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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03554785
Other study ID # 6271
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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