Use of an Electronic Medical Record in the Primary Care Setting to Improve Herpes Zoster Vaccination Rates
Primary Purpose
Herpes Zoster Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
An informational packet regarding shingles and the HZV was sent to patients identified by the EMR
Sponsored by
About this trial
This is an interventional health services research trial for Herpes Zoster Disease focused on measuring Herpes Zoster vaccine, Electronic patient portal, Electronic medical record, Primary care, Immunizations
Eligibility Criteria
Inclusion Criteria:
- Greater than 60 years of age
Exclusion Criteria:
- Documented herpes zoster vaccine in the EMR
Sites / Locations
- The Ohio State University Martha Morehouse General Internal Medicine Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
An informational packet regarding shingles and the HZV
Standard medical care from their primary care physician
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Amount of Time Required by a Clinical Pharmacist to Manage This Workflow
Full Information
NCT ID
NCT01519570
First Posted
January 12, 2012
Last Updated
August 27, 2018
Sponsor
Ohio State University
1. Study Identification
Unique Protocol Identification Number
NCT01519570
Brief Title
Use of an Electronic Medical Record in the Primary Care Setting to Improve Herpes Zoster Vaccination Rates
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster Disease
Keywords
Herpes Zoster vaccine, Electronic patient portal, Electronic medical record, Primary care, Immunizations
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2589 (Actual)
8. Arms, Groups, and Interventions
Arm Title
An informational packet regarding shingles and the HZV
Arm Type
Experimental
Arm Title
Standard medical care from their primary care physician
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
An informational packet regarding shingles and the HZV was sent to patients identified by the EMR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Received the Herpes Zoster Vaccine
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Difference in Vaccination Rates Between Patients Who Recieved a Mailed Letter Versus a Secure Email
Description
Difference in vaccination rates between patients sent communications via US postal service (USPS) and those sent communications via electronic patient portal (EPP)
Time Frame
6 months
Title
Amount of Time Required by a Clinical Pharmacist to Manage This Workflow
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Greater than 60 years of age
Exclusion Criteria:
Documented herpes zoster vaccine in the EMR
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart J Beatty, PharmD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shelley H Otsuka, PharmD
Organizational Affiliation
The Ohio State Univeristy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Neeraj H Tayal, MD
Organizational Affiliation
Ohio State University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kyle Porter, MAS
Organizational Affiliation
Ohio State University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter J Embi, MD, MS
Organizational Affiliation
Ohio State University
Official's Role
Study Chair
Facility Information:
Facility Name
The Ohio State University Martha Morehouse General Internal Medicine Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of an Electronic Medical Record in the Primary Care Setting to Improve Herpes Zoster Vaccination Rates
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