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

Primary Purpose

Herpes Zoster

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Personalized letter

Flyer advertisement

Newspaper press release

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring Herpes Zoster, Prevention & control, Pharmacists, Pharmacy, Pharmacies, Aged, Immunization, Vaccination

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Wilson Pharmacy
Marcrom's Pharmacy
Reeves-Sain Drug Store

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

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.

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.

Outcomes

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

Secondary Outcome Measures

To evaluate the relative efficacy of specific interventions on the rate of herpes zoster vaccinations

To evaluate the perception of patients receiving the herpes zoster vaccination as to the role of pharmacists as immunizers

Full Information

NCT ID

NCT00689013

First Posted

May 21, 2008

Last Updated

April 22, 2009

Sponsor

University of Tennessee

Collaborators

Merck Sharp & Dohme LLC, American Pharmacists Association

1. Study Identification

Unique Protocol Identification Number

NCT00689013

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Tennessee

Collaborators

Merck Sharp & Dohme LLC, American Pharmacists Association

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Zoster

Keywords

Herpes Zoster, Prevention & control, Pharmacists, Pharmacy, Pharmacies, Aged, Immunization, Vaccination

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

205 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Personalized letter

Other Intervention Name(s)

Letter

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Flyer advertisement

Other Intervention Name(s)

Flyer

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Newspaper press release

Other Intervention Name(s)

Newspaper Ad

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

To evaluate the relative efficacy of specific interventions on the rate of herpes zoster vaccinations

Time Frame

2 months

Title

To evaluate the perception of patients receiving the herpes zoster vaccination as to the role of pharmacists as immunizers

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: