Comprehensive Post-Acute Stroke Services

NCT02588664 | Completed Results DMC

• 2 other identifiers: IRB00035998PCS-1403-14532
• Study Type: interventional
• Target: 6,024
• Locations: 1 country
• Sites: 40

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.

Conditions

Stroke; Transient Ischemic Attack

Keywords

Early Supported Discharge; Transitional Care; Post-acute Stroke Care; Pragmatic Trial; Recovery and Rehabilitation; Secondary Prevention

Outcome Measures

Primary Outcomes (1)

• Stroke Impact Scale (SIS-16)

  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

  post-stroke day 90

Secondary Outcomes (20)

• Modified Caregiver Strain Index

  post-stroke day 90

• Self-reported General Health

  post-stroke day 90

• Modified Rankin Score

  post-stroke day 90

• Number of Participants Physically Active and Not Physically Active

  post-stroke day 90

• Number of Participants With or Without Depression

  post-stroke day 90

Other Outcomes (6)

• Subgroup Analysis: Race

  post-stroke day 90

• Subgroup Analysis: Sex

  measured 90 days post-stroke

• Subgroup Analysis: Age

  measured 90 days post-stroke

Study Arms (2)

Usual Care

NO INTERVENTION

Participating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.

COMPASS Intervention

ACTIVE COMPARATOR

Participating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care.

Other: COMPASS Intervention

Interventions

COMPASS Intervention OTHER

* 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.

COMPASS Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Excludes subdural or aneurysmal subarachnoid hemorrhage

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• University of North Carolina, Chapel Hill: collaborator
• Duke University: collaborator
• East Carolina University: collaborator

Study Sites (40)

CHS Stanly

Albemarle, North Carolina, 28001, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

UNC Hospital

Chapel Hill, North Carolina, 27514, United States

Location

CHS Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

CHS Carolinas Medical Center-Mercy

Charlotte, North Carolina, 28207, United States

Location

CHS University

Charlotte, North Carolina, 28265, United States

Location

CHS Northeast

Concord, North Carolina, 28025, United States

Location

Betsy Johnson Hospital

Dunn, North Carolina, 28334, United States

Location

Morehead Memorial Hospital

Eden, North Carolina, 27288, United States

Location

Hugh Chatham Memorial Hospital

Elkin, North Carolina, 28621, United States

Location

Cape Fear Valley Medical Center

Fayetteville, North Carolina, 28304, United States

Location

Angel Medical Center

Franklin, North Carolina, 28734, United States

Location

Pardee Health

Hendersonville, North Carolina, 28791, United States

Location

Frye Regional Medical Center

Hickory, North Carolina, 28601, United States

Location

Novant Health Huntersville

Huntersville, North Carolina, 28078, United States

Location

Onslow Memorial Hospital

Jacksonville, North Carolina, 28546, United States

Location

Ashe Memorial Hospital

Jefferson, North Carolina, 28640, United States

Location

Vidant Duplin Hospital

Kenansville, North Carolina, 28349, United States

Location

CHS Kings Mountain

Kings Mountain, North Carolina, 28086, United States

Location

Lenoir Memorial Hospital

Kinston, North Carolina, 28503, United States

Location

Caldwell Memorial Hospital

Lenoir, North Carolina, 28645, United States

Location

WFBH Lexington Medical Center

Lexington, North Carolina, 27292, United States

Location

CHS Lincoln

Lincolnton, North Carolina, 28092, United States

Location

Novant Health Matthews Medical Center

Matthews, North Carolina, 28105, United States

Location

CHS Union

Monroe, North Carolina, 28112, United States

Location

Carteret County General Hospital

Morehead City, North Carolina, 28557, United States

Location

CHS Blue Ridge

Morganton, North Carolina, 28655, United States

Location

Northern Hospital of Surry County

Mount Airy, North Carolina, 27030, United States

Location

Wilkes Regional Medical Center

North Wilkesboro, North Carolina, 28659, United States

Location

FirstHealth Moore Regional

Pinehurst, North Carolina, 28374, United States

Location

Washington County Hospital

Plymouth, North Carolina, 27962, United States

Location

UNC Rex Healthcare

Raleigh, North Carolina, 27607, United States

Location

Duke Raleigh Hospital

Raleigh, North Carolina, 27609, United States

Location

WakeMed Health and Hospital

Raleigh, North Carolina, 27610, United States

Location

CHS Cleveland

Shelby, North Carolina, 28150, United States

Location

Alleghany County Memorial Hospital

Sparta, North Carolina, 28675, United States

Location

Blue Ridge Regional Hospital

Spruce Pine, North Carolina, 28777, United States

Location

Vidant Edgecombe Hospital

Tarboro, North Carolina, 27886, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Related Publications (23)

• 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.

  PMID: 27125528 BACKGROUND

• 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.

  PMID: 28649454 BACKGROUND

• 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.

  PMID: 28716014 BACKGROUND

• 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.

  PMID: 29373987 BACKGROUND

• 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.

  PMID: 29572814 BACKGROUND

• 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.

  PMID: 29720489 BACKGROUND

• 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.

  PMID: 30354371 BACKGROUND

• 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.

  PMID: 30635495 BACKGROUND

• 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.

  PMID: 33543066 BACKGROUND

• 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.

  PMID: 32313700 BACKGROUND

• 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.

  PMID: 32275060 BACKGROUND

• 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.

  PMID: 33948280 BACKGROUND

• 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.

  PMID: 33263286 BACKGROUND

• 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.

  PMID: 33349012 BACKGROUND

• 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.

  PMID: 33273292 BACKGROUND

• 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.

  PMID: 31856808 RESULT

• 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.

  PMID: 32475159 RESULT

• 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.

  PMID: 39794769 DERIVED

• 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.

  PMID: 38189125 DERIVED

• 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.

  PMID: 36729552 DERIVED

• 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.

  PMID: 35603644 DERIVED

• 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.

  PMID: 34730000 DERIVED

• 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.

  PMID: 34657341 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Limitations and Caveats

Only 58% of intervention hospitals staffed TC clinics continuously. Patient-level barriers were also present and included preference to see primary care providers, affordability, and transportation. Only 35% of patients enrolled through Intervention hospitals received the COMPASS TC Intervention.

Results Point of Contact

• Title: Dr. Pamela W. Duncan
• Organization: Wake Forest University Health Sciences

pduncan@wakehealth.edu

(336) 716-5068

Study Officials

• Pamela Duncan, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 28, 2015
• Study Start: July 25, 2016
• Primary Completion: July 25, 2018
• Study Completion: March 15, 2020
• Last Updated: June 11, 2021
• Results First Posted: June 11, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (40)