Electronic Record Assimilation and Subsequent Eradication of Hepatitis C

Hepatitis C Clinical Trial

— ERASE-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873609
• Other study ID #: eP46287
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 54 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of HCV antibody test completion	completion of HCV antibody test	6 months
Secondary	Rate of positive HCV antibody or positive HCV RNA referred for treatment	referral to subspecialty for treatment of chronic HCV infection	8 months
Secondary	Rate of subspecialty visit completion	attended subspecialty visit for treatment	3 months
Secondary	Rate of HCV treatment initiation	chronic HCV treatment started	10 months
Secondary	Rate of sustained virologic response	HCV cured	10 months