Trial Title:
Sexual Orientation and Gender Identity (SOGI) Data Collection Program Implementation and Evaluation
NCT ID:
NCT05845476
Condition:
Cancer Surveillance
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Patient SOGI Self-Report
Description:
EPIC® MyChart electronic health records messages will go to OSUCCC patients of pilot
clinics who have incomplete SOGI data in their record and are enrolled in OSU MyChart.
The message will request that patients complete SOGI data fields, with an explanation
about why it is important for their health care, as well as links to document this
information in their electronic health record (EHR).
Intervention Description:
EPIC® MyChart EHR messages will go to OSUCCC patients of pilot clinics who have
incomplete SOGI data in their record and are enrolled in OSU MyChart. The message will
request that patients complete SOGI data fields, with an explanation about why it is
important for their health care, as well as links to document this information in their
electronic health record.
Arm group label:
SOGI Data Collection Intervention
Intervention type:
Other
Intervention name:
SOGI Resource for Clinical Care Education (SORCE)
Description:
SOGI Resource for Clinical Care Education (SORCE) training includes cultural competency
and health education. SORCE training has been used on a smaller scale for two years at
the OSUCCC-James, receiving excellent scores for presentation quality, knowledge gained,
and presenter expertise. For the present study, SORCE training will be tailored based on
results from Aim 1. The training curriculum includes didactic content (basics of the
LGBTQ+ community, SOGI data collection for patient care and research, and social
determinants of health for the LGBT community, 15 minutes), EHR SOGI data documentation
demonstration (10 minutes), and open dialogue and role play (20 minutes). Trainees will
be given EHR documentation tip sheets and laminated pocket cards with best practices for
asking about SOGI, steps for documenting in the EHR, and additional resources.
Arm group label:
SOGI Data Collection Intervention
Intervention type:
Other
Intervention name:
Cancer Center Care Environment
Description:
At the level of the OSUCCC, to include all inpatient and ambulatory spaces, the
investigators will implement important measures aimed at changing culture and practice.
This includes modification of policy and the EHR for SOGI documentation per National
Academy of Science Engineering and Medicine recommendations, a multi-pronged approach to
making the environment of care more visibly welcoming for SGM people, and leveraging
existing diversity, equity, and inclusion structures and initiatives to shift culture at
the cancer center.
Arm group label:
SOGI Data Collection Intervention
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Start date:
March 14, 2023
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05845476
http://cancer.osu.edu
