Gender Identity, Homosexuality
Conditions
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).
Interventions
OTHERMethods 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.
Sponsors
Johns Hopkins University
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Communication Climate Assessment Toolkit Questionnaire (Patient) | 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
| Measure | Time frame | Description |
|---|---|---|
| Staff-reported Outcomes Measure Questionnaire | Through study completion (approximately 1 year) | Measures responses to the staff survey question, Did you experience difficulty collecting sexual orientation data from patients? |
| Proportion of Patients Reporting SO/GI | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mode 0 Patients who were not asked their SO/GI | 209 |
| Mode 1 Patients who were verbally asked by a nurse their SO/GI | 342 |
| Mode 2 Patients whose SO/GI was collected non-verbally on a form | 198 |
| Total | 749 |
Baseline characteristics
| Characteristic | Mode 0 | Mode 1 | Mode 2 | Total |
|---|---|---|---|---|
| Age, Customized Age | 48 years STANDARD_DEVIATION 17.2 | 38.5 years STANDARD_DEVIATION 13.5 | 33 years STANDARD_DEVIATION 12.3 | 39.3 years STANDARD_DEVIATION 15.2 |
| Race/Ethnicity, Customized American Indian | 0 Participants | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 3 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized Black | 78 Participants | 178 Participants | 85 Participants | 341 Participants |
| Race/Ethnicity, Customized Declined | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 17 Participants | 30 Participants | 25 Participants | 72 Participants |
| Race/Ethnicity, Customized Missing | 34 Participants | 0 Participants | 0 Participants | 34 Participants |
| Race/Ethnicity, Customized Native Hawaiian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 69 Participants | 123 Participants | 77 Participants | 269 Participants |
| Sex/Gender, Customized Declined to State | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Female | 107 Participants | 149 Participants | 85 Participants | 341 Participants |
| Sex/Gender, Customized Male | 97 Participants | 75 Participants | 32 Participants | 204 Participants |
| Sex/Gender, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Queer/Genderqueer | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Questioning/Unsure | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Transgender Female to Male | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Sex/Gender, Customized Transgender Male to Female | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized Unavailable/Not Asked | 5 Participants | 114 Participants | 74 Participants | 193 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 209 | 0 / 342 | 0 / 198 |
| other Total, other adverse events | 0 / 209 | 0 / 342 | 0 / 198 |
| serious Total, serious adverse events | 0 / 209 | 0 / 342 | 0 / 198 |
Outcome results
Primary
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.
Time frame: Through study completion (approximately 1 year)
Population: Patients who were not asked SO/GI or who provided their SO/GI in the ED via verbal or nonverbal collection and provided complete data on the patient outcome survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mode 0 | Communication Climate Assessment Toolkit Questionnaire (Patient) | 92.78 Score | Standard Deviation 18.05 |
| Mode 1 | Communication Climate Assessment Toolkit Questionnaire (Patient) | 91.32 Score | Standard Deviation 18.52 |
| Mode 2 | Communication Climate Assessment Toolkit Questionnaire (Patient) | 94.14 Score | Standard Deviation 13.44 |
Secondary
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
Time frame: Through study completion (approximately 1 year)
Population: All adult patients who were seen in the ED during the intervention periods
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mode 0 | Proportion of Patients Reporting SO/GI | 228 Participants |
| Mode 1 | Proportion of Patients Reporting SO/GI | 132 Participants |
Comparison: Historical controls included all patients entering participating EDs as identified by the Electronic Health Record.
Secondary
Staff-reported Outcomes Measure Questionnaire
Measures responses to the staff survey question, Did you experience difficulty collecting sexual orientation data from patients?
Time frame: Through study completion (approximately 1 year)
Population: Nurses and registrars who completed staff outcome surveys
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mode 0 | Staff-reported Outcomes Measure Questionnaire | Sometimes | 16 Participants |
| Mode 0 | Staff-reported Outcomes Measure Questionnaire | Other | 6 Participants |
| Mode 0 | Staff-reported Outcomes Measure Questionnaire | Usually/Always | 7 Participants |
| Mode 0 | Staff-reported Outcomes Measure Questionnaire | Decline to answer | 1 Participants |
| Mode 0 | Staff-reported Outcomes Measure Questionnaire | Never/rarely | 11 Participants |
| Mode 1 | Staff-reported Outcomes Measure Questionnaire | Decline to answer | 0 Participants |
| Mode 1 | Staff-reported Outcomes Measure Questionnaire | Never/rarely | 14 Participants |
| Mode 1 | Staff-reported Outcomes Measure Questionnaire | Sometimes | 14 Participants |
| Mode 1 | Staff-reported Outcomes Measure Questionnaire | Usually/Always | 8 Participants |
| Mode 1 | Staff-reported Outcomes Measure Questionnaire | Other | 2 Participants |