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临床试验/NCT04873609
NCT04873609已完成不适用

Targeted Electronic Patient Portal Messaging Increases Hepatitis C Virus Screening in Primary Care: a Randomized Study

Stanford University1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2019年5月1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
1,600
试验地点
1
主要终点
Rate of HCV antibody test completion

研究概览

简要总结

Given the disproportionately high risk of chronic hepatitis C virus (HCV) infection in the baby boomer cohort, population-based screening has been demonstrated cost effective. Compared to point-of-care testing, however, bulk health messages with coupled lab requisitions delivered directly to patients meeting screening criteria via patient portals could improve HCV screening at minimal cost.

详细描述

The Centers for Disease Control and Prevention (CDC) and the United States Preventative Services Taskforce (USPSTF) recommend a one-time hepatitis C infection (HCV) screen in individuals born 1945-65 (baby boomer birth cohort) and in others with risk factors for infection. National adherence to this Grade B recommendation-carrying the same strength of evidence as mammography, and screening for depression, alcohol abuse, and type 2 diabetes-is estimated to be 13.8%. Efforts to increase screening and linkage to HCV care, and also to understand barriers to screening and linkage are therefore warranted.

One such intervention, direct-to-patient messages via electronic medical record (EMR), has been demonstrated to improve adherence in influenza and pneumococcal vaccination, colon cancer screening, immunosuppression after transplantation, among others, but has not been studied as a strategy to improve HCV screening rates within health systems.

Our institution, Stanford Health Care, comprises 86 distinct clinical sites with approximately 1.25 million outpatient visits per year. All clinical sites are linked with an EMR (Epic Systems Corp.) and patients are encouraged to opt-in to receive and send health-related messages through a secure internet and smartphone portal, MyHealth. Approximately 60% of patients at our institution are enrolled in MyHealth.

MyHealth additionally allows bulk-messaging of patients meeting specific characteristics, e.g. patients due for influenza vaccination. Bulk messages can be coupled with laboratory or radiology requisitions. Messages are delivered through the online portal, text message, e-mail, and/or smartphone application notification, depending on patient preference. Laboratory and radiology results are routed automatically to patients' primary care physicians for review.

The investigators propose to conduct a randomized study comparing the effectiveness of a direct-to-patient electronic health message on HCV screening coupled with a lab requisition, versus HCV screening initiated by primary care clinicians as part of routine clinical care alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
54 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •persons born between 1945-1965
  • •having an activated patient portal to receive secure messages (MyHealth)
  • •no prior HCV antibody test within our EHR (electronic health record), including externally accessible results

排除标准

  • •documented HCV viral load in our EHR
  • •diagnosis of chronic HCV in their problem list

研究组 & 干预措施

No primary care provider (PCP) appointment, No patient outreach

No Intervention

400 patients that did not have an upcoming PCP appointment in 6 months were randomly assigned to control group and did not receive a patient portal message with order for HCV antibody screening

No PCP appointment, Patient outreach

Active Comparator

400 patients that did not have an upcoming PCP appointment in 6 months were randomly assigned to receive a patient portal message with order for HCV antibody screening

干预措施: Patient portal message (Behavioral)

PCP appointment, No patient outreach

No Intervention

400 patients that had an upcoming PCP appointment in 6 months were randomly assigned to control group and did not receive a patient portal message with order for HCV antibody screening

PCP appointment, Patient outreach

Active Comparator

400 patients that had an upcoming PCP appointment in 6 months were randomly assigned to receive a patient portal message with order for HCV antibody screening

干预措施: Patient portal message (Behavioral)

结局指标

主要结局

Rate of HCV antibody test completion

时间窗: 6 months

completion of HCV antibody test

次要结局

  • Rate of HCV treatment initiation(10 months)
  • Rate of sustained virologic response(10 months)
  • Rate of positive HCV antibody or positive HCV RNA referred for treatment(8 months)
  • Rate of subspecialty visit completion(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aparna Goel

Assistant Professor

Stanford University

研究点 (1)

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