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OpenTrials
Completed

NCT Number: NCT02701049

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Communication Climate Assessment Toolkit Questionnaire (Patient)

    Time frame: Through study completion (approximately 1 year)

    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.

Secondary outcomes

  1. Staff-reported Outcomes Measure Questionnaire

    Time frame: Through study completion (approximately 1 year)

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

  2. Proportion of Patients Reporting SO/GI

    Time frame: Through study completion (approximately 1 year)

    Measures the proportion of all adult emergency department patients from whom SO/GI was collected during the study period

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Johns Hopkins University

Registry information

Official study title

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

Acronym: EQUALITY

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2016
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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