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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bulk ordering and bulk messaging
Routine alerting
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis C focused on measuring preventative screening, electronic health records, personal health records, population health tools

Eligibility Criteria

51 Years - 71 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    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)

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 26, 2018
    Last Updated
    August 29, 2018
    Sponsor
    MetroHealth Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03654365
    Brief Title
    Advanced Electronic Population Health and Personal Health Record Tools to Improve Once Lifetime Hepatitis C Screening
    Official Title
    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).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 17, 2016 (Actual)
    Primary Completion Date
    March 25, 2017 (Actual)
    Study Completion Date
    March 25, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    MetroHealth Medical Center

    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
    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C
    Keywords
    preventative screening, electronic health records, personal health records, population health tools

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    1024 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    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)
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Pts in the intervention arm receive bulk messaging and bulk ordering of the HCV ab test.
    Intervention Type
    Other
    Intervention Name(s)
    Bulk ordering and bulk messaging
    Intervention Description
    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 Type
    Other
    Intervention Name(s)
    Routine alerting
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Impact on hepatitis C antibody testing rates at 12 weeks post direct patient messaging
    Description
    Number of patients who remain untested for HCV at 12 weeks post direct patient messaging
    Time Frame
    12 weeks post-intervention
    Secondary Outcome Measure Information:
    Title
    Impact of bulk ordering vs bulk messaging and bulk ordering on HCV antibody testing rates
    Description
    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.
    Time Frame
    12 weeks post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    51 Years
    Maximum Age & Unit of Time
    71 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Learn more about this trial

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

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