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Comprehensive Post-Acute Stroke Services (COMPASS)

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ClinicalTrials.gov Identifier: NCT02588664
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : June 18, 2018
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 Detailed Description

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
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : September 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: 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

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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


Contacts
Contact: Mysha E Sissine, MSPH 336-713-2687 msissine@wakehealth.edu
Contact: Sara Jones, PhD 919-966-3161 sbjones@email.unc.edu

Locations
United States, North Carolina
CHS Stanly Recruiting
Albemarle, North Carolina, United States, 28001
Contact: Joan Stewart, RN, CSRN    704-403-2567    Joan.Stewart@carolinashealthcare.org   
Mission Hospital Recruiting
Asheville, North Carolina, United States, 28801
Contact: Alex Schneider, MD    828-213-1439    alex.schneider@msj.org   
UNC Hospital Active, not recruiting
Chapel Hill, North Carolina, United States, 27514
CHS Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Andrew Asimos, MD         
Novant Health Presbyterian Medical Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Tina Deatherage, RN, DNP    704-384-6623    tdcronin@novanthealth.org   
CHS Carolinas Medical Center-Mercy Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Andrew Asimos, MD         
CHS University Recruiting
Charlotte, North Carolina, United States, 28265
Contact: Christian Sonnefeld, MD    704-863-6000    Christian.Sonnefeld@carolinashealthcare.org   
CHS Northeast Recruiting
Concord, North Carolina, United States, 28025
Contact: Sam Saha, MD    704-403-1911    sam.saha@carolinashealthcare.org   
Betsy Johnson Hospital Recruiting
Dunn, North Carolina, United States, 28334
Contact: Tammy Woerner, BSIE, ME    910-892-1000 ext 5297    Tammy.woerner@harnetthealth.org   
Morehead Memorial Hospital Recruiting
Eden, North Carolina, United States, 27288
Contact: JoAnn Smith, DNP, RN, OCN    336-623-2292    joann.smith@morehead.org   
Hugh Chatham Memorial Hospital Recruiting
Elkin, North Carolina, United States, 28621
Contact: Doug Underwood, PhD, MSN, RN    336-527-7415    dunderwood@hughchatham.org   
Cape Fear Valley Medical Center Recruiting
Fayetteville, North Carolina, United States, 28304
Contact: Jan Matthews, RN, MPHA    910-615-6040      
Angel Medical Center Recruiting
Franklin, North Carolina, United States, 28734
Contact: Lisa Blankenship, CHSP    828-349-6647    Lisa.Blankenship@msj.org   
Pardee Health Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: Joel Callahan, MD       Joel.Callahan@pardeehospital.org   
Frye Regional Medical Center Recruiting
Hickory, North Carolina, United States, 28601
Contact: Robert Yapundich, MD    828-328-5500    noggindoc@yahoo.com   
Novant Health Huntersville Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Tina Deatherage, RN, DNP    704-384-6623    tdcronin@novanthealth.org   
Onslow Memorial Hospital Recruiting
Jacksonville, North Carolina, United States, 28546
Contact: Penney Burlingame Deal, DHA    910-577-4727    Penney.Burlingame@onslow.org   
Ashe Memorial Hospital Recruiting
Jefferson, North Carolina, United States, 28640
Contact: Brandy Olive    336-846-7101    brandy.olive@ashememorial.org   
Vidant Duplin Hospital Recruiting
Kenansville, North Carolina, United States, 28349
Contact: Debra Thompson, DNP    910-296-0941    DTHOMPSO@vidanthealth.com   
CHS Kings Mountain Active, not recruiting
Kings Mountain, North Carolina, United States, 28086
Lenoir Memorial Hospital Recruiting
Kinston, North Carolina, United States, 28503
Contact: Dawn Becker, RN, BSN    252-522-7575    dbecker@lenoir.org   
Caldwell Memorial Hospital Recruiting
Lenoir, North Carolina, United States, 28645
Contact: Denise Stiltner, RNC-NIC, MSN    828-572-4724    Denise.Stiltner@unchealth.unc.edu   
WFBH Lexington Medical Center Recruiting
Lexington, North Carolina, United States, 27292
Contact: Amy Guzik, MD    336-716-4101    aguzik@wakehealth.edu   
CHS Lincoln Active, not recruiting
Lincolnton, North Carolina, United States, 28092
Novant Health Matthews Medical Center Recruiting
Matthews, North Carolina, United States, 28105
Contact: Tina Deatherage, RN, DNP    704-384-6623    tdcronin@novanthealth.org   
CHS Union Recruiting
Monroe, North Carolina, United States, 28112
Contact: Jeanne Whalen, MSN, RN    980-993-3393    Jeanne.Whalen@carolinashealthcare.org   
Carteret County General Hospital Recruiting
Morehead City, North Carolina, United States, 28557
Contact: Cindy Rose, MSN, RN    252-808-6362    crose@ccgh.org   
CHS Blue Ridge Recruiting
Morganton, North Carolina, United States, 28655
Contact: Joseph Mazzola, DO    828-580-5000    Joseph.Mazzola@Blueridgehealth.org   
Northern Hospital of Surry County Recruiting
Mount Airy, North Carolina, United States, 27030
Contact: Lynn Lambert, RN, MPH    336-783-8023    llambert@nhsc.org   
Wilkes Regional Medical Center Recruiting
North Wilkesboro, North Carolina, United States, 28659
Contact: Earl Webster, MD       epwebste@wakehealth.edu   
FirstHealth Moore Regional Active, not recruiting
Pinehurst, North Carolina, United States, 28374
Washington County Hospital Recruiting
Plymouth, North Carolina, United States, 27962
Contact: Kina Collier, RN    252-793-4135    kina_collier@wchonline.com   
UNC Rex Healthcare Active, not recruiting
Raleigh, North Carolina, United States, 27607
Duke Raleigh Hospital Recruiting
Raleigh, North Carolina, United States, 27609
Contact: Paul Peterson, MD    919-862-5620    paul.peterson@duke.edu   
WakeMed Health and Hospital Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Kimberly Elks, BSN, RN, CCM    919-350-7269    kelks@wakemed.org   
CHS Cleveland Active, not recruiting
Shelby, North Carolina, United States, 28150
Alleghany County Memorial Hospital Recruiting
Sparta, North Carolina, United States, 28675
Contact: Elizabeth Jones, FNP    336-372-3110    ejones@amhsparta.org   
Blue Ridge Regional Hospital Recruiting
Spruce Pine, North Carolina, United States, 28777
Contact: Rebecca Carter, MSN, RN    828-765-4201    Becky.Carter@msj.org   
Vidant Edgecombe Hospital Recruiting
Tarboro, North Carolina, United States, 27886
Contact: Debra Thompson, DNP    252-847-1220    DTHOMPSO@vidanthealth.com   
New Hanover Regional Medical Center Recruiting
Wilmington, North Carolina, United States, 28401
Contact: James McKinney, MD, FAHA    910-899-6532    james.mckinney@nhrmc.org   
Sponsors and Collaborators
Wake Forest University Health Sciences
University of North Carolina, Chapel Hill
Duke University
East Carolina University
Investigators
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:

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02588664     History of Changes
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: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases