Syndemic Triple HIV/HBV/HCV Virus Screening Via EMR Automation at Primary Care Clinics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Bloodborne virus (BBV) screening tests
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Randomized encounters
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.
干预措施: electronic medical record alert linked to orders (Other)
结局指标
主要结局
Bloodborne virus (BBV) screening tests
时间窗: 24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation)
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
次要结局
- Prevalences of bloodborne viruses (BBVs)(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)(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(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(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(24 months total: from 12 months pre-enrollment through the end of study participation (i.e. maximum of 1 year of participation))
研究者
Mamta K. Jain, MD,MPH
Professor
University of Texas Southwestern Medical Center