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OpenTrials
Completed

NCT Number: NCT04873609

Electronic Record Assimilation and Subsequent Eradication of Hepatitis C

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.

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Key information

Age range

54 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Patient Portal Message

Behavioral

Direct-to-patient message via the electronic patient portal (MyHealth) with HCV antibody lab order directed to their preferred laboratory

Other names: outreach

Primary outcomes

  1. Rate of HCV antibody test completion

    Time frame: 6 months

    completion of HCV antibody test

Secondary outcomes

  1. Rate of positive HCV antibody or positive HCV RNA referred for treatment

    Time frame: 8 months

    referral to subspecialty for treatment of chronic HCV infection

  2. Rate of subspecialty visit completion

    Time frame: 3 months

    attended subspecialty visit for treatment

  3. Rate of HCV treatment initiation

    Time frame: 10 months

    chronic HCV treatment started

  4. Rate of sustained virologic response

    Time frame: 10 months

    HCV cured

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Acronym: ERASE-C

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 5, 2021
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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