Impact and Cost of a Pharmacist Pneumococcal Vaccination Program With PNEUMOVAX® 23 at an Urban Senior Center (PPVP)

May 26, 2017 updated by: Thomas Jefferson University

Impact and Cost of a Pharmacist Pneumococcal Vaccination Program With PNEUMOVAX® 23 at an Urban Senior Center for Adults Aged 65 Years or Older or Those With Defined Risk Factors for Invasive Pneumococcal Disease

The overall goals of this program are to measure the impact of a pharmacist pneumococcal vaccine education program (PPVP) using a senior center model of care and provide the pneumococcal vaccine to eligible participants.

Hypotheses

  1. PPVP will result in improved knowledge and awareness in older minorities in the senior center setting (primary hypothesis);
  2. Participants who are vaccinated through the project will experienced increased trust in receiving vaccines from a pharmacist;
  3. Participants will be satisfied with and trust the PV information provided by pharmacists in the PPVP;
  4. PPVP is an efficient approach to educating patients in the senior center based on its costs;
  5. Participating pharmacists will be activated to implement PPVP learnings in their practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
203

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19144
        • Center in the Park

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

A. Inclusions for PPVP:

  1. Age ≥ 50 years old
  2. Can attend a 1.5-hour session at CIP
  3. Cognitively intact based on responses to an Abbreviated Mental Test Score (AMTS) of ≥7 (see Appendix for AMTS instrument)
  4. Can speak and read English at ≥4th grade level as evidenced by ability to read a brief passage
  5. Access to a telephone

B. Inclusions to receive the optional pneumococcal vaccination:

Patient meets ≥1 of the following criteria for receiving their first pneumococcal vaccination:

  1. All adults age 65 years and older who have not had the vaccine previously

  2. Age 50-64 years with any of the following conditions:

    1. Cigarette smokers age 19 years and older
    2. Chronic cardiovascular disease (e.g., congestive heart failure, cardiomyopathies; excluding hypertension)
    3. Chronic pulmonary disease (including COPD and emphysema, and for adults ages 19 years and older, asthma)
    4. Diabetes mellitus
    5. Alcoholism
    6. Chronic liver disease, cirrhosis
    7. Candidate for or recipient of cochlear implant
    8. Functional or anatomic asplenia (e.g., sickle cell disease, splenectomy)
    9. Immunocompromising conditions or on immunosuppressive therapy
    10. Chronic renal failure or nephrotic syndrome

OR

Patient meets ≥1 of the following criteria for receiving a booster dose of the pneumococcal vaccination:

  1. Adults age 65 years and older who received their first dose for any indication when they were younger than age 65 years.

  2. Adults age 50-64 who have not received the vaccine for ≥5 years and have one of the following conditions:

    1. Functional or anatomic asplenia (including persons with sickle cell disease or splenectomy patients);
    2. Chronic renal failure (including dialysis patients) or nephrotic syndrome;
    3. Immunocompromising conditions or on immunosuppressive therapy

Exclusion Criteria:

A. Exclusions to the PPVP program: none

B. Exclusions to receiving the optional pneumococcal vaccine:

  1. Participant has a history of allergic reaction to pneumococcal vaccine
  2. Participant has a history of allergic reaction to any component of any vaccine
  3. Participant with moderate or severe illness (these individuals will be advised to speak to their doctor regarding the 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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pharmacist Pneumococcal Vaccine Program (PPVP)
Individuals receiving the PPVP intervention which consists of the educational program delivered on site at the collaborating senior center.
Behavioral: Pharmacist Pneumococcal Vaccine Program (PPVP)
1.5 hour educational intervention delivered onsite at collaborating senior center consisting of 3 components: presentation about pneumococcal disease and the vaccine given by a infectious disease-certified pharmacist; 2) skits given by volunteer actors at the senior center to illustrate real world scenarios related to pneumococcal disease and the vaccine; 3) action planning to consist of small group breakouts led by licensed pharmacists and 4) vaccination day which is an optional component following the education program, for participants eligible to receive the vaccine. Vaccination to be provided free of charge to eligible participants who opt to receive it.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knowledge and Awareness of Pneumococcal Disease
Time Frame: Baseline, post-test, 3 months
Change in knowledge and awareness of pneumococcal disease over time were assessed for the following domains: susceptibility to infection, symptoms of disease, severity of illness, and vaccination with an emphasis on vaccine efficacy, safety, and eligibility. Assessments at baseline, post-test (immediately following intervention), and 3 months using the Pneumonia Knowledge Questionnaire, an instrument developed by investigators to assess participants' knowledge and awareness in the domains of interest. Instrument consists of 5 "mark all that apply" items and one "mark the best response" item. Scores range from 0 (no correct responses) to 28 (all responses correct), with a higher score value corresponding to better knowledge and awareness.
Baseline, post-test, 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trust in Pharmacists as Vaccine Providers
Time Frame: Baseline, post-test (immediately following intervention), 3 months
Trust in pharmacists as vaccine providers were measured by comparing responses to the trust items in the baseline, post-test (immediately following intervention), and 3-month assessments. Trust items were coded on a 4-level Likert scale, with lower values corresponding to higher agreement with the trust statements (therefore a lower mean response indicates greater trust). Minimum possible score was 1 (indicating complete trust in pharmacists as vaccine providers) and maximum possible score was 4 (indicating complete lack of trust in pharmacists as vaccine providers).
Baseline, post-test (immediately following intervention), 3 months
Activation
Time Frame: 3 months
Activation was measured as number of participants having taken action at 3 months or planning action at baseline, post-test, and 3 months.
3 months
Satisfaction With PPPP
Time Frame: 3 months
Satisfaction with PPPP was measured as participants' overall satisfaction with the content of PPPP, extent to which the participant felt engaged, and belief that the program helped them learn about pneumonia and the vaccination.
3 months
Intervention Cost
Time Frame: 3 months
Measures PPPP intervention costs per participant. Consists of total program costs divided by number of participants. Value reported is the per-participant cost with measure type "number".
3 months
Pharmacist Satisfaction
Time Frame: 3 months
Pharmacists who participated in the intervention were surveyed to determine their satisfaction with the program, including: 1) satisfaction with live action skit, 2) belief that PPPP was successful in educating participants, 3) belief that PPPP was successful in building trust in pharmacists among participants, 4) belief that PPPP was successful in increasing acceptance of pharmacists as immunizers, and 5) belief that PPPP will decrease barriers to vaccination among participants.
3 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Jefferson University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura Pizzi, PharmD, MPH, Thomas Jefferson 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.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Merck IISP ID 50926

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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