Clinical trial NCT03239665: Vaccination Education Through Pharmacists and Senior Centers (VEPSC)
Official title: Randomized Trial of Peer-to-Peer Versus Pharmacist Education to Improve Older Adults' Vaccination Knowledge Through the Senior Center Model of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Disease
Pneumonia, Bacterial
Influenza
Zoster; Herpes
Keywords: Vaccine
Educational intervention
Senior Center Model of Care
Older adults
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Thomas Jefferson University
First posted: 2017-08-04
Enrollment: 335
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design is a randomized trial with randomization to PHARM or PEER performed at the program date level.
Primary purpose: PREVENTION

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in Knowledge and Awareness About Vaccine-Preventable Diseases
timeFrame: Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
Secondary outcomes:
measure: Within-Group Changes in Beliefs About Vaccine-Preventable Diseases and Vaccines
timeFrame: Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
measure: Cost Analysis
timeFrame: Measured after completion of all programs in both groups (an average of one year).
measure: Number of Participants Reporting Program Satisfaction
timeFrame: Measured immediately post-intervention (PT) and at 1 month follow-up (1M)
measure: Number of Participants Planning to Receive Each Vaccine
timeFrame: Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
measure: Number of Participants Reporting Positive Vaccination Status at Each Timepoint
timeFrame: Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
measure: Number of Participants Planning to Discuss Vaccines With Others as Assessed by the Activation Questionnaire
timeFrame: Baseline, immediately post-intervention, and 1 month follow-up
measure: Number of Participants Having Discussed Vaccines With Others at One-month Follow-up as Assessed by the Activation Questionnaire
timeFrame: One-month follow-up (1M)
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Laura T Pizzi, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
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