Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Use of an Electronic Medical Record in the Primary Care Setting to Improve Herpes Zoster Vaccination Rates

This study has been completed.
Information provided by (Responsible Party):
Stuart Beatty, Ohio State University Identifier:
First received: January 12, 2012
Last updated: January 24, 2012
Last verified: January 2012

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.

Condition Intervention
Herpes Zoster Disease
Other: An informational packet regarding shingles and the HZV was sent to patients identified by the EMR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Number of participants who received the herpes zoster vaccine [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 2589
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: An informational packet regarding shingles and the HZV Other: An informational packet regarding shingles and the HZV was sent to patients identified by the EMR
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.
No Intervention: Standard medical care from their primary care physician


Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Greater than 60 years of age

Exclusion Criteria:

  • Documented herpes zoster vaccine in the EMR
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01519570

United States, Ohio
The Ohio State University Martha Morehouse General Internal Medicine Clinic
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Ohio State University
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
  More Information

No publications provided

Responsible Party: Stuart Beatty, Assistant Professor, Ohio State University Identifier: NCT01519570     History of Changes
Other Study ID Numbers: 2010H0290
Study First Received: January 12, 2012
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Herpes Zoster vaccine
Electronic patient portal
Electronic medical record
Primary care

Additional relevant MeSH terms:
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections
Virus Diseases processed this record on February 27, 2015