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 (PCORI-SOGI)

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.

Study Overview

• Status: Completed
• Conditions: Education; Gender Identity; Sexual Orientation; LGBT Health; Cultural Competency
• Intervention / Treatment: Behavioral: Clinician and Non-clinician staff training

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Fenway Community Health Cetner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control/Usual Care; Readiness Assessment (web survey for CHC leadership and providers); Patient web surveys (10 total per site; 5 SGM and 5 cisgendered); Option to view 60 minute online webinar "Do Ask, Do Tell: Collecting Data on Sexual Orientation and Gender Identity at Health Centers"
Active Comparator: Intervention; Readiness Assessment (web survey for CHC leadership and providers); Patient web surveys (10 total per site; 5 SGM and 5 cisgendered); CHC staff leadership key informant interviews (up to 5 at each site); Tailored Educational Clinician and Non-clinician staff training intervention and technical assistance follow-up	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Orientation and Gender Identity (SOGI) status	% of patients at CHC with SOGI status documented	24 month follow up period
Behavioral Health and Substance Use Assessment	Documentation of PHQ9	24 month follow up period
Behavioral Health and Substance Use Assessment	Documentation of AUDIT	24 month follow up period
Behavioral Health and Substance Use Assessment	Documentation of tobacco status	24 month follow up period
Vital Sign	Documentation of weight or BMI	24 month follow up period
Vaccination	Documentation of Hepatitis A vaccination	24 month follow up period
Vaccination	Documentation of Hepatitis B vaccination	24 month follow up period
Mammography	Documentation of mammogram	24 month follow up period
Cervical PAP	Documentation of PAP	24 month follow up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral health referral, if problem identified	Documentation of referral among those where a behavioral health problem is identified	24 month follow up period
Tobacco counselling referral, if smoker	Documentation of referral among current smokers	24 month follow up period
Weight control referral, if problem identified	Documentation of referral among those where a weight problem is identified	24 month follow up period
HIV screening	% of patients at CHC with HIV screening	24 month follow up period
Bacterial STI screening	% of patients at CHC with STI screening	24 month follow up period
Anal cancer	% of patients at CHC with anal PAP screening	24 month follow up period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction rates	Measured through pre- and post-intervention patient web surveys	39 month study period
Patient service utilization	Measured through annual data reports from participating sites	24 month follow up period

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 6271

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No