Patient-Centred Innovations for Persons With Multimorbidity - Quebec

NCT02789800 | Completed

• 1 other identifier: 2013-010
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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; T4: one year after T3

Secondary Outcomes (10)

• Evaluation of Intervention Effectiveness - Change in Chronic Diseases

  T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3

• Evaluation of Intervention Effectiveness - Change in Health Status

  T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3

• Evaluation of Intervention Effectiveness - Change in Quality of Life

  T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3

• Evaluation of Intervention Effectiveness - Change in Psychological Well-being

  T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3

• Evaluation of Intervention Effectiveness - Change in Lifestyle/Health Behaviours

  T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3

Study Arms (3)

Group A

ACTIVE COMPARATOR

Intervention group (n = 163) Intervention: Participates in DIMAC02 Program

Behavioral: DIMAC02

Group B

NO INTERVENTION

Control group (n = 163)

Group C

NO INTERVENTION

Health Administrative Data Group (n = 1630) Number of matched data controls. Not taking part in intervention.

Interventions

DIMAC02 BEHAVIORAL

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(FMG) 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.

Group A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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, 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

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Western University, Canada: collaborator
• Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean: collaborator

Study Sites (2)

Université de Sherbrooke

Chicoutimi, Quebec, G7H 5H6, Canada

Location

CIUSSS du Sageunay-Lac-Saint-Jean

Chicoutimi, Quebec, G7H 7K9, Canada

Location

Related Publications (22)

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  PMID: 11032203 BACKGROUND

• 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.

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  BACKGROUND

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• 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.

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• Wodchis, WP, et al., Guidelines on Person-Level Costing Using Administrative Databases in Ontario. Toronto: Health System Performance Research Network, 2011.

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• Drummond, MF, et al., Methods for the economic evaluation of health care programmes. 3rd ed. New York: Oxford University Press, 2005.

  BACKGROUND

• Ngangue P, Brown JB, Forgues C, Ag Ahmed MA, Nguyen TN, Sasseville M, Loignon C, Gallagher F, Stewart M, Fortin M. Evaluating the implementation of interdisciplinary patient-centred care intervention for people with multimorbidity in primary care: a qualitative study. BMJ Open. 2021 Sep 24;11(9):e046914. doi: 10.1136/bmjopen-2020-046914.

  PMID: 34561255 DERIVED

• Stewart M, Fortin M; Patient-Centred Innovations for Persons with Multimorbidity Team*. Patient-Centred Innovations for Persons with Multimorbidity: funded evaluation protocol. CMAJ Open. 2017 May 9;5(2):E365-E372. doi: 10.9778/cmajo.20160097.

  PMID: 28487349 DERIVED

Related Links

• Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) Program Website

MeSH Terms

Conditions

Hypertension; Depression; Anxiety Disorders; Musculoskeletal Pain; Arthritis; Arthritis, Rheumatoid; Osteoporosis; Pulmonary Disease, Chronic Obstructive; Asthma; Bronchitis, Chronic; Cardiovascular Diseases; Heart Failure; Stroke; Ischemic Attack, Transient; Ulcer; Gastroesophageal Reflux; Irritable Bowel Syndrome; Crohn Disease; Colitis, Ulcerative; Diverticulum; Hepatitis, Chronic; Diabetes Mellitus; Thyroid Diseases; Neoplasms; Kidney Diseases; Dementia; Alzheimer Disease; Hyperlipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Bronchitis; Respiratory Tract Infections; Infections; Heart Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Colitis; Diverticular Diseases; Pathological Conditions, Anatomical; Hepatitis; Liver Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Martin Fortin, MD, M.Sc

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: June 3, 2016
• Study Start: April 22, 2016
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)