Enhancing a Sustainable Pharmacy-based Immunization Program in Two States

July 11, 2019 updated by: Salisa Westrick, Auburn University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36830
        • Auburn University
    • California
      • Claremont, California, United States, 91711
        • Keck Graduate Institute School of Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced immunization delivery model
Pharmacist-technician pairs employed by community pharmacies that are assigned to this arm will receive a) immunization update training, b) training by immunization experts to enhance immunization delivery model and foster practice change at the beginning of 6-month and c) regular feedback and clinical support for the period of 6 months.
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.
Active Comparator: Immunization update
Pharmacist-technician pairs employed by community pharmacies that are assigned to the control arm will receive an immunization update training. They will not receive a training by immunization experts nor regular feedback and clinical support.
Other: Immunization update
Basic immunization update online webinar will summarize changes in immunization schedules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Herpes Zoster and Pneumococcal Vaccinations Administered
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Strategies Implemented to Promote Immunization Activities
Time Frame: 6 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Level of Sustainability of Immunization Services
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auburn University

Collaborators

Merck Sharp & Dohme LLC
Keck Graduate Institute of Claremont, California

Investigators

  • Principal Investigator: Salisa C Westrick, PhD, Auburn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISP53380

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumococcal Infections

Clinical Trials on Enhanced immunization delivery model

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe