LGBT HealthPCORI-SOGINCT03554785
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
A study testing Clinician and Non-clinician staff training in people with LGBT Health and Cultural Competency, run by Fenway Community Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- LGBT Health, Cultural Competency, Education
- What is being tested?
- Clinician and Non-clinician staff training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Clinical staff or patient at participating clinical site (for staff interviews and web surveys)
- English speakers
Who cannot join
- Does not meet the inclusion criteria above
Trial locations and contacts
1 site in 1 country.
United States1 site
Fenway Community Health Cetner
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- LGBT Health, Cultural Competency, Education, Sexual Orientation, Gender Identity
- Being tested
- Clinician and Non-clinician staff training
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician and Non-clinician staff trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Clinician and Non-clinician staff training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Orientation and Gender Identity (SOGI) status
% of patients at CHC with SOGI status documented
Measured: 24 month follow up period
Behavioral Health and Substance Use Assessment
Documentation of PHQ9
Measured: 24 month follow up period
Behavioral Health and Substance Use Assessment
Documentation of AUDIT
Measured: 24 month follow up period
Behavioral Health and Substance Use Assessment
Documentation of tobacco status
Measured: 24 month follow up period
Vital Sign
Documentation of weight or BMI
Measured: 24 month follow up period
Vaccination
Documentation of Hepatitis A vaccination
Measured: 24 month follow up period
Vaccination
Documentation of Hepatitis B vaccination
Measured: 24 month follow up period
Mammography
Documentation of mammogram
Measured: 24 month follow up period
Cervical PAP
Documentation of PAP
Measured: 24 month follow up period
Secondary outcomes (6)
Behavioral health referral, if problem identified
Documentation of referral among those where a behavioral health problem is identified
Measured: 24 month follow up period
Tobacco counselling referral, if smoker
Documentation of referral among current smokers
Measured: 24 month follow up period
Weight control referral, if problem identified
Documentation of referral among those where a weight problem is identified
Measured: 24 month follow up period
HIV screening
% of patients at CHC with HIV screening
Measured: 24 month follow up period
Bacterial STI screening
% of patients at CHC with STI screening
Measured: 24 month follow up period
Anal cancer
% of patients at CHC with anal PAP screening
Measured: 24 month follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Mar 2018
- Primary completion30 Jun 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LGBT HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenway Community Health
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Kenneth H. Mayer, MD, Fenway Community Health
- Investigators
- Kenneth Mayer, MD, Principal investigator, Fenway Community Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554785
- Sponsor's protocol ID
- 6271
- Acronym
- PCORI-SOGI
- Status last verified
- Aug 2023
- First submitted
- 14 May 2018
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38052073Loo 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.
PubMed 36802213Mayer 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.
PubMed 35772015
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03554785
- Acronym / sponsor ID
- PCORI-SOGI / 6271
- Conditions
- LGBT Health, Cultural Competency, Education, Sexual Orientation, Gender Identity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fenway Community HealthUniversity, hospital or other
- 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
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Clinician and Non-clinician staff training* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Clinical staff or patient at participating clinical site (for staff interviews and web surveys)
- English speakers
Key exclusion criteria (1 listed)
- Does not meet the inclusion criteria above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician and Non-clinician staff trainingAn 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. | Behavioural | Intervention |
Primary outcome
Sexual Orientation and Gender Identity (SOGI) status
Time frame: 24 month follow up period
% of patients at CHC with SOGI status documented
Behavioral Health and Substance Use Assessment
Time frame: 24 month follow up period
Documentation of PHQ9
Behavioral Health and Substance Use Assessment
Time frame: 24 month follow up period
Documentation of AUDIT
Behavioral Health and Substance Use Assessment
Time frame: 24 month follow up period
Documentation of tobacco status
Vital Sign
Time frame: 24 month follow up period
Documentation of weight or BMI
Vaccination
Time frame: 24 month follow up period
Documentation of Hepatitis A vaccination
Vaccination
Time frame: 24 month follow up period
Documentation of Hepatitis B vaccination
Mammography
Time frame: 24 month follow up period
Documentation of mammogram
Cervical PAP
Time frame: 24 month follow up period
Documentation of PAP
6 secondary outcomes
Behavioral health referral, if problem identified
Time frame: 24 month follow up period
Tobacco counselling referral, if smoker
Time frame: 24 month follow up period
Weight control referral, if problem identified
Time frame: 24 month follow up period
HIV screening
Time frame: 24 month follow up period
Bacterial STI screening
Time frame: 24 month follow up period
Anal cancer
Time frame: 24 month follow up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Derived from this study: PubMed 38052073Mayer 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.
- Derived from this study: PubMed 36802213Loo 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.
- Derived from this study: PubMed 35772015Mayer 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Mayer, MD principal investigator
Fenway Community Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician and Non-clinician staff training in people with LGBT Health and Cultural Competency, run by Fenway Community Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Orientation and Gender Identity (SOGI) status (time frame: 24 month follow up period). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03554785, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.