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

Primary Purpose

Pneumococcal Pneumonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacist Vaccine Education
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Pneumonia focused on measuring vaccination

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kroger Pharmacy
  • Kroger Pharmacy
  • Kroger Pharmacy
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pharmacist Vaccine Education

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 18, 2019
Last Updated
March 14, 2019
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03851978
Brief Title
Pharmacist Impact on Pneumococcal Polysaccharide Vaccination Rates in Patients With Diabetes in a Supermarket Pharmacy Chain
Official Title
Pharmacist Impact on Pneumococcal Polysaccharide Vaccination Rates in Patients With Diabetes in a Supermarket Pharmacy Chain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Pneumonia
Keywords
vaccination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
431 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacist Vaccine Education
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Pharmacist Vaccine Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in vaccination rates
Description
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 Outcome Measure Information:
Title
Barriers to receiving vaccination
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Venable Goode, Pharm.D., BCPS, FAPhA, FCCP
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kroger Pharmacy
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23113
Country
United States
Facility Name
Kroger Pharmacy
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Kroger Pharmacy
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32192948
Citation
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.
Results Reference
derived

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

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