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CompletedNCT03851978Updated Mar 15, 2019

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

An interventional study of Pharmacist Vaccine Education in Pneumococcal Pneumonia, sponsored by Virginia Commonwealth University. Completed at 4 sites in United States. Open to participants aged 19 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-15.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2018, registered Feb 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
431
Allocation
Not applicable
Ages
19 Years to 64 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pneumococcal Pneumonia

Keywords

  • vaccination
03

In context

Pneumonia, Pneumococcal

121 studies on the registry are indexed under Pneumonia, Pneumococcal; 7 are open to participants now.

This study's enrollment of 431 is above the median of 304 across 79 interventional studies indexed under Pneumonia, Pneumococcal.

Browse Pneumonia, Pneumococcal studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with a known history pneumococcal polysaccharide vaccination
  • Patients with an allergy to any component of the pneumococcal polysaccharide vaccine
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
431 participants (actual)

Study arms

  • Experimental
    Pharmacist Vaccine Education

    Behavioral: Pharmacist Vaccine Education

Interventions

  • BehavioralPharmacist 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.

06

What researchers measure

Primary outcomes

  1. Change in vaccination rates

    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.

    Time frame: 4 months

Secondary outcomes

  1. Barriers to receiving vaccination

    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.

    Time frame: 4 months

07

Study locations

4 sites
  • Kroger Pharmacy
    Midlothian, Virginia 23113, United States
  • Kroger Pharmacy
    Richmond, Virginia 23230, United States
  • Kroger Pharmacy
    Richmond, Virginia 23233, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
08

References and documents

Publications

  • Page A, Harrison A, Nadpara P, Goode JR. Pharmacist impact on pneumococcal polysaccharide vaccination rates in patients with diabetes in a national grocery chain pharmacy. J Am Pharm Assoc (2003). 2020 May-Jun;60(3S):S51-S55.e1. doi: 10.1016/j.japh.2020.02.007. Epub 2020 Mar 17. PubMed 32192948 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03851978
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Feb 22, 2019
Start date
Nov 1, 2018
Primary completion
Feb 28, 2019
Completion
Feb 28, 2019
Last update
Mar 15, 2019

Study contacts

Jean-Venable Goode, Pharm.D., BCPS, FAPhA, FCCP
principal investigator · Virginia Commonwealth University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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