Frail Elderly SyndromeNCT03442426
Transforming Primary Care for Older Canadians Living With Frailty
A study testing Integrated model of primary care in people with Frail Elderly Syndrome, run by University of Waterloo at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Integrated model of primary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 695 participants
- Where
- 3 sitesCanada
- Study dates
- 20 Nov 2017to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- older adults age 70+ who attend the primary care clinic, speak and understand English language
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Alberta PCNs
Calgary, Alberta
Quebec Primary Care
Québec, Quebec
Ontario Primary Care
Waterloo
About this study
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.
Read more
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.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Integrated model of primary care
- Keywords
- Primary Health Care, Frail Elderly, Qualitative Methods, Quantitative Methods, Cost-Benefit Analysis, Patient Participation
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated model of primary careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Cohort | Experimental | Integrated model of primary care Receives: Other: Integrated model of primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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 survey addresses team function, involvement in governance, use of information technology and scope of practice.
Measured: 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
Self-reported health care utilization data including hospital admissions; emergency department visits, home care services; specialist visits and primary care visits.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start20 Nov 2017
- Primary completion30 Dec 2020
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 695 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University, University of Calgary, University of British Columbia, Laval University
- Responsible party
- Sponsor
- Investigators
- Paul Stolee, Dr., Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442426
- Sponsor's protocol ID
- ORE22446
- Status last verified
- Nov 2022
- First submitted
- 4 Dec 2017
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34348660Stolee 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Primary Care for Older Canadians Living With Frailty
- ClinicalTrials.gov ID
- NCT03442426
- Acronym / sponsor ID
- ORE22446
- Conditions
- Frail Elderly Syndrome
- Keywords
- Primary Health Care, Frail Elderly, Qualitative Methods, Quantitative Methods, Cost-Benefit Analysis, Patient Participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 695 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Dalhousie University, University of Calgary, University of British Columbia, Laval University
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Cohort | Experimental | Other: Integrated model of primary careIntegrated model of primary care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- older adults age 70+ who attend the primary care clinic, speak and understand English language
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated model of primary careIntervention 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. | Other | Intervention Cohort |
Primary outcome
Assessing change in 'Care for Chronic Conditions' scores
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.
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.
3 secondary outcomes
Assessing change in 5-Level EQ-5D questionnaire
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.
Assessing change in the Canadian Institute for Health Information Primary Care Provider Survey
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.
Assessing Healthcare Utilization across different time points
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Derived from this study: PubMed 34348660Sims-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.
- Derived from this study: PubMed 33986044Stolee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Stolee, Dr. principal investigator
University of Waterloo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated model of primary care in people with Frail Elderly Syndrome, run by University of Waterloo at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing change in 'Care for Chronic Conditions' scores (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03442426, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.