Engagement, Patient, Stroke, Stroke, Acute, Stroke Hemorrhagic, Stroke, Ischemic, Stroke Sequelae
Conditions
Keywords
Technology-enabled, Engagement, caregiver, Team-based, Integrated Care
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.
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.
Interventions
OTHERIntegrated 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.
OTHERComprehensive or Primary Stroke Center
Primary and secondary outcomes will be assessed at 3, 6, and 12 months.
Sponsors
Vanderbilt University Medical Center
Patient-Centered Outcomes Research Institute
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Primary outcomes will be assessed by telephone at 3, 6, and 12 months by the University of Alabama at Birmingham (UAB)'s Survey Research Unit (SRU). Research staff at the SRU will be masked to treatment arm.
Intervention model description
Pragmatic randomized trial of approximately 22 clinical sites in the United States; randomization is by clinical site.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale at 12 Months Post-stroke | 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 |
| Stroke Impact Scale (SIS) at 12-months Post-discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 6-months Post-discharge | 6-months post-stroke | 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). |
| Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 12-months Post-discharge | 12-months post-stroke | 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 |
| Stroke Risk Factors - Diet at 3-months Post-discharge | 3-months post-stroke | 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. |
| Stroke Risk Factors - Diet at 6-months Post-discharge | 6-months post-stroke | 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. |
| Stroke Risk Factors - Diet at 12-months Post-discharge | 12-months post-stroke | 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. |
| Stroke Risk Factors - Smoking Status/Cessation at 3-months Post-discharge | 3-months post-stroke | 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. |
| Stroke Risk Factors - Smoking Status/Cessation at 6-months Post-discharge | 6-months post-stroke | 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. |
| Stroke Risk Factors - Smoking Status/Cessation at 12-months Post-discharge | 12-months post-stroke | 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. |
| Stroke Impact Scale (SIS) at 3-months Post-discharge | 3-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. |
| Stroke Impact Scale (SIS) at 6-months Post-discharge | 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. |
| Modified Rankin Scale (mRS) at 3-months Post-discharge | 3-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 |
| Modified Rankin Scale (mRS) at 6-months Post-discharge | 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 |
| Stroke Risk Factors - Blood Pressure Control (BP) at 3-months Post-discharge | 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. |
| Stroke Risk Factors-Blood Pressure (BP) at 6-months Post-discharge | 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. |
| Stroke Risk Factors-BP at 12-months Post-discharge | 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. |
| Stroke Risk Factors - Cholesterol (LDL) at 3-months Post-discharge | 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. |
| Stroke Risk Factors - Cholesterol (LDL) at 6-months Post-discharge | 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. |
| Stroke Risk Factors - Cholesterol (LDL) at 12-months Post-discharge | 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. |
| Stroke Risk Factors - Blood Sugar (HgBA1c) at 3-months Post-discharge | 3-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. |
| Stroke Risk Factors - Blood Sugar (HgBA1c) at 6-months Post-discharge | 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. |
| Stroke Risk Factors - Exercise at 3-months Post-discharge | 3-months post-stroke | 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. . |
| Stroke Risk Factors - Exercise at 6-months Post-discharge | 6-months post-stroke | 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. . |
| Stroke Risk Factors - Exercise at 12-months Post-discharge | 12-months post-stroke | 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. . |
| Mortality at 12-months Post-discharge | 12-months post-discharge | Mortality following stroke will be assessed with family member, through study personnel, and/or using public sources. |
| Rehospitalization | 12-months post-stroke | Rehospitalization following stroke will be assessed/confirmed with study personnel. |
| Recurrence | 12-months post-stroke | Recurrence of stroke will be assessed/confirmed with study personnel. |
| Time at Home | 12-months post-stroke | 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. |
| Depression: Patient Health Questionnaire (PHQ-9) at 3-months Post-discharge | 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. |
| Depression: Patient Health Questionnaire (PHQ-9) at 6-months Post-discharge | 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. |
| Depression: Patient Health Questionnaire (PHQ-9) at 12-months Post-discharge | 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. |
| Modified Caregiver Strain Index (mCSI) at 3-months Post-discharge | 3-months post-stroke | 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. |
| Modified Caregiver Strain Index (mCSI) at 6-months Post-discharge | 6-months post-discharge | 13-item questionnaire to assess the level of strain in caregivers, with higher scores indicating increased caregiver strain. |
| Stroke Risk Factors - Blood Sugar (HgBA1c) at 12-months Post-discharge | 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. |
| Modified Caregiver Strain Index (mCSI) at 12-months Post-discharge | 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. |
| Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 3-months Post-discharge | 3-months post-stroke | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKenneth Gaines, MD
Vanderbilt University Medical Center
PRINCIPAL_INVESTIGATORBarry Jackson
PRINCIPAL_INVESTIGATORGeorge Howard, DrPH
University of Alabama at Birmingham
Participant flow
Recruitment details
23 United States clinical sites were screened for site eligibility.
Pre-assignment details
23 United States clinical sites were randomized stratified by region and admission volume.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.09 Years STANDARD_DEVIATION 13.27 |
| Body Mass Index (BMI) at baseline | 30.45 kg/m^2 STANDARD_DEVIATION 7.95 |
| Discharge National Institutes of Health Stroke Scale (NIHSS) Score=0 | 131 Participants |
| Discharge National Institutes of Health Stroke Scale (NIHSS) Score=1 | 141 Participants |
| Discharge National Institutes of Health Stroke Scale (NIHSS) Score=2-4 | 204 Participants |
| Discharge National Institutes of Health Stroke Scale (NIHSS) Score=5+ | 95 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 152 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Black | 129 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic White | 426 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 16 Participants |
| Sex: Female, Male Female | 261 Participants |
| Sex: Female, Male Male | 319 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 39 / 616 | 30 / 580 |
| other Total, other adverse events | 0 / 616 | 0 / 580 |
| serious Total, serious adverse events | 177 / 616 | 162 / 580 |
Outcome results
None listed