Vaccination Education Through Pharmacists and Senior Centers (VEPSC)

Influenza Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03239665
• Other study ID #: Pro20170000208
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: June 2020
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: August 31, 2019
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disease
• Influenza
• Pneumonia
• Pneumonia, Bacterial
• Zoster; Herpes

Intervention

Behavioral:
• Pharmacist-led Intervention (PHARM)
60 minute didactic lecture about vaccinations.
• Peer-led Intervention (PEER)
60 minute peer led small group intervention including skits and other educational material

Locations

Country	Name	City	State
United States	Rutgers University	Piscataway	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Merck Sharp & Dohme Corp., Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (34)

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Pizzi LT, Steele D, Sembhi H, Hark L, Waisbourd M, Katz LJ. Cost analysis of the Philadelphia glaucoma community detection and treatment project. Poster presentation at the ISPOR 20th Annual International Meeting, May 16-20, 2015 Philadelphia, PA.

Prioli K, Schafer J, Fields Harris L, McCoy M, Barber E, Marthol-Clark M, Pizzi LT. Awareness and beliefs about pneumococcal and influenza vaccination among older African Americans: Results from a survey of community-dwelling participants at an urban senior center. Poster presented at: The 18th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research; May 20, 2013; New Orleans, Louisiana.

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Schmader KE, Johnson GR, Saddier P, Ciarleglio M, Wang WW, Zhang JH, Chan IS, Yeh SS, Levin MJ, Harbecke RM, Oxman MN; Shingles Prevention Study Group. Effect of a zoster vaccine on herpes zoster-related interference with functional status and health-related quality-of-life measures in older adults. J Am Geriatr Soc. 2010 Sep;58(9):1634-41. doi: 10.1111/j.1532-5415.2010.03021.x. — View Citation

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Waisbourd M, Shafa A, Delvadia R, Sembhi H, Molineaux J, Henderer J, Pizzi LT, Myers JS, Hark LA, Katz LJ. Bilateral Same-day Laser Peripheral Iridotomy in the Philadelphia Glaucoma Detection and Treatment Project. J Glaucoma. 2016 Oct;25(10):e821-e825. — View Citation

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Knowledge and Awareness About Vaccine-Preventable Diseases	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	Within-Group Changes in Beliefs About Vaccine-Preventable Diseases and Vaccines	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 (a=0.05/3=0.0167).	Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
Secondary	Cost Analysis	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).
Secondary	Number of Participants Reporting Program Satisfaction	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)
Secondary	Number of Participants Planning to Receive Each Vaccine	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)
Secondary	Number of Participants Reporting Positive Vaccination Status at Each Timepoint	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)
Secondary	Number of Participants Planning to Discuss Vaccines With Others as Assessed by the Activation Questionnaire	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
Secondary	Number of Participants Having Discussed Vaccines With Others at One-month Follow-up as Assessed by the Activation Questionnaire	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)

External Links

•   Centers for Disease Control and Prevention. Pneumococcal Polysaccharide Vaccine: What You Need to Know.
•   Immunization Action Coalition. Pneumococcal Polysaccharide Vaccination Pocket Guide.
•   National Center for Health Statistics. Early Release of Selected Estimates Based on Data From the National Health Interview Survey.
•   U.S. Department of Health and Human Services. Office of Disease Prevention and Health Promotion. Healthy People 2020. Washington, DC.