Advanced Electronic Population Health and Personal Health Record Tools to Improve Once Lifetime Hepatitis C Screening
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| ClinicalTrials.gov Identifier: NCT03654365 |
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Recruitment Status :
Completed
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C | Other: Bulk ordering and bulk messaging Other: Routine alerting | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 1024 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Care Provider, Investigator) |
| Primary Purpose: | 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). |
| Actual Study Start Date : | November 17, 2016 |
| Actual Primary Completion Date : | March 25, 2017 |
| Actual Study Completion Date : | March 25, 2017 |
| Arm | Intervention/treatment |
|---|---|
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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)
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Other: 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). |
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Experimental: Intervention
Pts in the intervention arm receive bulk messaging and bulk ordering of the HCV ab test.
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Other: Bulk ordering and bulk messaging
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. Other: 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). |
- 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
- 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.
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| Ages Eligible for Study: | 51 Years to 71 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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)
| Responsible Party: | David Kaelber MD, Physician and Chief Medical Informatics Officer, MetroHealth Medical Center |
| ClinicalTrials.gov Identifier: | NCT03654365 |
| Other Study ID Numbers: |
IRB16-00776 |
| First Posted: | August 31, 2018 Key Record Dates |
| Last Update Posted: | August 31, 2018 |
| Last Verified: | August 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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preventative screening electronic health records personal health records population health tools |
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Hepatitis A Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections |
Communicable Diseases Flaviviridae Infections Caffeine Central Nervous System Stimulants Physiological Effects of Drugs Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |