Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care
NCT ID: NCT04000971
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1198 participants
INTERVENTIONAL
2020-02-25
2024-09-30
Brief Summary
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Scientific evidence that identifies the best stroke care delivery design is lacking. We completed a three-year, Centers for Medicare \& Medicaid Services (CMS) Health Care Innovation Award that tested a new stroke care design called an Integrated Practice Unit (IPU). This IPU was developed through stakeholder input from patients, caregivers, nurses, stroke specialists, rehabilitation specialists, patient advocacy groups, payers, and technology companies. This IPU design was associated with decreased hospital length of stay, readmissions, and stroke recurrence, as well as lower cost.
Based on the CMS study, a larger, pragmatic trial was developed that is called C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, and Technology-enabled Stroke Care). C3FIT will randomly assign approximately 22 US hospital sites to continue Joint Commission-certified Comprehensive/Primary (CSC/PSC) design or to the novel Integrated Stroke Practice Unit (ISPU) design for stroke care. C3FIT's ISPU uses team-based, enhanced collaboration (called Stroke Central) and follows patients from presentation at the Emergency Department (ED) through 12-months post-discharge (called Stroke Mobile). Stroke Mobile includes a nurse and lay health educator team who visit patients and caregivers at home or at a rehabilitation or skilled nursing facility to assess function and quality of life using telehealth technology to facilitate access to multiple providers. Results from C3FIT will provide high quality scientific evidence to determine the best stroke care design that ensures positive health for patients and caregivers.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Integrated Stroke Practice Unit (ISPU)
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Integrated Stroke Practice Unit
Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, and increase understanding and build positive behavior change for patients and caregivers. Primary and secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center
Primary and secondary outcomes will be assessed at 3, 6, and 12 months.
Interventions
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Integrated Stroke Practice Unit
Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, and increase understanding and build positive behavior change for patients and caregivers. Primary and secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center
Primary and secondary outcomes will be assessed at 3, 6, and 12 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of acute stroke with brain imaging compatible with intracerebral hemorrhage or ischemic stroke (including normal brain scan); see ICD 10 codes.
* English or Spanish speaking subjects.
* Patient admitted within 7 days of their index stroke event.
* Patient is discharged alive and not to hospice care.
* Patient living at discharge within the geography of recruitment for that C3FIT site.
* Pre-morbid mRS Rankin score of 0-1.
* Patient and/or surrogate give consent to participate after an informed consent process.
* Patients who go to rehabilitation inpatient therapy or other care facilities are eligible, as long as they reside in the geographic are of recruitment and do not go to hospice care.
Exclusion Criteria
* Already enrolled or planned enrollment in another clinical trial for which participation in C3FIT would be compromised with regard to follow-up assessment of outcomes or continuation in C3FIT.
* Patients with a planned admission to hospice care prior to consent.
* Patients not anticipated to survive for 1-year due to neurological or other medical status (i.e., advanced cancer, hospice care, heart disease, etc.).
* Patients who in the opinion of the site investigator cannot be involved in follow up care.
* Inability or unwillingness of subject or legal guardian/representative to understand and cooperate with study procedures or provide informed consent.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Alabama at Birmingham
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
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Kenneth Gaines
Professor, Neurology; Medical Director, Vanderbilt Teleneurology
Principal Investigators
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Kenneth Gaines, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Barry Jackson
Role: PRINCIPAL_INVESTIGATOR
George Howard, DrPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Hartford Hospital
Hartford, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
Emory University/Grady Health
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Intermountain
Las Vegas, Nevada, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Ohio Health Riverside Methodist Hospital
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Penn State
State College, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Johnson City Medical Center at Ballad Health
Johnson City, Tennessee, United States
Covenant Health Fort Sanders Regional Medical Center
Knoxville, Tennessee, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Doctors Hospital Renaissance
Edinburg, Texas, United States
University of Wisconsin Madison
Madison, Wisconsin, United States
Countries
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References
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Commiskey P, Long DL, Howard VJ, Braunlin J, Howard G, Cochran D, Jackson B, Bell D, Hill D, Callahan AE, Gaines K. Design and methods of a cluster-randomized pragmatic trial of post-discharge stroke care. Contemp Clin Trials. 2025 Jun;153:107890. doi: 10.1016/j.cct.2025.107890. Epub 2025 Apr 4.
Other Identifiers
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C3FIT
Identifier Type: -
Identifier Source: org_study_id
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