Electronic Record Assimilation and Subsequent Eradication of Hepatitis C (ERASE-C)

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Hepatitis C
• Intervention / Treatment: Behavioral: Patient portal message

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 54 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No primary care provider (PCP) appointment, No patient outreach; 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
Active Comparator: No PCP appointment, Patient outreach; 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	Behavioral: Patient portal message; Direct-to-patient message via the electronic patient portal (MyHealth) with HCV antibody lab order directed to their preferred laboratory; Other Names: outreach
No Intervention: PCP appointment, No patient outreach; 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
Active Comparator: PCP appointment, Patient outreach; 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	Behavioral: Patient portal message; Direct-to-patient message via the electronic patient portal (MyHealth) with HCV antibody lab order directed to their preferred laboratory; Other Names: outreach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of HCV antibody test completion	completion of HCV antibody test	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of positive HCV antibody or positive HCV RNA referred for treatment	referral to subspecialty for treatment of chronic HCV infection	8 months
Rate of subspecialty visit completion	attended subspecialty visit for treatment	3 months
Rate of HCV treatment initiation	chronic HCV treatment started	10 months
Rate of sustained virologic response	HCV cured	10 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Aparna Goel, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Population Health; Hepatitis C screening
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Liver Diseases; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: eP46287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No