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Comprehensive Post-Acute Stroke Services (COMPASS)

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ClinicalTrials.gov Identifier: NCT02588664
Recruitment Status : Completed
First Posted : October 28, 2015
Results First Posted : June 11, 2021
Last Update Posted : June 11, 2021
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
Duke University
East Carolina University
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE October 23, 2015
First Posted Date  ICMJE October 28, 2015
Results First Submitted Date  ICMJE April 12, 2021
Results First Posted Date  ICMJE June 11, 2021
Last Update Posted Date June 11, 2021
Actual Study Start Date  ICMJE July 25, 2016
Actual Primary Completion Date July 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
Stroke Impact Scale (SIS-16) [ Time Frame: measured 90 days post-stroke ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2021)
  • 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
  • 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.
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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).
  • 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.
  • 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
  • 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).
  • 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).
  • Number of Subjects With Claims-based All-cause Hospital Readmissions [ Time Frame: post-stroke day 30 ]
  • Number of Subjects With Claims-based All-cause Hospital Readmissions [ Time Frame: post-stroke day 90 ]
  • Number of Subjects With Claims-based All-cause Hospital Readmissions [ Time Frame: 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.
  • 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.
  • Number of Subjects With Claims-based Emergency Department Visits [ Time Frame: 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 ]
  • Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes [ Time Frame: post-discharge day 14 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
  • Modified Caregiver Strain Index [ Time Frame: measured 90 days post-stroke ]
  • All-cause hospital readmissions at 30- and 90-days post-stroke [ Time Frame: measured 1 year after index discharge ]
  • Mortality [ Time Frame: measured 1 year after index discharge ]
  • Number of Patient Emergency Department Visits [ Time Frame: measured 1 year after index discharge ]
  • Number of Patient Hospitalizations [ Time Frame: measured 1 year after index discharge ]
  • Number of Patients with Medication Adherence as measured by the Morisky Medication Adherence Scale (MMAS-4) [ Time Frame: measured 1 year after index discharge ]
  • Number of Patient Admissions to Skilled Nursing Facilities [ Time Frame: measured 1 year after index discharge ]
  • Number of Patient Admissions to Inpatient Rehabilitation Facilities [ Time Frame: measured 1 year after index discharge ]
Current Other Pre-specified Outcome Measures
 (submitted: May 17, 2021)
  • Subgroup Analysis: Race [ Time Frame: post-stroke day 90 ]
    Analyze the main endpoint of the study in white and non-white individuals
  • Subgroup Analysis: Sex [ Time Frame: measured 90 days post-stroke ]
    Analyze the main endpoint of the study in female and male individuals
  • 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
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comprehensive Post-Acute Stroke Services
Official Title  ICMJE Early Supported Discharge for Improving Functional Outcomes After Stroke
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Stroke
  • Transient Ischemic Attack
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: COMPASS Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2021)
6024
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2015)
6000
Actual Study Completion Date  ICMJE March 15, 2020
Actual Primary Completion Date July 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02588664
Other Study ID Numbers  ICMJE IRB00035998
PCS-1403-14532 ( Other Identifier: Patient-Centered Outcomes Research Institute (PCORI) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: De-identified data will be made available to researchers through the PCORI-Designated Repository in accordance with their Data Sharing Policy.
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE
  • University of North Carolina, Chapel Hill
  • Duke University
  • East Carolina University
Investigators  ICMJE
Principal Investigator: Pamela Duncan, PhD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP