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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 : Active, not recruiting
First Posted : October 28, 2015
Last Update Posted : November 25, 2020
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 Other: COMPASS Intervention Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 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
Study Start Date : July 2016
Actual Primary Completion Date : July 25, 2019
Estimated Study Completion Date : February 2021

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: measured 90 days post-stroke ]
    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: measured 90 days post-stroke ]
    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: measured 90 days post-stroke ]
    a single question; 5-point Likert Scale to self-rate their general health

  3. Modified Rankin Score [ Time Frame: measured 90 days post-stroke ]
    to measure the degree of disability or dependence; scores range from 0-6; higher scores correspond to less favorable outcomes

  4. Self-reported physical activity [ Time Frame: measured 90 days post-stroke ]
    2 questions to determine self-reported physical activity

  5. Depression (PHQ-2) [ Time Frame: measured 90 days post-stroke ]
    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: measured 90 days post-stroke ]
    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: measured 90 days post-stroke ]
    4 items with yes/no response options; scores range from 0-4; higher scores correspond to less medication adherence

  8. Self-reported falls [ Time Frame: measured 90 days post-stroke ]
    4 questions to determine self-reported falls

  9. Self-reported fatigue (PROMIS Fatigue Instrument) [ Time Frame: measured 90 days post-stroke ]
    4-question instrument to determine level of fatigue; higher scores correspond to less favorable outcomes

  10. Satisfaction with care [ Time Frame: measured 90 days post-stroke ]
    6 questions to determine satisfaction with care; scores range from 0-100; higher scores correspond to higher satisfaction of care

  11. Secondary prevention - Home blood pressure monitoring [ Time Frame: measured 90 days post-stroke ]
    2 questions to determine home blood pressure monitoring

  12. Self-reported blood pressure [ Time Frame: measured 90 days post-stroke ]
    1 question to determine self-reported blood pressure

  13. Claims-based all-cause hospital readmissions [ Time Frame: measured 30 days post-stroke ]
    Claims-based all-cause hospital readmissions

  14. Claims-based all-cause hospital readmissions [ Time Frame: measured 90 days post-stroke ]
    Claims-based all-cause hospital readmissions

  15. Claims-based all-cause hospital readmissions [ Time Frame: measured 1 year after index discharge ]
    Claims-based all-cause hospital readmissions

  16. All-cause mortality using NC State Death Index [ Time Frame: measured 90 days post-stroke ]
    All-cause mortality using NC State Death Index

  17. All-cause mortality using NC State Death Index [ Time Frame: measured 1 year after index discharge ]
    All-cause mortality using NC State Death Index

  18. Claims-based patient emergency department visits [ Time Frame: measured 1 year after index discharge ]
    Claims-based patient emergency department visits

  19. Claims-based patient admissions to skilled nursing facilities [ Time Frame: measured 1 year after index discharge ]
    Claims-based patient admissions to skilled nursing facilities

  20. Claims-based patient admissions to inpatient rehabilitation facilities [ Time Frame: measured 1 year after index discharge ]
    Claims-based patient admissions to inpatient rehabilitation facilities

  21. Claims-based use of transitional care management billing codes [ Time Frame: measured within 14 days of hospital discharge ]
    Claims-based use of transitional care management billing codes


Other Outcome Measures:
  1. Subgroup analysis: race [ Time Frame: measured 90 days post-stroke ]
    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  [PDF] May 15, 2018

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Last Update Posted: November 25, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases