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CompletedNCT03442426Updated Dec 1, 2022

Transforming Primary Care for Older Canadians Living With Frailty

An interventional study of Integrated model of primary care in Frail Elderly Syndrome, sponsored by University of Waterloo. Completed at 3 sites in Canada. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-01.

Sponsored by University of Waterloo · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
695
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Frail Elderly Syndrome

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Keywords

  • Primary Health Care
  • Frail Elderly
  • Qualitative Methods
  • Quantitative Methods
  • Cost-Benefit Analysis
  • Patient Participation
03

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
695 participants (actual)

Study arms

  • Experimental
    Intervention Cohort

    Integrated model of primary care

    Other: Integrated model of primary care

Interventions

  • OtherIntegrated 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.

05

What researchers measure

Primary outcomes

  1. Assessing change in 'Care for Chronic Conditions' scores

    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.

    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.

Secondary outcomes

  1. Assessing change in 5-Level EQ-5D questionnaire

    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).

    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.

  2. Assessing change in the Canadian Institute for Health Information Primary Care Provider Survey

    This survey addresses team function, involvement in governance, use of information technology and scope of practice.

    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.

  3. Assessing Healthcare Utilization across different time points

    Self-reported health care utilization data including hospital admissions; emergency department visits, home care services; specialist visits and primary care visits.

    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.

Other outcomes

  1. Assessing change in Goal Attainment Scaling (GAS)

    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.

    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).

  2. Assessing change in Canadian Institute for Health Information Primary Care Organizational Survey

    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.

    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.

06

Study locations

3 sites
  • Alberta PCNs
    Calgary, Alberta, Canada
  • Quebec Primary Care
    Quebec City, Quebec, Canada
  • Ontario Primary Care
    Waterloo, Canada
07

References and documents

Publications

  • Sims-Gould J, Elliott J, Tong CE, Giguere A, Mallinson S, Stolee P. A national intervention to support frail older adults in primary care: a protocol for an adapted implementation framework. BMC Geriatr. 2021 Aug 4;21(1):453. doi: 10.1186/s12877-021-02395-4. PubMed 34348660 ↗
  • Stolee P, Elliott J, Giguere AM, Mallinson S, Rockwood K, Sims Gould J, Baker R, Boscart V, Burns C, Byrne K, Carson J, Cook RJ, Costa AP, Giosa J, Grindrod K, Hajizadeh M, Hanson HM, Hastings S, Heckman G, Holroyd-Leduc J, Isaranuwatchai W, Kuspinar A, Meyer S, McMurray J, Puchyr P, Puchyr P, Theou O, Witteman H. Transforming primary care for older Canadians living with frailty: mixed methods study protocol for a complex primary care intervention. BMJ Open. 2021 May 13;11(5):e042911. doi: 10.1136/bmjopen-2020-042911. PubMed 33986044 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03442426
Lead sponsor
University of Waterloo
Collaborators
Dalhousie University, University of Calgary, University of British Columbia, Laval University
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Nov 20, 2017
Primary completion
Dec 30, 2020
Completion
Aug 30, 2022
Last update
Dec 1, 2022

Study contacts

Paul Stolee, Dr.
principal investigator · University of Waterloo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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