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

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689013
• Other study ID #: 8750
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: April 22, 2009
• Start date: February 2008
• Est. completion date: March 2008

Study information

• Verified date: April 2009
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Wilson Pharmacy	Johnson City	Tennessee
United States	Marcrom's Pharmacy	Manchester	Tennessee
United States	Reeves-Sain Drug Store	Murfreesboro	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
University of Tennessee	American Pharmacists Association, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of a pharmacist-driven immunization campaign on the rate of Zostavax immunizations in three separate community pharmacy settings		2 months	No
Secondary	To evaluate the relative efficacy of specific interventions on the rate of herpes zoster vaccinations		2 months	No
Secondary	To evaluate the perception of patients receiving the herpes zoster vaccination as to the role of pharmacists as immunizers		2 months	No