Social Determinants of HealthNCT07550101
Social Equity Data in Primary Care: How Best to Collect Data From Hard-to-Reach Populations
A study testing Community health surveyor in people with Social Determinants of Health and Healthcare Disparities, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Determinants of Health, Healthcare Disparities, Primary Health Care
- What is being tested?
- Community health surveyor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteCanada
- Study dates
- 11 Oct 2024to 18 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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)
Read the 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.
- Being tested
- Community health surveyor
- Keywords
- Sociodemographic Data Collection, Health Equity, Primary Care Engagement, social needs screening, community-based outreach, hard-to-reach populations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community health surveyorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community health surveyor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From participant assignment to study arms until the end of the intervention period (approximately 6 months), from October 11, 2024 to April 18, 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start11 Oct 2024
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Determinants of HealthStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550101
- Sponsor's protocol ID
- 24-026
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 24 Apr 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Equity Data in Primary Care: How Best to Collect Data From Hard-to-Reach Populations - A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07550101
- Acronym / sponsor ID
- 24-026
- Keywords
- Sociodemographic Data Collection, Health Equity, Primary Care Engagement, social needs screening, community-based outreach, hard-to-reach populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 24 Apr 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 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)
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Community health surveyorA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Community health surveyorParticipants 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. | Behavioural | Community health surveyor-assisted health equity questionnaire completion |
Primary outcome
HEQ Completion Rate Among Participants in Intervention and Usual Care Arms
Time frame: From participant assignment to study arms until the end of the intervention period (approximately 6 months), from October 11, 2024 to April 18, 2025.
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.
1 secondary outcome
HEQ Completion Among Participants With Need-Relevant Characteristics
Time frame: From participant assignment to study arms until the end of the intervention period (approximately 6 months), from October 11, 2024 to April 18, 2025.
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 24 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community health surveyor in people with Social Determinants of Health and Healthcare Disparities, 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 4 inclusion and 3 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 24 Apr 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?
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?
HEQ Completion Rate Among Participants in Intervention and Usual Care Arms (time frame: From participant assignment to study arms until the end of the intervention period (approximately 6 months), from October 11, 2024 to April 18, 2025.). 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 24 Apr 2026.