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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02701049
Recruitment Status : Completed
First Posted : March 8, 2016
Results First Posted : November 23, 2018
Last Update Posted : November 23, 2018
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Adil Haider, Brigham and Women's Hospital

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).


Condition or disease Intervention/treatment Phase
Homosexuality Gender Identity Other: Methods to collect SO/GI information in the ED Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 749 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Emergency Department Query For Patient-centered Approaches To Sexual Orientation And Gender Identity
Actual Study Start Date : February 16, 2016
Actual Primary Completion Date : March 29, 2017
Actual Study Completion Date : March 29, 2017

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701049


Sponsors and Collaborators
Brigham and Women's Hospital
Johns Hopkins University
Investigators
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Principal Investigator: Adil Haider, MD, MPH Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Adil Haider, Brigham and Women's Hospital:
Informed Consent Form  [PDF] March 14, 2018

Publications:

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Responsible Party: Adil Haider, Kessler Director, Center for Surgery and Public Health, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02701049    
Other Study ID Numbers: 2015P002475
First Posted: March 8, 2016    Key Record Dates
Results First Posted: November 23, 2018
Last Update Posted: November 23, 2018
Last Verified: November 2018