Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03654365
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
David Kaelber MD, MetroHealth Medical Center

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).

Condition or disease Intervention/treatment Phase
Hepatitis C Other: Bulk ordering and bulk messaging Other: Routine alerting Not Applicable

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.


Layout table for study information
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

Resource links provided by the National Library of Medicine


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)
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).

Experimental: Intervention
Pts in the intervention arm receive bulk messaging and bulk ordering of the HCV ab test.
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).




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   51 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Layout table for additonal information
Responsible Party: David Kaelber MD, Physician and Chief Medical Informatics Officer, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT03654365     History of Changes
Other Study ID Numbers: IRB16-00776
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Kaelber MD, MetroHealth Medical Center:
preventative screening
electronic health records
personal health records
population health tools

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
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