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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
1,196
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.
Primary and secondary outcomes will be assessed at 3, 6, and 12 months.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Hartford Hospital
Hartford, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
Emory University/Grady Health
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Intermountain
Las Vegas, Nevada, United States
...and 11 more locations
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.
Time frame: 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
Time frame: 12 months post-stroke
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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. .
Time frame: 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. .
Time frame: 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. .
Time frame: 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.
Time frame: 12-months post-discharge
Rehospitalization
Rehospitalization following stroke will be assessed/confirmed with study personnel.
Time frame: 12-months post-stroke
Recurrence
Recurrence of stroke will be assessed/confirmed with study personnel.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-months post-discharge
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