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

This study has been completed.
Sponsor:
Collaborators:
Merck
American Pharmacists Association
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00689013
First received: May 21, 2008
Last updated: April 22, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention
Herpes Zoster
 Other: Personalized letter
Other: Flyer advertisement
Other: Newspaper press release

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Pharmacist Intervention on the Use of Zostavax in a Community Pharmacy Setting

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the relative efficacy of specific interventions on the rate of herpes zoster vaccinations [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • To evaluate the perception of patients receiving the herpes zoster vaccination as to the role of pharmacists as immunizers [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: February 2008
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Newspaper Ad

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689013

Locations
United States, Tennessee
Wilson Pharmacy
Johnson City, Tennessee, United States, 37602
Marcrom's Pharmacy
Manchester, Tennessee, United States, 37355
Reeves-Sain Drug Store
Murfreesboro, Tennessee, United States, 37129
Sponsors and Collaborators
University of Tennessee
Merck
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
  More Information

No publications provided

Responsible Party: Lindsay J. Ford, Pharm.D./Community Pharmacy Resident, University of Tennessee Community Pharmacy Residency Program
ClinicalTrials.gov Identifier: NCT00689013     History of Changes
Other Study ID Numbers: 8750
Study First Received: May 21, 2008
Last Updated: April 22, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Herpes Zoster
Prevention & control
Pharmacists
Pharmacy
 Pharmacies
Aged
Immunization
Vaccination

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on June 18, 2013