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

NCT02701049 | Completed Results

• 1 other identifier: 2015P002475
• Study Type: interventional
• Target: 749
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Homosexuality; Gender Identity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Staff-reported Outcomes Measure Questionnaire

  Through study completion (approximately 1 year)

• Proportion of Patients Reporting SO/GI

  Through study completion (approximately 1 year)

Study Arms (1)

SO/GI Collection

OTHER

Methods to collect SO/GI information in the ED

Other: Methods to collect SO/GI information in the ED

Interventions

Methods to collect SO/GI information in the ED OTHER

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.

SO/GI Collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Children
• Any person not cognitively and physically capable of informed consent

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Johns Hopkins University: collaborator

Related Publications (9)

• 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.

  PMID: 19732695 BACKGROUND

• Lombardi EL, Wilchins RA, Priesing D, Malouf D. Gender violence: transgender experiences with violence and discrimination. J Homosex. 2001;42(1):89-101. doi: 10.1300/j082v42n01_05.

  PMID: 11991568 BACKGROUND

• 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.

  PMID: 21124295 BACKGROUND

• 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.

  PMID: 20670929 BACKGROUND

• 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.

  PMID: 20075319 BACKGROUND

• 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.

  PMID: 19696397 BACKGROUND

• 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. doi: 10.1007/s10461-007-9299-3. Epub 2007 Aug 13.

  PMID: 17694429 BACKGROUND

• 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. doi: 10.1080/00224490409552240.

  PMID: 15765273 BACKGROUND

• Diaz 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. doi: 10.2105/ajph.91.6.927.

  PMID: 11392936 BACKGROUND

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Limitations and Caveats

Patients who identified their SO/GI as "other" were not eligible for inclusion in the study. Patients who were admitted to the ED with a psychiatric diagnosis were not eligible for participation.

Results Point of Contact

• Title: Dr. Adil H. Haider
• Organization: Brigham and Women's Hospital

ahhaider@bwh.harvard.edu

617-525-9280

Study Officials

• Adil Haider, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kessler Director, Center for Surgery and Public Health

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: March 8, 2016
• Study Start: February 16, 2016
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: November 23, 2018
• Results First Posted: November 23, 2018

Record last verified: 2018-11