Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)|
- Blood Pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Lipid levels [ Time Frame: 12 month ] [ Designated as safety issue: No ]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.
- Medication Adherence [ Time Frame: 8 months ] [ Designated as safety issue: No ]Medication adherence will be measured in a self-report by the subjects.
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|Experimental: 1: Care management||
Behavioral: Care Management
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.
|Active Comparator: 2: Written Materials||
Behavioral: Written Materials
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.
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.
|United States, California|
|Rancho Los Amigos National Rehabilitation Center|
|Downey, California, United States, 90242|
|Los Angeles, California, United States, 90024|
|LAC+USC Medical Center|
|Los Angeles, California, United States, 90033|
|Olive View-UCLA Medical Center|
|Sylmar, California, United States, 91342|
|Harbor-UCLA Medical Center|
|Torrance, California, United States, 90502|
|Principal Investigator:||Barbara Vickrey, MD, MPH||University of California, Los Angeles|