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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 27 March 2023
Main ID:  NCT02742597
Date of registration: 21/03/2016
Prospective Registration: No
Primary sponsor: Lawson Health Research Institute
Public title: Patient-Centred Innovations for Persons With Multimorbidity - Ontario PACEinMM-ON
Scientific title: Patient-Centred Innovations for Persons With Multimorbidity - Ontario
Date of first enrolment: January 12, 2016
Target sample size: 175
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02742597
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Canada
Contacts
Name:     Moira Stewart
Address: 
Telephone:
Email:
Affiliation:  Western University
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Arthritis
Cancer
Chronic Bronchitis
Crohn's Disease
Diabetes
Multimorbidity
Osteoporosis
Chronic Hepatitis
Gastroesophageal Reflux
Kidney Disease
Stroke
Urinary Tract Problem
Dementia
Diverticulosis
Thyroid Disorder
HIV
Hypertension
Irritable Bowel
Transient Ischemic Attacks
Ulcerative Colitis
Rheumatoid Arthritis
Asthma
Cardiovascular Disease
Hyperlipidemia
Alzheimer's Disease
Anxiety
Chronic Obstructive Pulmonary Disease (COPD)
Depression
Ulcer
Heart Failure
Musculoskeletal Pain
Intervention(s)
Behavioral: TIP / IMPACT Plus Care Coordination
Primary Outcome(s)
Evaluation of Intervention Effectiveness - Change in Self-Management outcomes [Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
Evaluation of Intervention Effectiveness - Change in Self-Efficacy [Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
Evaluation of Intervention Effectiveness - Change in Patient-Centredness [Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
Evaluation of Intervention Effectiveness - Change in Transitions of Care [Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
Secondary Outcome(s)
Evaluation of Intervention Effectiveness - Change in Psychological Well-being [Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
Evaluation of Intervention Effectiveness - Change in Quality of Life [Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
Evaluation of Intervention Effectiveness - Change in Demographics [Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
Evaluation of Intervention Effectiveness - Change in Equity [Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
Evaluation of Intervention Effectiveness - Change in Health Status [Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
Evaluation of Intervention Effectiveness - Change in Lifestyle/Health Behaviours [Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
Evaluation of Intervention Effectiveness - Change in Chronic Diseases [Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2;]
Secondary ID(s)
104191
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Canadian Institutes of Health Research (CIHR)
University Health Network, Toronto
Women's College Hospital
Unity Health Toronto
Providence Healthcare
Michael Garron Hospital
Toronto Central Community Care Access Centre
Sunnybrook Health Sciences Centre
Western University, Canada
Mount Sinai Hospital, Canada
Université de Sherbrooke
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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