Clinical trial NCT04000971: Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care
Official title: C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Care): A Randomized Trial for Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke, Ischemic
Stroke, Acute
Stroke Sequelae
Engagement, Patient
Stroke Hemorrhagic
Keywords: Technology-enabled
Engagement, caregiver
Team-based
Integrated Care
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Alabama at Birmingham
First posted: 2019-06-27
Enrollment: 1198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized trial of approximately 22 clinical sites in the United States; randomization is by clinical site.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* Age 18+.
* 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:

* 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.

Primary outcomes:
measure: Stroke Impact Scale (SIS 3.0)
timeFrame: 12 months post-stroke
measure: Modified Rankin Scale
timeFrame: 12 months post-stroke
Secondary outcomes:
measure: Stroke Impact Scale 3.0
timeFrame: 3 and 6 months post-stroke
measure: Modified Rankin Scale
timeFrame: 3 and 6 months post-stroke
measure: Stroke Risk Factors - Blood Pressure Control (BP)
timeFrame: 3, 6, and 12 months post-stroke
measure: Stroke Risk Factors - Cholesterol (LDL)
timeFrame: 3, 6, and 12 months post-stroke
measure: Stroke Risk Factors - Blood Sugar (HgBA1c)
timeFrame: 3, 6, and 12 months post-stroke
measure: Stroke Risk Factors - Body Mass Index (BMI)
timeFrame: 3, 6, and 12 months post-stroke
measure: Stroke Risk Factors - Smoking Status/Cessation
timeFrame: 3, 6, and 12 months post-stroke
measure: Stroke Risk Factors - Diet
timeFrame: 3, 6, and 12 months post-stroke
measure: Stroke Risk Factors - Exercise
timeFrame: 3, 6, and 12 months post-stroke
measure: Mortality
timeFrame: 3, 6, and 12 months post-stroke
measure: Recurrence
timeFrame: 3, 6, and 12 months post-stroke
measure: Rehospitalization
timeFrame: 3, 6, and 12 months post-stroke
measure: Time at Home
timeFrame: 3, 6, and 12 months post-stroke
measure: Depression: Patient Health Questionnaire (PHQ-9)
timeFrame: 3, 6, and 12 months post-stroke
measure: Modified Caregiver Strain Index (mCSI)
timeFrame: 3, 6, and 12 months post-stroke
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Atlanta
country: United States
facility: Emory University/Grady Health
state: Georgia
city: Augusta
country: United States
facility: Augusta University Medical Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Las Vegas
country: United States
facility: Intermountain
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Columbus
country: United States
facility: Ohio Health Riverside Methodist Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: State College
country: United States
facility: Penn State
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Johnson City
country: United States
facility: Johnson City Medical Center at Ballad Health
state: Tennessee
city: Knoxville
country: United States
facility: Covenant Health Fort Sanders Regional Medical Center
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Edinburg
country: United States
facility: Doctors Hospital Renaissance
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
Study officials:
affiliation: Vanderbilt University Medical Center
name: Kenneth Gaines, MD
role: PRINCIPAL_INVESTIGATOR
name: Barry Jackson
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: George Howard, DrPH
role: PRINCIPAL_INVESTIGATOR
References: