Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to Stay Within the Guidelines

Study Overview
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Brief Summary
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The purpose of this study is to test a newly developed outpatient care intervention called SUSTAIN (Systematic Use of Stroke Averting Interventions) for improving delivery of stroke preventive services at Los Angeles County hospitals and to measure the costs of running such an intervention.

Detailed Description
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Patients randomized to SUSTAIN will participate in group clinics about stroke, given self-management tools about stroke, and will be called by nurse practitioners to coordinate their stroke care. Patients randomized to the control arm will be mailed educational materials about stroke. Subjects in either arm are eligible to receive their usual source of care.

Official Title
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RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to Stay Within the Guidelines (SUSTAIN)

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Care Management
* Behavioral: Written Materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of LAC+USC, Rancho Los Amigos, Olive View-UCLA, or Harbor-UCLA Patients who have had an acute transient ischemic attack (TIA) or ischemic stroke or carotid procedure within the last six months English or Spanish speaking At least 40 years of age Capable of giving informed consent (no proxies will be used to obtain consent) Blood pressure not optimally controlled (>120/80, at least 72 hours post-stroke) Exclusion Criteria: Age 39 years or younger Hemorrhagic stroke Patients with severe global disability which would preclude him/her from participating in group clinics Patients with advanced dementia

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Care management<br> | Behavioral: Care Management<br>* Over a period of one year, subjects will participate in two regular stroke clinics, three group clinics, obtain self-management tools, and will receive a series of four scheduled telephone calls by nurse practitioners to review information delivered during the group clinics and help with care coordination. Usual care will also be available.<br>|
| Active Comparator: 2: Written Materials<br> | Behavioral: Written Materials<br>* Educational materials about stroke that will be distributed during the group clinic session will be mailed to these subjects. These materials have been developed by the American Heart Association. Usual care will also be available.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid levels | LDL, HDL, triglycerides and total cholesterol will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period. | 12 month | 
| Medication Adherence | Medication adherence will be measured in a self-report by the subjects. | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group Clinics, Self Management