The SUCCEED Trial of Secondary Stroke Prevention

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

Secondary Stroke Prevention

Stroke

Treatments

Behavioral: Usual Care

Behavioral: Care Management+Community Health Worker

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01763203

U54NS081764 (U.S. NIH Grant/Contract)

5155 U54-NS081764

Details and patient eligibility

About

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.

Full 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.

Enrollment

487 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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