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

September 15, 2021 updated by: Aparna Goel, Stanford University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of HCV antibody test completion
Time Frame: 6 months
completion of HCV antibody test
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
8 months
Rate of subspecialty visit completion
Time Frame: 3 months
attended subspecialty visit for treatment
3 months
Rate of HCV treatment initiation
Time Frame: 10 months
chronic HCV treatment started
10 months
Rate of sustained virologic response
Time Frame: 10 months
HCV cured
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aparna Goel, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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