HIV/HBV/HCV Triple Screening in Primary Care

Официальное название

Syndemic Triple HIV/HBV/HCV Virus Screening Via EMR Automation at Primary Care Clinics

Обзор

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.

Вмешательства

• Другое electronic medical record alert linked to orders
  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 t

Первичные конечные точки

• Bloodborne virus (BBV) screening tests [Срок оценки: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)]

Вторичные конечные точки (5)

• Prevalences of bloodborne viruses (BBVs) [Срок оценки: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)]
• Incidences of bloodborne viruses (BBVs) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Texas Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT07031219 · STU20240019 · IN-US-973-7442

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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