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Transforming Primary Care for Older Canadians Living With Frailty

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ClinicalTrials.gov Identifier: NCT03442426
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : April 12, 2019
Sponsor:
Collaborators:
Dalhousie University
University of Calgary
University of British Columbia
Laval University
Information provided by (Responsible Party):
University of Waterloo

Brief Summary:

It is well known that older Canadians are high users of health care services. What is less well known is that the health care system is not well-designed to meet the needs of those who use it most. Older persons look to their primary care practitioners to assess their needs and coordinate their care. Unfortunately, the health concerns of older persons are often missed in too-short office visits. They may need care from a variety of providers and services, but this care is often not well-coordinated. Older persons and their caregivers are the experts in their own needs and preferences, but often do not have a chance to participate fully in treatment decisions or care planning. As a result, they may have health problems that are not properly assessed, managed or treated resulting in poorer health, as well as preventable and expensive emergency department visits and hospital stays.

Improving the health of older Canadians means identifying health problems early. It means providing timely supports so that manageable concerns do not spiral out of control. And, above all, it means helping health care providers actively engage older patients and their family caregivers as partners in care. Patients want to make informed choices about their health and the care they receive, based on their personal values, preferences and goals, and informed by available evidence.

Nine primary care clinics in three provinces (Quebec, Ontario, Alberta) will use a quick screening tool to identify older patients who are at risk of becoming frail. This will help initiate referral to health care or support services where necessary. Innovative technology will be used to streamline the referral process and help assist older adults in decision-making about their care.

With support from the Canadian Frailty Network (CFN, formerly TVN), researchers, collaborators, health care providers and older adults from across Canada will work together to transform primary health care for frail elderly Canadians.


Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Other: Integrated model of primary care Not Applicable

Detailed Description:
The team will be implementing evidence-based and tested interventions as a coherent strategy to enhance primary health care for older adults, working collaboratively with study sites, older adults, and other stakeholders to develop a scalable and sustainable model. The investigators aim to develop the capacity of primary health care teams to identify, assess, and support older adults (70+) who are frail, and to delay or prevent decline for those at lower risk. The project will support patient/caregiver engagement, and stronger care coordination and integration with other health and social services. The primary research question is: compared to usual care in primary care settings, does the proposed model improve health, social and economic outcomes for frail and at-risk older Canadians (aged 70+)? The investigators hypothesize that older adults will benefit from screening, active engagement in care planning, and appropriate referrals to services earlier in their care trajectories. In addition to improving health outcomes and quality of life for patients, more proactive interventions can reduce costly emergency department visits and unplanned hospital admissions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1260 participants
Intervention Model: Single Group Assignment
Intervention Model Description: We have proposed a strong quasi-experimental alternative with inclusion of a usual care group of patients prior to initiation of the intervention. Specifically, our study will use a quasi-experimental control group design with pre-test and post-test. Our control group will receive usual care, and the intervention group will receive the proposed intervention (screening, care coordination and individual care plans, engagement in decision making, and technology support). The usual care group will be followed for 6 months after study entry (baseline period). Once completed, the intervention will be implemented and recruitment for the intervention group will begin. The intervention group will also be followed for 6 months after study entry (intervention period). We will be able to compare the intervention group with the usual care group.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Transforming Primary Care for Older Canadians Living With Frailty
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Intervention Cohort
Integrated model of primary care
Other: Integrated model of primary care
Intervention includes: 1) consistent risk screening and assessment; 2) care coordination and system navigation; 3) patient/caregiver engagement and shared decision-making; and 4) enabling technology supports.




Primary Outcome Measures :
  1. Assessing change in 'Care for Chronic Conditions' scores [ Time Frame: The tool will be used at 4 time points: at baseline recruitment (B1), then 6 months later (B2), then 6 months later following intervention implementation (I1), and 6 months later (I2). Scores will be compared pre and post. ]
    This tools measures specific items related to the Chronic Care Model, and reports on patient experience with the system. There are 5 sub scales (patient activation, delivery system, goal setting, problem solving and coordination) and 26-items. This tool has been validated.


Secondary Outcome Measures :
  1. Assessing change in 5-Level EQ-5D questionnaire [ Time Frame: The tool will be used at 4 time points: at baseline recruitment (B1), then 6 months later (B2), then 6 months later following intervention implementation (I1), and 6 months later (I2). Scores will be compared pre and post. ]
    This tool measures health-related quality of life. The tool is comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).

  2. Assessing change in the Canadian Institute for Health Information Primary Care Provider Survey [ Time Frame: This tool will be used at two time points. Once at baseline (B1) and again at the end of the study (2.5 years later) post implementation (I2). All providers involved in the work will completed the tool. ]
    This survey addresses team function, involvement in governance, use of information technology and scope of practice.

  3. Assessing Healthcare Utilization across different time points [ Time Frame: The tool will be used at 4 time points: at baseline recruitment (B1), then 6 months later (B2), then 6 months later following intervention implementation (I1), and 6 months later (I2). Scores will be compared pre and post. ]
    Self-reported health care utilization data including hospital admissions; emergency department visits, home care services; specialist visits and primary care visits.


Other Outcome Measures:
  1. Assessing change in Goal Attainment Scaling (GAS) [ Time Frame: GAS will be completed with a small sub-set of participants during qualitative interviews at baseline recruitment (B1), then 6 months later (B2), then 6 months later following intervention implementation (I1), and 6 months later (I2). ]
    GAS is an individualized, client-centred goal-setting and measurement approach that can accommodate a client's individual wishes, values and preferences. Goals are scaled on a five-point rating scale from -2 (much less than expected) to +2 (much better than expected). The GAS formula translates the total GAS score into a standardized score, with a score of 50 representing overall goal attainment.

  2. Assessing change in Canadian Institute for Health Information Primary Care Organizational Survey [ Time Frame: This tool will be used at two time points. Once at baseline (B1) and again at the end of the study (2.5 years later) post implementation (I2).All providers involved in the work will completed the tool. ]
    This survey is usually completed by a manager or director of the primary care site. The survey covers many domains such as human resources, accessibility, coordination, quality improvement, and system integration.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • older adults age 70+ who attend the primary care clinic, speak and understand English language

Exclusion Criteria:

  • older adults less than 70 years of age, patients who don't not speak/understand English, patients living in long-term care, patients not rostered for 6 months.

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): NCT03442426


Contacts
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Contact: Jacobi Elliott, Dr. 519-888-4567 ext 38982 jacobi.elliott@uwaterloo.ca
Contact: Alison Kernoghan, MPH 519-888-4567 ext 37221 alison.kernoghan@uwaterloo.ca

Locations
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Canada, Alberta
Alberta PCNs Recruiting
Calgary, Alberta, Canada
Contact: Sara Mallinson, PhD    403 943 0449    sara.mallinson@albertahealthservices.ca   
Contact: Stephanie Hastings, PhD    403 943 0579    stephanie.hastings@albertahealthservices.ca   
Canada, Quebec
Quebec Primary Care Not yet recruiting
Quebec City, Quebec, Canada
Contact: Anik Giguere, PhD    418 656-2131 ext 8026    anik.giguere@fmed.ulaval.ca   
Contact: Laetitia Coudert, PhD    418 682 7511 ext 84942    laetitia.coudert.1@ulaval.ca   
Canada
Ontario Primary Care Not yet recruiting
Waterloo, Canada
Contact: Paul Stolee, PhD    519-888-4567 ext 35879    stolee@uwaterloo.ca   
Contact: Jacobi Elliott, PhD    519-888-4567 ext 38982    j7elliot@uwaterloo.ca   
Sponsors and Collaborators
University of Waterloo
Dalhousie University
University of Calgary
University of British Columbia
Laval University
Investigators
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Principal Investigator: Paul Stolee, Dr. University of Waterloo

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Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT03442426     History of Changes
Other Study ID Numbers: ORE22446
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Waterloo:
Primary Health Care
Frail Elderly
Qualitative Methods
Quantitative Methods
Cost-Benefit Analysis
Patient Participation

Additional relevant MeSH terms:
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Frailty
Pathologic Processes