Pharmacist Impact on Pneumococcal Polysaccharide Vaccination Rates in Patients With Diabetes in a Supermarket Pharmacy Chain

March 14, 2019 updated by: Virginia Commonwealth University
The goals of the study are to determine the pneumococcal polysaccharide vaccination rate in patients with diabetes before and after community pharmacist education and intervention. Assess barriers of receiving the pneumococcal polysaccharide vaccine in patients with diabetes after pharmacist education in a supermarket chain setting

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Three geographically and socioeconomically diverse Kroger pharmacies will be selected in the greater Richmond area. Eligible patients include patients with diabetes between the ages of 19 and 64 and patients who have filled a prescription for at least one diabetes medication in the past 90 days. An NDC (National Drug Code) activity report will be run through Kroger internal reporting to identify patients who have filled a prescription for a diabetes medication in the past 90 days. Excluded patients include those with a known history pneumococcal polysaccharide vaccination, and patients with an allergy to any component of the pneumococcal polysaccharide vaccine. All patients who are deemed eligible will have their immunization history assessed by verifying immunization records in their Kroger medication profile, in the Virginia Immunization Information System (VIIS) or with their primary care physician. The percentage of patients vaccinated with the pneumococcal polysaccharide vaccine in the three Kroger pharmacies will be calculated prior to the start of the intervention period.

Eligible patients will have a pop-up note added to their patient profile in the Kroger system. The pop-up note will indicate that the patient is eligible for education on the pneumococcal polysaccharide vaccine. When an eligible patient presents to the pharmacy for prescription pick up or drop off, the pop-up note will notify the technician to get a pharmacist for education. The pharmacist will educate the patient on the vaccine and then recommend that the patient receives the vaccine. If the patient accepts the recommendation, the pharmacist will then follow Kroger policies and protocol and administer the pneumococcal polysaccharide vaccine to the patient. Standard procedure of administering a pneumococcal vaccine at Kroger includes having the patient complete and sign a vaccination consent form. The consent form consists of questions that assess the patients current health status, immunocompromising conditions, allergies and pregnancy status This indicates to the pharmacist whether the vaccine requested is appropriate for the patient. The pharmacist will review the Kroger consent form and administer the pneumococcal vaccine, using sterile injection technique, if there are no contraindications. After the patient receives the vaccine or declines the vaccine recommendation, the pharmacist will then ask the patient to complete a brief survey. After completion or refusal of the survey, the pharmacist will document the date the survey was completed or denied and if the pneumococcal vaccine was given. After the patient encounter has ended, the pharmacist will edit the pop-up note in the patient profile to document the date the patient was educated, and no further intervention is needed.

Study Type

Interventional

Enrollment (Actual)

431

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Midlothian, Virginia, United States, 23113
        • Kroger Pharmacy
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23230
        • Kroger Pharmacy
      • Richmond, Virginia, United States, 23233
        • Kroger Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with diabetes
  • Patients who have filled a prescription for at least one diabetes medication in the past 90 days

Exclusion Criteria:

  • Patients with a known history pneumococcal polysaccharide vaccination
  • Patients with an allergy to any component of the pneumococcal polysaccharide vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacist Vaccine Education
Behavioral: Pharmacist Vaccine Education
When an eligible patient presents to the pharmacy for prescription pick up or drop off, the pop-up note will notify the technician to get a pharmacist for education. The pharmacist will educate the patient on the vaccine and then recommend that the patient receives the vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vaccination rates
Time Frame: 4 months
Percentage of patients with diabetes in a national grocery chain pharmacy who received the pneumococcal polysaccharide vaccine before the intervention compared to the percentage who received the vaccination after the intervention.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barriers to receiving vaccination
Time Frame: 4 months
Self-reported reasons for not receiving pneumococcal polysaccharide vaccine as measured by a categorical question asking why participants did not receive the vaccine and asking participants to select all reasons that apply and/or provide additional reason(s) not listed.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Jean-Venable Goode, Pharm.D., BCPS, FAPhA, FCCP, Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

February 18, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20014257

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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