Patient-Centred Innovations for Persons With Multimorbidity - Ontario

NCT02742597 | Completed

• 1 other identifier: 104191
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 9

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 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.

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; Multimorbidity

Outcome Measures

Primary Outcomes (4)

• 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;

• 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;

• 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;

• 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 Outcomes (7)

• Evaluation of Intervention Effectiveness - Change in Chronic Diseases

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

• Evaluation of Intervention Effectiveness - Change in Health Status

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

• Evaluation of Intervention Effectiveness - Change in Quality of Life

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

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

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

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

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

Study Arms (4)

Group A

ACTIVE COMPARATOR

Intervention group (n = 86) Intervention: Participates in Telemedicine Impact Plus (TIP)/ IMPACT Plus Care Coordination meeting

Behavioral: TIP / IMPACT Plus Care Coordination

Group B

ACTIVE COMPARATOR

Before/After Intervention group (n = 10) Intervention: Participates in TIP / IMPACT Plus Care Coordination meeting

Behavioral: TIP / IMPACT Plus Care Coordination

Group C

NO INTERVENTION

Control group (n = 77)

Group D

NO INTERVENTION

Health Administrative Data Group (n = 430) Number of matched data controls. Not taking part in intervention.

Interventions

TIP / IMPACT Plus Care Coordination BEHAVIORAL

The intervention will involve the patient attending an interdisciplinary team meeting, either through the Ontario Telemedicine Network's teleconferencing technology or in person, along with their caregiver(s), the referring practitioner, inter-professional (IP) teams and home care coordinators to discuss and uncover the patient's condition covering a diverse range of medical, functional and psycho-social issues and the development of a patient-centred treatment plan. The care plans are documented, shared, implemented and monitored by an assigned nurse from the program.

Group A; Group B

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 TIP/IMPACT Plus program
• Must live in catchment area for TIP/IMPACT Plus program (Toronto, Ontario, Canada)

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
• For Qualitative (Study 2.1):
• 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
• 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.
• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Western University, Canada: collaborator
• Université de Sherbrooke: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Unity Health Toronto: collaborator
• University Health Network, Toronto: collaborator
• Michael Garron Hospital: collaborator
• Providence Healthcare: collaborator
• Mount Sinai Hospital, Canada: collaborator
• Toronto Central Community Care Access Centre: collaborator
• Women's College Hospital: collaborator

Study Sites (9)

Western University

London, Ontario, N6A 3K7, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Providence Healthcare

Toronto, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Toronto Central Community Care Access Centre

Toronto, Ontario, Canada

Location

Toronto East General Hospital

Toronto, Ontario, Canada

Location

University Hospital Network

Toronto, Ontario, Canada

Location

Women's College Hospital

Toronto, Ontario, Canada

Location

Related Publications (21)

• 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.

  PMID: 22985277 BACKGROUND

• Pawson, R. and N. Tilley, Realistic evaluation. London: Sage Publications Inc., 1997.

  BACKGROUND

• Patton, M.Q., Qualitative Research & Evaluation. 3rd ed. Thousand Oaks, CA: Sage Publications Inc., 2002.

  BACKGROUND

• Crabtree, B.F. and W.L. Miller, Doing Qualitative Research. Thousand Oaks, CA: Sage Publications Inc., 1999.

  BACKGROUND

• 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.

  PMID: 20346624 BACKGROUND

• 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.

  PMID: 22333434 BACKGROUND

• 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.

  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.

  PMID: 17893379 BACKGROUND

• Stewart, M., et al., The patient perception of patient-centeredness questionnaire (PPPC). Working Paper Series #04-1, April 2004.

  BACKGROUND

• 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.

  PMID: 15725981 BACKGROUND

• 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.

  PMID: 17027221 BACKGROUND

• Sherer, M., et al., The self-efficacy scale: Construction and validation. Psychological Reports. 51: p. 663-671, 1982.

  BACKGROUND

• 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.

  PMID: 16571199 BACKGROUND

• 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.

  PMID: 12578436 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16895814 BACKGROUND

• Daniel, W.W., Biostatistics: A foundation for analysis in the health sciences. 9th ed. Hoboken, NJ: Wiley, 2009.

  BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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

• Website for PACE in MM

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

Interventions

Lysine Acetyltransferase 5

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

Intervention Hierarchy (Ancestors)

Histone Acetyltransferases; Lysine Acetyltransferases; Acetyltransferases; Acyltransferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Moira Stewart

  Western University

  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 21, 2016
• First Posted: April 19, 2016
• Study Start: January 12, 2016
• Primary Completion: April 7, 2019
• Study Completion: October 19, 2022
• Last Updated: March 17, 2023

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Study Protocol: 2017 onward Clinical Study Report: 2020 onward
• Access Criteria: The study protocol is available in a published paper (CMAJ Open 2017) Clinical Study Report: results published in British Journal of General Practice 2020

Locations

CA (9)