (NP) or physician assistant (PA), supervised by the site PI, and a community health worker (CHW). The CM will follow care protocols developed by the research team. The CHW will serve as a liaison between the patient and the health care system, and mobilize resources and system support to reduce social isolation and improve stroke risk factor control self-management, through a series of workshops and home visits. Intervention participants will receive home blood pressure monitors. Subjects in either arm are eligible to receive their usual source of care. Five hundred participants who have had a stroke or TIA will be enrolled, randomized to the intervention or to usual care in a 1:1 ratio, and followed for 12 months. The impact of the intervention on systolic blood pressure is the primary study outcome; secondary outcomes are other stroke risk factors. Enrollment will occur at four sites in Los Angeles County, and the study sample is projected to include over 90% socioeconomically disadvantaged individuals from minority groups.

Eligibility criteria: Inclusion Criteria:

* Patients of Los Angeles County+University of Southern California (LAC-USC), Rancho Los Amigos, Olive View-University of California, Los Angeles (UCLA), or Harbor-UCLA
* Transient ischemic attack (TIA), ischemic stroke or hemorrhagic stroke within the prior 90 days
* English, Spanish, Korean, Mandarin or Cantonese-speaking
* 40 years of age or older
* Capable of giving informed consent (no proxies will be used to obtain consent)
* Systolic blood pressure is 130 mm Hg or greater OR Systolic blood pressure is between 120 mm Hg and 130 mm Hg and there is diagnosed/treated hypertension prior to the stroke or TIA

Exclusion Criteria:

* Younger than 40 years
* Systolic Blood Pressure less than 120 mm Hg OR systolic blood pressure is between 120 mm Hg and 130 mm Hg and there is no known history of hypertension prior to the stroke or TIA
* Speaks language other than English, Spanish, Korean, Mandarin, and Cantonese
* Inability to comprehend the study because of communication or cognitive impairments

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 12 months
Secondary outcomes:
measure: Dyslipidemia
timeFrame: 12 months
measure: Percentage of Glycated Hemoglobin (Hemoglobin A1C)
timeFrame: 12 months
measure: Inflammation: C-reactive Protein
timeFrame: 12 months
measure: Body Mass Index
timeFrame: 12 months
measure: Waist Circumference
timeFrame: 12 months
measure: Physical Activity
timeFrame: 12 months
measure: Salt Intake
timeFrame: 12 months
measure: Soda Intake
timeFrame: 12 months
measure: Fruit and Vegetable Intake
timeFrame: 12 months
measure: Smoking
timeFrame: 12 months
measure: Knowledge About Stroke Signs
timeFrame: 12 months
measure: Knowledge About Stroke Risk Factors
timeFrame: 12 months
measure: Patient Perception of Quality of Stroke Preventative Care
timeFrame: 12 months
measure: Vascular Events
timeFrame: 12 months
measure: Medication Adherence - Global
timeFrame: 12 Months
measure: Medication Adherence - Blood Pressure Medication
timeFrame: 12 Months
measure: Medication Adherence - Cholesterol Medication
timeFrame: 12 months
measure: Medication Adherence - Antithrombotic Medication
timeFrame: 12 months
measure: Medication Adherence - Antidepressant Medication
timeFrame: 12 months
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Barbara G Vickrey, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: USC - Department of Neurology. Rancho Los Amigos National Rehabilitation Center
name: Amytis Towfighi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Towfighi A, Cheng EM, Ayala-Rivera M, McCreath H, Sanossian N, Dutta T, Mehta B, Bryg R, Rao N, Song S, Razmara A, Ramirez M, Sivers-Teixeira T, Tran J, Mojarro-Huang E, Montoya A, Corrales M, Martinez B, Willis P, Macias M, Ibrahim N, Wu S, Wacksman J, Haber H, Richards A, Barry F, Hill V, Mittman B, Cunningham W, Liu H, Ganz DA, Factor D, Vickrey BG. 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). BMC Neurol. 2017 Feb 6;17(1):24. doi: 10.1186/s12883-017-0792-7.
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citation: Towfighi A, Cheng EM, Ayala-Rivera M, Barry F, McCreath H, Ganz DA, Lee ML, Sanossian N, Mehta B, Dutta T, Razmara A, Bryg R, Song SS, Willis P, Wu S, Ramirez M, Richards A, Jackson N, Wacksman J, Mittman B, Tran J, Johnson RR, Ediss C, Sivers-Teixeira T, Shaby B, Montoya AL, Corrales M, Mojarro-Huang E, Castro M, Gomez P, Munoz C, Garcia D, Moreno L, Fernandez M, Lopez E, Valdez S, Haber HR, Hill VA, Rao NM, Martinez B, Hudson L, Valle NP, Vickrey BG; Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) Investigators. Effect of a Coordinated Community and Chronic Care Model Team Intervention vs Usual Care on Systolic Blood Pressure in Patients With Stroke or Transient Ischemic Attack: The SUCCEED Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2036227. doi: 10.1001/jamanetworkopen.2020.36227.
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