Access to Primary CareENGAGENCT07439627
Evaluating Novel Approaches That Engage and Support Vulnerable Patient Groups to Equitably Access Primary Care
A study testing Primary care connector in people with Access to Primary Care, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The goal of this initial clinical trial is to gather information for building a future national trial in Canada that can continuously look at different ways of helping people made vulnerable get a primary care provider. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Access to Primary Care
- What is being tested?
- Primary care connector
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unattached adults (18+) made vulnerable who are seeking a primary care provider within the boundaries created by the Toronto Region Primary Care Workforce Planning Toolkit.
Who cannot join
- Patients under 18 years old.
- Patients above 18 years who have not been made vulnerable and are already registered and/or attached to a primary care organization within the boundaries created by the Toronto Region Primary Care Workforce Planning Toolkit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Natricha A. Levy McFarlane, MPhil contact
Canada1 site
Unity Health Toronto
Toronto, Ontario, M5B 1W8
Andrew D. Pinto
Andrew D. Pinto, MD CCFP FRCPC MSc
About this study
Official title: Evaluating Novel Approaches That enGage And Support Vulnerable Patient Groups to Equitably Access Primary Care (ENGAGE): A Pilot Cluster Randomized Control Trial
The goal of this initial clinical trial is to gather information for building a future national trial in Canada that can continuously look at different ways of helping people made vulnerable get a primary care provider. The trial will take place in the Toronto region and will help researchers decide how to plan the future trial.
The main question that this trial is aiming to answer is:
Read more
- For those made vulnerable who do not currently have a primary care provider, will assistance from a Primary Care Connector trained specifically with knowledge of the local health system, help to better connect those people to primary care providers compared to written information alone?
Researchers will compare giving participants the name of a provider that is accepting new patients in their area, to only giving participants existing information on how to find a provider, to see if giving the name of a provider accepting new patients works better to help people get connected to a provider.
Participants will:
- Get the name of a primary care provider in their area who is accepting new patients or get existing information on how to find a primary care provider.
- Call the provider to try and get an appointment or use the information given to find a provider.
- Tell the study team if they have found a provider.
Read the detailed description
There is a serious crisis of people gaining access to primary care in Canada. It is estimated that 1 in 5 Canadians do not have a primary care provider. The challenge of access to primary care is exacerbated in populations that are made vulnerable such as newcomers, racialized individuals and low-income individuals.
In an effort to solve the access to primary care crisis, governments have announced billions in new funding, however, without planning and the engagement of patients made vulnerable by social and economic policies, these investments may actually widen inequities in access. Two key problems face policymakers: How to ensure investments reach and engage patients who are made vulnerable? How to adapt quickly, rather than implement a policy and wait years to decades before it is evaluated? Adaptive Platform Trials (APTs) are an ideal design to compare multiple approaches and to allow for new approaches to be added as they emerge.
APTs study multiple interventions in a single area in a perpetual manner, with new interventions allowed to enter or leave the platform over time based on a decision algorithm. APTs use a master protocol to establish standard operating procedures, including interim analyses to determine whether enrollment in interventions can be stopped early for statistical efficiencies (sequential designs). By using an APT design, researchers can respond swiftly to dynamic changes in policies and funding and continually refine strategies to ensure they remain effective and cost-effective.
The ENGAGE study will conduct a pilot cluster randomized control trial (cRCT) in two intervention and two comparison sub-regions in Toronto. Unattached adults (18+) made vulnerable who are seeking a primary care provider within the boundaries of the sub-regions of the study will be eligible to participate.
In the intervention sub-regions, posters bearing contact information for the study team will be displayed in public spaces including but not limited to bus stops and community notice boards. The study team will engage with primary care providers in the sub-regions to create a list of those accepting new patients, their general criteria for doing so and whether there are any exceptional circumstances under which they will accept new patients.
Persons made vulnerable who are unattached to primary care will contact the study team directly using the contact information from the posters. Primary care connectors will attempt to connect the unattached persons made vulnerable with a local primary care provider that can best serve them, based on the information gathered to create the list of practices accepting new patients. Because of this information, connectors may be able to more quickly direct those made vulnerable to primary care than they would be able to on their own. However, connectors will not guarantee that a connection to a local primary care provider will be made.
Posters will also be displayed in the the comparison sub-regions and persons made vulnerable who are seeking a primary care provider will contact the study team, similar to in the intervention sub-regions. Connectors will verbally inform participants of the existing resources for finding a primary care provider or services such as through Health Care Connect.
Connectors will follow-up with participants in both intervention and comparison sub-regions to to ascertain whether they were able to get access to a provider using the information that was shared with them. Access to a provider will be assessed as an appointment date or if the participant has been rostered with the provider.
- Conditions
- Access to Primary Care
- Being tested
- Primary care connector
- Keywords
- Primary care access, Adaptive platform trials, People made vulnerable, Primary care connector, Primary care attachment, Primary care engagement, Cluster randomized control trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary care connectorOther
A primary care connector will give participants the name of a primary care provider in their area who is accepting new patients based on a list containing this information generated prior to the start of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Use of a primary care connector | Other | A primary care connector will try to connect participants to a primary care provider in their area. Receives: Other: Primary care connector |
| Providing only information on finding a provider | No intervention | Participants will be provided with existing information on ways of finding a primary care provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient enrollment
The number of patients made vulnerable enrolled in the primary care organizations across the participating sub-regions of the study is the primary outcome measure.
Measured: From contact with a primary care connector to 3-4 weeks later.
Secondary outcomes (1)
Appointment with a primary care provider
An appointment to meet with a provider will also be an outcome measure. Appointments will be used along with enrollment as proxy measures to inform access and engagement of patients made vulnerable in primary care.
Measured: From contact with a primary care connector to 3-4 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Access to Primary CareStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Andrew D. Pinto, MD CCFP FRCPC MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439627
- Sponsor's protocol ID
- 24-186
- Acronym
- ENGAGE
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Novel Approaches That enGage And Support Vulnerable Patient Groups to Equitably Access Primary Care (ENGAGE): A Pilot Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07439627
- Acronym / sponsor ID
- ENGAGE / 24-186
- Conditions
- Access to Primary Care
- Keywords
- Primary care access, Adaptive platform trials, People made vulnerable, Primary care connector, Primary care attachment, Primary care engagement, Cluster randomized control trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 27 Feb 2026 (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.
The goal of this initial clinical trial is to gather information for building a future national trial in Canada that can continuously look at different ways of helping people made vulnerable get a primary care provider. The trial will take place in the Toronto region and will help researchers decide how to plan the future trial.
The main question that this trial is aiming to answer is:
- For those made vulnerable who do not currently have a primary care provider, will assistance from a Primary Care Connector trained specifically with knowledge of the local health system, help to better connect those people to primary care providers compared to written information alone?
Researchers will compare giving participants the name of a provider that is accepting new patients in their area, to only giving participants existing information on how to find a provider, to see if giving the name of a provider accepting new patients works better to help people get connected to a provider.
Participants will:
- Get the name of a primary care provider in their area who is accepting new patients or get existing information on how to find a primary care provider.
- Call the provider to try and get an appointment or use the information given to find a provider.
- Tell the study team if they have found a provider.
Detailed description
There is a serious crisis of people gaining access to primary care in Canada. It is estimated that 1 in 5 Canadians do not have a primary care provider. The challenge of access to primary care is exacerbated in populations that are made vulnerable such as newcomers, racialized individuals and low-income individuals.
In an effort to solve the access to primary care crisis, governments have announced billions in new funding, however, without planning and the engagement of patients made vulnerable by social and economic policies, these investments may actually widen inequities in access. Two key problems face policymakers: How to ensure investments reach and engage patients who are made vulnerable? How to adapt quickly, rather than implement a policy and wait years to decades before it is evaluated? Adaptive Platform Trials (APTs) are an ideal design to compare multiple approaches and to allow for new approaches to be added as they emerge.
APTs study multiple interventions in a single area in a perpetual manner, with new interventions allowed to enter or leave the platform over time based on a decision algorithm. APTs use a master protocol to establish standard operating procedures, including interim analyses to determine whether enrollment in interventions can be stopped early for statistical efficiencies (sequential designs). By using an APT design, researchers can respond swiftly to dynamic changes in policies and funding and continually refine strategies to ensure they remain effective and cost-effective.
The ENGAGE study will conduct a pilot cluster randomized control trial (cRCT) in two intervention and two comparison sub-regions in Toronto. Unattached adults (18+) made vulnerable who are seeking a primary care provider within the boundaries of the sub-regions of the study will be eligible to participate.
In the intervention sub-regions, posters bearing contact information for the study team will be displayed in public spaces including but not limited to bus stops and community notice boards. The study team will engage with primary care providers in the sub-regions to create a list of those accepting new patients, their general criteria for doing so and whether there are any exceptional circumstances under which they will accept new patients.
Persons made vulnerable who are unattached to primary care will contact the study team directly using the contact information from the posters. Primary care connectors will attempt to connect the unattached persons made vulnerable with a local primary care provider that can best serve them, based on the information gathered to create the list of practices accepting new patients. Because of this information, connectors may be able to more quickly direct those made vulnerable to primary care than they would be able to on their own. However, connectors will not guarantee that a connection to a local primary care provider will be made.
Posters will also be displayed in the the comparison sub-regions and persons made vulnerable who are seeking a primary care provider will contact the study team, similar to in the intervention sub-regions. Connectors will verbally inform participants of the existing resources for finding a primary care provider or services such as through Health Care Connect.
Connectors will follow-up with participants in both intervention and comparison sub-regions to to ascertain whether they were able to get access to a provider using the information that was shared with them. Access to a provider will be assessed as an appointment date or if the participant has been rostered with the provider.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of a primary care connector | Other | Other: Primary care connectorA primary care connector will try to connect participants to a primary care provider in their area. |
| Providing only information on finding a provider | No intervention | –Participants will be provided with existing information on ways of finding a primary care provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unattached adults (18+) made vulnerable who are seeking a primary care provider within the boundaries created by the Toronto Region Primary Care Workforce Planning Toolkit.
Key exclusion criteria (2 listed)
- Patients under 18 years old.
- Patients above 18 years who have not been made vulnerable and are already registered and/or attached to a primary care organization within the boundaries created by the Toronto Region Primary Care Workforce Planning Toolkit.
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 |
|---|---|---|
| Primary care connectorA primary care connector will give participants the name of a primary care provider in their area who is accepting new patients based on a list containing this information generated prior to the start of the trial. | Other | Use of a primary care connector |
Primary outcome
Patient enrollment
Time frame: From contact with a primary care connector to 3-4 weeks later.
The number of patients made vulnerable enrolled in the primary care organizations across the participating sub-regions of the study is the primary outcome measure.
1 secondary outcome
Appointment with a primary care provider
Time frame: From contact with a primary care connector to 3-4 weeks later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- 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.
Natricha A. Levy McFarlane, MPhil contact
Andrew D. Pinto, MD CCFP FRCPC MSc principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary care connector in people with Access to Primary Care, run by Unity Health Toronto 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 3 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew D. Pinto, MD CCFP FRCPC MSc (416-864-6060 ext. 76148, andrew.pinto@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient enrollment (time frame: From contact with a primary care connector to 3-4 weeks later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.