Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines"
SUSTAIN
RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
2 other identifiers
interventional
410
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Jan 2010
Longer than P75 for not_applicable stroke
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 13, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJune 6, 2018
June 1, 2018
3.7 years
March 12, 2009
June 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Lipid levels
12 month
Medication Adherence
8 months
Study Arms (2)
1: Care management
EXPERIMENTAL2: Written Materials
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Los Angeleslead
- University of Southern Californiacollaborator
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Centercollaborator
- Rancho Los Amigos National Rehabilitation Centercollaborator
- Olive View-UCLA Education & Research Institutecollaborator
- American Heart Associationcollaborator
Study Sites (5)
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
UCLA
Los Angeles, California, 90024, United States
LAC+USC Medical Center
Los Angeles, California, 90033, United States
Olive View-UCLA Medical Center
Sylmar, California, 91342, United States
Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Related Publications (3)
Cheng EM, Cunningham WE, Towfighi A, Sanossian N, Bryg RJ, Anderson TL, Guterman JJ, Gross-Schulman SG, Beanes S, Jones AS, Liu H, Ettner SL, Saver JL, Vickrey BG. Randomized, controlled trial of an intervention to enable stroke survivors throughout the Los Angeles County safety net to "stay with the guidelines". Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):229-34. doi: 10.1161/CIRCOUTCOMES.110.951012.
PMID: 21406671BACKGROUNDCheng EM, Cunningham WE, Towfighi A, Sanossian N, Bryg RJ, Anderson TL, Barry F, Douglas SM, Hudson L, Ayala-Rivera M, Guterman JJ, Gross-Schulman S, Beanes S, Jones AS, Liu H, Vickrey BG. Efficacy of a Chronic Care-Based Intervention on Secondary Stroke Prevention Among Vulnerable Stroke Survivors: A Randomized Controlled Trial. Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e003228. doi: 10.1161/CIRCOUTCOMES.116.003228.
PMID: 29321134RESULTRichards A, Jackson NJ, Cheng EM, Bryg RJ, Brown A, Towfighi A, Sanossian N, Barry F, Li N, Vickrey BG. Derivation and Application of a Tool to Estimate Benefits From Multiple Therapies That Reduce Recurrent Stroke Risk. Stroke. 2020 May;51(5):1563-1569. doi: 10.1161/STROKEAHA.119.027160. Epub 2020 Mar 23.
PMID: 32200759DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Vickrey, MD, MPH
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 12, 2009
First Posted
March 13, 2009
Study Start
January 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
June 6, 2018
Record last verified: 2018-06