Social Equity Data in Primary Care: How Best to Collect Data From Hard-to-Reach Populations

Social Equity Data in Primary Care: How Best to Collect Data From Hard-to-Reach Populations - A Pilot Randomized Control Trial

The goal of this clinical trial is to learn whether a community-based outreach approach can improve the collection of social and demographic information in adult primary care patients who may be harder to reach through standard clinic processes. The study focuses on patients who face potential barriers to care, such as limited income, housing instability, language differences, or other social challenges.

The main questions it aims to answer are:

• Does support from a Community Health Surveyor increase completion of a social and demographic questionnaire compared to usual care?
• Does this approach improve participation among patients with social needs or barriers to accessing care?

Researchers will compare usual care (standard questionnaire invitation methods) with an enhanced approach that includes proactive outreach and support from a Community Health Surveyor to see if this increases questionnaire completion.

Participants will:

• Be invited to complete a social and demographic questionnaire as part of routine care
• Complete the questionnaire either independently or with support from clinic staff or a Community Health Surveyor (depending on group assignment)

Study Overview

• Status: Completed
• Conditions: Primary Health Care; Healthcare Disparities; Social Determinants of Health; Health Equity
• Intervention / Treatment: Behavioral: Community health surveyor

Detailed Description

Health outcomes are strongly influenced by social, economic, and structural factors; however, routine collection of individual-level sociodemographic and social needs data in primary care remains inconsistent and often fails to capture information from populations experiencing marginalization. Existing data collection approaches, such as self-administered electronic questionnaires or opportunistic in-clinic screening, may underrepresent individuals facing barriers related to income, housing instability, language, disability, or limited access to digital tools. As a result, health systems lack the granular data needed to support equity-oriented care and planning.

Standardized tools for collecting sociodemographic and social needs information have been developed and implemented in some primary care settings, including the Health Equity Questionnaire (HEQ). However, prior implementation has demonstrated differential uptake, with lower participation among patients from underserved or structurally marginalized groups. Reported barriers include limited staff capacity, time constraints, discomfort with sensitive questions, and insufficient support for patients requiring assistance to complete questionnaires.

This study evaluates a community-engaged approach to improving the reach and completeness of sociodemographic data collection in primary care. The intervention introduces a Community Health Surveyor (CHS) role designed to proactively engage patients and support questionnaire completion, with a particular focus on individuals who may be less likely to participate through standard approaches.

The trial uses a parallel-group randomized design to compare usual care data collection practices with an enhanced model that includes CHS support. In usual care, patients are invited to complete the HEQ through existing clinic workflows, including electronic invitations linked to appointment reminders, in-person administration during clinic visits, or optional assistance from a virtual surveyor available by appointment. These approaches rely primarily on patient-initiated participation or time-limited interactions with clinic staff.

In the intervention arm, the CHS supplements usual care by proactively reaching out to patients to invite participation and facilitate questionnaire completion. The CHS is embedded within the clinical team and has experience in community-based health engagement. The role includes multiple contact attempts and flexible modes of administration, including telephone, in-clinic, or community-based completion, depending on patient preference. The CHS provides guided support throughout the questionnaire, including reading questions aloud, clarifying content, and facilitating completion in a manner that is responsive to patient needs. Language interpretation services are available to support participation in languages other than English.

The intervention is designed to address known barriers to participation by increasing accessibility, reducing reliance on digital tools, and providing individualized support from a trained staff member with relevant community experience. By incorporating proactive outreach and flexible delivery, the CHS model aims to improve engagement among patients who are less likely to complete sociodemographic surveys through standard clinic processes.

The study assesses whether this approach improves overall questionnaire completion and enhances representation of patients with unmet social needs or characteristics associated with barriers to care. Findings from this study will inform strategies for integrating equity-oriented data collection into routine primary care practice.

• Study Type: Interventional
• Enrollment (Actual): 760
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Unity Health Toronto

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults aged 18 years or older
• Registered patients of participating St. Michael's Hospital Academic Family Health Team (SMHAFHT) primary care sites
• Did not complete the Health Equity Questionnaire atthe time of study identification
• Classified as Hard-to-Reach (HTR), defined as meeting at least one of the following criteria based on electronic medical record (EMR) data: Residence in a lower-income area (priority postal code) or documented housing instability (no fixed address) AND at least one vulnerability indicator, including: No email address on file; Receipt of Ontario Works or Ontario Disability Support Program benefits (based on administrative/billing data within the past 5 years); EMR-identified priority population status, including gender diverse identity, severe mental illness (e.g., schizophrenia or bipolar disorder), or developmental disability

Exclusion Criteria:

• Age under 18 years
• Prior completion of the Health Equity Questionnaire (HEQ) before eligibility determination
• Not included in the St. Michael's Hospital Academic Family Health Team (SMHAFHT) electronic medical record patient population at the time of eligibility identification

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Arm; Participants in the usual care arm received standard Health Equity Questionnaire (HEQ) completion processes used in routine primary care practice. Patients were invited to complete the questionnaire through existing clinic workflows, including electronic invitations linked to appointment reminders, in-person completion during clinic visits with administrative or clinical staff, or optional assistance from a virtual surveyor available by phone upon patient request. The virtual surveyor provided standardized support but did not proactively contact patients and was not specifically trained or embedded as part of the intervention model. Usual care did not include proactive outreach or additional facilitation from a Community Health Surveyor
Experimental: Community health surveyor-assisted health equity questionnaire completion; A community health surveyor will proactively contact participants to complete the Health Equity Survey. They will provide support by reading items aloud, clarifying questions as needed, and facilitating responses, with access to interpretation services when required. In this group, participants will be able to complete the survey over the phone, in clinic, or in a community setting based on their preference.	Behavioral: Community health surveyor; Participants in the intervention arm received usual care for Health Equity Questionnaire (HEQ) completion plus additional support from a Community Health Surveyor (CHS). The CHS proactively contacted participants by telephone (up to three attempts) to invite them to complete the HEQ and provided assistance with questionnaire completion if the participant agreed. Participants could complete the HEQ by phone, in clinic, or in a community setting based on their preference. The CHS guided participants through the questionnaire by reading items aloud, clarifying questions as needed, and facilitating responses, with access to interpretation services when required. This arm was designed to evaluate whether proactive outreach and assisted completion improves HEQ completion rates compared with usual care alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HEQ Completion Rate Among Participants in Intervention and Usual Care Arms	The primary outcome is the proportion of participants who complete the Health Equity Questionnaire (HEQ) in each study arm. Completion is defined as providing a response to all questionnaire items, including selection of "prefer not to answer" where applicable. The outcome will be compared between participants receiving the Community Health Surveyor intervention and those receiving usual care. HEQ completion is assessed using clinic electronic records documenting questionnaire completion status.	From participant assignment to study arms until the end of the intervention period (approximately 6 months), from October 11, 2024 to April 18, 2025.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HEQ Completion Among Participants With Need-Relevant Characteristics	HEQ completion rates among participants reporting need-relevant characteristics captured through the Health Equity Questionnaire (HEQ), including financial constraints, recent immigration to Canada (within five years), primary language other than English, and disability requiring accommodation. Completion rates are compared between intervention and usual care groups.	From participant assignment to study arms until the end of the intervention period (approximately 6 months), from October 11, 2024 to April 18, 2025.

Collaborators and Investigators

• Sponsor: Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2024
• Primary Completion (Actual): April 18, 2025
• Study Completion (Actual): April 18, 2025

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Health Equity; Sociodemographic Data Collection; Primary Care Engagement; social needs screening; community-based outreach; hard-to-reach populations
• Other Study ID Numbers: 24-026

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