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

NCT07550101 | Completed

• 1 other identifier: 24-026
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Social Determinants of Health; Healthcare Disparities; Health Equity; Primary Health Care

Keywords

Sociodemographic Data Collection; Health Equity; Primary Care Engagement; social needs screening; community-based outreach; hard-to-reach populations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• HEQ Completion Among Participants With Need-Relevant Characteristics

  From participant assignment to study arms until the end of the intervention period (approximately 6 months), from October 11, 2024 to April 18, 2025.

Study Arms (2)

Usual Care Arm

NO INTERVENTION

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

Community health surveyor-assisted health equity questionnaire completion

EXPERIMENTAL

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

Interventions

Community health surveyor BEHAVIORAL

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.

Community health surveyor-assisted health equity questionnaire completion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No additional masking beyond the standard roles was implemented in this study. The trial was open-label, and participants, care providers, intervention staff, and outcome assessors were aware of group allocation. The virtual surveyor providing usual care support was not informed of participants' study group assignment when contacted by patients.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a parallel-group randomized controlled trial conducted in a primary care setting in which eligible participants are randomized in a 1:1 ratio to either usual care or an intervention group using a computer-generated allocation sequence. Participants in the control group receive standard questionnaire invitation methods used in routine practice, while those in the intervention group receive usual care plus proactive outreach and survey administration support from a Community Health Surveyor (CHS).

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 24, 2026
• Study Start: October 11, 2024
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)