The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial
Abstract Background Patients discharged home after stroke face significant challenges managing residual neurological deficits, secondary prevention, and pre-existing chronic conditions. Post-discharge care is often fragmented leading to increased healthcare costs, readmissions, and sub-optimal utili...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2017-07-01
|
| Series: | BMC Neurology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12883-017-0907-1 |
| _version_ | 1817997030144868352 |
|---|---|
| author | Pamela W. Duncan Cheryl D. Bushnell Wayne D. Rosamond Sara B. Jones Berkeley Sabina B. Gesell Ralph B. D’Agostino Walter T. Ambrosius Blair Barton-Percival Janet Prvu Bettger Sylvia W. Coleman Doyle M. Cummings Janet K. Freburger Jacqueline Halladay Anna M. Johnson Anna M. Kucharska-Newton Gladys Lundy-Lamm Barbara J. Lutz Laurie H. Mettam Amy M. Pastva Mysha E. Sissine Betsy Vetter |
| author_facet | Pamela W. Duncan Cheryl D. Bushnell Wayne D. Rosamond Sara B. Jones Berkeley Sabina B. Gesell Ralph B. D’Agostino Walter T. Ambrosius Blair Barton-Percival Janet Prvu Bettger Sylvia W. Coleman Doyle M. Cummings Janet K. Freburger Jacqueline Halladay Anna M. Johnson Anna M. Kucharska-Newton Gladys Lundy-Lamm Barbara J. Lutz Laurie H. Mettam Amy M. Pastva Mysha E. Sissine Betsy Vetter |
| author_sort | Pamela W. Duncan |
| collection | DOAJ |
| description | Abstract Background Patients discharged home after stroke face significant challenges managing residual neurological deficits, secondary prevention, and pre-existing chronic conditions. Post-discharge care is often fragmented leading to increased healthcare costs, readmissions, and sub-optimal utilization of rehabilitation and community services. The COMprehensive Post-Acute Stroke Services (COMPASS) Study is an ongoing cluster-randomized pragmatic trial to assess the effectiveness of a comprehensive, evidence-based, post-acute care model on patient-centered outcomes. Methods Forty-one hospitals in North Carolina were randomized (as 40 units) to either implement the COMPASS care model or continue their usual care. The recruitment goal is 6000 patients (3000 per arm). Hospital staff ascertain and enroll patients discharged home with a clinical diagnosis of stroke or transient ischemic attack. Patients discharged from intervention hospitals receive 2-day telephone follow-up; a comprehensive clinic visit within 2 weeks that includes a neurological evaluation, assessments of social and functional determinants of health, and an individualized COMPASS Care Plan™ integrated with a community-specific resource database; and additional follow-up calls at 30 and 60 days post-stroke discharge. This model is consistent with the Centers for Medicare and Medicaid Services transitional care management services provided by physicians or advanced practice providers with support from a nurse to conduct patient assessments and coordinate follow-up services. Patients discharged from usual care hospitals represent the control group and receive the standard of care in place at that hospital. Patient-centered outcomes are collected from telephone surveys administered at 90 days. The primary endpoint is patient-reported functional status as measured by the Stroke Impact Scale 16. Secondary outcomes are: caregiver strain, all-cause readmissions, mortality, healthcare utilization, and medication adherence. The study engages patients, caregivers, and other stakeholders (including policymakers, advocacy groups, payers, and local community coalitions) to advise and support the design, implementation, and sustainability of the COMPASS care model. Discussion Given the high societal and economic burden of stroke, identifying a care model to improve recovery, independence, and quality of life is critical for stroke survivors and their caregivers. The pragmatic trial design provides a real-world assessment of the COMPASS care model effectiveness and will facilitate rapid implementation into clinical practice if successful. Trial registration Clinicaltrials.gov: NCT02588664 ; October 23, 2015. |
| first_indexed | 2024-04-14T02:30:59Z |
| format | Article |
| id | doaj.art-5c9bd179a7a445db8cf10d1f0e28f141 |
| institution | Directory Open Access Journal |
| issn | 1471-2377 |
| language | English |
| last_indexed | 2024-04-14T02:30:59Z |
| publishDate | 2017-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Neurology |
| spelling | doaj.art-5c9bd179a7a445db8cf10d1f0e28f1412022-12-22T02:17:40ZengBMCBMC Neurology1471-23772017-07-0117111310.1186/s12883-017-0907-1The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trialPamela W. Duncan0Cheryl D. Bushnell1Wayne D. Rosamond2Sara B. Jones Berkeley3Sabina B. Gesell4Ralph B. D’Agostino5Walter T. Ambrosius6Blair Barton-Percival7Janet Prvu Bettger8Sylvia W. Coleman9Doyle M. Cummings10Janet K. Freburger11Jacqueline Halladay12Anna M. Johnson13Anna M. Kucharska-Newton14Gladys Lundy-Lamm15Barbara J. Lutz16Laurie H. Mettam17Amy M. Pastva18Mysha E. Sissine19Betsy Vetter20Department of Neurology, Wake Forest School of MedicineDepartment of Neurology, Wake Forest School of MedicineDepartment of Epidemiology, University of North Carolina at Chapel Hill, Gillings School of Global Public HealthDepartment of Epidemiology, University of North Carolina at Chapel Hill, Gillings School of Global Public HealthDepartment of Social Sciences & Health Policy, Division of Public Health Sciences, Wake Forest School of MedicineDepartment of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest School of MedicineDepartment of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest School of MedicinePiedmont Triad Regional Council Area Agency on AgingDuke University School of MedicineDepartment of Neurology, Wake Forest School of MedicineEast Carolina University, Brody School of Medicine, Family Medicine CenterDepartment of Physical Therapy, University of PittsburghDepartment of Family Medicine, University of North Carolina at Chapel HillDepartment of Epidemiology, University of North Carolina at Chapel Hill, Gillings School of Global Public HealthDepartment of Epidemiology, University of North Carolina at Chapel Hill, Gillings School of Global Public HealthMinority Women Health Alliance (TriStroke)University of North Carolina Wilmington School of NursingDepartment of Epidemiology, University of North Carolina at Chapel Hill, Gillings School of Global Public HealthDepartment of Orthopaedic Surgery, Doctor of Physical Therapy Division, & Center for the Study of Aging and Human Development, Duke UniversityDepartment of Neurology, Wake Forest School of MedicineAmerican Heart AssociationAbstract Background Patients discharged home after stroke face significant challenges managing residual neurological deficits, secondary prevention, and pre-existing chronic conditions. Post-discharge care is often fragmented leading to increased healthcare costs, readmissions, and sub-optimal utilization of rehabilitation and community services. The COMprehensive Post-Acute Stroke Services (COMPASS) Study is an ongoing cluster-randomized pragmatic trial to assess the effectiveness of a comprehensive, evidence-based, post-acute care model on patient-centered outcomes. Methods Forty-one hospitals in North Carolina were randomized (as 40 units) to either implement the COMPASS care model or continue their usual care. The recruitment goal is 6000 patients (3000 per arm). Hospital staff ascertain and enroll patients discharged home with a clinical diagnosis of stroke or transient ischemic attack. Patients discharged from intervention hospitals receive 2-day telephone follow-up; a comprehensive clinic visit within 2 weeks that includes a neurological evaluation, assessments of social and functional determinants of health, and an individualized COMPASS Care Plan™ integrated with a community-specific resource database; and additional follow-up calls at 30 and 60 days post-stroke discharge. This model is consistent with the Centers for Medicare and Medicaid Services transitional care management services provided by physicians or advanced practice providers with support from a nurse to conduct patient assessments and coordinate follow-up services. Patients discharged from usual care hospitals represent the control group and receive the standard of care in place at that hospital. Patient-centered outcomes are collected from telephone surveys administered at 90 days. The primary endpoint is patient-reported functional status as measured by the Stroke Impact Scale 16. Secondary outcomes are: caregiver strain, all-cause readmissions, mortality, healthcare utilization, and medication adherence. The study engages patients, caregivers, and other stakeholders (including policymakers, advocacy groups, payers, and local community coalitions) to advise and support the design, implementation, and sustainability of the COMPASS care model. Discussion Given the high societal and economic burden of stroke, identifying a care model to improve recovery, independence, and quality of life is critical for stroke survivors and their caregivers. The pragmatic trial design provides a real-world assessment of the COMPASS care model effectiveness and will facilitate rapid implementation into clinical practice if successful. Trial registration Clinicaltrials.gov: NCT02588664 ; October 23, 2015.http://link.springer.com/article/10.1186/s12883-017-0907-1StrokeTransitions of careRehabilitationFunctional statusPragmatic trialPatient-centered care |
| spellingShingle | Pamela W. Duncan Cheryl D. Bushnell Wayne D. Rosamond Sara B. Jones Berkeley Sabina B. Gesell Ralph B. D’Agostino Walter T. Ambrosius Blair Barton-Percival Janet Prvu Bettger Sylvia W. Coleman Doyle M. Cummings Janet K. Freburger Jacqueline Halladay Anna M. Johnson Anna M. Kucharska-Newton Gladys Lundy-Lamm Barbara J. Lutz Laurie H. Mettam Amy M. Pastva Mysha E. Sissine Betsy Vetter The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial BMC Neurology Stroke Transitions of care Rehabilitation Functional status Pragmatic trial Patient-centered care |
| title | The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial |
| title_full | The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial |
| title_fullStr | The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial |
| title_full_unstemmed | The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial |
| title_short | The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial |
| title_sort | comprehensive post acute stroke services compass study design and methods for a cluster randomized pragmatic trial |
| topic | Stroke Transitions of care Rehabilitation Functional status Pragmatic trial Patient-centered care |
| url | http://link.springer.com/article/10.1186/s12883-017-0907-1 |
| work_keys_str_mv | AT pamelawduncan thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT cheryldbushnell thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT waynedrosamond thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT sarabjonesberkeley thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT sabinabgesell thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT ralphbdagostino thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT waltertambrosius thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT blairbartonpercival thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT janetprvubettger thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT sylviawcoleman thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT doylemcummings thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT janetkfreburger thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT jacquelinehalladay thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT annamjohnson thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT annamkucharskanewton thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT gladyslundylamm thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT barbarajlutz thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT lauriehmettam thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT amympastva thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT myshaesissine thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT betsyvetter thecomprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT pamelawduncan comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT cheryldbushnell comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT waynedrosamond comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT sarabjonesberkeley comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT sabinabgesell comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT ralphbdagostino comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT waltertambrosius comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT blairbartonpercival comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT janetprvubettger comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT sylviawcoleman comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT doylemcummings comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT janetkfreburger comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT jacquelinehalladay comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT annamjohnson comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT annamkucharskanewton comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT gladyslundylamm comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT barbarajlutz comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT lauriehmettam comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT amympastva comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT myshaesissine comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial AT betsyvetter comprehensivepostacutestrokeservicescompassstudydesignandmethodsforaclusterrandomizedpragmatictrial |