Advanced Electronic Population Health and Personal Health Record Tools to Improve Once Lifetime Hepatitis C Screening

August 29, 2018 updated by: David Kaelber MD, MetroHealth Medical Center

Once Lifetime Hepatitis C (HCV) Screening Among Adults Using Advanced Electronic Population Health Tools and Personal Health Record Tools Tied to an Advanced Electronic Health Record (EHR).

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).

Study Overview

Status

Completed

Conditions

Detailed Description

All patients had to have an active personal health record account at the time of being randomized.

Patients had to have been seen by their primary care provider in the last 6 months to be eligible and therefore had a "missed opportunity" for Hepatitis C screening.

Control group received "usual care" which in our system included alert (health maintenance reminder) to the primary care provider at the time of the visit and passive alert in their personal health record (i.e. an alert if they log into their personal health record and look for reminders for preventative care that it due/overdue).

Intervention group received same care as control group plus automatic ordering of the hepatitis C screening test and active electronic letter their personal health record that they were due for hepatitis C screening, what hepatitis C is, what the testing and if positive, treatment could involve, and instruction to go to one of the laboratories in the healthcare system to have their blood drawn if they were interested in the testing.

Study Type

Interventional

Enrollment (Actual)

1024

Phase

  • Not Applicable

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

Ages Eligible for Study

51 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
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)
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).
Experimental: Intervention
Pts in the intervention arm receive bulk messaging and bulk ordering of the HCV ab test.
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on hepatitis C antibody testing rates at 12 weeks post direct patient messaging
Time Frame: 12 weeks post-intervention
Number of patients who remain untested for HCV at 12 weeks post direct patient messaging
12 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of bulk ordering vs bulk messaging and bulk ordering on HCV antibody testing rates
Time Frame: 12 weeks post-intervention
Assessment of if the patient in the intervention group seemed have the hepatitis screening done just because they were having other blood work done versus specifically wanting to be screened for hepatitis C.
12 weeks post-intervention

Collaborators and Investigators

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

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)

November 17, 2016

Primary Completion (Actual)

March 25, 2017

Study Completion (Actual)

March 25, 2017

Study Registration Dates

First Submitted

June 26, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

August 1, 2018

More Information

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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