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 Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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LGBT Health, Cultural Competency, Education, Sexual Orientation, Gender Identity

Intervention / Treatment
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* Behavioral: Clinician and Non-clinician staff training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control/Usual Care<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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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 |