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 |
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* 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; |
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