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Clinical Trials/NCT03554785
NCT03554785
Completed
Not Applicable

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

Fenway Community Health1 site in 1 country12 target enrollmentMarch 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
LGBT Health
Sponsor
Fenway Community Health
Enrollment
12
Locations
1
Primary Endpoint
Mammography
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
May 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fenway Community Health
Responsible Party
Principal Investigator
Principal Investigator

Kenneth H. Mayer, MD

Co-Chair and Medical Research Director

Fenway Community Health

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

Outcomes

Primary Outcomes

Mammography

Time Frame: 24 month follow up period

Documentation of mammogram

Sexual Orientation and Gender Identity (SOGI) status

Time Frame: 24 month follow up period

% of patients at CHC with SOGI status documented

Behavioral Health and Substance Use Assessment

Time Frame: 24 month follow up period

Documentation of tobacco status

Vital Sign

Time Frame: 24 month follow up period

Documentation of weight or BMI

Vaccination

Time Frame: 24 month follow up period

Documentation of Hepatitis B vaccination

Cervical PAP

Time Frame: 24 month follow up period

Documentation of PAP

Secondary Outcomes

  • Weight control referral, if problem identified(24 month follow up period)
  • HIV screening(24 month follow up period)
  • Bacterial STI screening(24 month follow up period)
  • Anal cancer(24 month follow up period)
  • Tobacco counselling referral, if smoker(24 month follow up period)
  • Behavioral health referral, if problem identified(24 month follow up period)

Study Sites (1)

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