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

NCT ID: NCT03554785

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2023-05-31

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.

Conditions

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LGBT Health Cultural Competency Education Sexual Orientation Gender Identity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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"

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

Clinician and Non-clinician staff training

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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OCHIN, Inc.

OTHER

Sponsor Role collaborator

AllianceChicago

OTHER

Sponsor Role collaborator

Association of Asian Pacific Community Health Organizations

UNKNOWN

Sponsor Role collaborator

Beaufort Jasper Hampton Comprehensive Health Services

UNKNOWN

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Piedmont Healthcare

OTHER

Sponsor Role collaborator

Howard Brown Health Center

OTHER

Sponsor Role collaborator

Heartland Alliance

OTHER

Sponsor Role collaborator

Near North Health Service Corporation

UNKNOWN

Sponsor Role collaborator

Legacy Health System

OTHER

Sponsor Role collaborator

Campus Health Center - Wayne State University (Nursing Practice Corporation)

UNKNOWN

Sponsor Role collaborator

Eureka Community Health & Wellness Center

UNKNOWN

Sponsor Role collaborator

Winding Waters Clinic

UNKNOWN

Sponsor Role collaborator

CHARLES B WANG COMMUNITY HEALTH CENTER

UNKNOWN

Sponsor Role collaborator

Waimanalo Health Center

UNKNOWN

Sponsor Role collaborator

Fenway Community Health

OTHER

Sponsor Role lead

Responsible Party

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Kenneth H. Mayer, MD

Co-Chair and Medical Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

Fenway Community Health Center

Locations

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Fenway Community Health Cetner

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Mayer KH, Peretti M, McBurnie MA, King D, Smith NX, Crawford P, Loo S, Sigal M, Gillespie S, Davis JA, Cahill S, Grasso C, Keuroghlian AS. Training Health Center Staff in the Provision of Culturally Responsive Care for Sexual and Gender Minority Patients: Results of a Randomized Controlled Trial. LGBT Health. 2024 Feb-Mar;11(2):131-142. doi: 10.1089/lgbt.2022.0322. Epub 2023 Dec 5.

Reference Type DERIVED
PMID: 38052073 (View on PubMed)

Loo S, Peretti M, Sigal M, Noe B, Grasso C, Keuroghlian AS, Mayer KH. Health Center Leadership Perspectives Regarding Barriers to and Facilitators of Providing Culturally Responsive Care for Sexual and Gender Minority Patients. LGBT Health. 2023 Jul;10(5):391-400. doi: 10.1089/lgbt.2022.0135. Epub 2023 Feb 21.

Reference Type DERIVED
PMID: 36802213 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35772015 (View on PubMed)

Other Identifiers

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6271

Identifier Type: -

Identifier Source: org_study_id

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