Evaluating Novel Approaches That Engage and Support Vulnerable Patient Groups to Equitably Access Primary Care (ENGAGE)

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:

• 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Access to Primary Care
• Intervention / Treatment: Other: Primary care connector

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew D. Pinto, MD CCFP FRCPC MSc; Phone Number: 76148 416-864-6060; Email: andrew.pinto@utoronto.ca
• Study Contact Backup: Name: Natricha A. Levy McFarlane, MPhil; Phone Number: 40218 416-864-6060; Email: natricha.levymcfarlane@unityhealth.to

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Unity Health Toronto
      • Contact: Andrew D. Pinto
      • Principal Investigator: Andrew D. Pinto, MD CCFP FRCPC MSc
      • Sub-Investigator: Benita Hosseini, PhD MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Use of a primary care connector; A primary care connector will try to connect participants to a primary care provider in their area.	Other: Primary care connector; 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.
No Intervention: Providing only information on finding a provider; Participants will be provided with existing information on ways of finding a primary care provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From contact with a primary care connector to 3-4 weeks later.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From contact with a primary care connector to 3-4 weeks later.

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Andrew D. Pinto, MD CCFP FRCPC MSc, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Primary care access; Adaptive platform trials; People made vulnerable; Primary care connector; Primary care attachment; Primary care engagement; Cluster randomized control trial
• Other Study ID Numbers: 24-186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No