Clinical trial NCT05845476: Sexual Orientation and Gender Identity (SOGI) Data Collection Program Implementation and Evaluation
Official title: Sexual Orientation and Gender Identity (SOGI) Data Collection Program Implementation and Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Surveillance
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * SGM community groups and OSUCCC-James patient advocacy group for feedback on best practices from collecting SOGI data
* OSUWMC Staff/Faculty: Recruit faculty and staff through the directories at the 3 pilot test clinic sites (thoracic clinic, breast-surgical oncology clinic, and hematology lymphoma clinic) to integrate SOGI data collection into clinical workflows. Faculty and staff will be recruited via meeting announcements and emails.

Participants will be JPAS and clinical staff from ambulatory departments at the 3 pilot clinics responsible for collecting SOGI data from OSUCCC-James patients. Ambulatory faculty and staff responsible for SOGI data collection will be systematically trained and begin data collection as part of their routine job responsibilities.

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.

Eligibility criteria: Inclusion Criteria:

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

1. Language or technology barriers that limit data collection
2. Insufficient evidence of meeting inclusion criteria

Primary outcomes:
measure: Sexual Orientation Documentation
timeFrame: Baseline (prior to intervention)
measure: Sexual Orientation Documentation
timeFrame: 1 month post intervention
measure: Sexual Orientation Documentation
timeFrame: 2 months post intervention
measure: Sexual Orientation Documentation
timeFrame: 3 months post intervention
measure: Sexual Orientation Documentation
timeFrame: 4 months post intervention
measure: Sexual Orientation Documentation
timeFrame: 5 months post intervention
measure: Sexual Orientation Documentation
timeFrame: 6 months post intervention
measure: Gender Identity Documentation
timeFrame: Baseline (prior to intervention)
measure: Gender Identity Documentation
timeFrame: 1 month post intervention
measure: Gender Identity Documentation
timeFrame: 2 months post intervention
measure: Gender Identity Documentation
timeFrame: 3 months post intervention
measure: Gender Identity Documentation
timeFrame: 4 months post intervention
measure: Gender Identity Documentation
timeFrame: 5 months post intervention
measure: Gender Identity Documentation
timeFrame: 6 months post intervention
measure: Clinics with Staff/Provider Training Completed
timeFrame: Baseline (prior to intervention)
measure: Clinics with Staff/Provider Training Completed
timeFrame: 1 month post intervention
measure: Clinics with Staff/Provider Training Completed
timeFrame: 2 months post intervention
measure: Clinics with Staff/Provider Training Completed
timeFrame: 3 months post intervention
measure: Clinics with Staff/Provider Training Completed
timeFrame: 4 months post intervention
measure: Clinics with Staff/Provider Training Completed
timeFrame: 5 months post intervention
measure: Clinics with Staff/Provider Training Completed
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Staff and Provider Implementation Survey
timeFrame: Baseline (prior to intervention)
measure: Staff and Provider Implementation Survey
timeFrame: Immediately post intervention
measure: Staff and Provider Implementation Survey
timeFrame: Month 6 post intervention
measure: Patient Experience Data
timeFrame: Baseline (prior to intervention)
measure: Patient Experience Data
timeFrame: 3 months post intervention
measure: Patient Experience Data
timeFrame: 6 months post intervention
measure: Environmental Scan Checklist
timeFrame: Baseline (prior to intervention)
measure: Environmental Scan Checklist
timeFrame: 6 months post intervention
measure: Clinical Cancer-Related Outcomes
timeFrame: 12-month project completion
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Ohio State University Comprehensive Cancer Center
name: Elizabeth Arthur, PhD
role: PRINCIPAL_INVESTIGATOR
References: