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Patient-Centred Innovations for Persons With Multimorbidity - Ontario (PACEinMM-ON)

This study is currently recruiting participants.
Verified March 2016 by Lawson Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02742597
First Posted: April 19, 2016
Last Update Posted: May 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Western University, Canada
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Sunnybrook Health Sciences Centre
St. Michael's Hospital, Toronto
University Health Network, Toronto
Toronto East General Hospital
Providence HealthCare
Mount Sinai Hospital, Canada
Toronto Central Community Care Access Centre
Women's College Hospital, Toronto
Information provided by (Responsible Party):
Lawson Health Research Institute
  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 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.

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 Multimorbidity Behavioral: TIP / IMPACT Plus Care Coordination

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Patient-Centred Innovations for Persons With Multimorbidity - Ontario

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

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

  • 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


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 - Change in Equity [ Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3 ]
    Vertical Equity. Score: Mean

  • Evaluation of Intervention Effectiveness - Change in Demographics [ Time Frame: T1: Initial evaluation; T2: after 4 months; T3: one year after T2; T4: one year after T3 ]
    Demographics. Score: frequencies, means


Estimated Enrollment: 1980
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 Telemedicine Impact Plus (TIP)/ IMPACT Plus Care Coordination meeting
Behavioral: TIP / IMPACT Plus Care Coordination
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.
Active Comparator: Group B
Before/After Intervention group (n = 24) Intervention: Participates in TIP / IMPACT Plus Care Coordination meeting
Behavioral: TIP / IMPACT Plus Care Coordination
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.
No Intervention: Group C
Control group (n = 163)
No Intervention: Group D
Health Administrative Data Group (n = 1630) Number of matched data controls. Not taking part in intervention.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742597


Contacts
Contact: Moira Stewart 519-661-2111 ext 22132 moira@uwo.ca
Contact: Rob Van Hoorn 519-661-2111 ext 22038 robert.vanhoorn@schulich.uwo.ca

Locations
Canada, Ontario
Western University Recruiting
London, Ontario, Canada, N6A 3K7
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada
Providence Healthcare Recruiting
Toronto, Ontario, Canada
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Toronto Central Community Care Access Centre Recruiting
Toronto, Ontario, Canada
Toronto East General Hospital Recruiting
Toronto, Ontario, Canada
University Hospital Network Recruiting
Toronto, Ontario, Canada
Women's College Hospital Recruiting
Toronto, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
Western University, Canada
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Sunnybrook Health Sciences Centre
St. Michael's Hospital, Toronto
University Health Network, Toronto
Toronto East General Hospital
Providence HealthCare
Mount Sinai Hospital, Canada
Toronto Central Community Care Access Centre
Women's College Hospital, Toronto
Investigators
Principal Investigator: Moira Stewart Western University
  More Information

Additional Information:
Publications:
Pawson, R. and N. Tilley, Realistic evaluation. London: Sage Publications Inc., 1997.
Patton, M.Q., Qualitative Research & Evaluation. 3rd ed. Thousand Oaks, CA: Sage Publications Inc., 2002.
Crabtree, B.F. and W.L. Miller, 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 March 14, 2016.
Wodchis, W.P., et al., Guidelines on Person-Level Costing Using Administrative Databases in Ontario. Toronto: Health System Performance Research Network, 2011.
Drummond, M.F., et al., Methods for the economic evaluation of health care programmes. 3rd ed. New York: Oxford University Press, 2005.

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02742597     History of Changes
Other Study ID Numbers: 104191
First Submitted: March 21, 2016
First Posted: April 19, 2016
Last Update Posted: May 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified subsets of data will be transferred upon request to healthcare providers at collaborating institutions under separate ethics approvals as/if required. Any transfers will be conducted by secure file transfer between encrypted devices. Any health information transferred will be de-identified.

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