NCT02615470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 20, 2019

Completed
Last Updated

August 20, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

November 19, 2015

Results QC Date

May 30, 2018

Last Update Submit

July 11, 2019

Conditions

Keywords

Pneumococcal VaccinesShinglesPharmacyVaccineImmunization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Strategies Implemented to Promote Immunization Activities

    6 months

Other Outcomes (1)

  • The Level of Sustainability of Immunization Services

    24 months

Study Arms (2)

Enhanced immunization delivery model

EXPERIMENTAL

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 modelOther: Immunization update

Immunization update

ACTIVE COMPARATOR

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

Interventions

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.

Enhanced immunization delivery model

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

Enhanced immunization delivery modelImmunization update

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Alabama and California community pharmacies
  • Must provide in-store prescription-dispensing service
  • Must provide pneumococcal vaccine and/or herpes zoster

You may not qualify if:

  • Must have no plan to close or change the ownership in the next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Auburn University

Auburn, Alabama, 36830, United States

Location

Keck Graduate Institute School of Pharmacy

Claremont, California, 91711, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Herpes ZosterPneumococcal Infections

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Results Point of Contact

Title
Salisa Westrick
Organization
Auburn University

Study Officials

  • Salisa C Westrick, PhD

    Auburn University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Health Outcomes Research and Policy

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 26, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

August 20, 2019

Results First Posted

August 20, 2019

Record last verified: 2019-07

Locations