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

Primary Purpose

Hepatitis C, Liver Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient portal message
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis C focused on measuring Hepatitis C screening, Population Health

Eligibility Criteria

54 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

No Intervention

Active Comparator

Arm Label

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

No PCP appointment, Patient outreach

PCP appointment, No patient outreach

PCP appointment, Patient outreach

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Rate of HCV antibody test completion
completion of HCV antibody test

Secondary Outcome Measures

Rate of positive HCV antibody or positive HCV RNA referred for treatment
referral to subspecialty for treatment of chronic HCV infection
Rate of subspecialty visit completion
attended subspecialty visit for treatment
Rate of HCV treatment initiation
chronic HCV treatment started
Rate of sustained virologic response
HCV cured

Full Information

First Posted
April 22, 2021
Last Updated
September 15, 2021
Sponsor
Stanford University
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04873609
Brief Title
Electronic Record Assimilation and Subsequent Eradication of Hepatitis C
Acronym
ERASE-C
Official Title
Targeted Electronic Patient Portal Messaging Increases Hepatitis C Virus Screening in Primary Care: a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Liver Diseases
Keywords
Hepatitis C screening, Population Health

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No primary care provider (PCP) appointment, No patient outreach
Arm Type
No Intervention
Arm Description
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
Arm Title
No PCP appointment, Patient outreach
Arm Type
Active Comparator
Arm Description
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
Arm Title
PCP appointment, No patient outreach
Arm Type
No Intervention
Arm Description
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
Arm Title
PCP appointment, Patient outreach
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Patient portal message
Other Intervention Name(s)
outreach
Intervention Description
Direct-to-patient message via the electronic patient portal (MyHealth) with HCV antibody lab order directed to their preferred laboratory
Primary Outcome Measure Information:
Title
Rate of HCV antibody test completion
Description
completion of HCV antibody test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of positive HCV antibody or positive HCV RNA referred for treatment
Description
referral to subspecialty for treatment of chronic HCV infection
Time Frame
8 months
Title
Rate of subspecialty visit completion
Description
attended subspecialty visit for treatment
Time Frame
3 months
Title
Rate of HCV treatment initiation
Description
chronic HCV treatment started
Time Frame
10 months
Title
Rate of sustained virologic response
Description
HCV cured
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
54 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aparna Goel, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared.

Learn more about this trial

Electronic Record Assimilation and Subsequent Eradication of Hepatitis C

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