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StrokeCOMPASSNCT02588664

Comprehensive Post-Acute Stroke Services

A study testing COMPASS Intervention in people with Stroke and Transient Ischemic Attack, run by Wake Forest University Health Sciences at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Transient Ischemic Attack
What is being tested?
COMPASS Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,024 participants
Where
40 sitesUnited States
Study dates
25 Jul 2016to 15 Mar 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Excludes subdural or aneurysmal subarachnoid hemorrhage

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • CHS Stanly

    Albemarle, North Carolina, 28001

  • Mission Hospital

    Asheville, North Carolina, 28801

  • UNC Hospital

    Chapel Hill, North Carolina, 27514

  • CHS Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • CHS Carolinas Medical Center-Mercy

    Charlotte, North Carolina, 28207

  • CHS University

    Charlotte, North Carolina, 28265

  • CHS Northeast

    Concord, North Carolina, 28025

  • Betsy Johnson Hospital

    Dunn, North Carolina, 28334

  • Morehead Memorial Hospital

    Eden, North Carolina, 27288

  • Hugh Chatham Memorial Hospital

    Elkin, North Carolina, 28621

  • Cape Fear Valley Medical Center

    Fayetteville, North Carolina, 28304

  • Angel Medical Center

    Franklin, North Carolina, 28734

  • Pardee Health

    Hendersonville, North Carolina, 28791

  • Frye Regional Medical Center

    Hickory, North Carolina, 28601

  • Novant Health Huntersville

    Huntersville, North Carolina, 28078

  • Onslow Memorial Hospital

    Jacksonville, North Carolina, 28546

  • Ashe Memorial Hospital

    Jefferson, North Carolina, 28640

  • Vidant Duplin Hospital

    Kenansville, North Carolina, 28349

  • CHS Kings Mountain

    Kings Mountain, North Carolina, 28086

  • Lenoir Memorial Hospital

    Kinston, North Carolina, 28503

  • Caldwell Memorial Hospital

    Lenoir, North Carolina, 28645

  • WFBH Lexington Medical Center

    Lexington, North Carolina, 27292

  • CHS Lincoln

    Lincolnton, North Carolina, 28092

  • Novant Health Matthews Medical Center

    Matthews, North Carolina, 28105

  • CHS Union

    Monroe, North Carolina, 28112

  • Carteret County General Hospital

    Morehead City, North Carolina, 28557

  • CHS Blue Ridge

    Morganton, North Carolina, 28655

  • Northern Hospital of Surry County

    Mount Airy, North Carolina, 27030

  • Wilkes Regional Medical Center

    North Wilkesboro, North Carolina, 28659

  • FirstHealth Moore Regional

    Pinehurst, North Carolina, 28374

  • Washington County Hospital

    Plymouth, North Carolina, 27962

  • UNC Rex Healthcare

    Raleigh, North Carolina, 27607

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609

  • WakeMed Health and Hospital

    Raleigh, North Carolina, 27610

  • CHS Cleveland

    Shelby, North Carolina, 28150

  • Alleghany County Memorial Hospital

    Sparta, North Carolina, 28675

  • Blue Ridge Regional Hospital

    Spruce Pine, North Carolina, 28777

  • Vidant Edgecombe Hospital

    Tarboro, North Carolina, 27886

  • New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: Early Supported Discharge for Improving Functional Outcomes After Stroke

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.

Read the detailed description

Stroke mortality is 20-40% higher in North Carolina (NC) than in the overall United States. After discharge, stroke patients are at high risk for complications. Although a model of stroke post-care (early supported discharge) exists in Europe and Canada, it has not been adapted for and tested in the US, although patients and stakeholders attest that post-acute care does not meet their needs. Transitional care services from hospital to home are now reimbursed by Centers for Medicaid and Medicare Services (CMS), but only for 30 days after discharge. The study team proposed a pragmatic, cluster randomized trial of 41 NC hospitals to determine the effectiveness of COMprehensive Post-Acute Stroke Services (COMPASS), a patient-centered intervention uniting transitional care management services and elements of early supported discharge in stroke patients discharged directly home.

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.

Being tested
COMPASS Intervention
Keywords
Early Supported Discharge, Transitional Care, Post-acute Stroke Care, Pragmatic Trial, Recovery and Rehabilitation, Secondary Prevention
Medical subject headings
Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COMPASS InterventionOther

    • 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.
Study groups in NCT02588664
Study groupRoleWhat they receive
Usual CareNo interventionParticipating hospitals randomized to the usual care group will provide their usual, post-acute stroke care to their patients.
COMPASS InterventionActive comparatorParticipating hospitals randomized to the intervention will change the structure and process for delivery of post-acute stroke care.
Receives: Other: COMPASS Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: post-stroke day 90

Secondary outcomes (20)

  1. Modified Caregiver Strain Index

    13-item survey to measure strain that caregivers may experience; scores range from 0-100; higher scores indicate more caregiver burden

    Measured: post-stroke day 90

  2. Self-reported General Health

    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.

    Measured: post-stroke day 90

  3. Modified Rankin Score

    to measure the degree of disability or dependence; scores range from 0-6; higher scores correspond to less favorable outcomes

    Measured: post-stroke day 90

  4. Number of Participants Physically Active and Not Physically Active

    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.

    Measured: post-stroke day 90

  5. Number of Participants With or Without Depression

    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

    Measured: post-stroke day 90

  6. Cognition (MoCA 5-min Protocol)

    4-item questionnaire to determine vascular cognitive impairment; scores range from 0-30; higher scores are more favorable

    Measured: post-stroke day 90

  7. Medication Adherence (Morisky Green Levine Scale-4)

    4 items with yes/no response options; scores range from 0-4; higher scores correspond to less medication adherence

    Measured: post-stroke day 90

  8. Number of Participants With or Without Falls

    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).

    Measured: post-stroke day 90

  9. Self-reported Fatigue (PROMIS Fatigue Instrument)

    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.

    Measured: post-stroke day 90

  10. Satisfaction With Care

    6 questions to determine satisfaction with care; scores range from 0-100; higher scores correspond to higher satisfaction of care

    Measured: post-stroke day 90

  11. Number of Participants Who Do or Do Not Monitor Blood Pressure at Home

    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).

    Measured: post-stroke day 90

  12. Self-reported Blood Pressure

    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).

    Measured: post-stroke day 90

  13. Number of Subjects With Claims-based All-cause Hospital Readmissions

    Measured: post-stroke day 30

  14. Number of Subjects With Claims-based All-cause Hospital Readmissions

    Measured: post-stroke day 90

  15. Number of Subjects With Claims-based All-cause Hospital Readmissions

    Measured: post-discharge year 1

  16. Number of Subjects With All-cause Mortality Using NC State Death Index

    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.

    Measured: post-stroke day 90

  17. Number of Subjects With All-cause Mortality Using NC State Death Index & Fee-For-Service (FFS) Medicare

    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.

    Measured: post-discharge year 1

  18. Number of Subjects With Claims-based Emergency Department Visits

    Measured: post-discharge year 1

  19. Number of Subjects With Claims-based Admissions to Skilled Nursing Facilities (SNF) and Inpatient Rehabilitation Facilities (IRF)

    Measured: post-discharge year 1

  20. Number of Subjects With Claims-based Use of Transitional Care Management Billing Codes

    Measured: post-discharge day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2015 (estimated)
  2. Study start25 Jul 2016
  3. Primary completion25 Jul 2018
  4. Study completion15 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
6,024 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02588664
Sponsor's protocol ID
IRB00035998
Other IDs
PCS-1403-14532
Acronym
COMPASS
Status last verified
Dec 2020
First submitted
23 Oct 2015
Last updated
11 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified data will be made available to researchers through the PCORI-Designated Repository in accordance with their Data Sharing Policy.

Publications

  • 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.

    PubMed 27125528

  • 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.

    PubMed 28649454

  • 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.

    PubMed 28716014

  • 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.

    PubMed 29373987

  • 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.

    PubMed 29572814

  • 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.

    PubMed 29720489

  • 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.

    PubMed 30354371

  • 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.

    PubMed 30635495

  • 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.

    PubMed 33543066

  • 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.

    PubMed 32313700

  • 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.

    PubMed 32275060

  • 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.

    PubMed 33948280

  • 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.

    PubMed 33263286

  • 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.

    PubMed 33349012

  • 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.

    PubMed 33273292

Questions about this trial

What is this clinical trial studying?

A study testing COMPASS Intervention in people with Stroke and Transient Ischemic Attack, run by Wake Forest University Health Sciences at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke Impact Scale (SIS-16) (time frame: post-stroke day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02588664, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.

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Comprehensive Post-Acute Stroke Services (NCT02588664) | AzTrials