Herpes Zoster DiseaseNCT01519570
Use of an Electronic Medical Record in the Primary Care Setting to Improve Herpes Zoster Vaccination Rates
A study testing An informational packet regarding shingles and the HZV was sent to patients identified by the EMR in people with Herpes Zoster Disease, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster Disease
- What is being tested?
- An informational packet regarding shingles and the HZV was sent to patients identified by the EMR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,589 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Greater than 60 years of age
Who cannot join
- Documented herpes zoster vaccine in the EMR
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Martha Morehouse General Internal Medicine Clinic
Columbus, Ohio, 43221
About this study
Official title: 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.
- Conditions
- Herpes Zoster Disease
- Being tested
- An informational packet regarding shingles and the HZV was sent to patients identified by the EMR
- Keywords
- Herpes Zoster vaccine, Electronic patient portal, Electronic medical record, Primary care, Immunizations
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An informational packet regarding shingles and the HZV was sent to patients identified by the EMROther
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.
| Study group | Role | What they receive |
|---|---|---|
| An informational packet regarding shingles and the HZV | Experimental | Not described Receives: Other: An informational packet regarding shingles and the HZV was sent to patients identified by the EMR |
| Standard medical care from their primary care physician | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received the Herpes Zoster Vaccine
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.
Measured: 6 months
Secondary outcomes (2)
Difference in Vaccination Rates Between Patients Who Recieved a Mailed Letter Versus a Secure Email
Difference in vaccination rates between patients sent communications via US postal service (USPS) and those sent communications via electronic patient portal (EPP)
Measured: 6 months
Amount of Time Required by a Clinical Pharmacist to Manage This Workflow
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Herpes Zoster DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,589 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Beatty, Ohio State University
- Investigators
- Stuart J Beatty, PharmD, Principal investigator, Ohio State UniversityShelley H Otsuka, PharmD, Study chair, The Ohio State UniveristyNeeraj H Tayal, MD, Study chair, Ohio State UniversityKyle Porter, MAS, Study chair, Ohio State UniversityPeter J Embi, MD, MS, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519570
- Sponsor's protocol ID
- 2010H0290
- Status last verified
- Aug 2018
- First submitted
- 12 Jan 2012
- Last updated
- 1 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Electronic Medical Record to Improve Standard Practice in the Primary Care Setting: A Randomized-Controlled Study of Herpes Zoster Vaccination Rates
- ClinicalTrials.gov ID
- NCT01519570
- Acronym / sponsor ID
- 2010H0290
- Conditions
- Herpes Zoster Disease
- Keywords
- Herpes Zoster vaccine, Electronic patient portal, Electronic medical record, Primary care, Immunizations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,589 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Posted 1 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| An informational packet regarding shingles and the HZV | Experimental | Other: An informational packet regarding shingles and the HZV was sent to patients identified by the EMR |
| Standard medical care from their primary care physician | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Greater than 60 years of age
Key exclusion criteria (1 listed)
- Documented herpes zoster vaccine in the EMR
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 |
|---|---|---|
| An informational packet regarding shingles and the HZV was sent to patients identified by the EMRThe 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. | Other | An informational packet regarding shingles and the HZV |
Primary outcome
Number of Participants Who Received the Herpes Zoster Vaccine
Time frame: 6 months
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.
2 secondary outcomes
Difference in Vaccination Rates Between Patients Who Recieved a Mailed Letter Versus a Secure Email
Time frame: 6 months
Amount of Time Required by a Clinical Pharmacist to Manage This Workflow
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stuart J Beatty, PharmD principal investigator
Ohio State University
Shelley H Otsuka, PharmD study chair
The Ohio State Univeristy
Neeraj H Tayal, MD study chair
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An informational packet regarding shingles and the HZV was sent to patients identified by the EMR in people with Herpes Zoster Disease, run by Ohio State University at 1 site in United States.
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 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 1 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Received the Herpes Zoster Vaccine (time frame: 6 months). 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 1 Feb 2019.