Clinical trial NCT00861081: Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines"
Official title: RCT of an Intervention to Enable Stroke Survivors in Los Angeles County Hospitals to "Stay Within the Guidelines" (SUSTAIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Group Clinics
Self Management
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: Rancho Los Amigos National Rehabilitation Center
name: Olive View-UCLA Education & Research Institute
name: American Heart Association
First posted: 2009-03-13
Enrollment: 410
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure
timeFrame: 12 months
Secondary outcomes:
measure: Lipid levels
timeFrame: 12 month
measure: Medication Adherence
timeFrame: 8 months
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Barbara Vickrey, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cheng 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.
citation: Richards 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.