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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03442426
Other study ID # ORE22446
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2017
Est. completion date August 30, 2022

Study information

Verified date November 2022
Source University of Waterloo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 695
Est. completion date August 30, 2022
Est. primary completion date December 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 70 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada Alberta PCNs Calgary Alberta
Canada Quebec Primary Care Quebec City Quebec
Canada Ontario Primary Care Waterloo

Sponsors (5)

Lead Sponsor Collaborator
University of Waterloo Dalhousie University, Laval University, University of British Columbia, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other 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. 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).
Other 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. 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.
Primary 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 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). 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 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. 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.
Secondary 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. 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.
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