Clinical trial NCT03554785: Comparative Effectiveness Research to Improve the Health of Sexual and Gender Minority Patients Through Cultural Competence and Skill Training of Community Health Center Providers and Non-clinical Staff
Official title: Comparative Effectiveness Research to Improve the Health of Sexual and Gender Minority Patients Through Cultural Competence and Skill Training of Community Health Center Providers and Non-clinical Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LGBT Health
Cultural Competency
Education
Sexual Orientation
Gender Identity
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
Collaborators: name: OCHIN, Inc.
name: AllianceChicago
name: Association of Asian Pacific Community Health Organizations
name: Beaufort Jasper Hampton Comprehensive Health Services
name: Kaiser Permanente
name: Patient-Centered Outcomes Research Institute
name: Piedmont Healthcare
name: Howard Brown Health Center
name: Heartland Alliance
name: Near North Health Service Corporation
name: Legacy Health System
name: Campus Health Center - Wayne State University (Nursing Practice Corporation)
name: Eureka Community Health & Wellness Center
name: Winding Waters Clinic
name: CHARLES B WANG COMMUNITY HEALTH CENTER
name: Waimanalo Health Center
First posted: 2018-06-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary goal of this PCORI proposal is to evaluate the impact of enhanced provider and clinical staff training to address the health disparities of SGM CHC patients to ultimately improve their health outcomes because CHCs are a key part of the U.S. health care delivery system for underserved populations. The current application proposes to test an intervention designed to understand how CHCs, including front line staff and safety net clinical providers, can identify and provide optimal care for their SGM patients, and will determine whether enhanced training of CHC staff in best practices for the provision of primary care for SGM patients will improve their clinical outcomes. The time is right for routinization of SOGI measures in EHRs and evaluation of the optimal methods to train primary care providers in the best practices for the care of SGM patients.

Detailed description: This project will work with 12 community health centers across the country that are part of and extended from the HRSA-established Community Health Applied Research Network (CHARN) to determine the optimal way to train CHC staff in the collection of SOGI data, and will evaluate the impact of enhanced SOGI data collection on health outcomes for LGBT patients. The project will build on more than six years of collaborations of a network of safety-net CHCs, including patient investigators from the inception of the project, with a plan for ongoing local patient engagement. Aim 1: Conduct interviews with patient and clinical stakeholders regarding how SOGI data are being used to inform patient care, and how they feel SOGI data should best be collected and utilized. Aim 2: Educate providers in culturally competent patient-centered care with sexual and gender minority populations. Aim 3: Compare the effect of a SOGI educational training program to usual practice on SOGI documentation rates and appropriate screening rates for LGBT patients.

The project will determine the optimal way to train CHC staff in the collection of SOGI data, and will evaluate the impact of enhanced SOGI data collection on health outcomes for LGBT patients. The project team proposes a study design that is commonly employed to examine changes in outcomes (e.g., screening rates) across time, comparing rates prior to and after the educational training intervention. The project will measure the impact of changes to practice and to patient outcomes (e.g., depression screening, appropriate use of mammography and HPV screening for lesbians and transgender women), as well as patient satisfaction.

Results of this study would be the first of their kind to evaluate the impact of a series of educational programs on the healthcare outcomes of LGBT patients and could provide a replicable patient-centered model for routinely collecting and documenting sexual and gender minority information at CHCs and improving provider competence in care. Ultimately, the study has strong potential for improving the quality of care for sexual and gender minorities and reducing health disparities.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Clinical staff or patient at participating clinical site (for staff interviews and web surveys)
* English speakers

Exclusion Criteria:

* Does not meet the inclusion criteria above

Primary outcomes:
measure: Sexual Orientation and Gender Identity (SOGI) status
timeFrame: 24 month follow up period
measure: Behavioral Health and Substance Use Assessment
timeFrame: 24 month follow up period
measure: Behavioral Health and Substance Use Assessment
timeFrame: 24 month follow up period
measure: Behavioral Health and Substance Use Assessment
timeFrame: 24 month follow up period
measure: Vital Sign
timeFrame: 24 month follow up period
measure: Vaccination
timeFrame: 24 month follow up period
measure: Vaccination
timeFrame: 24 month follow up period
measure: Mammography
timeFrame: 24 month follow up period
measure: Cervical PAP
timeFrame: 24 month follow up period
Secondary outcomes:
measure: Behavioral health referral, if problem identified
timeFrame: 24 month follow up period
measure: Tobacco counselling referral, if smoker
timeFrame: 24 month follow up period
measure: Weight control referral, if problem identified
timeFrame: 24 month follow up period
measure: HIV screening
timeFrame: 24 month follow up period
measure: Bacterial STI screening
timeFrame: 24 month follow up period
measure: Anal cancer
timeFrame: 24 month follow up period
Other outcomes:
measure: Patient satisfaction rates
timeFrame: 39 month study period
measure: Patient service utilization
timeFrame: 24 month follow up period
Locations:
city: Boston
country: United States
facility: Fenway Community Health Cetner
state: Massachusetts
Study officials:
affiliation: Fenway Community Health Center
name: Kenneth Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayer KH, Peretti M, McBurnie MA, King D, Smith NX, Crawford P, Loo S, Sigal M, Gillespie S, Cahill S, Keuroghlian AS, Grasso C. Wide Variability in Documentation of Sexual Orientation, Gender Identity, and Preventive Health Screenings in a Diverse Sample of U.S. Community Health Centers. LGBT Health. 2022 Nov;9(8):571-581. doi: 10.1089/lgbt.2021.0362. Epub 2022 Jun 30.