Clinical trial NCT02615470: Enhancing a Sustainable Pharmacy-based Immunization Program in Two States
Official title: Impact of a Multicomponent Immunization Intervention on Pneumococcal and Herpes Zoster Vaccinations: A Randomized Controlled Trial of Community Pharmacies in 2 States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Zoster
Pneumococcal Infections
Keywords: Pneumococcal Vaccines
Shingles
Pharmacy
Vaccine
Immunization
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Keck Graduate Institute of Claremont, California
name: Merck Sharp & Dohme LLC
First posted: 2015-11-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Herpes Zoster and Pneumococcal Vaccinations Administered
timeFrame: 6 months
Secondary outcomes:
measure: Number of Strategies Implemented to Promote Immunization Activities
timeFrame: 6 months
Other outcomes:
measure: The Level of Sustainability of Immunization Services
timeFrame: 24 months
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
city: Claremont
country: United States
facility: Keck Graduate Institute School of Pharmacy
state: California
Study officials:
affiliation: Auburn University
name: Salisa C Westrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.