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

November 21, 2018 updated by: Adil Haider, Brigham and Women's Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

749

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: SO/GI Collection
Methods to collect SO/GI information in the ED
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion (approximately 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?"
Through study completion (approximately 1 year)
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
Through study completion (approximately 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Johns Hopkins University

Investigators

  • Principal Investigator: Adil Haider, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2016

Primary Completion (Actual)

March 29, 2017

Study Completion (Actual)

March 29, 2017

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

November 23, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2015P002475

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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