Vaccination Education Through Pharmacists and Senior Centers (VEPSC) (VEPSC)

June 15, 2020 updated by: Laura T. Pizzi, PharmD, MPH, Rutgers, The State University of New Jersey

Randomized Trial of Peer-to-Peer Versus Pharmacist Education to Improve Older Adults' Vaccination Knowledge Through the Senior Center Model of Care

The study consists of two arms (PHARM and PEER) designed to educate participants about three vaccine-preventable diseases (zoster, pneumonia, and influenza) and vaccination. PHARM will consist of a 60-minute presentation about the three vaccine-preventable diseases and their vaccinations delivered by a pharmacist, featuring a didactic lecture and discussion supplemented by video clips of community members discussing their experiences around vaccination, as well as physicians underscoring the importance of vaccination. PEER will consist of a 60-minute small-group session led by a peer educator which includes scripted roleplaying exercises designed to reinforce learnings pertaining to these three vaccine-preventable diseases and their vaccinations. The components of these interventions will be designed to address specific barriers to vaccination identified by literature search and our prior work in the area of community-based vaccine education. Both arms will focus primarily on pneumococcal disease and zoster but will include limited content on influenza because participants are likely to have questions about how the flu and its vaccination differ from pneumococcal diseases and zoster. The study will be implemented in an older, predominantly African-American (AA) population, consistent with our prior work in this area.

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.

Detailed Description

In the pharmacist-led ("PHARM") intervention group, participants will be given a 60-minute formal didactic presentation on vaccine-preventable diseases and vaccination. This presentation will be designed to address knowledge and beliefs related to zoster, pneumonia, and influenza, as well as barriers to receiving vaccination. It will be delivered by a pharmacist, will be appropriate for the participants' educational level, and will aim to establish an understanding of vaccine-preventable illnesses. The presentation will specifically discuss the following: causes, symptoms and potential complications of infections in the three diseases of interest (pneumococcal disease, zoster, and influenza); risk factors for developing the infections; incidence and prevalence of each disease of interest; modes of transmission; and disease prevention through vaccination. To improve the interactivity of the presentation, brief 30-60 second video clips excerpted from interviews with community members and physicians will be shown. Community member clips will consist of older adults from the African-American (AA) population who have experienced vaccine-preventable infections. These clips will provide culturally relevant testimony to the program audience and reinforce participant understanding of concepts introduced during didactic teaching.

In the peer-led ("PEER") intervention, peer educators will be recruited from an experienced cohort of peer educators at our senior center partner site. A pharmacist will train the peer educators about vaccine-preventable diseases over the course of two didactic sessions. Following this training, a third session will be held to train the peer educators on the script that they will deliver to participants. The script will include the key learning points to be taught by the peer educators to participants about vaccine preventable diseases and vaccination. The script will also include roleplay exercises. In the roleplay exercises, 3 scripted vaccination-related scenarios (one for each disease of interest) will be acted out by participants to illustrate scenarios participants might encounter when interacting with healthcare providers or friends/family. The skit and roleplay exercises will be practiced as needed, under the leadership of the senior center's project manager, to ensure that the peer educators are confident and consistent when delivering PEER. After completing the training, peer educators' competency on PEER program content will be assessed through a formal multiple-choice knowledge test. Each peer educator must achieve a minimum score of 80% correct over all items assessed, and 100% correct for all items deemed "core" knowledge. Once peer educator competency has been established, each peer educator will deliver PEER through a 60-minute small group session. During this session, peer educators will deliver the educational objectives through an informal discussion and will lead the group through the roleplay exercises. Participants will then be asked what key points they learned about vaccine-preventable diseases and vaccines. Finally, the peer educator will engage in a dialogue to clarify and summarize these key points.

Objectives are:

  1. Compare the efficacy of PHARM vs. PEER at improving participant's knowledge regarding vaccine-preventable diseases
  2. Compare the efficacy of PHARM vs. PEER at improving participants' beliefs about vaccination
  3. Measure the costs of PHARM and PEER from the senior center perspective
  4. Compare the percent of participants taking activation step(s) to get vaccinated following receipt of PHARM vs. PEER
  5. Determine the extent to which participants are satisfied with and trust the PHARM vs. PEER interventions

Hypotheses supporting these objective are:

  1. PHARM and PEER will achieve similar improvements in older adults' knowledge of vaccine preventable diseases (primary hypothesis)
  2. PHARM and PEER will improved beliefs about vaccine-preventable disease
  3. PEER will be a lower cost approach to educating participants in the senior center compared to PHARM
  4. PHARM and PEER will result in similar rates of participants taking one or more activation step(s) to obtain vaccination
  5. Participants will be highly satisfied with the PHARM and PEER interventions

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.
335

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.
  • 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
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Rutgers University

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:

  • Age ≥50;
  • Can attend a 2-hour session (though both PHARM and PEER entail 60 minutes of intervention, an additional hour is needed to allow for informed consent and data collection);
  • Speak and read English at ≥4th grade level as determined by a brief reading passage;
  • Cognitively intact as evidenced by an Abbreviated Mental Status Test score ≥7.

Exclusion Criteria:

  • Failure to meet inclusion criteria
  • Failure to give informed consent to participate in the study

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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.
ACTIVE_COMPARATOR: Pharmacist-led Intervention (PHARM)
In the PHARM intervention group, participants will be given a 60-minute formal presentation on vaccine-preventable diseases to address knowledge and beliefs related to zoster, pneumonia, and influenza and to address barriers to receiving vaccination. In several studies, it has been demonstrated that those who believe it is wise to receive vaccinations and those that have discussed vaccination with their healthcare provider are more likely to receive a vaccine.
Behavioral: Pharmacist-led Intervention (PHARM)
60 minute didactic lecture about vaccinations.
EXPERIMENTAL: Peer-led Intervention (PEER)
A pharmacist will train the peer educators about vaccine-preventable diseases over the course of two didactic sessions. Following this training, a third session will be held to train the peer educators on the script that they will deliver to participants. The script will include the key learning points to be taught by the peer educators to participants about vaccine preventable diseases and vaccination. The script will also include role-play exercises. In the role-play exercises, 3 vaccination-related scenarios (one for each disease- zoster, pneumonia, and influenza) will be delivered to illustrate situations participants might encounter when interacting with healthcare providers or friends/family.
Behavioral: Peer-led Intervention (PEER)
60 minute peer led small group intervention including skits and other educational material

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
Mean Change in Knowledge and Awareness About Vaccine-Preventable Diseases
Time Frame: Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
Knowledge and awareness about the target vaccine-preventable diseases was assessed at each timepoint using the VEPSC Knowledge Instrument, a 3-section, 22-item instrument categorical response instrument. Scores consist of number of correct responses to the questions on the knowledge instrument, thus a higher score indicates better performance. Four scores are possible: three disease-specific subscores (one each for pneumonia, influenza, and zoster) and one total score (equaling the sum of the three disease-specific subscores). Possible score ranges are as follows: pneumonia 0-7; influenza 0-7; zoster 0-8; total 0-22. For each score type, pairwise score differences were calculated between all 3 timepoints (baseline, post-test, and one-month follow-up). Positive values indicate increased knowledge among participants; negative values indicate decreased knowledge.
Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)

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
Within-Group Changes in Beliefs About Vaccine-Preventable Diseases and Vaccines
Time Frame: Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
Beliefs about vaccine-preventable diseases and vaccination were assessed via agreement with 5 statements scored on a 4-point Likert scale (1-Completely disagree, 2-Somewhat disagree, 3-Somewhat agree, 4-Completely agree) at each timepoint. The changes in beliefs between baseline, post-intervention, and the one-month follow-up were assessed in both PHARM and PEER groups. Pairwise Wilcoxon Signed-Rank tests were run comparing within-group changes in beliefs across timepoints and applying the Bonferroni correction (α=0.05/3=0.0167).
Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
Cost Analysis
Time Frame: Measured after completion of all programs in both groups (an average of one year).
Measure the program costs of PHARM and PEER from the senior center perspective. Costs were measured in total for each group, and per-participant costs were calculated by dividing total group cost by group sample size. Outcome measure type is thus reported as "number" rather than choosing measures of central tendency and dispersion/precision (i.e., there are no standard deviations, confidence intervals, or ranges with this methodology).
Measured after completion of all programs in both groups (an average of one year).
Number of Participants Reporting Program Satisfaction
Time Frame: Measured immediately post-intervention (PT) and at 1 month follow-up (1M)
Satisfaction was assessed on the post-intervention and one-month follow-up surveys using two statements that were each scored on a 4-point Likert scale (1-Completely disagree, 2-Somewhat disagree, 3-Somewhat agree, 4-Completely agree). The statements were: 1) "The educational program kept me interested or engaged" and 2) "I was satisfied with the content of the educational program". At each timepoint, responses were dichotomized as "agree" (comprising the "Somewhat agree" and "Completely agree" response options) and "disagree" (comprising the "Somewhat disagree" and "Completely disagree" response options), and these dichotomous responses were compared between PHARM and PEER via Fisher's exact test.
Measured immediately post-intervention (PT) and at 1 month follow-up (1M)
Number of Participants Planning to Receive Each Vaccine
Time Frame: Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
Compare the number of participants planning to receive vaccine in PHARM vs. PEER at each timepoint as assessed by the activation questionnaire
Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
Number of Participants Reporting Positive Vaccination Status at Each Timepoint
Time Frame: Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
Compare the number participants reporting positive vaccination status in PHARM vs. PEER at each timepoint as assessed by the activation questionnaire
Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
Number of Participants Planning to Discuss Vaccines With Others as Assessed by the Activation Questionnaire
Time Frame: Baseline, immediately post-intervention, and 1 month follow-up
Compare the number of participants planning to discuss vaccines with doctor, pharmacist, or family/friends in PHARM vs. PEER at each timepoint
Baseline, immediately post-intervention, and 1 month follow-up
Number of Participants Having Discussed Vaccines With Others at One-month Follow-up as Assessed by the Activation Questionnaire
Time Frame: One-month follow-up (1M)
Compare the number of participants reporting that they have discussed vaccines with their doctor, pharmacist, or family/friends at the one-month follow-up for PHARM vs. PEER
One-month follow-up (1M)

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.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC
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 T Pizzi, PharmD, MPH, Rutgers 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

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 (ACTUAL)

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.
October 10, 2017

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.
September 28, 2018

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.
August 31, 2019

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).
July 20, 2017

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.
August 2, 2017

First Posted (ACTUAL)

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.
August 4, 2017

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.
July 1, 2020

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.
June 15, 2020

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.
June 1, 2020

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.
  • Pro20170000208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be made available to any researchers external to this study.

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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