NCT04873609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

1 year

First QC Date

April 22, 2021

Last Update Submit

September 15, 2021

Conditions

Hepatitis CLiver Diseases

Keywords

Hepatitis C screeningPopulation Health

Outcome Measures

Primary Outcomes (1)

  • Rate of HCV antibody test completion

    completion of HCV antibody test

    6 months

Secondary Outcomes (4)

  • Rate of positive HCV antibody or positive HCV RNA referred for treatment

    8 months

  • Rate of subspecialty visit completion

    3 months

  • Rate of HCV treatment initiation

    10 months

  • Rate of sustained virologic response

    10 months

Study Arms (4)

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

NO INTERVENTION

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

No PCP appointment, Patient outreach

ACTIVE COMPARATOR

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

PCP appointment, No patient outreach

NO INTERVENTION

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

PCP appointment, Patient outreach

ACTIVE COMPARATOR

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

Interventions

Patient portal messageBEHAVIORAL

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

Also known as: outreach
No PCP appointment, Patient outreachPCP appointment, Patient outreach

Eligibility Criteria

Age54 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Hepatitis CLiver Diseases

Interventions

Community-Institutional Relations

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisDigestive System Diseases

Intervention Hierarchy (Ancestors)

Public RelationsOrganization and AdministrationHealth Services Administration

Study Officials

  • Aparna Goel, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 22, 2021

First Posted

May 5, 2021

Study Start

May 1, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Data will not be shared.

Locations

US(1)