NCT03442426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
695

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

December 1, 2022

Status Verified

November 1, 2022

Enrollment Period

3.1 years

First QC Date

December 4, 2017

Last Update Submit

November 30, 2022

Conditions

Keywords

Primary Health CareFrail ElderlyQualitative MethodsQuantitative MethodsCost-Benefit AnalysisPatient Participation

Outcome Measures

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.

    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 (3)

  • Assessing change in 5-Level EQ-5D questionnaire

    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.

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

    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.

  • Assessing Healthcare Utilization across different time points

    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 (2)

  • Assessing change in Goal Attainment Scaling (GAS)

    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).

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

    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.

Study Arms (1)

Intervention Cohort

EXPERIMENTAL

Integrated model of primary care

Other: Integrated model of primary care

Interventions

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.

Intervention Cohort

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alberta PCNs

Calgary, Alberta, Canada

Location

Quebec Primary Care

Québec, Quebec, Canada

Location

Ontario Primary Care

Waterloo, Canada

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Paul Stolee, Dr.

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2017

First Posted

February 22, 2018

Study Start

November 20, 2017

Primary Completion

December 30, 2020

Study Completion

August 30, 2022

Last Updated

December 1, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations