NCT00689013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2009

Enrollment Period

29 days

First QC Date

May 21, 2008

Last Update Submit

April 22, 2009

Conditions

Keywords

Herpes ZosterPrevention & controlPharmacistsPharmacyPharmaciesAgedImmunizationVaccination

Outcome Measures

Primary Outcomes (1)

  • To assess the effect of a pharmacist-driven immunization campaign on the rate of Zostavax immunizations in three separate community pharmacy settings

    2 months

Secondary Outcomes (2)

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

    2 months

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

    2 months

Study Arms (2)

1

NO INTERVENTION

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.

2

EXPERIMENTAL

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 letterOther: Flyer advertisementOther: Newspaper press release

Interventions

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.

Also known as: Letter
2

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.

Also known as: Flyer
2

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.

Also known as: Newspaper Ad
2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women aged 60 or older without contraindications for the herpes zoster vaccination

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wilson Pharmacy

Johnson City, Tennessee, 37602, United States

Location

Marcrom's Pharmacy

Manchester, Tennessee, 37355, United States

Location

Reeves-Sain Drug Store

Murfreesboro, Tennessee, 37129, United States

Location

MeSH Terms

Conditions

Herpes Zoster

Interventions

College Fraternities and Sororities

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Lindsay J Ford, Pharm.D.

    University of Tennessee Community Pharmacy Residency Program

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR
  • Stephan L Foster, Pharm.D.

    University of Tennessee Community Pharmacy Residency Program

    STUDY DIRECTOR
  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2008

First Posted

June 3, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 23, 2009

Record last verified: 2009-04

Locations