Enhancing a Sustainable Pharmacy-based Immunization Program in Two States

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. To compare the extent of immunization activity implementation during the intervention period between intervention pharmacies and control pharmacies. 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. To explore facilitators and barriers to implementing immunization services. To explore factors affecting patient acceptance of pharmacist's vaccine recommendations within the intervention pharmacies.

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

Conditions
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Herpes Zoster, Pneumococcal Infections

Intervention / Treatment
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* Behavioral: Enhanced immunization delivery model
* Other: Immunization update


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced immunization delivery model<br>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<br>* 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.<br>Other: Immunization update<br>* Basic immunization update online webinar will summarize changes in immunization schedules.<br>|
| Active Comparator: Immunization update<br>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<br>* Basic immunization update online webinar will summarize changes in immunization schedules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, Pneumococcal Vaccines, Shingles, Pharmacy, Immunization