Sexual Orientation and Gender Identity (SOGI) Data Collection Program Implementation and Evaluation
- Conditions
- Cancer Surveillance
- Interventions
- Other: Patient SOGI Self-ReportOther: SOGI Resource for Clinical Care Education (SORCE)Other: Cancer Center Care Environment
- Registration Number
- NCT05845476
- Brief Summary
Sexual and gender minority (SGM) individuals experience significant cancer-related health disparities across the cancer continuum. The overall goal of this proposal is to assess multi-level barriers associated with sexual orientation and gender identity (SOGI) data collection in the health record as well as implementation factors including feasibility, acceptability, and data completeness. The results of this study will make a significant impact by making SOGI data available for research, addressing barriers to SOGI data collection in a large comprehensive cancer center, and informing compassionate cancer care for SGM people.
- Detailed Description
Sex and gender minority people (SGM, i.e., lesbian, gay, bisexual, transgender, queer, and other people of diverse sexual orientation or gender identity (SOGI) experience significant cancer-related health disparities across the cancer continuum. SGM people have an increased risk for some cancers, may be diagnosed at more advanced stages of the disease, and have poor mental health outcomes. Despite calls from national organizations for systematic collection of SOGI data, this information is not routinely collected in health research or clinical health records, perpetuating the invisibility of SGM people in research and clinical care and fueling health disparities. Systematic and standardized collection of SOGI data is necessary for assessing cancer-related health outcomes through cancer registries, for comparing outcomes and care delivery in clinical trials, and for providing culturally relevant care for SGM people. Barriers to systematic SOGI data collection come from patient, clinician, and system levels. Multilevel barriers to SOGI data collection require a multilevel approach to create standardized, systematic program implementation and evaluation at cancer centers across the country. Barriers and best practices for SOGI data collection likely differ by region and institutional history and culture. Ohio is traditionally a conservative 'red' state, with large rural and Appalachian regions. The catchment area for The Ohio State University Comprehensive Cancer Center (OSUCCC) encompasses Ohio's 88 counties and nearly 11.8 million people -- many of whom come from diverse, and often underserved, populations including urban, rural, Appalachia, immigrant, Amish, and SGM communities. Thus, OSUCCC is well-positioned to make a significant impact in the health of SGM Ohioans through systematic SOGI data collection and improved SGM-sensitive clinical care and culture. The overall goal of this Administrative Supplement is to assess multi-level barriers associated with SOGI data collection as well as implementation factors including feasibility, acceptability, and data completeness. To accomplish this goal, the investigators propose two aims. First, the investigators will develop effective strategies to collect SOGI data based on barriers and facilitators identified at the patient, staff/provider, and cancer center levels. The investigators will accomplish this through community and patient focus groups, staff/provider interviews, and a cancer center environmental scan. Second, the investigators will implement a systematic SOGI data collection program at the patient, staff/provider, and cancer center levels with systematic program evaluation at all levels. The investigators will accomplish this through patient self-report, staff/provider training, and changes in cancer center medical record, policy, and environment of care. This proposal is innovative because our SOGI data collection program operates at multiple levels within the healthcare delivery context and includes both central medical campuses and satellite clinics. The results of this study will make a significant impact by 1) making SOGI data available for cancer registries, 2) addressing factors associated with implementation in a large comprehensive cancer center, and 3) informing culturally responsive cancer care for SGM Ohioans.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Aim 1
- Community group members that represent sex and gender minority (SGM) people
- Cisgender/ heterosexual patients and family members
- Ambulatory clinic provider and staff responsible for collecting sexual orientation and gender identity (SOGI) data
- Age ≥18 years at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Able to provide informed consent
- Able to read and speak English
Aim 2
- Ambulatory clinic providers and staff responsible for collecting sexual orientation and gender identity (SOGI) data
- Age ≥18 years at the time of signing the informed consent form
- Able to adhere to the study visit schedule and other protocol requirements
- Able to provide informed consent
- Able to read and speak English
Exclusion Criteria
- Language or technology barriers that limit data collection
- Insufficient evidence of meeting inclusion criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SOGI Data Collection Intervention Patient SOGI Self-Report This single arm is an educational intervention for clinicians. After consent, they provide baseline survey fata, then the training intervention, then a post assessment. SOGI Data Collection Intervention SOGI Resource for Clinical Care Education (SORCE) This single arm is an educational intervention for clinicians. After consent, they provide baseline survey fata, then the training intervention, then a post assessment. SOGI Data Collection Intervention Cancer Center Care Environment This single arm is an educational intervention for clinicians. After consent, they provide baseline survey fata, then the training intervention, then a post assessment.
- Primary Outcome Measures
Name Time Method Clinics with Staff/Provider Training Completed 6 months post intervention The investigators will record and analyze the count (number of staff, providers, and clinics that have completed the tailored cultural competency and EHR documentation training; SORCE) as well as the percent of staff, providers, and clinics trained out of the total number selected for training and program implementation.
Sexual Orientation Documentation 6 months post intervention This variable is observed from the electronic health record (EHR) and reported in aggregate form. The investigators will record and analyze the count (number of patients with sexual orientation documented), percent of patient records containing this documentation out of the total number of patient records, and completeness of variable fields (count and percent).
Gender Identity Documentation 6 months post intervention This variable is observed from the electronic health record (EHR) and reported in aggregate form. The investigators will record and analyze the count (number of patients with gender identity documented percent of patient records containing this documentation out of the total number of patient records, and completeness of variable fields (count and percent).
- Secondary Outcome Measures
Name Time Method Clinical Cancer-Related Outcomes 12-month project completion From the electronic health record, The investigators will obtain cancer-related health outcome data for SGM people and matched controls (cisgender, heterosexual people) to include vital status, cancer stage and recurrence, second cancers, and mental and physical functioning.
From the electronic health record, The investigators will obtain cancer-related health outcome data for SGM people and matched controls (cisgender, heterosexual people) to include vital status, cancer stage and recurrence, second cancers, and mental and physical functioning.Staff and Provider Implementation Survey Month 6 post intervention The investigators will administer a brief, online survey of trained staff and clinicians evaluating awareness or comfort level with SOGI data collection, workflow integration, and obstacles to implementation.
Environmental Scan Checklist 6 months post intervention Environmental scan checklist includes chart reviews, review of internal documents (e.g. intake forms) and policies, and assessment of the physical environment (e.g. gendered colors or names, presence of gender-neutral restroom, rainbow flag or other sign of safety, gendered waiting rooms) by study staff for identification of the ways the physical and virtual spaces may be unwelcoming to or discriminatory against SGM people
Patient Experience Data 6 months post intervention OSUCCC Patient Experience department provides data on patient concerns (presented at point of care) and complaints (formal and written complaints) by type and frequency. Concerns and complaints specifically related to SOGI data collection or the care of SGM people will be reported.
Trial Locations
- Locations (1)
The Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States