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Completed

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fenway Community Health Cetner

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinician and Non-clinician staff training

Behavioral

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.

Primary outcomes

  1. Sexual Orientation and Gender Identity (SOGI) status

    Time frame: 24 month follow up period

    % of patients at CHC with SOGI status documented

  2. Behavioral Health and Substance Use Assessment

    Time frame: 24 month follow up period

    Documentation of PHQ9

  3. Behavioral Health and Substance Use Assessment

    Time frame: 24 month follow up period

    Documentation of AUDIT

  4. Behavioral Health and Substance Use Assessment

    Time frame: 24 month follow up period

    Documentation of tobacco status

  5. Vital Sign

    Time frame: 24 month follow up period

    Documentation of weight or BMI

  6. Vaccination

    Time frame: 24 month follow up period

    Documentation of Hepatitis A vaccination

  7. Vaccination

    Time frame: 24 month follow up period

    Documentation of Hepatitis B vaccination

  8. Mammography

    Time frame: 24 month follow up period

    Documentation of mammogram

  9. Cervical PAP

    Time frame: 24 month follow up period

    Documentation of PAP

Secondary outcomes

  1. Behavioral health referral, if problem identified

    Time frame: 24 month follow up period

    Documentation of referral among those where a behavioral health problem is identified

  2. Tobacco counselling referral, if smoker

    Time frame: 24 month follow up period

    Documentation of referral among current smokers

  3. Weight control referral, if problem identified

    Time frame: 24 month follow up period

    Documentation of referral among those where a weight problem is identified

  4. HIV screening

    Time frame: 24 month follow up period

    % of patients at CHC with HIV screening

  5. Bacterial STI screening

    Time frame: 24 month follow up period

    % of patients at CHC with STI screening

  6. Anal cancer

    Time frame: 24 month follow up period

    % of patients at CHC with anal PAP screening

Other outcomes

  1. Patient satisfaction rates

    Time frame: 39 month study period

    Measured through pre- and post-intervention patient web surveys

  2. Patient service utilization

    Time frame: 24 month follow up period

    Measured through annual data reports from participating sites

Sponsors and collaborators

Lead sponsor

Fenway Community Health

Other

Collaborators

  • AllianceChicago
  • Association of Asian Pacific Community Health Organizations
  • Beaufort Jasper Hampton Comprehensive Health Services
  • CHARLES B WANG COMMUNITY HEALTH CENTER
  • Campus Health Center - Wayne State University (Nursing Practice Corporation)
  • 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

Registry information

Acronym: PCORI-SOGI

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jun 13, 2018
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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