Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care (C3FIT)

• ClinicalTrials.gov Identifier: NCT04000971
• Recruitment Status: Enrolling by invitation
• First Posted: June 27, 2019
• Last Update Posted: April 6, 2020
• Sponsor: Vanderbilt University Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute; University of Alabama at Birmingham
• Information provided by (Responsible Party): Kenneth Gaines, Vanderbilt University Medical Center

Study Description

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 18 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.

Condition or disease	Intervention/treatment	Phase
Stroke; Stroke, Ischemic; Stroke, Acute; Stroke Sequelae; Engagement, Patient; Stroke Hemorrhagic	Other: Integrated Stroke Practice Unit; Other: Comprehensive or Primary Stroke Center	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Pragmatic randomized trial of 18 clinical sites in the United States; randomization is by clinical site.
• Masking: Single (Outcomes Assessor)
• Masking Description: Primary outcomes will be assessed by telephone at 3, 6, 12, and 24 months by C3FIT's Statistical and Data Coordinating Center (SDCC) Survey Research Unit (SRU) at the University of Alabama Birmingham (UAB). Research staff at the SRU will be masked to treatment arm.
• Primary Purpose: Health Services Research
• Official Title: C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Care): A Randomized Trial for Stroke
• Actual Study Start Date: February 25, 2020
• Estimated Primary Completion Date: April 30, 2022
• Estimated Study Completion Date: April 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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, 12, and 24 months; secondary outcomes will be assessed at 3, 6, and 12 months.	Other: 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 and by phone at 24 months.; Other Name: ISPU
Active Comparator: 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, 12, and 24 months; secondary outcomes will be assessed at 3, 6, and 12 months.	Other: Comprehensive or Primary Stroke Center; Primary and secondary outcomes will be assessed at 3,6,and 12 months and by phone at 24 months.; Other Name: CSC/PSC

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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 Outcome Measures :

1. Stroke Impact Scale 3.0 [ Time Frame: 3 and 6 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.
2. Modified Rankin Scale [ Time Frame: 3 and 6 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).
3. Stroke Impact Scale 3.0 [ Time Frame: 24 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.
4. Modified Rankin Scale [ Time Frame: 24 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).
5. Stroke Risk Factors - Blood Pressure Control (BP) [ Time Frame: 3, 6, and 12 months post-stroke ]
   To assess BP control through measurement of a seated patient using a blood pressure cuff; controlled BP is 120-130/80 or below for ischemic stroke patients and 140/80 or below for hemorrhagic stroke patients.
6. Stroke Risk Factors - Cholesterol (LDL) [ Time Frame: 3, 6, and 12 months post-stroke ]
   To assess LDL/lipids control through a LDL or lipids blood draw (standard of care) for patients with elevated cholesterol at baseline (prior to hospital discharge); controlled LDL is less than/equal to 70 for stroke patients.
7. Stroke Risk Factors - Blood Sugar (HgBA1c) [ Time Frame: 3, 6, and 12 months post-stroke ]
   To assess blood sugar control through a HgBA1c blood draw (standard of care) for patients with elevated blood sugar at baseline (prior to hospital discharge); controlled HgBA1c is less than/equal to 7% for stroke patients.
8. Stroke Risk Factors - Body Mass Index (BMI) [ Time Frame: 3, 6, and 12 months post-stroke ]
   To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI=18.5-24.9 (BMI less than 18.5 is underweight, and BMI 25.0 or above is overweight (BMI=25.0-29.9) or obese (BMI=30.0 or above).
9. Stroke Risk Factors - Smoking Status/Cessation [ Time Frame: 3, 6, and 12 months post-stroke ]
   To assess smoking status and cessation efforts through self-reported, yes or no questions.
10. Stroke Risk Factors - Diet [ Time Frame: 3, 6, and 12 months post-stroke ]
    To assess awareness of the DASH or Mediterranean diet through self-reported, yes or no questions.
11. Stroke Risk Factors - Exercise [ Time Frame: 3, 6, and 12 months post-stroke ]
    To assess adherence to exercise guidelines that physician or physical therapist advised through self-reported, yes or no questions.
12. Mortality [ Time Frame: 3, 6, and 12 months post-stroke ]
    Mortality following stroke will be assessed with family member, through study personnel, and/or using public sources.
13. Recurrence [ Time Frame: 3, 6, and 12 months post-stroke ]
    Recurrence of stroke will be assessed/confirmed with study personnel.
14. Rehospitalization [ Time Frame: 3, 6, and 12 months post-stroke ]
    Rehospitalization following stroke will be assessed/confirmed with study personnel.
15. Time at Home [ Time Frame: 3, 6, and 12 months post-stroke ]
    Time spent at home compared to institution will be assessed/confirmed with study personnel.
16. Depression: Patient Health Questionnaire (PHQ-9) [ Time Frame: 3, 6, and 12 months post-stroke ]
    9-item questionnaire to assess presence and/or severity of patient depression (includes an additional question to assess difficulty that doesn't impact scoring); scores range from 0-27, with 0=No depression, 1-4=Minimal depression, 5-9=Mild depression, 10-14=Moderate depression, 15-19=Moderately severe depression; and 20-27=Severe depression.
17. Modified Caregiver Strain Index (mCSI) [ Time Frame: 3, 6, and 12 months post-stroke ]
    13-item questionnaire to assess the level of strain in caregivers; scores range from 0-100, with higher score indicating increased caregiver strain.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 in Table 4.
• 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.

Contacts and Locations

Locations

United States, Arizona

Mayo Clinic Hospital

Scottsdale, Arizona, United States, 85054

United States, Georgia

Augusta University Medical Center

Augusta, Georgia, United States, 30912

United States, Illinois

Nortwestern Memorial Hospital

Chicago, Illinois, United States, 60611

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

United States, Kentucky

University of Louisville Hospital

Louisville, Kentucky, United States, 40202

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

United States, Ohio

Ohio Health Riverside Methodist Hospital

Columbus, Ohio, United States, 43214

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Tennessee

Johnson City Medical Center at Ballad Health

Johnson City, Tennessee, United States, 37604

Fort Sanders Regional Medical Center

Knoxville, Tennessee, United States, 37916

Baptist Memorial Hospital

Memphis, Tennessee, United States, 38120

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37322

United States, Texas

Doctors Hospital Renaissance

Edinburg, Texas, United States, 78539

United States, Wisconsin

University of Wisconsin Madison

Madison, Wisconsin, United States, 53705

Sponsors and Collaborators

Vanderbilt University Medical Center

Patient-Centered Outcomes Research Institute

University of Alabama at Birmingham

Investigators

• Principal Investigator: Kenneth Gaines, MD; Vanderbilt University Medical Center
• Principal Investigator: Barry Jackson
• Principal Investigator: George Howard, DrPH; University of Alabama at Birmingham

More Information

• Responsible Party: Kenneth Gaines, Professor, Neurology; Medical Director, Vanderbilt Teleneurology, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT04000971
• Other Study ID Numbers: C3FIT
• First Posted: June 27, 2019
• Last Update Posted: April 6, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kenneth Gaines, Vanderbilt University Medical Center:

Technology-enabled; Engagement, caregiver; Team-based; Integrated Care

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases