Comprehensive Post-Acute Stroke Services (COMPASS)

May 17, 2021 updated by: Wake Forest University Health Sciences

Early Supported Discharge for Improving Functional Outcomes After Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

6024

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Albemarle, North Carolina, United States, 28001
        • CHS Stanly
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Hospital
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Presbyterian Medical Center
      • Charlotte, North Carolina, United States, 28203
        • CHS Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28207
        • CHS Carolinas Medical Center-Mercy
      • Charlotte, North Carolina, United States, 28265
        • CHS University
      • Concord, North Carolina, United States, 28025
        • CHS Northeast
      • Dunn, North Carolina, United States, 28334
        • Betsy Johnson Hospital
      • Eden, North Carolina, United States, 27288
        • Morehead Memorial Hospital
      • Elkin, North Carolina, United States, 28621
        • Hugh Chatham Memorial Hospital
      • Fayetteville, North Carolina, United States, 28304
        • Cape Fear Valley Medical Center
      • Franklin, North Carolina, United States, 28734
        • Angel Medical Center
      • Hendersonville, North Carolina, United States, 28791
        • Pardee Health
      • Hickory, North Carolina, United States, 28601
        • Frye Regional Medical Center
      • Huntersville, North Carolina, United States, 28078
        • Novant Health Huntersville
      • Jacksonville, North Carolina, United States, 28546
        • Onslow Memorial Hospital
      • Jefferson, North Carolina, United States, 28640
        • Ashe Memorial Hospital
      • Kenansville, North Carolina, United States, 28349
        • Vidant Duplin Hospital
      • Kings Mountain, North Carolina, United States, 28086
        • CHS Kings Mountain
      • Kinston, North Carolina, United States, 28503
        • Lenoir Memorial Hospital
      • Lenoir, North Carolina, United States, 28645
        • Caldwell Memorial Hospital
      • Lexington, North Carolina, United States, 27292
        • WFBH Lexington Medical Center
      • Lincolnton, North Carolina, United States, 28092
        • CHS Lincoln
      • Matthews, North Carolina, United States, 28105
        • Novant Health Matthews Medical Center
      • Monroe, North Carolina, United States, 28112
        • CHS Union
      • Morehead City, North Carolina, United States, 28557
        • Carteret County General Hospital
      • Morganton, North Carolina, United States, 28655
        • CHS Blue Ridge
      • Mount Airy, North Carolina, United States, 27030
        • Northern Hospital of Surry County
      • North Wilkesboro, North Carolina, United States, 28659
        • Wilkes Regional Medical Center
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth Moore Regional
      • Plymouth, North Carolina, United States, 27962
        • Washington County Hospital
      • Raleigh, North Carolina, United States, 27607
        • UNC Rex Healthcare
      • Raleigh, North Carolina, United States, 27609
        • Duke Raleigh Hospital
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Health and Hospital
      • Shelby, North Carolina, United States, 28150
        • CHS Cleveland
      • Sparta, North Carolina, United States, 28675
        • Alleghany County Memorial Hospital
      • Spruce Pine, North Carolina, United States, 28777
        • Blue Ridge Regional Hospital
      • Tarboro, North Carolina, United States, 27886
        • Vidant Edgecombe Hospital
      • Wilmington, North Carolina, United States, 28401
        • New Hanover Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.
Active Comparator: COMPASS Intervention
Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care.
Other: COMPASS Intervention
  • 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Caregiver Strain Index
Time Frame: post-stroke day 90
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
Time Frame: post-stroke day 90
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
Time Frame: post-stroke day 90
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
Time Frame: post-stroke day 90
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
Time Frame: post-stroke day 90
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)
Time Frame: post-stroke day 90
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)
Time Frame: post-stroke day 90
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
Time Frame: post-stroke day 90
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)
Time Frame: post-stroke day 90
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
Time Frame: post-stroke day 90
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
Time Frame: post-stroke day 90
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
Time Frame: post-stroke day 90
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
Time Frame: post-stroke day 30
post-stroke day 30
Number of Subjects With Claims-based All-cause Hospital Readmissions
Time Frame: post-stroke day 90
post-stroke day 90
Number of Subjects With Claims-based All-cause Hospital Readmissions
Time Frame: post-discharge year 1
post-discharge year 1
Number of Subjects With All-cause Mortality Using NC State Death Index
Time Frame: post-stroke day 90
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
Time Frame: post-discharge year 1
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
Time Frame: post-discharge year 1
post-discharge year 1
Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF)
Time Frame: post-discharge year 1
post-discharge year 1
Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes
Time Frame: post-discharge day 14
post-discharge day 14

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroup Analysis: Race
Time Frame: post-stroke day 90
Analyze the main endpoint of the study in white and non-white individuals
post-stroke day 90
Subgroup Analysis: Sex
Time Frame: measured 90 days post-stroke
Analyze the main endpoint of the study in female and male individuals
measured 90 days post-stroke
Subgroup Analysis: Age
Time Frame: measured 90 days post-stroke
Analyze the main endpoint of the study in <45; 45-<55; 55-<65; 65-<75; >=75 individuals
measured 90 days post-stroke
Subgroup Analysis: Diagnosis (Stroke Versus TIA)
Time Frame: measured 90 days post-stroke
Analyze the main endpoint of the study in stroke versus TIA individuals
measured 90 days post-stroke
Subgroup Analysis: Stroke Severity
Time Frame: measured 90 days post-stroke
Analyze the main endpoint of the study in NIHSS=0, NIHSS=1-4, NIHSS>4 individuals
measured 90 days post-stroke
Subgroup Analysis: Type of Health Insurance
Time Frame: measured 90 days post-stroke
Analyze the main endpoint of the study in insured and uninsured individuals
measured 90 days post-stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Duke University
University of North Carolina, Chapel Hill
East Carolina University

Investigators

  • Principal Investigator: Pamela Duncan, PhD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2016

Primary Completion (Actual)

July 25, 2018

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00035998
  • PCS-1403-14532 (Other Identifier: Patient-Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified data will be made available to researchers through the PCORI-Designated Repository in accordance with their Data Sharing Policy.

Study Data/Documents

  1. Full Data Package

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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