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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 (PCORI-SOGI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03554785
Recruitment Status : Active, not recruiting
First Posted : June 13, 2018
Last Update Posted : August 30, 2022
Sponsor:
Collaborators:
OCHIN, Inc.
AllianceChicago
Association of Asian Pacific Community Health Organizations
Beaufort Jasper Hampton Comprehensive Health Services
Kaiser Permanente
Patient-Centered Outcomes Research Institute
Piedmont Healthcare
Howard Brown Health Center
Heartland Alliance
Near North Health Service Corporation
Legacy Health System
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
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health

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
LGBT Health Cultural Competency Education Sexual Orientation Gender Identity Behavioral: Clinician and Non-clinician staff training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 1, 2018
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: LGBTQ+ Health

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.




Primary Outcome Measures :
  1. Sexual Orientation and Gender Identity (SOGI) status [ Time Frame: 24 month follow up period ]
    % of patients at CHC with SOGI status documented

  2. Behavioral Health and Substance Use Assessment [ Time Frame: 24 month follow up period ]
    Documentation of PHQ9

  3. Behavioral Health and Substance Use Assessment [ Time Frame: 24 month follow up period ]
    Documentation of AUDIT

  4. Behavioral Health and Substance Use Assessment [ Time Frame: 24 month follow up period ]
    Documentation of tobacco status

  5. Vital Sign [ Time Frame: 24 month follow up period ]
    Documentation of weight or BMI

  6. Vaccination [ Time Frame: 24 month follow up period ]
    Documentation of Hepatitis A vaccination

  7. Vaccination [ Time Frame: 24 month follow up period ]
    Documentation of Hepatitis B vaccination

  8. Mammography [ Time Frame: 24 month follow up period ]
    Documentation of mammogram

  9. Cervical PAP [ Time Frame: 24 month follow up period ]
    Documentation of PAP


Secondary Outcome Measures :
  1. Behavioral health referral, if problem identified [ Time Frame: 24 month follow up period ]
    Documentation of referral among those where a behavioral health problem is identified

  2. Tobacco counselling referral, if smoker [ Time Frame: 24 month follow up period ]
    Documentation of referral among current smokers

  3. Weight control referral, if problem identified [ Time Frame: 24 month follow up period ]
    Documentation of referral among those where a weight problem is identified

  4. HIV screening [ Time Frame: 24 month follow up period ]
    % of patients at CHC with HIV screening

  5. Bacterial STI screening [ Time Frame: 24 month follow up period ]
    % of patients at CHC with STI screening

  6. Anal cancer [ Time Frame: 24 month follow up period ]
    % of patients at CHC with anal PAP screening


Other Outcome Measures:
  1. Patient satisfaction rates [ Time Frame: 39 month study period ]
    Measured through pre- and post-intervention patient web surveys

  2. Patient service utilization [ Time Frame: 24 month follow up period ]
    Measured through annual data reports from participating sites



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554785


Locations
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United States, Massachusetts
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 Healthcare
Howard Brown Health Center
Heartland Alliance
Near North Health Service Corporation
Legacy Health System
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
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Principal Investigator: Kenneth Mayer, MD Fenway Community Health Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: June 13, 2018    Key Record Dates
Last Update Posted: August 30, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No