Patient Centered Methods to Collect Sexual Orientation and Gender Identity Status in the ED

Gender Identity Clinical Trial

— EQUALITY  

Official title:

Emergency Department Query For Patient-centered Approaches To Sexual Orientation And Gender Identity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701049
• Other study ID #: 2015P002475
• Status: Completed
• Phase: N/A
• Start date: February 16, 2016
• Est. completion date: March 29, 2017

Study information

• Verified date: November 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is the final phase of a three phase PCORI-funded study to develop and test patient-centered approaches to collect sexual orientation and gender identity (SO/GI) information in the ED. From the results of Phase 1 qualitative interviews and national quantitative survey and Phase 2 Delphi rounds with the Stakeholder Advisory Board, we have determined two methods of collection favored by patients and providers to implement in the trial. The first method, nurse verbal collection, is in alignment with Partners recommended clinical practice and is therefore a quality improvement (QI) evaluation. The second method, non-verbal registrar form collection with nurse verbal confirmation, is a research intervention to evaluate and compare a new patient-centered approach to SO/GI collection. To compare the patient-centeredness of the two different approaches, satisfaction surveys will be administered to ED patients and staff members involved in collection.

In summary, the study design (1) evaluates recommended current practice (QI), (2) evaluates a quality improvement project to increase recommended current practice, and (3) evaluates a new method of collecting SO/GI (research intervention).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 749
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult ED patients who are cognitively and physically capable of informed consent

• Adult ED nurses and registrars who are cognitively and physically capable of informed consent

Exclusion Criteria:

• Children

• Any person not cognitively and physically capable of informed consent

Related Conditions & MeSH terms

• Gender Identity
• Homosexuality

Intervention

Other:
• Methods to collect SO/GI information in the ED
In Mode 1, all patients presenting to the ED will have SO/GI information collected verbally by the nurse, which is standard of care. In Mode 2, all patients presenting to the ED will have SO/GI information collected in a non-verbal manner, in which the registrar will ask them to complete an electronic form.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Johns Hopkins University

References & Publications (9)

Buchmueller T, Carpenter CS. Disparities in health insurance coverage, access, and outcomes for individuals in same-sex versus different-sex relationships, 2000-2007. Am J Public Health. 2010 Mar;100(3):489-95. doi: 10.2105/AJPH.2009.160804. Epub 2010 Jan 14. — View Citation

Centers for Disease Control and Prevention (CDC). Vital signs: HIV testing and diagnosis among adults--United States, 2001-2009. MMWR Morb Mortal Wkly Rep. 2010 Dec 3;59(47):1550-5. — View Citation

De Santis JP. HIV infection risk factors among male-to-female transgender persons: a review of the literature. J Assoc Nurses AIDS Care. 2009 Sep-Oct;20(5):362-72. doi: 10.1016/j.jana.2009.06.005. Review. — View Citation

Díaz RM, Ayala G, Bein E, Henne J, Marin BV. The impact of homophobia, poverty, and racism on the mental health of gay and bisexual Latino men: findings from 3 US cities. Am J Public Health. 2001 Jun;91(6):927-32. — View Citation

Dilley JA, Simmons KW, Boysun MJ, Pizacani BA, Stark MJ. Demonstrating the importance and feasibility of including sexual orientation in public health surveys: health disparities in the Pacific Northwest. Am J Public Health. 2010 Mar;100(3):460-7. doi: 10.2105/AJPH.2007.130336. Epub 2009 Aug 20. — View Citation

Herbst JH, Jacobs ED, Finlayson TJ, McKleroy VS, Neumann MS, Crepaz N; HIV/AIDS Prevention Research Synthesis Team. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: a systematic review. AIDS Behav. 2008 Jan;12(1):1-17. Epub 2007 Aug 13. Review. — View Citation

Lombardi EL, Wilchins RA, Priesing D, Malouf D. Gender violence: transgender experiences with violence and discrimination. J Homosex. 2001;42(1):89-101. — View Citation

Struble CB, Lindley LL, Montgomery K, Hardin J, Burcin M. Overweight and obesity in lesbian and bisexual college women. J Am Coll Health. 2010;59(1):51-6. doi: 10.1080/07448481.2010.483703. — View Citation

Whitbeck LB, Chen X, Hoyt DR, Tyler KA, Johnson KD. Mental disorder, subsistence strategies, and victimization among gay, lesbian, and bisexual homeless and runaway adolescents. J Sex Res. 2004 Nov;41(4):329-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Communication Climate Assessment Toolkit Questionnaire (Patient)	The primary outcome was patient satisfaction as measured by a modified Communication Climate Assessment Toolkit (CCAT) patient survey, an assessment of attitudes towards organizational climate and provider/patient communication.The CCAT is reliable, validated in geographically and ethnically diverse health care organizations, and accurately predicts patient-reported quality and trust. Containing 5/7 items from the full CCAT, our pre-specified modified scale included only questions that were applicable to the ED population, e.g. we kept the question "Do you feel welcome at the hospital?" but eliminated the question "Was it easy to reach someone on the phone if you had a question?" from analyses.Each scale item was scored as a 0 (most disagreement), ½ (neutral), or 1 (agreement), resulting in a scale score ranging from 0-5; higher scores were considered more favorable. The average score for the modified scale was calculated and multiplied by 20 to provide the overall score out of 100.	Through study completion (approximately 1 year)
Secondary	Staff-reported Outcomes Measure Questionnaire	Measures responses to the staff survey question, "Did you experience difficulty collecting sexual orientation data from patients?"	Through study completion (approximately 1 year)
Secondary	Proportion of Patients Reporting SO/GI	Measures the proportion of all adult emergency department patients from whom SO/GI was collected during the study period	Through study completion (approximately 1 year)

External Links

•   EQUALITY Study Website