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.

Study Overview

• Status: Completed
• 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

Detailed Description

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 Type: Interventional
• Enrollment (Actual): 1196
• 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
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • 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 International Classification of Disease 10 (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 Modified Rankin Score (mRS) 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) at 12-months Post-discharge	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 at 12 Months Post-stroke	The Modified Rankin Score (mRS) is a widely used scale to measure the degree of disability or dependence in daily activities of individuals who have suffered a stroke. Scores were categorized as 0-2 or >2. Overview of the Modified Rankin Scale; 0: No symptoms at all; 1: No significant disability; able to carry out all usual activities; 2: Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance; 3: Moderate disability; requiring some help, but able to walk unassisted; 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe disability; bedridden, incontinent, and requiring constant nursing care; 6: Dead	12 months post-stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke Impact Scale (SIS) at 3-months Post-discharge	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-months post-stroke
Stroke Impact Scale (SIS) at 6-months Post-discharge	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.	6-months post-discharge
Modified Rankin Scale (mRS) at 3-months Post-discharge	The Modified Rankin Score (mRS) is a widely used scale to measure the degree of disability or dependence in daily activities of individuals who have suffered a stroke. Scores were categorized as 0-2 or >2. Overview of the Modified Rankin Scale; 0: No symptoms at all; 1: No significant disability; able to carry out all usual activities; 2: Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance; 3: Moderate disability; requiring some help, but able to walk unassisted; 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe disability; bedridden, incontinent, and requiring constant nursing care; 6: Dead	3-months post-stroke
Modified Rankin Scale (mRS) at 6-months Post-discharge	The Modified Rankin Score (mRS) is a widely used scale to measure the degree of disability or dependence in daily activities of individuals who have suffered a stroke. Scores were categorized as 0-2 or >2. Overview of the Modified Rankin Scale; 0: No symptoms at all; 1: No significant disability; able to carry out all usual activities; 2: Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance; 3: Moderate disability; requiring some help, but able to walk unassisted; 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5: Severe disability; bedridden, incontinent, and requiring constant nursing care; 6: Dead	6-months post-discharge
Stroke Risk Factors - Blood Pressure Control (BP) at 3-months Post-discharge	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-months post-discharge
Stroke Risk Factors-Blood Pressure (BP) at 6-months Post-discharge	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-months post-discharge
Stroke Risk Factors-BP at 12-months Post-discharge	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.	12-months post-discharge
Stroke Risk Factors - Cholesterol (LDL) at 3-months Post-discharge	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-months post-discharge
Stroke Risk Factors - Cholesterol (LDL) at 6-months Post-discharge	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.	6-months post-discharge
Stroke Risk Factors - Cholesterol (LDL) at 12-months Post-discharge	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.	12-months post-discharge
Stroke Risk Factors - Blood Sugar (HgBA1c) at 3-months Post-discharge	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-months post-stroke
Stroke Risk Factors - Blood Sugar (HgBA1c) at 6-months Post-discharge	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.	6-months post-discharge
Stroke Risk Factors - Blood Sugar (HgBA1c) at 12-months Post-discharge	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.	12-months post-discharge
Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 3-months Post-discharge	To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI kg/m*2=18.5-24.9 (BMI less than 18.5 kg/m^2 is underweight, and BMI 25.0 kg/m^2 or above is overweight (BMI=25.0-29.9 kg/m^2 ) or obese (BMI=30.0 kg/m^2 or above).	3-months post-stroke
Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 6-months Post-discharge	To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI kg/m*2=18.5-24.9 (BMI less than 18.5 kg/m^2 is underweight, and BMI 25.0 kg/m^2 or above is overweight (BMI=25.0-29.9 kg/m^2) or obese (BMI=30.0 kg/m2 or above).	6-months post-stroke
Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 12-months Post-discharge	To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI kg/m*2=18.5-24.9 (BMI less than 18.5 kg/m^2 is underweight, and BMI 25.0 kg/m^2 or above is overweight (BMI=25.0-29.9 kg/m^2) or obese (BMI=30.0 kg/m^2 or above). All measures are in kg/m*2	12-months post-stroke
Stroke Risk Factors - Diet at 3-months Post-discharge	Participants were asked one yes/no question to measure awareness of and adherence to the DASH (Dietary Approaches to Stop Hypertension) eating plan and the Mediterranean Diet. Total number of yes scores is provided where a yes score indicates better adherence to the dietary pattern and therefore in control and a no answer indicated poorer adherence and not in control.	3-months post-stroke
Stroke Risk Factors - Diet at 6-months Post-discharge	Participants were asked one yes/no question to measure awareness of and adherence to the DASH (Dietary Approaches to Stop Hypertension) eating plan and the Mediterranean Diet. Total number of yes scores is provided where a yes score indicates better adherence to the dietary pattern and therefore in control and a no answer indicated poorer adherence and not in control.	6-months post-stroke
Stroke Risk Factors - Diet at 12-months Post-discharge	Participants were asked one yes/no question to measure awareness of and adherence to the DASH (Dietary Approaches to Stop Hypertension) eating plan and the Mediterranean Diet. Total number of yes scores is provided where a yes score indicates better adherence to the dietary pattern and therefore in control and a no answer indicated poorer adherence and not in control.	12-months post-stroke
Stroke Risk Factors - Smoking Status/Cessation at 3-months Post-discharge	Participants who ever smoked were asked one yes/no question "Do you smoke now?" to measure compliance with the smoking cessation recommendation. Total number of participants answering yes indicates adherence to the smoking cessation recommendation pattern and therefore in-control while a no answer indicates non-adherence and not in control.	3-months post-stroke
Stroke Risk Factors - Smoking Status/Cessation at 6-months Post-discharge	Participants who ever smoked were asked one yes/no question "Do you smoke now?" to measure compliance with the smoking cessation recommendation. Total number of participants answering yes indicates adherence to the smoking cessation recommendation pattern and therefore in-control while a no answer indicates non-adherence and not in control.	6-months post-stroke
Stroke Risk Factors - Smoking Status/Cessation at 12-months Post-discharge	Participants who ever smoked were asked one yes/no question "Do you smoke now?" to measure compliance with the smoking cessation recommendation. Total number of participants answering yes indicates adherence to the smoking cessation recommendation pattern and therefore in-control while a no answer indicates non-adherence and not in control.	12-months post-stroke
Stroke Risk Factors - Exercise at 3-months Post-discharge	To assess self-reported adherence to American Stroke Association exercise guidelines (patients with stroke or transient ischemic attack (TIA) who are capable of at least moderate-intensity aerobic activity for a minimum of 10 minutes 4x per week, or vigorous intensity activity for a minimum of 20 minutes 2x per week is indicated) except as modified by the participants physician or physical therapist, Participants were asked one yes/no question to measure awareness of and adherence to the exercise recommendations Total number of participants with a yes score indicates adherence to the exercise recommendation pattern and therefore in-control while a no answer indicates non-adherence to the recommendation and not in control. .	3-months post-stroke
Stroke Risk Factors - Exercise at 6-months Post-discharge	To assess self-reported adherence to American Stroke Association exercise guidelines (patients with stroke or transient ischemic attack (TIA) who are capable of at least moderate-intensity aerobic activity for a minimum of 10 minutes 4x per week, or vigorous intensity activity for a minimum of 20 minutes 2x per week is indicated) except as modified by the participants physician or physical therapist, Participants were asked one yes/no question to measure awareness of and adherence to the exercise recommendations Total number of participants with a yes score indicates adherence to the exercise recommendation pattern and therefore in-control while a no answer indicates non-adherence to the recommendation and not in control. .	6-months post-stroke
Stroke Risk Factors - Exercise at 12-months Post-discharge	To assess self-reported adherence to American Stroke Association exercise guidelines (patients with stroke or transient ischemic attack (TIA) who are capable of at least moderate-intensity aerobic activity for a minimum of 10 minutes 4x per week, or vigorous intensity activity for a minimum of 20 minutes 2x per week is indicated) except as modified by the participants physician or physical therapist, Participants were asked one yes/no question to measure awareness of and adherence to the exercise recommendations Total number of participants with a yes score indicates adherence to the exercise recommendation pattern and therefore in-control while a no answer indicates non-adherence to the recommendation and not in control. .	12-months post-stroke
Mortality at 12-months Post-discharge	Mortality following stroke will be assessed with family member, through study personnel, and/or using public sources.	12-months post-discharge
Rehospitalization	Rehospitalization following stroke will be assessed/confirmed with study personnel.	12-months post-stroke
Recurrence	Recurrence of stroke will be assessed/confirmed with study personnel.	12-months post-stroke
Time at Home	Time spent at home compared to institution assessed/confirmed with study personnel. Time at home is the proportion of time the participant spent at home out of their time at risk in this study (defined as being alive and with known status). The time at home is defined by subtracting time during hospitalization/rehabilitation/skilled nursing from the total time at risk and divided by total time at risk to get the proportion of time at home.	12-months post-stroke
Depression: Patient Health Questionnaire (PHQ-9) at 3-months Post-discharge	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-months post-discharge
Depression: Patient Health Questionnaire (PHQ-9) at 6-months Post-discharge	Depression: Patient Health Questionnaire (PHQ-9) at 3-months post-discharge 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.	6-months post-discharge
Depression: Patient Health Questionnaire (PHQ-9) at 12-months Post-discharge	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.	12-months post-discharge
Modified Caregiver Strain Index (mCSI) at 3-months Post-discharge	13-item questionnaire to assess the level of strain in caregivers. Scores can range from 0-26, with higher scores indicating increased caregiver strain. Mean scores for each arm are provided and standard deviation of the mean.	3-months post-stroke
Modified Caregiver Strain Index (mCSI) at 6-months Post-discharge	13-item questionnaire to assess the level of strain in caregivers, with higher scores indicating increased caregiver strain.	6-months post-discharge
Modified Caregiver Strain Index (mCSI) at 12-months Post-discharge	13-item questionnaire to assess the level of strain in caregivers. Scores can range from 0-26, with higher scores indicating increased caregiver strain. Mean scores for each arm are provided and standard deviation of the mean.	12-months post-discharge

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): 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 15, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Technology-enabled; Engagement, caregiver; Team-based; Integrated Care
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Ischemic Stroke; Hemorrhagic Stroke; Stroke; Patient Participation
• 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