Study Results
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View full resultsBasic Information
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COMPLETED
NA
6024 participants
INTERVENTIONAL
2016-07-25
2020-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Usual Care
Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.
No interventions assigned to this group
COMPASS Intervention
Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Must be 18 years of age and older at the time of the stroke
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Duke University
OTHER
East Carolina University
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Pamela Duncan, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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CHS Stanly
Albemarle, North Carolina, United States
Mission Hospital
Asheville, North Carolina, United States
UNC Hospital
Chapel Hill, North Carolina, United States
CHS Carolinas Medical Center
Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
CHS Carolinas Medical Center-Mercy
Charlotte, North Carolina, United States
CHS University
Charlotte, North Carolina, United States
CHS Northeast
Concord, North Carolina, United States
Betsy Johnson Hospital
Dunn, North Carolina, United States
Morehead Memorial Hospital
Eden, North Carolina, United States
Hugh Chatham Memorial Hospital
Elkin, North Carolina, United States
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States
Angel Medical Center
Franklin, North Carolina, United States
Pardee Health
Hendersonville, North Carolina, United States
Frye Regional Medical Center
Hickory, North Carolina, United States
Novant Health Huntersville
Huntersville, North Carolina, United States
Onslow Memorial Hospital
Jacksonville, North Carolina, United States
Ashe Memorial Hospital
Jefferson, North Carolina, United States
Vidant Duplin Hospital
Kenansville, North Carolina, United States
CHS Kings Mountain
Kings Mountain, North Carolina, United States
Lenoir Memorial Hospital
Kinston, North Carolina, United States
Caldwell Memorial Hospital
Lenoir, North Carolina, United States
WFBH Lexington Medical Center
Lexington, North Carolina, United States
CHS Lincoln
Lincolnton, North Carolina, United States
Novant Health Matthews Medical Center
Matthews, North Carolina, United States
CHS Union
Monroe, North Carolina, United States
Carteret County General Hospital
Morehead City, North Carolina, United States
CHS Blue Ridge
Morganton, North Carolina, United States
Northern Hospital of Surry County
Mount Airy, North Carolina, United States
Wilkes Regional Medical Center
North Wilkesboro, North Carolina, United States
FirstHealth Moore Regional
Pinehurst, North Carolina, United States
Washington County Hospital
Plymouth, North Carolina, United States
UNC Rex Healthcare
Raleigh, North Carolina, United States
Duke Raleigh Hospital
Raleigh, North Carolina, United States
WakeMed Health and Hospital
Raleigh, North Carolina, United States
CHS Cleveland
Shelby, North Carolina, United States
Alleghany County Memorial Hospital
Sparta, North Carolina, United States
Blue Ridge Regional Hospital
Spruce Pine, North Carolina, United States
Vidant Edgecombe Hospital
Tarboro, North Carolina, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Countries
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References
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Condon C, Lycan S, Duncan P, Bushnell C. Reducing Readmissions After Stroke With a Structured Nurse Practitioner/Registered Nurse Transitional Stroke Program. Stroke. 2016 Jun;47(6):1599-604. doi: 10.1161/STROKEAHA.115.012524. Epub 2016 Apr 28.
Gesell SB, Klein KP, Halladay J, Bettger JP, Freburger J, Cummings DM, Lutz BJ, Coleman S, Bushnell C, Rosamond W, Duncan PW. Methods guiding stakeholder engagement in planning a pragmatic study on changing stroke systems of care. J Clin Transl Sci. 2017 Apr;1(2):121-128. doi: 10.1017/cts.2016.26. Epub 2017 Feb 27.
Duncan PW, Bushnell CD, Rosamond WD, Jones Berkeley SB, Gesell SB, D'Agostino RB Jr, Ambrosius WT, Barton-Percival B, Bettger JP, Coleman SW, Cummings DM, Freburger JK, Halladay J, Johnson AM, Kucharska-Newton AM, Lundy-Lamm G, Lutz BJ, Mettam LH, Pastva AM, Sissine ME, Vetter B. The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial. BMC Neurol. 2017 Jul 17;17(1):133. doi: 10.1186/s12883-017-0907-1.
Johnson AM, Jones SB, Duncan PW, Bushnell CD, Coleman SW, Mettam LH, Kucharska-Newton AM, Sissine ME, Rosamond WD. Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study. Trials. 2018 Jan 26;19(1):74. doi: 10.1186/s13063-017-2434-1.
Bushnell CD, Duncan PW, Lycan SL, Condon CN, Pastva AM, Lutz BJ, Halladay JR, Cummings DM, Arnan MK, Jones SB, Sissine ME, Coleman SW, Johnson AM, Gesell SB, Mettam LH, Freburger JK, Barton-Percival B, Taylor KM, Prvu-Bettger J, Lundy-Lamm G, Rosamond WD; COMPASS Trial.. A Person-Centered Approach to Poststroke Care: The COMprehensive Post-Acute Stroke Services Model. J Am Geriatr Soc. 2018 May;66(5):1025-1030. doi: 10.1111/jgs.15322. Epub 2018 Mar 23.
Andrews JE, Moore JB, Weinberg RB, Sissine M, Gesell S, Halladay J, Rosamond W, Bushnell C, Jones S, Means P, King NMP, Omoyeni D, Duncan PW; COMPASS investigators and stakeholders. Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial. J Med Ethics. 2018 Aug;44(8):560-566. doi: 10.1136/medethics-2017-104478. Epub 2018 May 2.
Duncan PW, Abbott RM, Rushing S, Johnson AM, Condon CN, Lycan SL, Lutz BJ, Cummings DM, Pastva AM, D'Agostino RB Jr, Stafford JM, Amoroso RM, Jones SB, Psioda MA, Gesell SB, Rosamond WD, Prvu-Bettger J, Sissine ME, Boynton MD, Bushnell CD; COMPASS Investigative Team. COMPASS-CP: An Electronic Application to Capture Patient-Reported Outcomes to Develop Actionable Stroke and Transient Ischemic Attack Care Plans. Circ Cardiovasc Qual Outcomes. 2018 Aug;11(8):e004444. doi: 10.1161/CIRCOUTCOMES.117.004444.
Bettger JP, Jones SB, Kucharska-Newton AM, Freburger JK, Coleman SW, Mettam LH, Sissine ME, Gesell SB, Bushnell CD, Duncan PW, Rosamond WD. Meeting Medicare requirements for transitional care: Do stroke care and policy align? Neurology. 2019 Feb 26;92(9):427-434. doi: 10.1212/WNL.0000000000006921. Epub 2019 Jan 11.
Halladay J, Bushnell C, Psioda M, Jones S, Lycan S, Condon C, Xenakis J, Prvu-Bettger J; COMPASS Investigative Team. Patient Factors Associated With Attendance at a Comprehensive Postacute Stroke Visit: Insight From the Vanguard Site. Arch Rehabil Res Clin Transl. 2019 Dec 21;2(1):100037. doi: 10.1016/j.arrct.2019.100037. eCollection 2020 Mar.
Gesell SB, Halladay JR, Mettam LH, Sissine ME, Staplefoote-Boynton BL, Duncan PW. Using REDCap to track stakeholder engagement: A time-saving tool for PCORI-funded studies. J Clin Transl Sci. 2020 Feb 6;4(2):108-114. doi: 10.1017/cts.2019.444. eCollection 2020 Apr.
Lutz BJ, Reimold AE, Coleman SW, Guzik AK, Russell LP, Radman MD, Johnson AM, Duncan PW, Bushnell CD, Rosamond WD, Gesell SB. Implementation of a Transitional Care Model for Stroke: Perspectives From Frontline Clinicians, Administrators, and COMPASS-TC Implementation Staff. Gerontologist. 2020 Aug 14;60(6):1071-1084. doi: 10.1093/geront/gnaa029.
Gesell SB, Coleman SW, Mettam LH, Johnson AM, Sissine ME, Duncan PW. How engagement of a diverse set of stakeholders shaped the design, implementation, and dissemination of a multicenter pragmatic trial of stroke transitional care: The COMPASS study. J Clin Transl Sci. 2020 Nov 5;5(1):e60. doi: 10.1017/cts.2020.552.
Pastva AM, Coyle PC, Coleman SW, Radman MD, Taylor KM, Jones SB, Bushnell CD, Rosamond WD, Johnson AM, Duncan PW, Freburger JK; COMPASS Investigative Team. Movement Matters, and So Does Context: Lessons Learned From Multisite Implementation of the Movement Matters Activity Program for Stroke in the Comprehensive Postacute Stroke Services Study. Arch Phys Med Rehabil. 2021 Mar;102(3):532-542. doi: 10.1016/j.apmr.2020.09.386. Epub 2020 Oct 22.
Duncan PW, Bushnell C, Sissine M, Coleman S, Lutz BJ, Johnson AM, Radman M, Pvru Bettger J, Zorowitz RD, Stein J. Comprehensive Stroke Care and Outcomes: Time for a Paradigm Shift. Stroke. 2021 Jan;52(1):385-393. doi: 10.1161/STROKEAHA.120.029678. Epub 2020 Dec 22.
Bayliss WS, Bushnell CD, Halladay JR, Duncan PW, Freburger JK, Kucharska-Newton AM, Trogdon JG. The Cost of Implementing and Sustaining the COMprehensive Post-Acute Stroke Services Model. Med Care. 2021 Feb 1;59(2):163-168. doi: 10.1097/MLR.0000000000001462.
Gesell SB, Bushnell CD, Jones SB, Coleman SW, Levy SM, Xenakis JG, Lutz BJ, Bettger JP, Freburger J, Halladay JR, Johnson AM, Kucharska-Newton AM, Mettam LH, Pastva AM, Psioda MA, Radman MD, Rosamond WD, Sissine ME, Halls J, Duncan PW. Implementation of a billable transitional care model for stroke patients: the COMPASS study. BMC Health Serv Res. 2019 Dec 19;19(1):978. doi: 10.1186/s12913-019-4771-0.
Duncan PW, Bushnell CD, Jones SB, Psioda MA, Gesell SB, D'Agostino RB Jr, Sissine ME, Coleman SW, Johnson AM, Barton-Percival BF, Prvu-Bettger J, Calhoun AG, Cummings DM, Freburger JK, Halladay JR, Kucharska-Newton AM, Lundy-Lamm G, Lutz BJ, Mettam LH, Pastva AM, Xenakis JG, Ambrosius WT, Radman MD, Vetter B, Rosamond WD; COMPASS Site Investigators and Teams.. Randomized Pragmatic Trial of Stroke Transitional Care: The COMPASS Study. Circ Cardiovasc Qual Outcomes. 2020 Jun;13(6):e006285. doi: 10.1161/CIRCOUTCOMES.119.006285. Epub 2020 Jun 1.
Zhang S, Mormer ER, Johnson AM, Bushnell CD, Duncan PW, Wen F, Pathak S, Pastva AM, Freburger JK, Jones Berkeley SB. The association between neighborhood social vulnerability and community-based rehabilitation after stroke. BMC Health Serv Res. 2025 Jan 10;25(1):55. doi: 10.1186/s12913-024-12142-1.
Jones Berkeley SB, Johnson AM, Mormer ER, Ressel K, Pastva AM, Wen F, Patterson CG, Duncan PW, Bushnell CD, Zhang S, Freburger JK. Referral to Community-Based Rehabilitation Following Acute Stroke: Findings From the COMPASS Pragmatic Trial. Circ Cardiovasc Qual Outcomes. 2024 Jan;17(1):e010026. doi: 10.1161/CIRCOUTCOMES.123.010026. Epub 2024 Jan 8.
Kucharska-Newton AM, Halladay JR, Psioda MA, Jones SB, Johnson AM, Coleman SW, Cummings DM, Freburger JK, Daras LC, Rosamond WD, Duncan PW, Bushnell CD. Post-acute Ambulatory Care Service Use Among Patients Discharged Home After Stroke or TIA: The Cluster-randomized COMPASS Study. Med Care. 2023 Mar 1;61(3):137-144. doi: 10.1097/MLR.0000000000001798. Epub 2022 Dec 15.
Lutz BJ, Kucharska-Newton AM, Jones SB, Psioda MA, Gesell SB, Coleman SW, Johnson AM, Radman MD, Levy S, Bettger JP, Freburger JK, Chou A, Celestino J, Rosamond WD, Bushnell CD, Duncan PW. Familial caregiving following stroke: findings from the comprehensive post-acute stroke services (COMPASS) pragmatic cluster-randomized transitional care study. Top Stroke Rehabil. 2023 Jul;30(5):436-447. doi: 10.1080/10749357.2022.2077520. Epub 2022 May 22.
Bushnell CD, Kucharska-Newton AM, Jones SB, Psioda MA, Johnson AM, Daras LC, Halladay JR, Prvu Bettger J, Freburger JK, Gesell SB, Coleman SW, Sissine ME, Wen F, Hunt GP, Rosamond WD, Duncan PW. Hospital Readmissions and Mortality Among Fee-for-Service Medicare Patients With Minor Stroke or Transient Ischemic Attack: Findings From the COMPASS Cluster-Randomized Pragmatic Trial. J Am Heart Assoc. 2021 Dec 7;10(23):e023394. doi: 10.1161/JAHA.121.023394. Epub 2021 Nov 3.
Rosamond WD, Kucharska-Newton AM, Jones SB, Psioda MA, Lutz BJ, Johnson AM, Coleman SW, Schilsky SR, Patel MD, Duncan PW. Emergency department utilization after hospitalization discharge for acute stroke: The COMprehensive Post-Acute Stroke Services (COMPASS) study. Acad Emerg Med. 2022 Mar;29(3):369-371. doi: 10.1111/acem.14401. Epub 2021 Nov 1. No abstract available.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan: Phase 1
Document Type: Statistical Analysis Plan: Phase 2
Document Type: Statistical Analysis Plan: Claims Data
Study Documents
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Document Type: Full Data Package
View DocumentOther Identifiers
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PCS-1403-14532
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00035998
Identifier Type: -
Identifier Source: org_study_id
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