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Pneumococcal PneumoniaNCT03851978

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

A study testing Pharmacist Vaccine Education in people with Pneumococcal Pneumonia, run by Virginia Commonwealth University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Pneumococcal Pneumonia
What is being tested?
Pharmacist Vaccine Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
431 participants
Where
4 sitesUnited States
Study dates
1 Nov 2018to 28 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Kroger Pharmacy

    Midlothian, Virginia, 23113

  • Kroger Pharmacy

    Richmond, Virginia, 23230

  • Kroger Pharmacy

    Richmond, Virginia, 23233

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

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.

Being tested
Pharmacist Vaccine Education
Keywords
vaccination
Medical subject headings
Pneumonia, Pneumococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmacist Vaccine EducationBehavioural

    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.

Study groups in NCT03851978
Study groupRoleWhat they receive
Pharmacist Vaccine EducationExperimentalNot described
Receives: Behavioral: Pharmacist Vaccine Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 months

Secondary outcomes (1)
  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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start1 Nov 2018
  3. Primary completion28 Feb 2019
  4. Study completion28 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
431 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03851978
Sponsor's protocol ID
HM20014257
Status last verified
Mar 2019
First submitted
18 Feb 2019
Last updated
15 Mar 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacist Vaccine Education in people with Pneumococcal Pneumonia, run by Virginia Commonwealth University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in vaccination rates (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03851978, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.

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