ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02615470
Previous Study | Return to List | Next Study

Enhancing a Sustainable Pharmacy-based Immunization Program in Two States

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02615470
Recruitment Status : Active, not recruiting
First Posted : November 26, 2015
Last Update Posted : May 31, 2017
Sponsor:
Collaborators:
Keck Graduate Institute of Claremont, California
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Salisa Westrick, Auburn University

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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Pneumococcal Infections Behavioral: Enhanced immunization delivery model Other: Immunization update Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Impact of a Multicomponent Immunization Intervention on Pneumococcal and Herpes Zoster Vaccinations: A Randomized Controlled Trial of Community Pharmacies in 2 States
Actual Study Start Date : November 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Other: Immunization update
Basic immunization update online webinar will summarize changes in immunization schedules.

Active Comparator: 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.
Other: Immunization update
Basic immunization update online webinar will summarize changes in immunization schedules.




Primary Outcome Measures :
  1. Number of herpes zoster and pneumococcal vaccinations administered [ Time Frame: 6 months ]
    The change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from the 6-month baseline to the 6-month intervention period.


Secondary Outcome Measures :
  1. Number of strategies implemented to promote immunization activities [ Time Frame: 6 months ]
    Strategies include advertising strategies and direct assessment of patients' immunization status as reported at 6 months.


Other Outcome Measures:
  1. The level of sustainability of immunization services [ Time Frame: 7-12 months ]
    The number of pneumococcal and herpes zoster vaccinations administered in pharmacy during months 7-12 after the intervention ended between intervention pharmacies and the control pharmacies is the measure of sustainability

  2. Number of facilitators and barriers of immunization services reported [ Time Frame: 6 months ]
    Facilitators and barriers of the implementation of immunization services include staff and physician support, vaccine cost and reimbursement as reported at 6 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615470


Locations
United States, Alabama
Auburn University
Auburn, Alabama, United States, 36830
United States, California
Keck Graduate Institute School of Pharmacy
Claremont, California, United States, 91711
Sponsors and Collaborators
Auburn University
Keck Graduate Institute of Claremont, California
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Salisa C Westrick, PhD Auburn University

Responsible Party: Salisa Westrick, Associate Professor of Health Outcomes Research and Policy, Auburn University
ClinicalTrials.gov Identifier: NCT02615470     History of Changes
Other Study ID Numbers: MISP53380
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Salisa Westrick, Auburn University:
Pneumococcal Vaccines
Shingles
Pharmacy
Vaccine
Immunization

Additional relevant MeSH terms:
Herpes Zoster
Pneumococcal Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs