C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Care): A Randomized Trial for Stroke
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,198
- Locations
- 21
- Primary Endpoint
- Stroke Impact Scale (SIS 3.0)
Overview
Brief Summary
Stroke is the 5th leading cause of death and the leading cause of adult disability in the United States (US). Stroke is a complex disease with multiple interacting risk factors (including genetic, high blood pressure and cholesterol, and lifestyle factors like smoking, diet, and exercise) that lead to initial and recurrent stroke. Up to 90% of stroke survivors have some functional deficit that impacts both physical and mental health.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
Primary outcomes will be assessed by telephone at 3, 6, and 12 months by the University of Alabama at Birmingham (UAB)'s Survey Research Unit (SRU). Research staff at the SRU will be masked to treatment arm.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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
- •Clinical transient ischemic attack (TIA)38-41 is excluded even if there is a computerized tomography (CT) or magnetic resonance imaging (MRI) lesion corresponding to the clinical syndrome at presentation.
- •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.
Outcomes
Primary Outcomes
Stroke Impact Scale (SIS 3.0)
Time Frame: 12 months post-stroke
59-item questionnaire to assess aspects of patient quality of life following stroke; includes 8 dimensions assessed on a 5-point Likert scale that are summed by domain. Scores range from 0-100, with higher scores indicating less difficulty.
Modified Rankin Scale
Time Frame: 12 months post-stroke
7-item scale to assess the degree of disability/dependence in the daily activities of stroke patients; scores range from 0-5, with higher score indicating higher disability (a score of 6 indicates that the patient expired).
Secondary Outcomes
- Modified Rankin Scale(3 and 6 months post-stroke)
- Rehospitalization(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Cholesterol (LDL)(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Diet(3, 6, and 12 months post-stroke)
- Depression: Patient Health Questionnaire (PHQ-9)(3, 6, and 12 months post-stroke)
- Stroke Impact Scale 3.0(3 and 6 months post-stroke)
- Stroke Risk Factors - Exercise(3, 6, and 12 months post-stroke)
- Recurrence(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Blood Pressure Control (BP)(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Body Mass Index (BMI)(3, 6, and 12 months post-stroke)
- Modified Caregiver Strain Index (mCSI)(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Blood Sugar (HgBA1c)(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Smoking Status/Cessation(3, 6, and 12 months post-stroke)
- Mortality(3, 6, and 12 months post-stroke)
- Time at Home(3, 6, and 12 months post-stroke)
Investigators
Kenneth Gaines
Professor, Neurology; Medical Director, Vanderbilt Teleneurology
Vanderbilt University Medical Center