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

Study Overview
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Brief Summary
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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.

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

Conditions
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Engagement, Patient, Stroke, Stroke, Ischemic, Stroke, Acute, Stroke Sequelae, Stroke Hemorrhagic

Intervention / Treatment
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* Other: Integrated Stroke Practice Unit
* Other: Comprehensive or Primary Stroke Center


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic randomized trial of approximately 18 clinical sites in the United States; randomization is by clinical site.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Integrated Stroke Practice Unit (ISPU)<br>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<br>* 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.<br>* Other names: ISPU;|
| Active Comparator: Comprehensive or Primary Stroke Center (CSC/PSC)<br>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<br>* Primary and secondary outcomes will be assessed at 3, 6, and 12 months.<br>* Other names: CSC/PSC;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Technology-enabled, Engagement, caregiver, Team-based, Integrated Care