NCT03554785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

4.3 years

First QC Date

May 14, 2018

Last Update Submit

August 23, 2023

Conditions

LGBT HealthCultural CompetencyEducationSexual OrientationGender Identity

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (6)

  • Behavioral health referral, if problem identified

    24 month follow up period

  • Tobacco counselling referral, if smoker

    24 month follow up period

  • 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

  • +1 more secondary outcomes

Other Outcomes (2)

  • Patient satisfaction rates

    39 month study period

  • Patient service utilization

    24 month follow up period

Study Arms (2)

Control/Usual Care

NO INTERVENTION

* 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"

Intervention

ACTIVE COMPARATOR

* 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

Interventions

Clinician and Non-clinician staff trainingBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Clinical staff or patient at participating clinical site (for staff interviews and web surveys)
  • English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fenway Community Health Cetner

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • 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.

    PMID: 38052073DERIVED

  • 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.

    PMID: 36802213DERIVED

  • 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.

    PMID: 35772015DERIVED

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kenneth Mayer, MD

    Fenway Community Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Chair and Medical Research Director

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 13, 2018

Study Start

March 1, 2018

Primary Completion

June 30, 2022

Study Completion

May 31, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

US(1)