Enhancing a Sustainable Pharmacy-based Immunization Program in Two States

Herpes Zoster Clinical Trial

Official title:

Impact of a Multicomponent Immunization Intervention on Pneumococcal and Herpes Zoster Vaccinations: A Randomized Controlled Trial of Community Pharmacies in 2 States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615470
• Other study ID #: MISP53380
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2019
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study's aim is to enhance current immunization activities in community pharmacies through targeting the two most commonly available non-seasonal vaccines in community pharmacies, namely pneumococcal and herpes zoster vaccination services. The study will compare the change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from the corresponding 6-month period prior to the intervention to the 6-month intervention period between intervention pharmacies and the control pharmacies.

Description:

Community pharmacies are in a unique position and have potential to help increase immunization rates, especially among those who do not visit their primary care provider regularly. This study seeks to increase the level of pharmacy-based immunization delivery.

The study intervention is designed to increase the current level of pharmacy-based immunization delivery and foster practice change to sustain the intervention effect. Our intervention combines evidence-based strategies for improving immunization coverage and strategies to overcome system barriers to increase sustainability of the intervention over time. The study will focus on pneumococcal and herpes zoster vaccination services.

Specific aims include:

1. To compare the change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from the corresponding 6-month period prior to the intervention to the 6-month intervention period between intervention pharmacies and the control pharmacies. The pre-intervention period will correspond to the intervention period.

2. To compare the extent of immunization activity implementation during the intervention period between intervention pharmacies and control pharmacies.

3. To compare the level of sustainability of immunization services over the period of 6 months after the intervention period ends between the intervention group and the control group.

4. To explore facilitators and barriers to implementing immunization services.

5. To explore factors affecting patient acceptance of pharmacist's vaccine recommendations within the intervention pharmacies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Alabama and California community pharmacies

• Must provide in-store prescription-dispensing service

• Must provide pneumococcal vaccine and/or herpes zoster

Exclusion Criteria:

• Must have no plan to close or change the ownership in the next 12 months

Related Conditions & MeSH terms

• Herpes Zoster
• Pneumococcal Infections

Intervention

Behavioral:
• Enhanced immunization delivery model
Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.

Other:
• Immunization update
Basic immunization update online webinar will summarize changes in immunization schedules.

Locations

Country	Name	City	State
United States	Auburn University	Auburn	Alabama
United States	Keck Graduate Institute School of Pharmacy	Claremont	California

Sponsors (3)

Lead Sponsor	Collaborator
Auburn University	Keck Graduate Institute of Claremont, California, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Level of Sustainability of Immunization Services	Change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from 12 Months Pre- to 12 Months Post-Intervention. A representative of each pharmacy unit reported vaccine doses.	24 months
Primary	Number of Herpes Zoster and Pneumococcal Vaccinations Administered	The change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy during the 6-month intervention period from the 6-month baseline.	6 months
Secondary	Number of Strategies Implemented to Promote Immunization Activities	During the study, pharmacist-technician pairs engaged in on-going strategies used to advertise, market and assess non-seasonal immunization service processes. Of the total of 10 strategies possible, each pair selected strategies that they implemented. Results were reported by a representative from each pharmacy unit.	6 months