- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01519570
Use of an Electronic Medical Record in the Primary Care Setting to Improve Herpes Zoster Vaccination Rates
August 27, 2018 updated by: Stuart Beatty, Ohio State University
Use of an Electronic Medical Record to Improve Standard Practice in the Primary Care Setting: A Randomized-Controlled Study of Herpes Zoster Vaccination Rates
Despite the significant benefits of herpes zoster vaccine (HZV), vaccination rates remain low.
Electronic medical records (EMR) can serve as a practical strategy to better facilitate the application of preventative health care, such as increasing immunization rates.
A new care model that can increase the herpes zoster vaccination rate, as well as other preventative health services, is warranted.
The objective of this study is to investigate if the functions of an EMR, in combination with a pharmacist as part of the care team, can improve the herpes zoster vaccination rate.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
2589
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States, 43221
- The Ohio State University Martha Morehouse General Internal Medicine Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
58 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Greater than 60 years of age
Exclusion Criteria:
- Documented herpes zoster vaccine in the EMR
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: An informational packet regarding shingles and the HZV
|
The EMR generated a list of patients aged 60 or older without HZV documentation.
Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status.
Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status.
A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.
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No Intervention: Standard medical care from their primary care physician
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Received the Herpes Zoster Vaccine
Time Frame: 6 months
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Six months after the intervention, a second EMR report was generated to determine the change in vaccination rate of both the intervention and control groups.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Vaccination Rates Between Patients Who Recieved a Mailed Letter Versus a Secure Email
Time Frame: 6 months
|
Difference in vaccination rates between patients sent communications via US postal service (USPS) and those sent communications via electronic patient portal (EPP)
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6 months
|
Amount of Time Required by a Clinical Pharmacist to Manage This Workflow
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stuart J Beatty, PharmD, Ohio State University
- Study Chair: Shelley H Otsuka, PharmD, The Ohio State Univeristy
- Study Chair: Neeraj H Tayal, MD, Ohio State University
- Study Chair: Kyle Porter, MAS, Ohio State University
- Study Chair: Peter J Embi, MD, MS, Ohio State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
January 12, 2012
First Submitted That Met QC Criteria
January 24, 2012
First Posted (Estimate)
January 27, 2012
Study Record Updates
Last Update Posted (Actual)
February 1, 2019
Last Update Submitted That Met QC Criteria
August 27, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010H0290
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Herpes Zoster Disease
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Immorna Biotherapeutics, Inc.ICON plcActive, not recruitingInfectious Disease | Shingles | Herpes Zoster (HZ)United States
-
GlaxoSmithKlineCompletedHerpes Zoster | Herpes Zoster VaccineCanada, Spain, Korea, Republic of, United Kingdom, France, Czechia
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Merck Sharp & Dohme LLCCompletedHerpes Zoster | Herpes Zoster-related Complications
-
GlaxoSmithKlineCompletedHerpes Zoster | Herpes Zoster VaccineUnited States, Canada, Belgium
-
GlaxoSmithKlineCompletedHerpes Zoster | Herpes Zoster VaccineUnited States, Australia, Spain, Finland, Germany, Japan, Taiwan, Canada, Sweden, Korea, Republic of, Czechia, Hong Kong, Mexico, Italy, Brazil, Estonia, France, United Kingdom
-
Tanta UniversityNot yet recruitingAcute Herpes Zoster Pain Managment
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Merck Sharp & Dohme LLCCompleted
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Northwestern UniversityBausch & Lomb IncorporatedTerminatedHerpes Zoster KeratitisUnited States
-
GlaxoSmithKlineCompletedHerpes Zoster | Herpes Zoster VaccineUnited States, Estonia, Canada
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The University of Texas Medical Branch, GalvestonShriners Hospitals for ChildrenCompletedBurns | Chickenpox | Cytomegalovirus | Herpes Simplex Virus | Varicella-zoster Virus | Human Herpes Virus