Clinical trial NCT03442426: Transforming Primary Care for Older Canadians Living With Frailty
Official title: Transforming Primary Care for Older Canadians Living With Frailty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Keywords: Primary Health Care
Frail Elderly
Qualitative Methods
Quantitative Methods
Cost-Benefit Analysis
Patient Participation
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Dalhousie University
name: University of Calgary
name: University of British Columbia
name: Laval University
First posted: 2018-02-22
Enrollment: 695
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Assessing change in 'Care for Chronic Conditions' scores
timeFrame: 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:
measure: Assessing change in 5-Level EQ-5D questionnaire
timeFrame: 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.
measure: Assessing change in the Canadian Institute for Health Information Primary Care Provider Survey
timeFrame: 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.
measure: Assessing Healthcare Utilization across different time points
timeFrame: 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:
measure: Assessing change in Goal Attainment Scaling (GAS)
timeFrame: 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).
measure: Assessing change in Canadian Institute for Health Information Primary Care Organizational Survey
timeFrame: 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.
Locations:
city: Calgary
country: Canada
facility: Alberta PCNs
state: Alberta
city: Quebec City
country: Canada
facility: Quebec Primary Care
state: Quebec
city: Waterloo
country: Canada
facility: Ontario Primary Care
Study officials:
affiliation: University of Waterloo
name: Paul Stolee, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.