Comprehensive Post-Acute Stroke Services

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The trial has three integrated intervention components: (1) COMPASS, which combines transitional care services provided by advanced practice providers (APPs) and early supported discharge services coordinated by the Post-Acute Coordinators (PAC); (2) COMPASS-funded post-acute care coordinators who will engage patient and stakeholder communities to improve post-acute stroke comprehensive stroke services; and (3) development of a stroke metrics scorecard for participating sites. Well-trained APPs and coordinators will have access to online learning and ongoing support/consultation from WFBH personnel and board-certified vascular neurologists. The study team will assess 90-day and 1-year outcomes. Outcomes at 90-days will be assessed by telephone surveyors blinded to patient's group assignment. Patients will be informed about COMPASS in the hospital and can opt out of 90-day phone follow-up at any time. Those who agree to be surveyed will be asked to provide informed consent at the 90-day phone call to collect outcomes data. This proposal is led by three highly experienced researchers as co-principal investigators. The team includes expertise in stroke care, large clinical trials, biostatistics, managing clinical registries, survey and acquisition of patient or proxy-reported outcomes, community-based practice improvement, building community coalitions to reduce readmissions, claims analyses, registry management, translating evidence into practice with large multi-site collaboratives, and engaging patients and stakeholders in research. The planning phase of this project has been guided by patients and stakeholders. Each community will form a community resource network to advise and support the implementation of COMPASS, provide feedback to the team, and help create sustainability. If the COMPASS model shows effectiveness, engaged patients and stakeholders will be key partners to disseminate and implement COMPASS throughout the state and beyond.

Official Title
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Early Supported Discharge for Improving Functional Outcomes After Stroke

Conditions
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Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Other: COMPASS Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Excludes subdural or aneurysmal subarachnoid hemorrhage

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients. | |
| Active Comparator: COMPASS Intervention<br>Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care. | Other: COMPASS Intervention<br>* A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital. Patient will receive a follow-up telephone call two days after having been discharged. 7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving. Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Impact Scale (SIS-16) | 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 | post-stroke day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Caregiver Strain Index | 13-item survey to measure strain that caregivers may experience; scores range from 0-100; higher scores indicate more caregiver burden | post-stroke day 90 | 
| Self-reported General Health | Self-reported general health is a single question to rate their general health. Responses on a 5-point Likert Scale (Excellent, Very Good, Good, Fair, or Poor) will be analyzed as a continuous variable. Scores range from 95-15 with a higher score indicating better health. | post-stroke day 90 | 
| Modified Rankin Score | to measure the degree of disability or dependence; scores range from 0-6; higher scores correspond to less favorable outcomes | post-stroke day 90 | 
| Number of Participants Physically Active and Not Physically Active | Participants are asked whether they walked continuously for at least 10 minutes on any of the last seven days, how many of those days they walked continuously for at least 10 minutes and how many minutes they walked, on average, each day. The physical activity endpoint will be self-reported total number of minutes walked during the past seven days. | post-stroke day 90 | 
| Number of Participants With or Without Depression | Based on answers to Patient Health Questionnaire 2-Item (PHQ-2) which is a 2-item questionnaire to determine the frequency of depressed mood; scores range from 0-6; higher scores correspond to less favorable outcomes | post-stroke day 90 | 
| Cognition (MoCA 5-min Protocol) | 4-item questionnaire to determine vascular cognitive impairment; scores range from 0-30; higher scores are more favorable | post-stroke day 90 | 
| Medication Adherence (Morisky Green Levine Scale-4) | 4 items with yes/no response options; scores range from 0-4; higher scores correspond to less medication adherence | post-stroke day 90 | 
| Number of Participants With or Without Falls | Participants are asked 4 questions to determine whether they have fallen (yes versus no) since hospital discharge, whether or not the fall resulted in a doctor/emergency room visit, whether they have fallen multiple times since discharge, and how many times they have fallen since discharge. Analysis of falls will be based on incidence of any fall since hospital discharge (no falls versus at least one fall). | post-stroke day 90 | 
| Self-reported Fatigue (PROMIS Fatigue Instrument) | 4-question instrument to determine level of fatigue; higher scores correspond to less favorable outcomes; The total raw score is obtained by summing individual question scores and has a range of 4-20. For analysis, raw scores are translated into T-scores which range from 33.7 - 75.8. The T-score rescales the raw score into a standardized score with a mean of 50 and a SD of 10. | post-stroke day 90 | 
| Satisfaction With Care | 6 questions to determine satisfaction with care; scores range from 0-100; higher scores correspond to higher satisfaction of care | post-stroke day 90 | 
| Number of Participants Who Do or Do Not Monitor Blood Pressure at Home | Participants are asked 2 questions to determine whether they monitor their blood pressure at home (yes or no) and, if they answer in the affirmative, how frequently (daily, weekly, and monthly). Home blood pressure monitoring was analyzed as a dichotomous endpoint (monitoring with any frequency versus no monitoring). | post-stroke day 90 | 
| Self-reported Blood Pressure | 1 question to determine self-reported blood pressure. Self-reported systolic and diastolic BP will each be analyzed as a continuous endpoint. In addition, self-reported systolic and diastolic BP will be used to create a dichotomous hypertension endpoint (systolic BP >= 140 versus systolic BP < 140). | post-stroke day 90 | 
| Number of Subjects With Claims-based All-cause Hospital Readmissions |  | post-stroke day 30 | 
| Number of Subjects With Claims-based All-cause Hospital Readmissions |  | post-stroke day 90 | 
| Number of Subjects With Claims-based All-cause Hospital Readmissions |  | post-discharge year 1 | 
| Number of Subjects With All-cause Mortality Using NC State Death Index | Deaths within 90 days of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death. | post-stroke day 90 | 
| Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare | Deaths within 1 year of index discharge were ascertained from the North Carolina State Death Index as well as insurance claims beneficiary summary files (i.e. FFS Medicare). A death identified in either database is considered a death. | post-discharge year 1 | 
| Number of Subjects With Claims-based Emergency Department Visits |  | post-discharge year 1 | 
| Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF) |  | post-discharge year 1 | 
| Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes |  | post-discharge day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Supported Discharge, Transitional Care, Post-acute Stroke Care, Pragmatic Trial, Recovery and Rehabilitation, Secondary Prevention