The Effect of Pharmacist Intervention on the Use of Zostavax in a Community Pharmacy Setting

April 22, 2009 updated by: University of Tennessee
The purpose of this study is to determine whether pharmacist-driven patient interventions can have an effect on the number of herpes zoster (Zostavax) vaccinations given in a community pharmacy setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several studies exist documenting the perception and satisfaction of patients receiving immunizations from pharmacists, as well as the effects of pharmacist involvement in advocating and administering vaccinations. The most well documented studies have been conducted in hospital settings. Undoubtedly, there is enormous opportunity for the community pharmacist to identify potential vaccine recipients, advocate immunization and administer said immunizations to their established patient populations. However, there is a lack of concentrated study in the implementation of immunization services in the community setting and their effects. The investigators intend to evaluate the intervention of pharmacists in an immunization program and the resulting changes in immunization rates.

Study Type

Interventional

Enrollment (Actual)

205

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

  • United States
    • Tennessee
      • Johnson City, Tennessee, United States, 37602
        • Wilson Pharmacy
      • Manchester, Tennessee, United States, 37355
        • Marcrom's Pharmacy
      • Murfreesboro, Tennessee, United States, 37129
        • Reeves-Sain Drug Store

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men and women aged 60 or older without contraindications for the herpes zoster vaccination
  • patients who have already experienced one or more episodes of herpes zoster infection were considered for vaccine receipt and study inclusion secondary to CDC ACIP recommendations

Exclusion Criteria:

  • Patients aged < 60 years
  • Anyone who has previously received the herpes zoster vaccine
  • Anyone with an allergy to neomycin, gelatin or any other component of the vaccine
  • Anyone receiving a live vaccine within 4 weeks
  • Anyone with a compromised or weakened immune systems such as those receiving radiation, corticosteroids, or those with HIV/AIDS, cancer in the lymph, bone or blood systems
  • Pregnant women or those in close contact with a pregnant woman

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Patients voluntarily presenting to community pharmacies who request receipt of the herpes zoster vaccine during the first month of observation. These patients have not been exposed to pharmacist-driven interventions utilized in this study. This group serves as the control group.
Experimental: 2
Patients voluntarily presenting to community pharmacies who request receipt of the herpes zoster vaccine during the second month of observation. These patients may or may not have been exposed to pharmacist-driven interventions utilized in this study. This group serves as the study/intervention group.
Other: Personalized letter
On Day 1 of the 2nd month, a personalized letter (addressing specific patient) was mailed to current pharmacy patients with indications for the Zostavax vaccine. Current patients were defined as those receiving at least one prescription medication from the pharmacy within 6 months. The personalized letter provided detailed information about herpes zoster infection, the vaccine for herpes zoster prevention, indications for vaccine receipt and contraindications for vaccine receipt.
Other Names:
  • Letter
Other: Flyer advertisement
Beginning on Day 1 of the 2nd month, flyer advertisements were distributed with all pharmacy sales. Flyer advertisements provided detailed information about herpes zoster infection, the vaccine for herpes zoster prevention, indications for vaccine receipt and contraindications for vaccine receipt.
Other Names:
  • Flyer
Other: Newspaper press release
During the first week of the 2nd month, local newspapers published press releases. The press release provided detailed information about herpes zoster infection, the vaccine for herpes zoster prevention, indications for vaccine receipt and contraindications for vaccine receipt.
Other Names:
  • Newspaper Ad

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the effect of a pharmacist-driven immunization campaign on the rate of Zostavax immunizations in three separate community pharmacy settings
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the relative efficacy of specific interventions on the rate of herpes zoster vaccinations
Time Frame: 2 months
2 months
To evaluate the perception of patients receiving the herpes zoster vaccination as to the role of pharmacists as immunizers
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

Merck Sharp & Dohme LLC
American Pharmacists Association

Investigators

  • Principal Investigator: Lindsay J Ford, Pharm.D., University of Tennessee Community Pharmacy Residency Program
  • Study Chair: Sarah K Frank, Pharm.D., University of Tennessee Community Pharmacy Residency Program
  • Study Chair: Nina H Jaber, Pharm.D., University of Tennessee Community Pharmacy Residency Program
  • Study Director: Stephan L Foster, Pharm.D., University of Tennessee Community Pharmacy Residency Program
  • Study Chair: Richard Randolph, Pharm.D., University of Tennessee Community Pharmacy Residency Program
  • Study Chair: Steve Lane, Pharm.D., University of Tennessee Community Pharmacy Residency Program
  • Study Chair: Cindy T Smith, Pharm.D., University of Tennessee Community Pharmacy Residency Program

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

February 1, 2008

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

April 23, 2009

Last Update Submitted That Met QC Criteria

April 22, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8750

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.

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