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HomosexualityEQUALITYNCT02701049

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

A study testing Methods to collect SO/GI information in the ED in people with Homosexuality and Gender Identity, run by Brigham and Women's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Homosexuality, Gender Identity
What is being tested?
Methods to collect SO/GI information in the ED
Could I receive a placebo?
No, everyone receives an active treatment
How many people
749 participants
Where
No sites listed yet
Study dates
16 Feb 2016to 29 Mar 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

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

About this study

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

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).

Being tested
Methods to collect SO/GI information in the ED
Medical subject headings
Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methods to collect SO/GI information in the EDOther

    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.

Study groups in NCT02701049
Study groupRoleWhat they receive
SO/GI CollectionOtherMethods to collect SO/GI information in the ED
Receives: Other: Methods to collect SO/GI information in the ED

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion (approximately 1 year)

Secondary outcomes (2)

  1. Staff-reported Outcomes Measure Questionnaire

    Measures responses to the staff survey question, "Did you experience difficulty collecting sexual orientation data from patients?"

    Measured: Through study completion (approximately 1 year)

  2. 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

    Measured: Through study completion (approximately 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2016 (estimated)
  2. Study start16 Feb 2016
  3. Primary completion29 Mar 2017
  4. Study completion29 Mar 2017

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
749 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02701049
Sponsor's protocol ID
2015P002475
Acronym
EQUALITY
Status last verified
Nov 2018
First submitted
7 Jan 2016
Last updated
23 Nov 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 19732695

  • 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.

    PubMed 11991568

  • 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.

    PubMed 21124295

  • 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.

    PubMed 20670929

  • 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.

    PubMed 20075319

  • 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.

    PubMed 19696397

  • 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.

    PubMed 17694429

  • 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.

    PubMed 15765273

  • 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.

    PubMed 11392936

Questions about this trial

What is this clinical trial studying?

A study testing Methods to collect SO/GI information in the ED in people with Homosexuality and Gender Identity, run by Brigham and Women's Hospital.

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 2 inclusion and 2 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 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 23 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Communication Climate Assessment Toolkit Questionnaire (Patient) (time frame: Through study completion (approximately 1 year)). 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 NCT02701049, which also lists 9 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 23 Nov 2018.

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