NCT03654365

Brief Summary

This study involves randomizing patients due for once in a lifetime Hepatitis C screening based on Center for Disease Control and Prevention and United States Preventative Services Task Force guidelines in one of three primary care clinics within the MetroHealth System to bulk messaging and bulk ordering for HCV antibody vs usual care (routine alerting).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,024

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

June 26, 2018

Last Update Submit

August 29, 2018

Conditions

Keywords

preventative screeningelectronic health recordspersonal health recordspopulation health tools

Outcome Measures

Primary Outcomes (1)

  • Impact on hepatitis C antibody testing rates at 12 weeks post direct patient messaging

    Number of patients who remain untested for HCV at 12 weeks post direct patient messaging

    12 weeks post-intervention

Secondary Outcomes (1)

  • Impact of bulk ordering vs bulk messaging and bulk ordering on HCV antibody testing rates

    12 weeks post-intervention

Study Arms (2)

Control

ACTIVE COMPARATOR

Pts in the control arm receive usual care. Usual care includes a EHR based reminder of single HCV testing for patients who are in the birth cohort. (routine alerting)

Other: Routine alerting

Intervention

EXPERIMENTAL

Pts in the intervention arm receive bulk messaging and bulk ordering of the HCV ab test.

Other: Bulk ordering and bulk messagingOther: Routine alerting

Interventions

Patients in the intervention group had the hepatitis screening test ordered for them in bulk and then a bulk message sent to them through the personal health record describing hepatitis C and how they could be tested.

Intervention

Passive alerting to providers (during face-to-face encounters using the electronic health record) and to patient (when they review preventative screening recommendations through their personal health record).

ControlIntervention

Eligibility Criteria

Age51 Years - 71 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • seen recently in one of the three primary care study sites and have an active person health record at the time of randomization; and meet Centers for Disease Control and Prevention/United States Preventative Services Task Force guidelines for once in a lifetime hepatitis C screening

You may not qualify if:

  • already had once in a lifetime screen for hepatitis C or positive for hepatitis C (by lab test or International Classification of Disease code)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician and Chief Medical Informatics Officer

Study Record Dates

First Submitted

June 26, 2018

First Posted

August 31, 2018

Study Start

November 17, 2016

Primary Completion

March 25, 2017

Study Completion

March 25, 2017

Last Updated

August 31, 2018

Record last verified: 2018-08