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Patient-Centred Innovations for Persons With Multimorbidity - Quebec (PACEinMM-QC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Université de Sherbrooke
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Western University, Canada
Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean
Information provided by (Responsible Party):
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT02789800
First received: March 16, 2016
Last updated: May 27, 2016
Last verified: March 2016
  Purpose
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 3 other provinces: British Columbia (BC); Manitoba (MB); and Nova Scotia (NS). 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.

Condition Intervention
Hypertension
Depression
Anxiety
Musculoskeletal Pain
Arthritis
Rheumatoid Arthritis
Osteoporosis
Chronic Obstructive Pulmonary Disease (COPD)
Asthma
Chronic Bronchitis
Cardiovascular Disease
Heart Failure
Stroke
Transient Ischemic Attacks
Ulcer
Gastroesophageal Reflux
Irritable Bowel
Crohn's Disease
Ulcerative Colitis
Diverticulosis
Chronic Hepatitis
Diabetes
Thyroid Disorder
Cancer
Kidney Disease
Urinary Tract Problem
Dementia
Alzheimer's Disease
Hyperlipidemia
HIV
Behavioral: DIMAC02

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Patient-Centred Innovations for Persons With Multimorbidity - Quebec

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Evaluation of Intervention Effectiveness - Change in Self-Management outcomes [ Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3 ]
    Health Education Impact Questionnaire (HeiQ). Score: Reliable improvement


Secondary Outcome Measures:
  • Evaluation of Intervention Effectiveness - Change in Chronic Diseases [ Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3 ]
    Multimorbidity/Chronic Disease (MM-21): Score: number of Chronic diseases

  • Evaluation of Intervention Effectiveness - Change in Health Status [ Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3 ]
    Health Status (VR-12): Score: Physical Component Summary (PCS) and the Mental Component Summary (MCS)

  • Evaluation of Intervention Effectiveness - Change in Quality of Life [ Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3 ]
    Quality of Life (EQ-5D-5L): Score: mean

  • Evaluation of Intervention Effectiveness - Change in Psychological Well-being [ Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3 ]
    Psychological Well-being (Kessler 6 Scale).Score: mean

  • Evaluation of Intervention Effectiveness - Change in Lifestyle/Health Behaviours [ Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3 ]
    Lifestyle/Health Behaviours Questionnaire. Score: mean

  • Evaluation of Intervention Effectiveness - Equity [ Time Frame: T1: Baseline ]
  • Demographics [ Time Frame: T1: Baseline ]
  • Evaluation of Intervention Effectiveness - Change in Transitions of Care [ Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3 ]
    Patient Perception of Transitions of Care. Score: Mean

  • Evaluation of Intervention Effectiveness - Change in Self-Efficacy [ Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3 ]
    Self-Efficacy for Managing Chronic Disease Scale (SEM-CD). Score: mean

  • Evaluation of Intervention Effectiveness - Change in Patient-Centredness [ Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3 ]
    Patient Perception of Patient-Centredness (PPPC). Score: Mean


Estimated Enrollment: 1956
Study Start Date: January 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Intervention group (n = 163) Intervention: Participates in DIMAC02 Program
Behavioral: DIMAC02
Integrated Approach For Chronic Diseases (DIMAC02) is an integrated approach for chronic disease prevention and management services that aims to improve and coordinate different regional initiatives in 11 Family Medicine Groups related to : Self-management, Case management, Patient-centred care for persons with multimorbidity, Motivational approach, Interprofessional collaboration. DIMAC 02 specific objectives are: 1) To make available, in FMG's, an interdisciplinary educational intervention for prevention and management of chronic diseases for patients with low and high risk for complication. 2) To Increase the flow of communications between FMG and hospital facilities to improve continuity of care.
Other Name: Démarche intégrée en maladies chroniques - Région 02
No Intervention: Group B
Control group (n = 163)
No Intervention: Group C
Health Administrative Data Group (n = 1630) Number of matched data controls. Not taking part in intervention.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PATIENTS (Studies 2.1 & 2.2):

Inclusion Criteria:

  • 3+ Chronic Conditions
  • 18 to 80 years of age
  • Eligible for DIMAC02 intervention

Exclusion Criteria:

  • Unable to reasonably respond to questionnaires or provide informed consent (ie. cognitive impairment or language barrier)
  • Deemed by provider to be too fragile

CAREGIVERS (Study 2.1):

  • Close family member (wife/husband, parent, son/daughter, brother/sister) and/or caregiver to a patient that has received DIMAC02 intervention (first component)
  • Sharing time with the patient (before, during and after the intervention)
  • French speaking

DECISION-MAKERS (Study 2.1):

  • FMG Physician-Manager, FMG Coordinators, CIUSSS Decision-Makers/Managers
  • Involved/Familiar with DIMAC02 program

DIMAC02 INTERDISCIPLINARY TEAM (Study 2.1):

  • Nurse, Nutritionist, Kinesiologist, Social Worker, Psychologist
  • Has delivered DIMAC02 intervention to at least one patient

REFERRAL PROFESSIONALS (Study 2.1):

- Family physician or nurse/nurse practitioner

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02789800

Contacts
Contact: Martin Fortin, MD, M.Sc 1-418-541-1234 ext 2281 Martin.Fortin@USherbrooke.ca
Contact: Tarek Bouhali, M.Sc 1-418-541-1234 ext 3579 Tarek.Bouhali@USherbrooke.ca

Locations
Canada, Quebec
Université de Sherbrooke Recruiting
Chicoutimi, Quebec, Canada, G7H 5H6
Contact: Martin Fortin, MD, M.Sc    1-418-541-1234 ext 2281    Martin.Fortin@USherbrooke.ca   
Contact: Tarek Bouhali, M.Sc    1-418-541-1234 ext 3579    Tarek.Bouhali@USherbrooke.ca   
CIUSSS du Sageunay-Lac-Saint-Jean Recruiting
Chicoutimi, Quebec, Canada, G7H 7K9
Sponsors and Collaborators
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Western University, Canada
Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean
Investigators
Principal Investigator: Martin Fortin, MD, M.Sc Université de Sherbrooke
  More Information

Additional Information:
Publications:
Pawson R, Tilley N. Realistic evaluation. London: Sage, 1997
Patton MQ. Qualitative research & evaluation. 3rd ed. Thousand Oaks, CA: Sage Publication. 2002
Crabtree BF, Miller WL. Doing Qualitative Research. Thousand Oaks, CA: Sage Publications Inc. 1999.
Stewart M, et al., The patient perception of patient-centeredness questionnaire (PPPC). Working Paper Series #04-1, April 2004.
Sherer M., et al., The self-efficacy scale: Construction and validation. Psychological Reports. 51: p. 663-671,1982.
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.
Daniel, W.W., Biostatistics: A foundation for analysis in the health sciences. 9th ed. Hoboken. NJ: Wiley. 2009.
Canadian Institute for Health Information. Canadian Hospital Reporting Project (CHRP). 2012; https://secure.cihi.ca/free_products/HI2013_Jan30_EN.pdf . Accessed 2016 March 14.
Wodchis, WP, et al., Guidelines on Person-Level Costing Using Administrative Databases in Ontario. Toronto: Health System Performance Research Network, 2011.
Drummond, MF, et al., Methods for the economic evaluation of health care programmes. 3rd ed. New York: Oxford University Press, 2005.

Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02789800     History of Changes
Other Study ID Numbers: 2013-010
Study First Received: March 16, 2016
Last Updated: May 27, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Arthritis
Arthritis, Rheumatoid
Lung Diseases
Alzheimer Disease
Cardiovascular Diseases
Lung Diseases, Obstructive
Kidney Diseases
Pulmonary Disease, Chronic Obstructive
Hepatitis, Chronic
Dementia
Osteoporosis
Crohn Disease
Colitis, Ulcerative
Irritable Bowel Syndrome
Gastroesophageal Reflux
Hyperlipidemias
Bronchitis
Ischemic Attack, Transient
Musculoskeletal Pain
Bronchitis, Chronic
Thyroid Diseases
Diverticulum
Heart Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on March 28, 2017