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Transforming Primary Care for Older Canadians Living With Frailty

Primary Purpose

Frail Elderly Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Integrated model of primary care
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Frail Elderly Syndrome focused on measuring Primary Health Care, Frail Elderly, Qualitative Methods, Quantitative Methods, Cost-Benefit Analysis, Patient Participation

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Alberta PCNs
  • Quebec Primary Care
  • Ontario Primary Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Cohort

Arm Description

Integrated model of primary care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
December 4, 2017
Last Updated
November 30, 2022
Sponsor
University of Waterloo
Collaborators
Dalhousie University, University of Calgary, University of British Columbia, Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT03442426
Brief Title
Transforming Primary Care for Older Canadians Living With Frailty
Official Title
Transforming Primary Care for Older Canadians Living With Frailty
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo
Collaborators
Dalhousie University, University of Calgary, University of British Columbia, Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome
Keywords
Primary Health Care, Frail Elderly, Qualitative Methods, Quantitative Methods, Cost-Benefit Analysis, Patient Participation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
695 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Cohort
Arm Type
Experimental
Arm Description
Integrated model of primary care
Intervention Type
Other
Intervention Name(s)
Integrated model of primary care
Intervention Description
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 Measure Information:
Title
Assessing change in 'Care for Chronic Conditions' scores
Description
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 Outcome Measure Information:
Title
Assessing change in 5-Level EQ-5D questionnaire
Description
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.
Title
Assessing change in the Canadian Institute for Health Information Primary Care Provider Survey
Description
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.
Title
Assessing Healthcare Utilization across different time points
Description
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 Pre-specified Outcome Measures:
Title
Assessing change in Goal Attainment Scaling (GAS)
Description
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).
Title
Assessing change in Canadian Institute for Health Information Primary Care Organizational Survey
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Stolee, Dr.
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta PCNs
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Quebec Primary Care
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Ontario Primary Care
City
Waterloo
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34348660
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.
Results Reference
derived
PubMed Identifier
33986044
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.
Results Reference
derived

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Transforming Primary Care for Older Canadians Living With Frailty

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