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

NCT ID: NCT00689013

Last Updated: 2009-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Herpes Zoster

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Personalized letter

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Letter Flyer Newspaper Ad

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

American Pharmacists Association

OTHER

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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University of Tennessee Community Pharmacy Residency Program

Principal Investigators

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Lindsay J Ford, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee Community Pharmacy Residency Program

Sarah K Frank, Pharm.D.

Role: STUDY_CHAIR

University of Tennessee Community Pharmacy Residency Program

Nina H Jaber, Pharm.D.

Role: STUDY_CHAIR

University of Tennessee Community Pharmacy Residency Program

Stephan L Foster, Pharm.D.

Role: STUDY_DIRECTOR

University of Tennessee Community Pharmacy Residency Program

Richard Randolph, Pharm.D.

Role: STUDY_CHAIR

University of Tennessee Community Pharmacy Residency Program

Steve Lane, Pharm.D.

Role: STUDY_CHAIR

University of Tennessee Community Pharmacy Residency Program

Cindy T Smith, Pharm.D.

Role: STUDY_CHAIR

University of Tennessee Community Pharmacy Residency Program

Locations

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Wilson Pharmacy

Johnson City, Tennessee, United States

Site Status

Marcrom's Pharmacy

Manchester, Tennessee, United States

Site Status

Reeves-Sain Drug Store

Murfreesboro, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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8750

Identifier Type: -

Identifier Source: org_study_id

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