Social Equity Data in Primary Care: How Best to Collect Data From Hard-to-Reach Populations - A Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 760
- 试验地点
- 1
- 主要终点
- HEQ Completion Rate Among Participants in Intervention and Usual Care Arms
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
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.
干预措施: Community health surveyor (Behavioral)
结局指标
主要结局
HEQ Completion Rate Among Participants in Intervention and Usual Care Arms
时间窗: 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.
次要结局
- 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.)
