Trial Outcomes & Findings for Patient Centered Methods to Collect Sexual Orientation and Gender Identity Status in the ED (NCT NCT02701049)
NCT ID: NCT02701049
Last Updated: 2018-11-23
Results Overview
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.
COMPLETED
NA
749 participants
Through study completion (approximately 1 year)
2018-11-23
Participant Flow
Participant milestones
| Measure |
Mode 0
Patients who were not asked their SO/GI
|
Mode 1
Patients who were verbally asked by a nurse their SO/GI
|
Mode 2
Patients whose SO/GI was collected non-verbally on a form
|
|---|---|---|---|
|
Overall Study
STARTED
|
209
|
342
|
198
|
|
Overall Study
COMPLETED
|
209
|
342
|
198
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Centered Methods to Collect Sexual Orientation and Gender Identity Status in the ED
Baseline characteristics by cohort
| Measure |
Mode 0
n=209 Participants
Patients who were not asked their SO/GI
|
Mode 1
n=342 Participants
Patients who were verbally asked by a nurse their SO/GI
|
Mode 2
n=198 Participants
Patients whose SO/GI was collected non-verbally on a form
|
Total
n=749 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age
|
48 years
STANDARD_DEVIATION 17.2 • n=39 Participants
|
38.5 years
STANDARD_DEVIATION 13.5 • n=41 Participants
|
33 years
STANDARD_DEVIATION 12.3 • n=35 Participants
|
39.3 years
STANDARD_DEVIATION 15.2 • n=31 Participants
|
|
Sex/Gender, Customized
Male
|
97 Participants
n=39 Participants
|
75 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
204 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Female
|
107 Participants
n=39 Participants
|
149 Participants
n=41 Participants
|
85 Participants
n=35 Participants
|
341 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Transgender Male to Female
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Transgender Female to Male
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Queer/Genderqueer
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Questioning/Unsure
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Declined to State
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Other
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Unavailable/Not Asked
|
5 Participants
n=39 Participants
|
114 Participants
n=41 Participants
|
74 Participants
n=35 Participants
|
193 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
69 Participants
n=39 Participants
|
123 Participants
n=41 Participants
|
77 Participants
n=35 Participants
|
269 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black
|
78 Participants
n=39 Participants
|
178 Participants
n=41 Participants
|
85 Participants
n=35 Participants
|
341 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
17 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
72 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Declined
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Missing
|
34 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
34 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Mode 0
n=209 Participants
Patients who were not asked their SO/GI
|
Mode 1
n=342 Participants
Patients who were verbally asked by a nurse their SO/GI
|
Mode 2
n=198 Participants
Patients whose SO/GI was collected non-verbally on a form
|
|---|---|---|---|
|
Communication Climate Assessment Toolkit Questionnaire (Patient)
|
92.78 Score
Standard Deviation 18.05
|
91.32 Score
Standard Deviation 18.52
|
94.14 Score
Standard Deviation 13.44
|
SECONDARY outcome
Timeframe: Through study completion (approximately 1 year)Population: Nurses and registrars who completed staff outcome surveys
Measures responses to the staff survey question, "Did you experience difficulty collecting sexual orientation data from patients?"
Outcome measures
| Measure |
Mode 0
n=41 Participants
Patients who were not asked their SO/GI
|
Mode 1
n=38 Participants
Patients who were verbally asked by a nurse their SO/GI
|
Mode 2
Patients whose SO/GI was collected non-verbally on a form
|
|---|---|---|---|
|
Staff-reported Outcomes Measure Questionnaire
Never/rarely
|
11 Participants
|
14 Participants
|
—
|
|
Staff-reported Outcomes Measure Questionnaire
Sometimes
|
16 Participants
|
14 Participants
|
—
|
|
Staff-reported Outcomes Measure Questionnaire
Usually/Always
|
7 Participants
|
8 Participants
|
—
|
|
Staff-reported Outcomes Measure Questionnaire
Other
|
6 Participants
|
2 Participants
|
—
|
|
Staff-reported Outcomes Measure Questionnaire
Decline to answer
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Through study completion (approximately 1 year)Population: All adult patients who were seen in the ED during the intervention periods
Measures the proportion of all adult emergency department patients from whom SO/GI was collected during the study period
Outcome measures
| Measure |
Mode 0
n=342 Participants
Patients who were not asked their SO/GI
|
Mode 1
n=198 Participants
Patients who were verbally asked by a nurse their SO/GI
|
Mode 2
Patients whose SO/GI was collected non-verbally on a form
|
|---|---|---|---|
|
Proportion of Patients Reporting SO/GI
|
228 Participants
|
132 Participants
|
—
|
Adverse Events
Mode 0
Mode 1
Mode 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place