HIV/HBV/HCV Triple Screening in Primary Care

The University of Texas System (UT)

Status: Begins enrollment this month

Conditions: HIV; HCV; HBV (Hepatitis B Virus)

Treatments: Other: electronic medical record alert linked to orders

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07031219

IN-US-973-7442 (Other Grant/Funding Number)

STU20240019

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatient primary care adult providers at participating institutions
• Providers who provide consent to participate in this study.
• Providers must intend to continue their current practice for at least 12 months.
• Providers with at least 12 months experience in their current practice.

Exclusion criteria

• Providers who do not consent to participate
• Sub-specialty providers
• Pediatric providers
• Providers who anticipate leaving their current practice within the next 12 months (i.e. providers who plan to retire, move, etc.).
• Providers with less than 12 months experience in their current practice (i.e. new providers or trainees who joined the practice within the last year)
• Note: family medicine and med/peds providers can participate, but only for their adult patients. The intervention alert+order panel and any data collection will be restricted to adult patients ≥ 18 years old.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Randomized encounters

Other group

Description:

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.

Treatment:

Other: electronic medical record alert linked to orders