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

NCT ID: NCT00861081

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1: Care management

Group Type EXPERIMENTAL

Care Management

Intervention Type BEHAVIORAL

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.

2: Written Materials

Group Type ACTIVE_COMPARATOR

Written Materials

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Southern California

OTHER

Sponsor Role collaborator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role collaborator

Rancho Los Amigos National Rehabilitation Center

OTHER

Sponsor Role collaborator

Olive View-UCLA Education & Research Institute

OTHER

Sponsor Role collaborator

American Heart Association

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Barbara Vickrey, MD, MPH

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Barbara Vickrey, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rancho Los Amigos National Rehabilitation Center

Downey, California, United States

Site Status

UCLA

Los Angeles, California, United States

Site Status

LAC+USC Medical Center

Los Angeles, California, United States

Site Status

Olive View-UCLA Medical Center

Sylmar, California, United States

Site Status

Harbor-UCLA Medical Center

Torrance, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21406671 (View on PubMed)

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.

Reference Type RESULT
PMID: 29321134 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32200759 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0875133N

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

G-08-07-019-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Rehab CARES In USA: Clinical Trial
NCT05542121 COMPLETED NA
PROPEL Randomized Trial
NCT02951338 TERMINATED NA