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临床试验/NCT04525690
NCT04525690已完成不适用

Improving Inpatient Screening for Hepatitis C: A Stepped-Wedge Randomized Clinical Trial

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 7,634 人开始时间: 2020年9月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
7,634
试验地点
1
主要终点
Change in percentage of eligible patients that receive HCV antibody screening

研究概览

简要总结

This study will use a stepped-wedge cluster randomized clinical trial to evaluate a health system initiative to set defaults in the electronic health record admission order set to nudge inpatient hepatitis C (HCV) screening.

详细描述

The hepatitis C virus (HCV) is the leading cause of liver transplant and hepatocellular carcinoma in the United States, but direct-acting antiviral medications are now available and can cure the disease in over 95% of those that are treated. The Centers for Disease Control and Prevention (CDC) estimate that 75% of all chronic HCV infections in the United States are among adults born between 1945 and 1965. The CDC and US Preventive Services Task Force (USPTF) therefore recommends birth cohort screening for all adults born in this time period. In 2016, the Commonwealth of Pennsylvania signed into law a requirement that all hospitalized patients born during this time period be offered HCV screening. In this study, a stepped-wedge cluster randomized clinical trial will be conducted to test the effect of defaulting HCV screening into the admission order set to improve screening rates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The principal study investigator and data analyst will not have knowledge of when the hospital sites are randomized to the intervention.

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

  • •Be admitted to the Hospital of the University of Pennsylvania (HUP) or Penn Presbyterian Medical Center (PPMC)
  • •Born between 1945 and 1965

排除标准

  • •Patients will be excluded if they have already received Hepatitis C screening or have been previously diagnosed with Hepatitis C.

研究组 & 干预措施

HCV Screening Default-1 Hospital Crossed Over

Experimental

Upon entering the admission order set in the EHR clinicians will receive a default order for HCV screening for eligible patients. Clinicians will have the opportunity to opt-out and not order screening

干预措施: Nudge (Behavioral)

HCV Screening Default-2 Hospitals Crossed Over

Experimental

Upon entering the admission order set in the EHR clinicians will receive a default order for HCV screening for eligible patients. Clinicians will have the opportunity to opt-out and not order screening.

干预措施: Nudge (Behavioral)

结局指标

主要结局

Change in percentage of eligible patients that receive HCV antibody screening

时间窗: 6 months

The change in the percentage of eligible hospitalized patients that receive HCV antibody screening

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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