Enhancing a Sustainable Pharmacy-based Immunization Program in Two States

NCT ID: NCT02615470

Last Updated: 2019-08-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-12-31

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:

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.

Conditions

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Herpes Zoster Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Enhanced immunization delivery model

Intervention Type BEHAVIORAL

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.

Immunization update

Intervention Type OTHER

Basic immunization update online webinar will summarize changes in immunization schedules.

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.

Group Type ACTIVE_COMPARATOR

Immunization update

Intervention Type OTHER

Basic immunization update online webinar will summarize changes in immunization schedules.

Interventions

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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.

Intervention Type BEHAVIORAL

Immunization update

Basic immunization update online webinar will summarize changes in immunization schedules.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Keck Graduate Institute of Claremont, California

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Auburn University

OTHER

Sponsor Role lead

Responsible Party

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Salisa Westrick

Professor of Health Outcomes Research and Policy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salisa C Westrick, PhD

Role: PRINCIPAL_INVESTIGATOR

Auburn University

Locations

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Auburn University

Auburn, Alabama, United States

Site Status

Keck Graduate Institute School of Pharmacy

Claremont, California, United States

Site Status

Countries

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United States

References

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Hastings TJ, Hohmann LA, Huston SA, Ha D, Westrick SC, Garza KB. Enhancing pharmacy personnel immunization-related confidence, perceived barriers, and perceived influence: The We Immunize program. J Am Pharm Assoc (2003). 2020 Mar-Apr;60(2):344-351.e2. doi: 10.1016/j.japh.2019.10.005. Epub 2019 Nov 14.

Reference Type DERIVED
PMID: 31735650 (View on PubMed)

Hohmann LA, Hastings TJ, Ha DR, Garza KB, Huston SA, Chen L, Westrick SC. Impact of a multi-component immunization intervention on pneumococcal and herpes zoster vaccinations: A randomized controlled trial of community pharmacies in 2 states. Res Social Adm Pharm. 2019 Dec;15(12):1453-1463. doi: 10.1016/j.sapharm.2019.01.006. Epub 2019 Feb 7.

Reference Type DERIVED
PMID: 30777645 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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MISP53380

Identifier Type: -

Identifier Source: org_study_id

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