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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SO/GI Collection | Other | Methods to collect SO/GI information in the ED |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion (approximately 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Staff-reported Outcomes Measure Questionnaire | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adil Haider, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19732695 | Background | De Santis JP. HIV infection risk factors among male-to-female transgender persons: a review of the literature. J Assoc Nurses AIDS Care. 2009 Sep-Oct;20(5):362-72. doi: 10.1016/j.jana.2009.06.005. | |
| 11991568 | Background | Lombardi EL, Wilchins RA, Priesing D, Malouf D. Gender violence: transgender experiences with violence and discrimination. J Homosex. 2001;42(1):89-101. doi: 10.1300/j082v42n01_05. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mode 0 | Patients who were not asked their SO/GI |
| FG001 | Mode 1 | Patients who were verbally asked by a nurse their SO/GI |
| FG002 | Mode 2 | Patients whose SO/GI was collected non-verbally on a form |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients who were not asked their SO/GI or who provided their SO/GI in the ED via verbal or nonverbal collection and completed a patient outcome survey
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| ID | Title | Description |
|---|---|---|
| BG000 | Mode 0 | Patients who were not asked their SO/GI |
| BG001 | Mode 1 | Patients who were verbally asked by a nurse their SO/GI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | Score | Through study completion (approximately 1 year) |
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mode 0 | Patients who were not asked their SO/GI | 0 |
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Patients who identified their SO/GI as "other" were not eligible for inclusion in the study. Patients who were admitted to the ED with a psychiatric diagnosis were not eligible for participation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adil H. Haider | Brigham and Women's Hospital | 617-525-9280 | ahhaider@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 14, 2018 | Mar 14, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2016 | Nov 6, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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|
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) |
| 21124295 | Background | Centers for Disease Control and Prevention (CDC). Vital signs: HIV testing and diagnosis among adults--United States, 2001-2009. MMWR Morb Mortal Wkly Rep. 2010 Dec 3;59(47):1550-5. |
| 20670929 | Background | Struble CB, Lindley LL, Montgomery K, Hardin J, Burcin M. Overweight and obesity in lesbian and bisexual college women. J Am Coll Health. 2010;59(1):51-6. doi: 10.1080/07448481.2010.483703. |
| 20075319 | Background | Buchmueller T, Carpenter CS. Disparities in health insurance coverage, access, and outcomes for individuals in same-sex versus different-sex relationships, 2000-2007. Am J Public Health. 2010 Mar;100(3):489-95. doi: 10.2105/AJPH.2009.160804. Epub 2010 Jan 14. |
| 19696397 | Background | Dilley JA, Simmons KW, Boysun MJ, Pizacani BA, Stark MJ. Demonstrating the importance and feasibility of including sexual orientation in public health surveys: health disparities in the Pacific Northwest. Am J Public Health. 2010 Mar;100(3):460-7. doi: 10.2105/AJPH.2007.130336. Epub 2009 Aug 20. |
| 17694429 | Background | Herbst JH, Jacobs ED, Finlayson TJ, McKleroy VS, Neumann MS, Crepaz N; HIV/AIDS Prevention Research Synthesis Team. Estimating HIV prevalence and risk behaviors of transgender persons in the United States: a systematic review. AIDS Behav. 2008 Jan;12(1):1-17. doi: 10.1007/s10461-007-9299-3. Epub 2007 Aug 13. |
| 15765273 | Background | Whitbeck LB, Chen X, Hoyt DR, Tyler KA, Johnson KD. Mental disorder, subsistence strategies, and victimization among gay, lesbian, and bisexual homeless and runaway adolescents. J Sex Res. 2004 Nov;41(4):329-42. doi: 10.1080/00224490409552240. |
| 11392936 | Background | Diaz RM, Ayala G, Bein E, Henne J, Marin BV. The impact of homophobia, poverty, and racism on the mental health of gay and bisexual Latino men: findings from 3 US cities. Am J Public Health. 2001 Jun;91(6):927-32. doi: 10.2105/ajph.91.6.927. |
| BG002 | Mode 2 | Patients whose SO/GI was collected non-verbally on a form |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Mode 0 | Patients who were not asked their SO/GI |
| OG001 | Mode 1 | Patients who were verbally asked by a nurse their SO/GI |
| OG002 | Mode 2 | Patients whose SO/GI was collected non-verbally on a form |
|
|
| Secondary | Staff-reported Outcomes Measure Questionnaire | Measures responses to the staff survey question, "Did you experience difficulty collecting sexual orientation data from patients?" | Nurses and registrars who completed staff outcome surveys | Posted | Count of Participants | Participants | Through study completion (approximately 1 year) |
|
|
|
| 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 | All adult patients who were seen in the ED during the intervention periods | Posted | Count of Participants | Participants | Through study completion (approximately 1 year) |
|
|
|
|
| 209 |
| 0 |
| 209 |
| 0 |
| 209 |
| EG001 | Mode 1 | Patients who were verbally asked by a nurse their SO/GI | 0 | 342 | 0 | 342 | 0 | 342 |
| EG002 | Mode 2 | Patients whose SO/GI was collected non-verbally on a form | 0 | 198 | 0 | 198 | 0 | 198 |
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| Usually/Always |
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| Other |
|
| Decline to answer |
|