Stroke Clinical Trial
— PACEinMM-ONOfficial title:
Patient-Centred Innovations for Persons With Multimorbidity - Ontario
Verified date | September 2020 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is to reorient the health care system from a single disease focus to a multimorbidity focus; centre on not only disease but also the patient in context; and realign the health care system from separate silos to coordinated collaborations in care. PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be grounded in current realities (i.e. Chronic Care Models including Self-Management Programs), that are linked to Primary Care (PC) reform efforts. The study will build on this firm foundation, will design and test promising innovations and will achieve transformation by creating structures to sustain relationships among researchers, decision-makers, practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 4 other provinces: British Columbia (BC); Manitoba (MB); Nova Scotia (NS); and New Brunswick (NB). The Team's objectives are: 1) to identify factors responsible for success or failure of current CDPM programs linked to the PC reform, by conducting a realist synthesis of their quantitative and qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1, by aligning them to promising interventions on patient-centred care for multimorbidity patients, and to test these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and tested/proven in Objective 2, and to conduct research on different approaches to scaling-up. This registration for Clinical Trials only pertains to Objective 2 of the study.
Status | Completed |
Enrollment | 175 |
Est. completion date | October 19, 2022 |
Est. primary completion date | April 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | For Quantitative (Study 2.2): Inclusion Criteria for Patients: - 3+ Chronic Conditions - 18 to 80 years of age - Eligible for TIP/IMPACT Plus program - Must live in catchment area for TIP/IMPACT Plus program (Toronto, Ontario, Canada) Exclusion Criteria for Patients: - Unable to reasonably respond to questionnaires or provide informed consent (ie. cognitive impairment or language barrier) - Deemed by provider to be too fragile For Qualitative (Study 2.1): Inclusion Criteria: - Decision Makers: Responsible for policy and financial decisions related to the TIP / IMPACT Plus program - TIP / IMPACT Providers: Providers that have delivered the TIP / IMPACT Plus intervention to at least one patient, including pharmacist, nurse, nurse practitioner, physiotherapist, social worker, dietitian, occupational therapist, personal care worker / home care coordinator - Family Physicians / Specialists: Those that take part in the TIP / IMPACT Plus intervention, including internist, psychiatrist, and family physician - Patients: Need to meet the inclusion criteria of the TIP / IMPACT Plus program, 18 to 80 years of age, 3+ chronic conditions, and have received the intervention a minimum of 4 months prior to the qualitative interview - Family and Caregivers: Need to be a family member or caregiver of a TIP / IMPACT Plus patient that has received the intervention a minimum of 4 months prior to the qualitative interview. - Referral Provider: Emergency Department doctor, nurse practitioner, CCAC coordinator or representative community family doctor that has referred patients to the TIP / IMPACT Plus program. Exclusion criteria: - Decision Makers that are not knowledgeable about or involved with the TIP / IMPACT Plus program - Providers/Family Physicians/Specialists that have not ever referred to or taken part in a TIP / IMPACT Plus intervention or have not been active with the program in the last year - Family and Caregivers of Patients or Patients themselves that haven't yet received the TIP / IMPACT Plus intervention or those that received the intervention within the last 4 months |
Country | Name | City | State |
---|---|---|---|
Canada | Western University | London | Ontario |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | Providence Healthcare | Toronto | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Toronto Central Community Care Access Centre | Toronto | Ontario |
Canada | Toronto East General Hospital | Toronto | Ontario |
Canada | University Hospital Network | Toronto | Ontario |
Canada | Women's College Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | Canadian Institutes of Health Research (CIHR), Michael Garron Hospital, Mount Sinai Hospital, Canada, Providence Healthcare, Sunnybrook Health Sciences Centre, Toronto Central Community Care Access Centre, Unity Health Toronto, Université de Sherbrooke, University Health Network, Toronto, Western University, Canada, Women's College Hospital |
Canada,
Best A, Greenhalgh T, Lewis S, Saul JE, Carroll S, Bitz J. Large-system transformation in health care: a realist review. Milbank Q. 2012 Sep;90(3):421-56. doi: 10.1111/j.1468-0009.2012.00670.x. — View Citation
Canadian Institute for Health Information. Canadian Hospital Reporting Project (CHRP). 2012; https://secure.cihi.ca/free_products/HI2013_Jan30_EN.pdf . Accessed March 14, 2016.
Centers for Disease Control and Prevention (CDC), Behavioral Risk Factor Surveillance System Survey Questionnaire. 2007, Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.
Coleman EA, Mahoney E, Parry C. Assessing the quality of preparation for posthospital care from the patient's perspective: the care transitions measure. Med Care. 2005 Mar;43(3):246-55. doi: 10.1097/00005650-200503000-00007. — View Citation
Crabtree, B.F. and W.L. Miller, Doing Qualitative Research. Thousand Oaks, CA: Sage Publications Inc., 1999.
Daniel, W.W., Biostatistics: A foundation for analysis in the health sciences. 9th ed. Hoboken, NJ: Wiley, 2009.
Drummond, M.F., et al., Methods for the economic evaluation of health care programmes. 3rd ed. New York: Oxford University Press, 2005.
Kessler RC, Barker PR, Colpe LJ, Epstein JF, Gfroerer JC, Hiripi E, Howes MJ, Normand SL, Manderscheid RW, Walters EE, Zaslavsky AM. Screening for serious mental illness in the general population. Arch Gen Psychiatry. 2003 Feb;60(2):184-9. doi: 10.1001/archpsyc.60.2.184. — View Citation
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):e1-37. doi: 10.1016/j.jclinepi.2010.03.004. Epub 2010 Mar 25. Erratum In: J Clin Epidemiol. 2012 Mar;65(3):351. — View Citation
Nolte S, Elsworth GR, Sinclair AJ, Osborne RH. The extent and breadth of benefits from participating in chronic disease self-management courses: a national patient-reported outcomes survey. Patient Educ Couns. 2007 Mar;65(3):351-60. doi: 10.1016/j.pec.2006.08.016. Epub 2006 Oct 5. — View Citation
Patton, M.Q., Qualitative Research & Evaluation. 3rd ed. Thousand Oaks, CA: Sage Publications Inc., 2002.
Pawson, R. and N. Tilley, Realistic evaluation. London: Sage Publications Inc., 1997.
Poitras ME, Fortin M, Hudon C, Haggerty J, Almirall J. Validation of the disease burden morbidity assessment by self-report in a French-speaking population. BMC Health Serv Res. 2012 Feb 14;12:35. doi: 10.1186/1472-6963-12-35. — View Citation
Rasanen P, Roine E, Sintonen H, Semberg-Konttinen V, Ryynanen OP, Roine R. Use of quality-adjusted life years for the estimation of effectiveness of health care: A systematic literature review. Int J Technol Assess Health Care. 2006 Spring;22(2):235-41. doi: 10.1017/S0266462306051051. — View Citation
Sherer, M., et al., The self-efficacy scale: Construction and validation. Psychological Reports. 51: p. 663-671, 1982.
Stewart M, Brown JB, Donner A, McWhinney IR, Oates J, Weston WW, Jordan J. The impact of patient-centered care on outcomes. J Fam Pract. 2000 Sep;49(9):796-804. — View Citation
Stewart M, Brown JB, Hammerton J, Donner A, Gavin A, Holliday RL, Whelan T, Leslie K, Cohen I, Weston W, Freeman T. Improving communication between doctors and breast cancer patients. Ann Fam Med. 2007 Sep-Oct;5(5):387-94. doi: 10.1370/afm.721. — View Citation
Stewart, M., et al., The patient perception of patient-centeredness questionnaire (PPPC). Working Paper Series #04-1, April 2004.
Van Breukelen GJ. ANCOVA versus change from baseline: more power in randomized studies, more bias in nonrandomized studies [corrected]. J Clin Epidemiol. 2006 Sep;59(9):920-5. doi: 10.1016/j.jclinepi.2006.02.007. Epub 2006 Jun 23. Erratum In: J Clin Epidemiol. 2006 Dec;59(12):1334. — View Citation
Wodchis, W.P., et al., Guidelines on Person-Level Costing Using Administrative Databases in Ontario. Toronto: Health System Performance Research Network, 2011.
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of Intervention Effectiveness - Change in Self-Management outcomes | Health Education Impact Questionnaire (HeiQ). Score: Reliable improvement | T1: Initial evaluation; T2: after 4 months; T3: one year after T2; | |
Primary | Evaluation of Intervention Effectiveness - Change in Transitions of Care | Patient Perception of Transitions of Care. Score: Mean | T1: Initial evaluation; T2: after 4 months; T3: one year after T2; | |
Primary | Evaluation of Intervention Effectiveness - Change in Self-Efficacy | Self-Efficacy for Managing Chronic Disease Scale (SEM-CD). Score: Mean | T1: Initial evaluation; T2: after 4 months; T3: one year after T2; | |
Primary | Evaluation of Intervention Effectiveness - Change in Patient-Centredness | Patient Perception of Patient-Centredness (PPPC). Score: Mean | T1: Initial evaluation; T2: after 4 months; T3: one year after T2; | |
Secondary | Evaluation of Intervention Effectiveness - Change in Chronic Diseases | Multimorbidity/Chronic Disease (MM-21): Score: Number of Chronic diseases | T1: Initial evaluation; T2: after 4 months; T3: one year after T2; | |
Secondary | Evaluation of Intervention Effectiveness - Change in Health Status | Health Status (VR-12): Score: Physical Component Summary (PCS) and the Mental Component Summary (MCS) | T1: Initial evaluation; T2: after 4 months; T3: one year after T2; | |
Secondary | Evaluation of Intervention Effectiveness - Change in Quality of Life | Quality of Life (EQ-5D-5L): Score: Mean | T1: Initial evaluation; T2: after 4 months; T3: one year after T2; | |
Secondary | Evaluation of Intervention Effectiveness - Change in Psychological Well-being | Psychological Well-being (Kessler 6 Scale). Score: Mean | T1: Initial evaluation; T2: after 4 months; T3: one year after T2; | |
Secondary | Evaluation of Intervention Effectiveness - Change in Lifestyle/Health Behaviours | Lifestyle/Health Behaviours Questionnaire. Score: Mean | T1: Initial evaluation; T2: after 4 months; T3: one year after T2; | |
Secondary | Evaluation of Intervention Effectiveness - Change in Equity | Vertical Equity. Score: Mean | T1: Initial evaluation; T2: after 4 months; T3: one year after T2; | |
Secondary | Evaluation of Intervention Effectiveness - Change in Demographics | Demographics. Score: frequencies, means | T1: Initial evaluation; T2: after 4 months; T3: one year after T2; |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |