Herpes ZosterNCT00689013
The Effect of Pharmacist Intervention on the Use of Zostavax in a Community Pharmacy Setting
A study testing Personalized letter, Flyer advertisement and Newspaper press release in people with Herpes Zoster, run by University of Tennessee at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Personalized letter, Flyer advertisement and Newspaper press release
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2008to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Wilson Pharmacy
Johnson City, Tennessee, 37602
Marcrom's Pharmacy
Manchester, Tennessee, 37355
Reeves-Sain Drug Store
Murfreesboro, Tennessee, 37129
About this study
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.
Read the 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.
- Conditions
- Herpes Zoster
- Being tested
- Personalized letter, Flyer advertisement, Newspaper press release
- Keywords
- Herpes Zoster, Prevention & control, Pharmacists, Pharmacy, Pharmacies, Aged, Immunization, Vaccination
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized letterOther
Also called 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 advertisementOther
Also called Flyer
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 releaseOther
Also called Newspaper Ad
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Personalized letter; Other: Flyer advertisement; Other: Newspaper press release |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of a pharmacist-driven immunization campaign on the rate of Zostavax immunizations in three separate community pharmacy settings
Measured: 2 months
Secondary outcomes (2)
To evaluate the relative efficacy of specific interventions on the rate of herpes zoster vaccinations
Measured: 2 months
To evaluate the perception of patients receiving the herpes zoster vaccination as to the role of pharmacists as immunizers
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, American Pharmacists Association
- Investigators
- Lindsay J Ford, Pharm.D., Principal investigator, University of Tennessee Community Pharmacy Residency ProgramSarah K Frank, Pharm.D., Study chair, University of Tennessee Community Pharmacy Residency ProgramNina H Jaber, Pharm.D., Study chair, University of Tennessee Community Pharmacy Residency ProgramStephan L Foster, Pharm.D., Study director, University of Tennessee Community Pharmacy Residency ProgramRichard Randolph, Pharm.D., Study chair, University of Tennessee Community Pharmacy Residency ProgramSteve Lane, Pharm.D., Study chair, University of Tennessee Community Pharmacy Residency ProgramCindy T Smith, Pharm.D., Study chair, University of Tennessee Community Pharmacy Residency Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689013
- Sponsor's protocol ID
- 8750
- Status last verified
- Apr 2009
- First submitted
- 21 May 2008
- Last updated
- 23 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pharmacist Intervention on the Use of Zostavax in a Community Pharmacy Setting
- ClinicalTrials.gov ID
- NCT00689013
- Acronym / sponsor ID
- 8750
- Conditions
- Herpes Zoster
- Keywords
- Herpes Zoster, Prevention & control, Pharmacists, Pharmacy, Pharmacies, Aged, Immunization, Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, American Pharmacists Association
- Study start
- Feb 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Personalized letter, Other: Flyer advertisement, Other: Newspaper press releasePatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized letterAlso: LetterOn 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 | 2 |
| Flyer advertisementAlso: FlyerBeginning 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 | 2 |
| Newspaper press releaseAlso: Newspaper AdDuring 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 | 2 |
Primary outcome
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
2 secondary outcomes
To evaluate the relative efficacy of specific interventions on the rate of herpes zoster vaccinations
Time frame: 2 months
To evaluate the perception of patients receiving the herpes zoster vaccination as to the role of pharmacists as immunizers
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay J Ford, Pharm.D. principal investigator
University of Tennessee Community Pharmacy Residency Program
Sarah K Frank, Pharm.D. study chair
University of Tennessee Community Pharmacy Residency Program
Nina H Jaber, Pharm.D. study chair
University of Tennessee Community Pharmacy Residency Program
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized letter, Flyer advertisement and Newspaper press release in people with Herpes Zoster, run by University of Tennessee at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2009.