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

Education Clinical Trial

— PCORI-SOGI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554785
• Other study ID #: 6271
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: August 2023
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 31, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cultural Competency
• Education
• Gender Identity
• LGBT Health
• Sexual Orientation

Intervention

Behavioral:
• Clinician and Non-clinician staff training
An optimized training program for non-clinical staff, clinicians and administrators developed by TFI's National LGBT Health Education Center that will include content-specific webinars and "Office Hours" for specific CHC consultations to optimize the provision of SGM health services at each CHC and to foster the development of in-house expertise to sustain ongoing training and quality improvement in the provision of care for LGBT patients.

Locations

Country	Name	City	State
United States	Fenway Community Health Cetner	Boston	Massachusetts

Sponsors (17)

Lead Sponsor

Collaborator

Fenway Community Health

AllianceChicago, Association of Asian Pacific Community Health Organizations, Beaufort Jasper Hampton Comprehensive Health Services, Campus Health Center - Wayne State University (Nursing Practice Corporation), CHARLES B WANG COMMUNITY HEALTH CENTER, Eureka Community Health & Wellness Center, Heartland Alliance, Howard Brown Health Center, Kaiser Permanente, Legacy Health System, Near North Health Service Corporation, OCHIN, Inc., Patient-Centered Outcomes Research Institute, Piedmont Healthcare, Waimanalo Health Center, Winding Waters Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction rates	Measured through pre- and post-intervention patient web surveys	39 month study period
Other	Patient service utilization	Measured through annual data reports from participating sites	24 month follow up period
Primary	Sexual Orientation and Gender Identity (SOGI) status	% of patients at CHC with SOGI status documented	24 month follow up period
Primary	Behavioral Health and Substance Use Assessment	Documentation of PHQ9	24 month follow up period
Primary	Behavioral Health and Substance Use Assessment	Documentation of AUDIT	24 month follow up period
Primary	Behavioral Health and Substance Use Assessment	Documentation of tobacco status	24 month follow up period
Primary	Vital Sign	Documentation of weight or BMI	24 month follow up period
Primary	Vaccination	Documentation of Hepatitis A vaccination	24 month follow up period
Primary	Vaccination	Documentation of Hepatitis B vaccination	24 month follow up period
Primary	Mammography	Documentation of mammogram	24 month follow up period
Primary	Cervical PAP	Documentation of PAP	24 month follow up period
Secondary	Behavioral health referral, if problem identified	Documentation of referral among those where a behavioral health problem is identified	24 month follow up period
Secondary	Tobacco counselling referral, if smoker	Documentation of referral among current smokers	24 month follow up period
Secondary	Weight control referral, if problem identified	Documentation of referral among those where a weight problem is identified	24 month follow up period
Secondary	HIV screening	% of patients at CHC with HIV screening	24 month follow up period
Secondary	Bacterial STI screening	% of patients at CHC with STI screening	24 month follow up period
Secondary	Anal cancer	% of patients at CHC with anal PAP screening	24 month follow up period