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| ID | Type | Description | Link |
|---|---|---|---|
| IN-US-973-7442 | Other Grant/Funding Number | Gilead |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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Design:
This will be a within-subjects repeated-measures design, testing an electronic medical record pop-up alert linked to order panels for screening blood tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV). Study participants will be primary care providers. For each participating provider, their encounter will be randomized to either control (no alert; no changes to EMR interface) or an alert with triple-testing order panel intervention arm (alert linked to order panel with screening tests for all three bloodborne viruses (BBVs) selected by default; the alert will be triggered when a provider attempts to order a screening test for at least one BBV). The alert linked to triple testing orders will only be triggered if the provider orders a virus BBV screening test based on their normal practice and standard of care for their patient. Providers will see which orders are selected prior to signing (finalizing) them; therefore, this study will be unblinded. To mitigate the effect of unblinding, randomization will occur at the encounter level which will lead to providers experiencing both the control and intervention conditions randomly throughout the duration of the study.
Outcomes/endpoints:
The investigators will compare incidences of HIV, HBV, and HCV diagnoses between the two encounter conditions, estimate number of cases missed by not triple-testing, estimate laboratory costs per condition, and measure patient encounters per condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized encounters | Other | For participating providers, each of their encounters will be randomized to either control (no alert; no changes to EMR interface; standard of care) or intervention (alert linked to triple testing orders will trigger when the provider attempts to order a screening test for HIV, hepatitis B, or hepatitis C). Since randomization will occur at the encounter level, participating providers will randomly experience control and intervention encounters throughout the duration of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electronic medical record alert linked to orders | Other | An electronic medical record alert linked to triple testing orders will be built specifically for this study. An order for a screening blood test for any of the three bloodborne viruses (BBVs; i.e. HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)) will trigger an electronic medical record alert linked to orders for screening blood tests for all three BBVs to be selected by default. If participants accept the alert, the individual BBV order that triggered the alert will be replaced with the pre-selected screening orders for all three BBVs. If the participants dismiss the alert, the individual BBV screening test order that triggered the alert will be accepted without the addition of screening test orders for the other two BBVs. This alert with linked orders will only be available to participating providers throughout the duration of the study, and will only activate for encounters randomized to "intervention" encounters. |
| Measure | Description | Time Frame |
|---|---|---|
| Bloodborne virus (BBV) screening tests | For total bloodborne virus (BBV) screening tests (HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) combined) and each individual BBV (HIV, HBV, or HCV independently), the investigators will measure the number of screening tests: 1) ordered, 2) performed, 3) with a positive result, 4) with a negative result: overall across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline | 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation) |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalences of bloodborne viruses (BBVs) | Prevalences of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) as well as BBV co-infections among patients of participating providers overall across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline | 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole E Naiman, MD/PhD | Contact | 214-645-9317 | nicole.naiman@utsouthwestern.edu | |
| Stephanie Reyes | Contact | 214-645-9317 | Stephanie.Reyes@UTSouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mamta K Jain, MD, MPH | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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This is a within-subjects repeated-measures unblinded design. All providers (participants) will have encounters randomized to control (no alert) or intervention (alert) throughout the duration of the study. Therefore, all providers (participants) are technically assigned to the same "study arm".
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| Incidences of bloodborne viruses (BBVs) | Incidences of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) as well as BBV co-infections among patients of participating providers overall across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline | 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation) |
| Number of patient encounters required to make a virus diagnosis and link patients to care | Number of patient encounters required to make a virus diagnosis and link patients to care overall across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline | 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation) |
| Cost efficiency analysis | Assess and determine cost efficiency via analysis of laboratory costs by estimating laboratory costs per patient and per new diagnosis overall across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline | 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation) |
| Repeated BBV tests | Measure frequencies of repeated tests before and after excluding those with a known BBV diagnosis prior to the study across all encounters, and compared between control and intervention encounters as well as normalized to the providers' pre-study baseline | 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation) |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |