Early Supported Discharge for Improving Functional Outcomes After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,024
- 试验地点
- 80
- 主要终点
- Stroke Impact Scale (SIS-16)
研究概览
简要总结
The purpose of this pragmatic study is to investigate whether implementation of a comprehensive post-acute stroke service model that integrates Early Supported Discharge (ESD) and Transitional Care Management (TCM) for stroke survivors discharged home improves functional outcomes post-stroke, reduces caregiver stress, and reduces readmission rates.
详细描述
Stroke mortality is 20-40% higher in North Carolina (NC) than in the overall United States. After discharge, stroke patients are at high risk for complications. Although a model of stroke post-care (early supported discharge) exists in Europe and Canada, it has not been adapted for and tested in the US, although patients and stakeholders attest that post-acute care does not meet their needs. Transitional care services from hospital to home are now reimbursed by Centers for Medicaid and Medicare Services (CMS), but only for 30 days after discharge. The study team proposed a pragmatic, cluster randomized trial of 41 NC hospitals to determine the effectiveness of COMprehensive Post-Acute Stroke Services (COMPASS), a patient-centered intervention uniting transitional care management services and elements of early supported discharge in stroke patients discharged directly home.
The study team will build on the successful North Carolina Stroke Care Collaborative (NCSCC) registry, a prospective stroke database in which 51 (of 113) hospitals in NC enroll patients. In preparation for COMPASS, the study team engaged these hospitals via webinars. Over 80% of NCSCC hospitals demonstrated an interest in participation and provided letters of support.
The main question of this pragmatic trial is: Does implementation of COMPASS for all stroke patients discharged directly home improve functional outcomes as measured by the Stroke Impact Scale-16 (SIS-16) at 90 days post-stroke? The primary aim is to: compare the COMPASS model versus usual care on stroke survivors' self-reported functional status at 90 days post-stroke. The secondary aims are to determine if the COMPASS model affects: (1) caregiver strain (Modified Caregiver Strain Index); (2) self-reported general health; (3) disability (Modified Rankin Score); (4) self-reported physical activity; (5) depression (PHQ-2); (6) cognition (MoCA 5-min protocol); (7) medication adherence (Morisky Green Levine Scale-4); (8) self-reported falls; (9) self-reported fatigue (PROMIS Fatigue Instrument); (10) satisfaction with care; (11) secondary prevention - home blood pressure monitoring; (12) self-reported blood pressure; (13-15) all-cause hospital readmissions at 30-days, at 90-days and at 1 year after index discharge; (16-17) mortality at 90-days and at 1 year after index discharge; (18-20) healthcare utilization (emergency department visits, admissions to skilled nursing facilities/inpatient rehabilitation facilities); and (21) use of transitional care management billing codes. This study will also evaluate the effectiveness of the COMPASS Intervention in key patient subgroups based on race, sex, age, diagnosis (stroke versus TIA), stroke severity, and type of health insurance.
English and Spanish-speaking patients ages 18 and older who are admitted to a participating hospital with a diagnosis of ischemic or hemorrhagic stroke or transient ischemic attack and discharged from acute care hospitalization to home will be included (about 6,000 patients/year).
Participating hospitals will be randomized (stratified by stroke volume and primary stroke center status) to receive COMPASS or usual care (control group) in Phase 1. In Phase 2, usual care hospitals will cross over to COMPASS, while the early intervention hospitals sustain the intervention using hospital-based resources.
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)
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
- •English and Spanish speaking stroke patients with diagnosis of ischemic stroke, hemorrhagic stroke or TIA who are discharged home from participating hospitals
- •Must be 18 years of age and older at the time of the stroke
排除标准
- •Excludes subdural or aneurysmal subarachnoid hemorrhage
结局指标
主要结局
Stroke Impact Scale (SIS-16)
时间窗: post-stroke day 90
16-item survey to assess the difficulty level of performing basic physical activities; scores range from 0-100; higher scores correspond to more favorable outcomes
次要结局
- Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare(post-discharge year 1)
- Cognition (MoCA 5-min Protocol)(post-stroke day 90)
- Number of Participants Physically Active and Not Physically Active(post-stroke day 90)
- Number of Participants With or Without Falls(post-stroke day 90)
- Self-reported Fatigue (PROMIS Fatigue Instrument)(post-stroke day 90)
- Number of Subjects With Claims-based All-cause Hospital Readmissions(post-discharge year 1)
- Modified Caregiver Strain Index(post-stroke day 90)
- Self-reported General Health(post-stroke day 90)
- Modified Rankin Score(post-stroke day 90)
- Satisfaction With Care(post-stroke day 90)
- Self-reported Blood Pressure(post-stroke day 90)
- Number of Participants With or Without Depression(post-stroke day 90)
- Medication Adherence (Morisky Green Levine Scale-4)(post-stroke day 90)
- Number of Participants Who Do or Do Not Monitor Blood Pressure at Home(post-stroke day 90)
- Number of Subjects With All-cause Mortality Using NC State Death Index(post-stroke day 90)
- Number of Subjects With Claims-based Emergency Department Visits(post-discharge year 1)
- Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes(post-discharge day 14)
- Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF)(post-discharge year 1)