Hepatitis CNCT03654365
Advanced Electronic Population Health and Personal Health Record Tools to Improve Once Lifetime Hepatitis C Screening
A study testing Bulk ordering and bulk messaging and Routine alerting in people with Hepatitis C, run by MetroHealth Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 51 to 71 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Bulk ordering and bulk messaging and Routine alerting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,024 participants
- Where
- No sites listed yet
- Study dates
- 17 Nov 2016to 25 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 71 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- already had once in a lifetime screen for hepatitis C or positive for hepatitis C (by lab test or International Classification of Disease code)
About this study
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).
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).
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Bulk ordering and bulk messaging, Routine alerting
- Keywords
- preventative screening, electronic health records, personal health records, population health tools
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulk ordering and bulk messagingOther
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.
Routine alertingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Routine alerting |
| Intervention | Experimental | Pts in the intervention arm receive bulk messaging and bulk ordering of the HCV ab test. Receives: Other: Bulk ordering and bulk messaging; Other: Routine alerting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks post-intervention
Secondary outcomes (1)
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.
Measured: 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start17 Nov 2016
- Primary completion25 Mar 2017
- Study completion25 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 1,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kaelber MD, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654365
- Sponsor's protocol ID
- IRB16-00776
- Status last verified
- Aug 2018
- First submitted
- 26 Jun 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT03654365
- Acronym / sponsor ID
- IRB16-00776
- Conditions
- Hepatitis C
- Keywords
- preventative screening, electronic health records, personal health records, population health tools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- 25 Mar 2017 (actual)
- Study completion
- 25 Mar 2017 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Routine alertingPts 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 | Experimental | Other: Bulk ordering and bulk messaging, Other: Routine alertingPts in the intervention arm receive bulk messaging and bulk ordering of the HCV ab test. |
Who may qualify
- Ages
- 51 to 71 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- already had once in a lifetime screen for hepatitis C or positive for hepatitis C (by lab test or International Classification of Disease code)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bulk ordering and bulk messagingPatients 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. | Other | Intervention |
| Routine alertingPassive 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). | Other | Control, Intervention |
Primary outcome
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
1 secondary outcome
Impact of bulk ordering vs bulk messaging and bulk ordering on HCV antibody testing rates
Time frame: 12 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bulk ordering and bulk messaging and Routine alerting in people with Hepatitis C, run by MetroHealth Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on hepatitis C antibody testing rates at 12 weeks post direct patient messaging (time frame: 12 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.