PCORI-SOGI: 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

Sponsor
Fenway Community Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03554785
Collaborator
OCHIN, Inc. (Other), AllianceChicago (Other), Association of Asian Pacific Community Health Organizations (Other), Beaufort Jasper Hampton Comprehensive Health Services (Other), Kaiser Permanente (Other), Patient-Centered Outcomes Research Institute (Other), Piedmont Health (Other), Howard Brown Health Center (Other), Heartland Alliance Health (Other), Near North Health Service Corporation (Other), Legacy Community Health (Other), Campus Health Center - Wayne State University (Nursing Practice Corporation) (Other), Eureka Community Health & Wellness Center (Other), Winding Waters Clinic (Other), CHARLES B WANG COMMUNITY HEALTH CENTER (Other), Waimanalo Health Center (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Clinician and Non-clinician staff training
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
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
Actual Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 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"

Active Comparator: 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

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.

Outcome Measures

Primary Outcome Measures

  1. Sexual Orientation and Gender Identity (SOGI) status [24 month follow up period]

    % of patients at CHC with SOGI status documented

  2. Behavioral Health and Substance Use Assessment [24 month follow up period]

    Documentation of PHQ9

  3. Behavioral Health and Substance Use Assessment [24 month follow up period]

    Documentation of AUDIT

  4. Behavioral Health and Substance Use Assessment [24 month follow up period]

    Documentation of tobacco status

  5. Vital Sign [24 month follow up period]

    Documentation of weight or BMI

  6. Vaccination [24 month follow up period]

    Documentation of Hepatitis A vaccination

  7. Vaccination [24 month follow up period]

    Documentation of Hepatitis B vaccination

  8. Mammography [24 month follow up period]

    Documentation of mammogram

  9. Cervical PAP [24 month follow up period]

    Documentation of PAP

Secondary Outcome Measures

  1. Behavioral health referral, if problem identified [24 month follow up period]

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

  2. Tobacco counselling referral, if smoker [24 month follow up period]

    Documentation of referral among current smokers

  3. Weight control referral, if problem identified [24 month follow up period]

    Documentation of referral among those where a weight problem is identified

  4. HIV screening [24 month follow up period]

    % of patients at CHC with HIV screening

  5. Bacterial STI screening [24 month follow up period]

    % of patients at CHC with STI screening

  6. Anal cancer [24 month follow up period]

    % of patients at CHC with anal PAP screening

Other Outcome Measures

  1. Patient satisfaction rates [39 month study period]

    Measured through pre- and post-intervention patient web surveys

  2. Patient service utilization [24 month follow up period]

    Measured through annual data reports from participating sites

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fenway Community Health Cetner Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Fenway Community Health
  • OCHIN, Inc.
  • AllianceChicago
  • Association of Asian Pacific Community Health Organizations
  • Beaufort Jasper Hampton Comprehensive Health Services
  • Kaiser Permanente
  • Patient-Centered Outcomes Research Institute
  • Piedmont Health
  • Howard Brown Health Center
  • Heartland Alliance Health
  • Near North Health Service Corporation
  • Legacy Community Health
  • Campus Health Center - Wayne State University (Nursing Practice Corporation)
  • Eureka Community Health & Wellness Center
  • Winding Waters Clinic
  • CHARLES B WANG COMMUNITY HEALTH CENTER
  • Waimanalo Health Center

Investigators

  • Principal Investigator: Kenneth Mayer, MD, Fenway Community Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kenneth H. Mayer, MD, Co-Chair and Medical Research Director, Fenway Community Health
ClinicalTrials.gov Identifier:
NCT03554785
Other Study ID Numbers:
  • 6271
First Posted:
Jun 13, 2018
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 11, 2021