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

C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Care): A Randomized Trial for Stroke

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke; Stroke, Ischemic; Stroke, Acute; Stroke Sequelae; Engagement, Patient; Stroke Hemorrhagic
• Intervention / Treatment: Other: Integrated Stroke Practice Unit; Other: Comprehensive or Primary Stroke Center

• Study Type: Interventional
• Enrollment (Anticipated): 1800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Hospital
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University/Grady Health
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Intermountain
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Health Sciences Center
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Ohio Health Riverside Methodist Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • State College, Pennsylvania, United States, 16802
      • Penn State
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • Johnson City Medical Center at Ballad Health
    • Knoxville, Tennessee, United States, 37916
      • Covenant Health Fort Sanders Regional Medical Center
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
    • Nashville, Tennessee, United States, 37322
      • Vanderbilt University Medical Center
  • Texas
    • Edinburg, Texas, United States, 78539
      • Doctors Hospital Renaissance
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin Madison

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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, and 12 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.; Other Names: 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, and 12 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.; Other Names: CSC/PSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Impact Scale (SIS 3.0)	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.	12 months post-stroke
Modified Rankin Scale	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).	12 months post-stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Impact Scale 3.0	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.	3 and 6 months post-stroke
Modified Rankin Scale	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 and 6 months post-stroke
Stroke Risk Factors - Blood Pressure Control (BP)	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.	3, 6, and 12 months post-stroke
Stroke Risk Factors - Cholesterol (LDL)	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.	3, 6, and 12 months post-stroke
Stroke Risk Factors - Blood Sugar (HgBA1c)	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.	3, 6, and 12 months post-stroke
Stroke Risk Factors - Body Mass Index (BMI)	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).	3, 6, and 12 months post-stroke
Stroke Risk Factors - Smoking Status/Cessation	To assess smoking status and cessation efforts through self-reported, yes or no questions.	3, 6, and 12 months post-stroke
Stroke Risk Factors - Diet	To assess awareness of the DASH or Mediterranean diet through self-reported, yes or no questions.	3, 6, and 12 months post-stroke
Stroke Risk Factors - Exercise	To assess adherence to exercise guidelines that physician or physical therapist advised through self-reported, yes or no questions.	3, 6, and 12 months post-stroke
Mortality	Mortality following stroke will be assessed with family member, through study personnel, and/or using public sources.	3, 6, and 12 months post-stroke
Recurrence	Recurrence of stroke will be assessed/confirmed with study personnel.	3, 6, and 12 months post-stroke
Rehospitalization	Rehospitalization following stroke will be assessed/confirmed with study personnel.	3, 6, and 12 months post-stroke
Time at Home	Time spent at home compared to institution will be assessed/confirmed with study personnel.	3, 6, and 12 months post-stroke
Depression: Patient Health Questionnaire (PHQ-9)	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.	3, 6, and 12 months post-stroke
Modified Caregiver Strain Index (mCSI)	13-item questionnaire to assess the level of strain in caregivers; scores range from 0-100, with higher score indicating increased caregiver strain.	3, 6, and 12 months post-stroke

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Technology-enabled; Engagement, caregiver; Team-based; Integrated Care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: C3FIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No