Advanced Electronic Population Health and Personal Health Record Tools to Improve Once Lifetime Hepatitis C Screening
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).
1 other identifier
interventional
1,024
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2017
CompletedFirst Submitted
Initial submission to the registry
June 26, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedAugust 31, 2018
August 1, 2018
4 months
June 26, 2018
August 29, 2018
Conditions
Keywords
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 COMPARATORPts 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)
Intervention
EXPERIMENTALPts in the intervention arm receive bulk messaging and bulk ordering of the HCV ab test.
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.
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).
Eligibility Criteria
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
Condition Hierarchy (Ancestors)
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