C3FIT (Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Care): A Randomized Trial for Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,196
- 试验地点
- 42
- 主要终点
- Stroke Impact Scale (SIS 3.0)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Integrated Stroke Practice Unit (Other)
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.
干预措施: Comprehensive or Primary Stroke Center (Other)
结局指标
主要结局
Stroke Impact Scale (SIS 3.0)
时间窗: 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.
Modified Rankin Scale
时间窗: 12 months post-stroke
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).
Stroke Impact Scale (SIS) at 12-months Post-discharge
时间窗: 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.
Modified Rankin Scale at 12 Months Post-stroke
时间窗: 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
次要结局
- Modified Rankin Scale(3 and 6 months post-stroke)
- Rehospitalization(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Cholesterol (LDL)(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Diet(3, 6, and 12 months post-stroke)
- Depression: Patient Health Questionnaire (PHQ-9)(3, 6, and 12 months post-stroke)
- Stroke Impact Scale 3.0(3 and 6 months post-stroke)
- Stroke Risk Factors - Exercise(3, 6, and 12 months post-stroke)
- Recurrence(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Blood Pressure Control (BP)(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Body Mass Index (BMI)(3, 6, and 12 months post-stroke)
- Modified Caregiver Strain Index (mCSI)(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Blood Sugar (HgBA1c)(3, 6, and 12 months post-stroke)
- Stroke Risk Factors - Smoking Status/Cessation(3, 6, and 12 months post-stroke)
- Mortality(3, 6, and 12 months post-stroke)
- Time at Home(3, 6, and 12 months post-stroke)
- Stroke Impact Scale (SIS) at 3-months Post-discharge(3-months post-stroke)
- Stroke Impact Scale (SIS) at 6-months Post-discharge(6-months post-discharge)
- Modified Rankin Scale (mRS) at 3-months Post-discharge(3-months post-stroke)
- Modified Rankin Scale (mRS) at 6-months Post-discharge(6-months post-discharge)
- Stroke Risk Factors - Blood Pressure Control (BP) at 3-months Post-discharge(3-months post-discharge)
- Stroke Risk Factors-Blood Pressure (BP) at 6-months Post-discharge(6-months post-discharge)
- Stroke Risk Factors-BP at 12-months Post-discharge(12-months post-discharge)
- Stroke Risk Factors - Cholesterol (LDL) at 3-months Post-discharge(3-months post-discharge)
- Stroke Risk Factors - Cholesterol (LDL) at 6-months Post-discharge(6-months post-discharge)
- Stroke Risk Factors - Cholesterol (LDL) at 12-months Post-discharge(12-months post-discharge)
- Stroke Risk Factors - Blood Sugar (HgBA1c) at 3-months Post-discharge(3-months post-stroke)
- Stroke Risk Factors - Blood Sugar (HgBA1c) at 6-months Post-discharge(6-months post-discharge)
- Stroke Risk Factors - Blood Sugar (HgBA1c) at 12-months Post-discharge(12-months post-discharge)
- Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 3-months Post-discharge(3-months post-stroke)
- Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 6-months Post-discharge(6-months post-stroke)
- Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 12-months Post-discharge(12-months post-stroke)
- Stroke Risk Factors - Diet at 3-months Post-discharge(3-months post-stroke)
- Stroke Risk Factors - Diet at 6-months Post-discharge(6-months post-stroke)
- Stroke Risk Factors - Diet at 12-months Post-discharge(12-months post-stroke)
- Stroke Risk Factors - Smoking Status/Cessation at 3-months Post-discharge(3-months post-stroke)
- Stroke Risk Factors - Smoking Status/Cessation at 6-months Post-discharge(6-months post-stroke)
- Stroke Risk Factors - Smoking Status/Cessation at 12-months Post-discharge(12-months post-stroke)
- Stroke Risk Factors - Exercise at 3-months Post-discharge(3-months post-stroke)
- Stroke Risk Factors - Exercise at 6-months Post-discharge(6-months post-stroke)
- Stroke Risk Factors - Exercise at 12-months Post-discharge(12-months post-stroke)
- Mortality at 12-months Post-discharge(12-months post-discharge)
- Rehospitalization(12-months post-stroke)
- Recurrence(12-months post-stroke)
- Time at Home(12-months post-stroke)
- Depression: Patient Health Questionnaire (PHQ-9) at 3-months Post-discharge(3-months post-discharge)
- Depression: Patient Health Questionnaire (PHQ-9) at 6-months Post-discharge(6-months post-discharge)
- Depression: Patient Health Questionnaire (PHQ-9) at 12-months Post-discharge(12-months post-discharge)
- Modified Caregiver Strain Index (mCSI) at 3-months Post-discharge(3-months post-stroke)
- Modified Caregiver Strain Index (mCSI) at 6-months Post-discharge(6-months post-discharge)
- Modified Caregiver Strain Index (mCSI) at 12-months Post-discharge(12-months post-discharge)
研究者
Kenneth Gaines
Professor, Neurology; Medical Director, Vanderbilt Teleneurology
Vanderbilt University Medical Center