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Enhancing a Sustainable Pharmacy-based Immunization Program in Two States

Primary Purpose

Herpes Zoster, Pneumococcal Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced immunization delivery model
Immunization update
Sponsored by
Auburn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Herpes Zoster focused on measuring Pneumococcal Vaccines, Shingles, Pharmacy, Vaccine, Immunization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Auburn University
  • Keck Graduate Institute School of Pharmacy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced immunization delivery model

Immunization update

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 19, 2015
Last Updated
July 11, 2019
Sponsor
Auburn University
Collaborators
Keck Graduate Institute of Claremont, California, Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02615470
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
Collaborators
Keck Graduate Institute of Claremont, California, Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster, Pneumococcal Infections
Keywords
Pneumococcal Vaccines, Shingles, Pharmacy, Vaccine, Immunization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced immunization delivery model
Arm Type
Experimental
Arm Description
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.
Arm Title
Immunization update
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced immunization delivery model
Intervention Description
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
Other
Intervention Name(s)
Immunization update
Intervention Description
Basic immunization update online webinar will summarize changes in immunization schedules.
Primary Outcome Measure Information:
Title
Number of Herpes Zoster and Pneumococcal Vaccinations Administered
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Strategies Implemented to Promote Immunization Activities
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
The Level of Sustainability of Immunization Services
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salisa C Westrick, PhD
Organizational Affiliation
Auburn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auburn University
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36830
Country
United States
Facility Name
Keck Graduate Institute School of Pharmacy
City
Claremont
State/Province
California
ZIP/Postal Code
91711
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31735650
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.
Results Reference
derived
PubMed Identifier
30777645
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.
Results Reference
derived

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Enhancing a Sustainable Pharmacy-based Immunization Program in Two States

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