Health Care Inequity, Patient NavigationARCNCT03451552
Patient Navigation in Primary Care and Access to Resources in the Community
A study testing Patient Navigator in people with Health Care Inequity, Patient Navigation, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Some people living with health problems require extra support to properly manage their conditions, as family doctors are only able to spend limited time in the office with these patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Care Inequity, Patient Navigation
- What is being tested?
- Patient Navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to 1 May 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any practice providing comprehensive primary care services (i.e. excludes practices that provide walk in services only), except for Community Health Centres. This includes Reformed Fee For Service (Family Health Groups, Comprehensive Care Model), Capitation based models (Family Health Networks, Family Health Organizations), and interprofessional models (Family Health Teams)
- Located in a neighbourhood of the Champlain (Ottawa area) or North East (Sudbury area) LHIN that has a francophone population of 20% of greater, as listed identified in the Ottawa Neighbourhood Study and in custom neighbourhoods created by the city of Greater Sudbury for city planning purposes, both linked to Statistics Canada's 2011 Population Census, respectively.
- Having at least one primary care provider agreeing to participate in the study
- Work in a practice that meets the eligibility criteria participating practice will be invited to participate in the study.
- Is a Primary Health Care Provider: A health professional that may refer patients to CRs such as physicians, nurses, and social workers.
- Patient identifies a primary care provider participating in the study as their main primary care provider
Show all 9Show fewer
- Has received a recommendation for a CR from their PHCP
- Is able to communicate in English or French, or is willing to be served via a cultural interpreter/translator, preferably a family member.
- Is able to provide consent for the study (18 years of age or older), or has parental/guardian proxy to provide consent (minor patients, patients with cognitive deficits)
Who cannot join
- A Community Health Centre or clinics providing walk-in services only
- Practices that are under the traditional fee for service remuneration
- Located in a neighbourhood with less than 20% Francophone residents
- Primary care providers:
- None
- Primary care patients:
- Unable to provide consent and does not have a family member/guardian who can provide proxy consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Navigation in Primary Care and Access to Resources in the Community - A Randomized Controlled Trial
Some people living with health problems require extra support to properly manage their conditions, as family doctors are only able to spend limited time in the office with these patients. There are many resources and programs in the community that can provide the necessary time and support for these patients, yet many patients are unaware that such resources exist. Patient navigators have been shown to be useful in helping patients with certain conditions (such as cancer) to get to the resources they need, especially when they have social challenges that make it difficult for them to reach these programs (for example, language or transportation barriers, poverty, or poor social support). This study will look at how helpful Navigators are to link patients at family doctors' offices to community resources. To do this, family doctors' offices in Ottawa and Sudbury will be recruited. All offices will receive training on directing patients to CRs and will be assigned a patient navigator to support patients access CRs. Half of the patients referred to CRs by their providers will have access to the navigator (intervention) assigned to the practice. This study will assess whether access to a navigator increases patients' access to community health and social services compared to usual standard of care. In addition, the study aims to understand whether English and French speaking individuals are as likely to benefit from a navigator in accessing community resources in the language of their choice.
Read the detailed description
The proposed project builds on work conducted between 2013 and today. The Canadian Institutes of Health Research's Community Based Primary Health Care Team Grant SPOR initiative funded a five-year program of research (known as IMPACT: Innovative Models Promoting Access-to-Care Transformation, http://www.impactresearchprogram.com/). The goal of the IMPACT Project is to increase access to community-based primary health care for vulnerable populations. The lead for the Ontario arm of the IMPACT project, Simone Dahrouge, has undertaken a community engagement initiative within the Champlain Local Health Integration Network (LHIN) to understand the barriers patients face to adequately access community based health and social resources (CRs) and how these can be overcome. Under that funding, the team undertook an extensive consultation process to identify a regional priority gap, select and adapt an intervention, and implement and evaluate a single arm intervention. The investigators are currently in the last phase of that project, which is serving as a feasibility phase for the randomized controlled trial. The feasibility study is evaluating the acceptability, demand, implementation, adaption, integration, and practicality of the study intervention and related activities to optimize appropriate access to CRs for primary care patients. Enrolment for that project will be completed by March 2018. This study received ethics approval from the OHSN Research Ethics Board (Protocol #20160914-01H), Bruyère Continuing Care Research Ethics Board (Protocol #M16-1616-055), Hôpital Montfort Research Ethics Board (Protocol # SD-DP-27-02-17), and the University of Ottawa Research Ethics Board (Protocol # A05-17-04).That trial is a registered clinical trial: NCT03105635.
During the feasibility phase the team established a regional stakeholder advisory group (Champlain LHIN). The composition of the advisory group has been adapted to meet the needs of the study. In the initial phase the composition was broad until the region identified the priority area and approach to addressing the gap. The committee is now composed of patients of various minority communities who contribute their lived experience, primary care providers from different care models and leaders from organizations responsible for community services (Community Care Access Centres and Community Health Centres) who inform the feasibility of the approach for each context, and best approach to integrating of the two sectors, health planners (the LHIN Primary Care Lead, senior integration specialist and others) who bring their broader context health services knowledge as well as resources (such as practice transformation facilitation services) to the project, as well as other stakeholders that inform specific components of the intervention (Ontario 211, Champlain Healthline). That Committee meets regularly and contributes directly to the direction of the study design, implementation, evaluation and dissemination. Because the committee fundamentally represents the interests of the region, it is often referred to in this document as 'the region".
The initial consultative phase identified poor access to CRs as a priority access gap. The research team relied on a scoping review conducted for the IMPACT program and conducted several interviews and focus groups with community stakeholders to inform the best approach addressing this gap. The region selected to implement a patient navigator who can assist patients for whom the use of a community service is recommended by their primary care provider achieve access to that service. Primary care providers rarely make specific recommendations to access CRs; largely because they are unaware of these. They make general recommendations to improve healthy behaviours, but do not refer to specific types of services. Two realist reviews have been commissioned and completed by a team of experts to help us understand the critical success factors and shape our intervention. One review is focused on "community navigators" and the other on "primary care referral to community services" to help the team understand the factors that support us. This information was used to develop the ARC intervention. A number of themes identified in these reviews including training for clinical staff to identify and refer to relevant CRs to address patients' social barriers; implementing a champion within practice to integrate referral into usual care; use of electronic health records to prompt provider referral and share information between provider and the community; and developing a screening process and promotional material to prompt referral.
As a result, the region developed the Access to Resources in the Community/Accès aux Resources Communautaires (ARC) intervention. The ARC project will build on this work by focussing on improving access to community resources in patients' language of choice and emphasizing access to French-language resources for Francophones in Ontario.
PURPOSE
The purpose of this project is to optimize appropriate access to community based services for socially complex primary care patients, including Franco-Ontarians living in minority situations, and promote the continuity of information across primary and community care.
OBJECTIVES AND DELIVERABLES
Objective A: Optimize equitable utilization of community based resources
Deliverable 1: Effectiveness of a patient navigator on utilization of CRs
Deliverable 2: Make policy recommendations to address remaining gaps
Deliverable 3: Establish a model of navigation that is transferable and scalable.
Objective B: Support continuity of information across Primary and Community Care
Deliverable 4: Establish a process that support appropriate exchange of information across the two sectors
- Conditions
- Health Care Inequity, Patient Navigation
- Being tested
- Patient Navigator
- Keywords
- Community Resources, Patient Navigator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigatorBehavioural
Navigators will support patients to access community based resources for healthy living and self-management, rather than providing specific information about health issues. Navigators will teach patients how to identify available and relevant programs to meet their health-related goals, in their language of choice. The navigator will ensure that the individual understands the reason for referral and potential benefits. They will discuss social barriers potentially affecting patients' access to community health resources, and assist patients to prioritize their health goals and relevant resources to achieve these. The navigator will then assist patients to access the community-based services in the language of their choice to which they have been referred. The navigator may assist the patient in making appointments, coordinating transportation, and/or accompaniment to resources as required).
| Study group | Role | What they receive |
|---|---|---|
| Control (211 services) | No intervention | Patients allocated to the control arm will be directed to the Ontario 211 navigation service, which is already available to the general public free of charge. After consenting to participate in the study and completing the telephone survey, the research assistant will inform these patients that they can use existing navigation services provided by Ontario 211 to help them access the CR referred to them by their PHCP. The research assistant will instruct patients to dial 2-1-1 to obtain additional information on the nature of this service. |
| Intervention (Patient Navigator) | Experimental | Patients allocated to the intervention arm will be offered the services of the ARC Patient Navigator. After consenting to participate in the study and completing the telephone survey, the research assistant will inform these patients that they can use the services offered by the ARC patient navigator to help them access the CR referred to them by their PHCP. Following a brief description of the services provided by the navigator (e.g., arrange transportation, make appointments, fill out forms, etc.), patients will be offered to be contacted by the navigator by telephone or to meet with the navigator in person on a day and time that is most convenient for them. Receives: Behavioral: Patient Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access to Community Resources
The primary outcome measure is access to CRs amongst the patients participating in the study. This outcome reflects the ability of the navigator to help patients overcome barriers to access and reach the community resource. We will assess this outcome in both arms (control and intervention) three months after enrolment in the study through a patient survey. The outcome will be a count of the CRs accessed (as a patient may access more than one CR).
Measured: Three months
Secondary outcomes (18)
Ability of the intervention to address equity
Patient sociodemographic characteristics captured in the baseline survey (e.g. income, language, sex, age, immigration status) will be used to evaluate the intervention's success in supporting patients access the desired resource (main outcome variable) across various social strata.
Measured: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Needs/Difficulties
Section B in patient survey - related to ability to pay
Measured: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Use of Healthcare
Section B in patient survey - related to relationship with providers
Measured: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Ability to engage
Section C in the patient survey, one scale (including three concepts)
Measured: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Quality of Life VR-12
Section F in patient survey
Measured: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Health Action Process Approach
Section L in the patient survey - related to self efficacy and behaviour change
Measured: Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Patient Activation Measure
Section M of patient survey - related to knowledge, confidence, and motivation to access services
Measured: Baseline(i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Community service evaluation
Section O in Patient Survey: used to evaluate whether the community service(s) were appropriate for the needs of the patient
Measured: Assessed after the three month patient intervention period.
Navigator Assessment (intervention arm only)
An assessment of the Patient Navigator service received by patients in the intervention arm
Measured: Assessed after the three month patient intervention period.
Attitudes with reference to vulnerable populations
An assessment of primary care providers attitudes with reference to socially vulnerable populations
Measured: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Practices with reference to vulnerable populations
An assessment of primary care providers practices with reference to socially vulnerable populations
Measured: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Knowledge with reference to vulnerable populations
An assessment of primary care providers' Knowledge with reference to socially vulnerable populations
Measured: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Contextual factors (e.g., organizational structure)
An assessment of the organization's (primary care organizations) organizational structure (section B of Provider survey)
Measured: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Change valence
Section C of the provider survey
Measured: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Change Climate
Section D of the provider survey
Measured: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Organizational readiness for change
Section E of Provider Survey; An assessment of the organization's readiness to implement the navigator intervention
Measured: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Implementation effectiveness
Section F of Provider SurveyAn assessment of the effectiveness of the navigator intervention within the primary care practice
Measured: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Experience with the Navigator
Section G of Provider Survey; An assessment of the providers' experience with the patient navigator, and how the intervention has affected their practice
Measured: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Mar 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Care Inequity, Patient NavigationStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, mixed method (patient) randomized controlled trial of navigation services provided by Ontario 211 vs. navigation services provided by a lay Patient Navigator. Randomization is 1:1 control:intervention. The mixed method design is a sequential, explanatory design. Patients having consented to participate in the study will complete a survey, after which their random assignment to one of two arms (intervention or control) will be revealed. The randomization schedule will be blocked at the practice level to ensure a balance of control and intervention patients for each practice, including all providers. Patients randomized to the intervention arm will have access to services provided by the ARC Patient Navigator, whereas patients randomized to the control arm will be directed to the Ontario 211 navigation service.
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa, University of Ontario Institute of Technology, Laurentian University, Bruyère Health Research Institute., Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Simone Dahrouge, PhD, Principal investigator, Bruyère Health Research Institute.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451552
- Sponsor's protocol ID
- 20171215
- Acronym
- ARC
- Status last verified
- Oct 2020
- First submitted
- 11 Jan 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saluja K, Mahbub A, Gauthier AP, Lemonde M, Timony P, Durand F, Dahrouge S. Understanding patient barriers and enablers to accessing community resources: a qualitative study to inform navigation service delivery. BMC Prim Care. 2025 Oct 24;26(1):322. doi: 10.1186/s12875-025-03029-z.
PubMed 41136927
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Navigation in Primary Care and Access to Resources in the Community - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03451552
- Acronym / sponsor ID
- ARC / 20171215
- Conditions
- Health Care Inequity, Patient Navigation
- Keywords
- Community Resources, Patient Navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Ottawa, University of Ontario Institute of Technology, Laurentian University, Bruyère Health Research Institute., Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 1 Mar 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.
Some people living with health problems require extra support to properly manage their conditions, as family doctors are only able to spend limited time in the office with these patients. There are many resources and programs in the community that can provide the necessary time and support for these patients, yet many patients are unaware that such resources exist. Patient navigators have been shown to be useful in helping patients with certain conditions (such as cancer) to get to the resources they need, especially when they have social challenges that make it difficult for them to reach these programs (for example, language or transportation barriers, poverty, or poor social support). This study will look at how helpful Navigators are to link patients at family doctors' offices to community resources. To do this, family doctors' offices in Ottawa and Sudbury will be recruited. All offices will receive training on directing patients to CRs and will be assigned a patient navigator to support patients access CRs. Half of the patients referred to CRs by their providers will have access to the navigator (intervention) assigned to the practice. This study will assess whether access to a navigator increases patients' access to community health and social services compared to usual standard of care. In addition, the study aims to understand whether English and French speaking individuals are as likely to benefit from a navigator in accessing community resources in the language of their choice.
Detailed description
The proposed project builds on work conducted between 2013 and today. The Canadian Institutes of Health Research's Community Based Primary Health Care Team Grant SPOR initiative funded a five-year program of research (known as IMPACT: Innovative Models Promoting Access-to-Care Transformation, http://www.impactresearchprogram.com/). The goal of the IMPACT Project is to increase access to community-based primary health care for vulnerable populations. The lead for the Ontario arm of the IMPACT project, Simone Dahrouge, has undertaken a community engagement initiative within the Champlain Local Health Integration Network (LHIN) to understand the barriers patients face to adequately access community based health and social resources (CRs) and how these can be overcome. Under that funding, the team undertook an extensive consultation process to identify a regional priority gap, select and adapt an intervention, and implement and evaluate a single arm intervention. The investigators are currently in the last phase of that project, which is serving as a feasibility phase for the randomized controlled trial. The feasibility study is evaluating the acceptability, demand, implementation, adaption, integration, and practicality of the study intervention and related activities to optimize appropriate access to CRs for primary care patients. Enrolment for that project will be completed by March 2018. This study received ethics approval from the OHSN Research Ethics Board (Protocol #20160914-01H), Bruyère Continuing Care Research Ethics Board (Protocol #M16-1616-055), Hôpital Montfort Research Ethics Board (Protocol # SD-DP-27-02-17), and the University of Ottawa Research Ethics Board (Protocol # A05-17-04).That trial is a registered clinical trial: NCT03105635.
During the feasibility phase the team established a regional stakeholder advisory group (Champlain LHIN). The composition of the advisory group has been adapted to meet the needs of the study. In the initial phase the composition was broad until the region identified the priority area and approach to addressing the gap. The committee is now composed of patients of various minority communities who contribute their lived experience, primary care providers from different care models and leaders from organizations responsible for community services (Community Care Access Centres and Community Health Centres) who inform the feasibility of the approach for each context, and best approach to integrating of the two sectors, health planners (the LHIN Primary Care Lead, senior integration specialist and others) who bring their broader context health services knowledge as well as resources (such as practice transformation facilitation services) to the project, as well as other stakeholders that inform specific components of the intervention (Ontario 211, Champlain Healthline). That Committee meets regularly and contributes directly to the direction of the study design, implementation, evaluation and dissemination. Because the committee fundamentally represents the interests of the region, it is often referred to in this document as 'the region".
The initial consultative phase identified poor access to CRs as a priority access gap. The research team relied on a scoping review conducted for the IMPACT program and conducted several interviews and focus groups with community stakeholders to inform the best approach addressing this gap. The region selected to implement a patient navigator who can assist patients for whom the use of a community service is recommended by their primary care provider achieve access to that service. Primary care providers rarely make specific recommendations to access CRs; largely because they are unaware of these. They make general recommendations to improve healthy behaviours, but do not refer to specific types of services. Two realist reviews have been commissioned and completed by a team of experts to help us understand the critical success factors and shape our intervention. One review is focused on "community navigators" and the other on "primary care referral to community services" to help the team understand the factors that support us. This information was used to develop the ARC intervention. A number of themes identified in these reviews including training for clinical staff to identify and refer to relevant CRs to address patients' social barriers; implementing a champion within practice to integrate referral into usual care; use of electronic health records to prompt provider referral and share information between provider and the community; and developing a screening process and promotional material to prompt referral.
As a result, the region developed the Access to Resources in the Community/Accès aux Resources Communautaires (ARC) intervention. The ARC project will build on this work by focussing on improving access to community resources in patients' language of choice and emphasizing access to French-language resources for Francophones in Ontario.
PURPOSE
The purpose of this project is to optimize appropriate access to community based services for socially complex primary care patients, including Franco-Ontarians living in minority situations, and promote the continuity of information across primary and community care.
OBJECTIVES AND DELIVERABLES
Objective A: Optimize equitable utilization of community based resources
Deliverable 1: Effectiveness of a patient navigator on utilization of CRs
Deliverable 2: Make policy recommendations to address remaining gaps
Deliverable 3: Establish a model of navigation that is transferable and scalable.
Objective B: Support continuity of information across Primary and Community Care
Deliverable 4: Establish a process that support appropriate exchange of information across the two sectors
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, mixed method (patient) randomized controlled trial of navigation services provided by Ontario 211 vs. navigation services provided by a lay Patient Navigator. Randomization is 1:1 control:intervention. The mixed method design is a sequential, explanatory design. Patients having consented to participate in the study will complete a survey, after which their random assignment to one of two arms (intervention or control) will be revealed. The randomization schedule will be blocked at the practice level to ensure a balance of control and intervention patients for each practice, including all providers. Patients randomized to the intervention arm will have access to services provided by the ARC Patient Navigator, whereas patients randomized to the control arm will be directed to the Ontario 211 navigation service.
| Arm | Type | Receives |
|---|---|---|
| Control (211 services) | No intervention | –Patients allocated to the control arm will be directed to the Ontario 211 navigation service, which is already available to the general public free of charge. After consenting to participate in the study and completing the telephone survey, the research assistant will inform these patients that they can use existing navigation services provided by Ontario 211 to help them access the CR referred to them by their PHCP. The research assistant will instruct patients to dial 2-1-1 to obtain additional information on the nature of this service. |
| Intervention (Patient Navigator) | Experimental | Behavioral: Patient NavigatorPatients allocated to the intervention arm will be offered the services of the ARC Patient Navigator. After consenting to participate in the study and completing the telephone survey, the research assistant will inform these patients that they can use the services offered by the ARC patient navigator to help them access the CR referred to them by their PHCP. Following a brief description of the services provided by the navigator (e.g., arrange transportation, make appointments, fill out forms, etc.), patients will be offered to be contacted by the navigator by telephone or to meet with the navigator in person on a day and time that is most convenient for them. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Any practice providing comprehensive primary care services (i.e. excludes practices that provide walk in services only), except for Community Health Centres. This includes Reformed Fee For Service (Family Health Groups, Comprehensive Care Model), Capitation based models (Family Health Networks, Family Health Organizations), and interprofessional models (Family Health Teams)
- Located in a neighbourhood of the Champlain (Ottawa area) or North East (Sudbury area) LHIN that has a francophone population of 20% of greater, as listed identified in the Ottawa Neighbourhood Study and in custom neighbourhoods created by the city of Greater Sudbury for city planning purposes, both linked to Statistics Canada's 2011 Population Census, respectively.
- Having at least one primary care provider agreeing to participate in the study
- Work in a practice that meets the eligibility criteria participating practice will be invited to participate in the study.
- Is a Primary Health Care Provider: A health professional that may refer patients to CRs such as physicians, nurses, and social workers.
Key exclusion criteria (7 listed)
- A Community Health Centre or clinics providing walk-in services only
- Practices that are under the traditional fee for service remuneration
- Located in a neighbourhood with less than 20% Francophone residents
- None
- Unable to provide consent and does not have a family member/guardian who can provide proxy consent
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 |
|---|---|---|
| Patient NavigatorNavigators will support patients to access community based resources for healthy living and self-management, rather than providing specific information about health issues. Navigators will teach patients how to identify available and relevant programs to meet their health-related goals, in their language of choice. The navigator will ensure that the individual understands the reason for referral and potential benefits. They will discuss social barriers potentially affecting patients' access to community health resources, and assist patients to prioritize their health goals and relevant resources to achieve these. The navigator will then assist patients to access the community-based services in the language of their choice to which they have been referred. The navigator may assist the patient in making appointments, coordinating transportation, and/or accompaniment to resources as required). | Behavioural | Intervention (Patient Navigator) |
Primary outcome
Access to Community Resources
Time frame: Three months
The primary outcome measure is access to CRs amongst the patients participating in the study. This outcome reflects the ability of the navigator to help patients overcome barriers to access and reach the community resource. We will assess this outcome in both arms (control and intervention) three months after enrolment in the study through a patient survey. The outcome will be a count of the CRs accessed (as a patient may access more than one CR).
18 secondary outcomes
Ability of the intervention to address equity
Time frame: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Needs/Difficulties
Time frame: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Use of Healthcare
Time frame: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Ability to engage
Time frame: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Quality of Life VR-12
Time frame: Baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Health Action Process Approach
Time frame: Time Frame: baseline (i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Patient Activation Measure
Time frame: Baseline(i.e. the time of referrals (Pre-intervention) as well three months later, at the end of the patient three months intervention period
Community service evaluation
Time frame: Assessed after the three month patient intervention period.
Navigator Assessment (intervention arm only)
Time frame: Assessed after the three month patient intervention period.
Attitudes with reference to vulnerable populations
Time frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Practices with reference to vulnerable populations
Time frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Knowledge with reference to vulnerable populations
Time frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Contextual factors (e.g., organizational structure)
Time frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Change valence
Time frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Change Climate
Time frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Organizational readiness for change
Time frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Implementation effectiveness
Time frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
Experience with the Navigator
Time frame: Baseline(i.e. the time of referrals (Pre-intervention) and 10 months into the study intervention period.
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 19 Oct 2020.
- Derived from this study: PubMed 41136927Saluja K, Mahbub A, Gauthier AP, Lemonde M, Timony P, Durand F, Dahrouge S. Understanding patient barriers and enablers to accessing community resources: a qualitative study to inform navigation service delivery. BMC Prim Care. 2025 Oct 24;26(1):322. doi: 10.1186/s12875-025-03029-z.
- Individual participant dataSharing planned: No
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.
Simone Dahrouge, PhD principal investigator
Bruyère Health Research Institute.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigator in people with Health Care Inequity, Patient Navigation, run by Ottawa Hospital Research Institute at 1 site 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 9 inclusion and 7 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Access to Community Resources (time frame: Three months). 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 NCT03451552, which also lists 1 linked publication.
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 19 Oct 2020.