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Comprehensive Post-Acute Stroke Services (COMPASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Stroke Transient Ischemic Attack Other: COMPASS Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6024 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Early Supported Discharge for Improving Functional Outcomes After Stroke
Actual Study Start Date : July 25, 2016
Actual Primary Completion Date : July 25, 2018
Actual Study Completion Date : March 15, 2020

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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).

  9. 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.

  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

  11. 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).

  12. 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).

  13. Number of Subjects With Claims-based All-cause Hospital Readmissions [ Time Frame: post-stroke day 30 ]
  14. Number of Subjects With Claims-based All-cause Hospital Readmissions [ Time Frame: post-stroke day 90 ]
  15. Number of Subjects With Claims-based All-cause Hospital Readmissions [ Time Frame: post-discharge year 1 ]
  16. 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.

  17. 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.

  18. Number of Subjects With Claims-based Emergency Department Visits [ Time Frame: post-discharge year 1 ]
  19. Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF) [ Time Frame: post-discharge year 1 ]
  20. Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes [ Time Frame: post-discharge day 14 ]

Other Outcome Measures:
  1. Subgroup Analysis: Race [ Time Frame: post-stroke day 90 ]
    Analyze the main endpoint of the study in white and non-white individuals

  2. Subgroup Analysis: Sex [ Time Frame: measured 90 days post-stroke ]
    Analyze the main endpoint of the study in female and male individuals

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588664


Locations
Show Show 40 study locations
Sponsors and Collaborators
Wake Forest University Health Sciences
University of North Carolina, Chapel Hill
Duke University
East Carolina University
Investigators
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Principal Investigator: Pamela Duncan, PhD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Statistical Analysis Plan: Phase 1  [PDF] May 15, 2018

Additional Information:
Study Data/Documents: Full Data Package  This link exits the ClinicalTrials.gov site

Publications of Results:
Other Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02588664    
Other Study ID Numbers: IRB00035998
PCS-1403-14532 ( Other Identifier: Patient-Centered Outcomes Research Institute (PCORI) )
First Posted: October 28, 2015    Key Record Dates
Results First Posted: June 11, 2021
Last Update Posted: June 11, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Early Supported Discharge
Transitional Care
Post-acute Stroke Care
Pragmatic Trial
Recovery and Rehabilitation
Secondary Prevention
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia