Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities: the SUCCEED Trial

University of California, Los Angeles6 sites in 1 country487 target enrollmentFebruary 13, 2014

ConditionsStroke Secondary Stroke Prevention

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: University of California, Los Angeles
Enrollment: 487
Locations: 6
Primary Endpoint: Systolic Blood Pressure
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 13, 2014

End Date

February 11, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of California, Los Angeles

Responsible Party

Principal Investigator

Barbara Vickrey, MD, MPH

Principal Investigator

University of California, Los Angeles

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

Outcomes

Primary Outcomes

Systolic Blood Pressure

Time Frame: 12 months

Blood pressure at 12 months will be the primary outcome. Blood pressure will also be measured at baseline and at the 3-month mark to track blood pressure during the entire participation period.