Infectious DiseaseVEPSCNCT03239665

Vaccination Education Through Pharmacists and Senior Centers (VEPSC)

A study testing Pharmacist-led Intervention (PHARM) and Peer-led Intervention (PEER) in people with Infectious Disease and Pneumonia, Bacterial, run by Rutgers, The State University of New Jersey at 1 site 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

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Infectious Disease, Pneumonia, Bacterial, Influenza
What is being tested?: Pharmacist-led Intervention (PHARM) and Peer-led Intervention (PEER)
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 335 participants
Where: 1 siteUnited States
Study dates: 10 Oct 2017to 31 Aug 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Rutgers University
Piscataway, New Jersey, 08854

Other trials in United States

About this study

Official title: 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.

Read the 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:

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

Hypotheses supporting these objective are:

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

Conditions: Infectious Disease, Pneumonia, Bacterial, Influenza, Zoster; Herpes
Being tested: Pharmacist-led Intervention (PHARM), Peer-led Intervention (PEER)
Keywords: Vaccine, Educational intervention, Senior Center Model of Care, Older adults
Medical subject headings: Communicable Diseases, Pneumonia, Bacterial, Influenza, Human, Chickenpox

What participants receive

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

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

Study groups in NCT03239665
Study group	Role	What they receive
Pharmacist-led Intervention (PHARM)	Active comparator	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. Receives: Behavioral: Pharmacist-led Intervention (PHARM)
Peer-led Intervention (PEER)	Experimental	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. Receives: Behavioral: Peer-led Intervention (PEER)

What is being measured

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

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: Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)

Secondary outcomes (7)

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 (α=0.05/3=0.0167).
Measured: Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
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: Measured after completion of all programs in both groups (an average of one year).
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: Measured immediately post-intervention (PT) and at 1 month follow-up (1M)
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: Measured at baseline (BL), immediately post-intervention (PT), and 1 month follow-up (1M)
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: 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
Compare the number of participants planning to discuss vaccines with doctor, pharmacist, or family/friends in PHARM vs. PEER at each timepoint
Measured: 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
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
Measured: One-month follow-up (1M)

Timeline

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

10 Oct 201731 Aug 2019

First posted4 Aug 2017
Study start10 Oct 2017
Primary completion28 Sep 2018
Study completion31 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Infectious DiseaseStudies of the same condition, open and under way.
More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Model description: The design is a randomized trial with randomization to PHARM or PEER performed at the program date level.
Masking: None (open label)
Enrolment: 335 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03239665
Sponsor's protocol ID: Pro20170000208
Acronym: VEPSC
Status last verified: Jun 2020
First submitted: 20 Jul 2017
Last updated: 1 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No IPD will be made available to any researchers external to this study.

Publications

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.
Tomczyk S, Bennett NM, Stoecker C, Gierke R, Moore MR, Whitney CG, Hadler S, Pilishvili T; Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged >/=65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014 Sep 19;63(37):822-5.
PubMed 25233284
Forbes HJ, Thomas SL, Langen SM. The epidemiology and prevention of herpes zoster. Curr Derm Rep 2012;1:39-47
Yawn BP, Saddier P, Wollan PC, St Sauver JL, Kurland MJ, Sy LS. A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction. Mayo Clin Proc. 2007 Nov;82(11):1341-9. doi: 10.4065/82.11.1341.
PubMed 17976353
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.
PubMed 20863322
Williams WW, Lu PJ, O'Halloran A, Bridges CB, Kim DK, Pilishvili T, Hales CM, Markowitz LE; Centers for Disease Control and Prevention (CDC). Vaccination coverage among adults, excluding influenza vaccination - United States, 2013. MMWR Morb Mortal Wkly Rep. 2015 Feb 6;64(4):95-102.
PubMed 25654611
Pizzi LT, Jutkowitz E, Frick KD, Suh DC, Prioli KM, Gitlin LN. Cost-effectiveness of a community-integrated home-based depression intervention in older African Americans. J Am Geriatr Soc. 2014 Dec;62(12):2288-95. doi: 10.1111/jgs.13146.
PubMed 25516025
Gitlin LN, Harris LF, McCoy MC, Chernett NL, Pizzi LT, Jutkowitz E, Hess E, Hauck WW. A home-based intervention to reduce depressive symptoms and improve quality of life in older African Americans: a randomized trial. Ann Intern Med. 2013 Aug 20;159(4):243-52. doi: 10.7326/0003-4819-159-4-201308200-00005.
PubMed 24026257
Gitlin LN, Harris LF, McCoy M, Chernett NL, Jutkowitz E, Pizzi LT; Beat the Blues Team. A community-integrated home based depression intervention for older African Americans: [corrected] description of the Beat the Blues randomized trial and intervention costs. BMC Geriatr. 2012 Feb 10;12:4. doi: 10.1186/1471-2318-12-4.
PubMed 22325065
Hark L, Waisbourd M, Myers JS, Henderer J, Crews JE, Saaddine JB, Molineaux J, Johnson D, Sembhi H, Stratford S, Suleiman A, Pizzi L, Spaeth GL, Katz LJ. Improving Access to Eye Care among Persons at High-Risk of Glaucoma in Philadelphia--Design and Methodology: The Philadelphia Glaucoma Detection and Treatment Project. Ophthalmic Epidemiol. 2016;23(2):122-130. doi: 10.3109/09286586.2015.1099683. Epub 2016 Mar 7.
PubMed 26950056
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. doi: 10.1097/IJG.0000000000000409.
PubMed 26950579
Alcusky MJ, Cannon-Dang E, Steele D, Schafer JJ, DeSimone Jr. JA, Pizzi LT. Cost of a pharmacist-led pneumonia education and immunization program for older Philadelphians. Poster presentation at the ISPOR 20th Annual International Meeting, May 16-20 2015 Philadelphia, PA.
Schafer JJ, Steele D, Marthol MM, Harris LF, Pizzi LT. Knowledge gaps about pneumonia in older adults: results from the pharmacists' pneumonia prevention project. Poster presentation at the ISPOR 20th Annual International Meeting, May 16-20, 2015 Philadelphia, PA.
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.
Luque JS, Ross L, Gwede CK. Qualitative systematic review of barber-administered health education, promotion, screening and outreach programs in African-American communities. J Community Health. 2014 Feb;39(1):181-90. doi: 10.1007/s10900-013-9744-3.
PubMed 23913106

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial of Peer-to-Peer Versus Pharmacist Education to Improve Older Adults' Vaccination Knowledge Through the Senior Center Model of Care
ClinicalTrials.gov ID: NCT03239665
Acronym / sponsor ID: VEPSC / Pro20170000208
Conditions: Infectious Disease, Pneumonia, Bacterial, Influenza, Zoster; Herpes
Keywords: Vaccine, Educational intervention, Senior Center Model of Care, Older adults
Study type: Interventional
Recruitment status: Completed
Enrolment: 335 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC, Thomas Jefferson University
Study start: 10 Oct 2017 (actual)
Primary completion: 28 Sep 2018 (actual)
Study completion: 31 Aug 2019 (actual)
First posted: 4 Aug 2017 (actual)
Results: Posted 1 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objectives are:

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

Hypotheses supporting these objective are:

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: The design is a randomized trial with randomization to PHARM or PEER performed at the program date level.

Arm	Type	Receives
Pharmacist-led Intervention (PHARM)	Active comparator	Behavioral: 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.
Peer-led Intervention (PEER)	Experimental	Behavioral: 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

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.

7 secondary outcomes

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)
Cost Analysis
Time frame: 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)
Number of Participants Planning to Receive Each Vaccine
Time frame: 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)
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
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)

Results and safety

Results posted to the registry on 1 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pharmacist-led Intervention (PHARM)	175	147
Peer-led Intervention (PEER)	160	140

Primary outcome: 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). Mean (Standard Deviation). Unit: Scores on a scale

Measure	Pharmacist-led Intervention (PHARM) n = 147	Peer-led Intervention (PEER) n = 140
Baseline to Post Test score change - Total	3.5 (4.03)	4.9 (4.25)
Baseline to Post Test score change - Zoster	1.3 (1.85)	1.8 (1.86)
Baseline to Post Test score change - Pneumonia	1.5 (1.89)	1.9 (1.97)
Baseline to Post Test change - Influenza	0.5 (1.38)	1.1 (1.58)
Baseline to 1 month follow up change - Total	3.4 (4.22)	4.3 (4.82)
Baseline to 1 month follow up change - Zoster	1.3 (1.97)	1.5 (2.04)
Baseline to 1 month follow up change - Pneumonia	1.5 (1.83)	1.5 (2.22)
Baseline to 1 month follow up change - Influenza	0.5 (1.49)	1.2 (1.83)

Pharmacist-led Intervention (PHARM) vs Peer-led Intervention (PEER): p = 0.0081, Wilcoxon (Mann-Whitney)
Pharmacist-led Intervention (PHARM) vs Peer-led Intervention (PEER): p = 0.0243, Wilcoxon (Mann-Whitney)
Pharmacist-led Intervention (PHARM) vs Peer-led Intervention (PEER): p = 0.0710, Wilcoxon (Mann-Whitney)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Not Applicable - Study was a minimal-risk educational intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pharmacist-led Intervention (PHARM)	0 of 0	0 of 0	0
Peer-led Intervention (PEER)	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Study results may not be generalizable to non-Black subpopulations. Real number receiving the vaccination could be either higher or lower than reported due to self-report. Peer leader trust might have already been established prior to the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundPrioli 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.
Background: PubMed 25233284Tomczyk S, Bennett NM, Stoecker C, Gierke R, Moore MR, Whitney CG, Hadler S, Pilishvili T; Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged >/=65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014 Sep 19;63(37):822-5.
BackgroundForbes HJ, Thomas SL, Langen SM. The epidemiology and prevention of herpes zoster. Curr Derm Rep 2012;1:39-47
Background: PubMed 17976353Yawn BP, Saddier P, Wollan PC, St Sauver JL, Kurland MJ, Sy LS. A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction. Mayo Clin Proc. 2007 Nov;82(11):1341-9. doi: 10.4065/82.11.1341.
Background: PubMed 20863322Schmader 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.
Background: PubMed 25654611Williams WW, Lu PJ, O'Halloran A, Bridges CB, Kim DK, Pilishvili T, Hales CM, Markowitz LE; Centers for Disease Control and Prevention (CDC). Vaccination coverage among adults, excluding influenza vaccination - United States, 2013. MMWR Morb Mortal Wkly Rep. 2015 Feb 6;64(4):95-102.
Background: PubMed 25516025Pizzi LT, Jutkowitz E, Frick KD, Suh DC, Prioli KM, Gitlin LN. Cost-effectiveness of a community-integrated home-based depression intervention in older African Americans. J Am Geriatr Soc. 2014 Dec;62(12):2288-95. doi: 10.1111/jgs.13146.
Background: PubMed 24026257Gitlin LN, Harris LF, McCoy MC, Chernett NL, Pizzi LT, Jutkowitz E, Hess E, Hauck WW. A home-based intervention to reduce depressive symptoms and improve quality of life in older African Americans: a randomized trial. Ann Intern Med. 2013 Aug 20;159(4):243-52. doi: 10.7326/0003-4819-159-4-201308200-00005.
Background: PubMed 22325065Gitlin LN, Harris LF, McCoy M, Chernett NL, Jutkowitz E, Pizzi LT; Beat the Blues Team. A community-integrated home based depression intervention for older African Americans: [corrected] description of the Beat the Blues randomized trial and intervention costs. BMC Geriatr. 2012 Feb 10;12:4. doi: 10.1186/1471-2318-12-4.
Background: PubMed 26950056Hark L, Waisbourd M, Myers JS, Henderer J, Crews JE, Saaddine JB, Molineaux J, Johnson D, Sembhi H, Stratford S, Suleiman A, Pizzi L, Spaeth GL, Katz LJ. Improving Access to Eye Care among Persons at High-Risk of Glaucoma in Philadelphia--Design and Methodology: The Philadelphia Glaucoma Detection and Treatment Project. Ophthalmic Epidemiol. 2016;23(2):122-130. doi: 10.3109/09286586.2015.1099683. Epub 2016 Mar 7.
Background: PubMed 26950579Waisbourd 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. doi: 10.1097/IJG.0000000000000409.
BackgroundAlcusky MJ, Cannon-Dang E, Steele D, Schafer JJ, DeSimone Jr. JA, Pizzi LT. Cost of a pharmacist-led pneumonia education and immunization program for older Philadelphians. Poster presentation at the ISPOR 20th Annual International Meeting, May 16-20 2015 Philadelphia, PA.
Centers for Disease Control and Prevention. Pneumococcal Polysaccharide Vaccine: What You Need to Know.Link provided by the sponsor.
Immunization Action Coalition. Pneumococcal Polysaccharide Vaccination Pocket Guide.Link provided by the sponsor.
Individual participant dataSharing planned: No. No IPD will be made available to any researchers external to this study.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura T Pizzi, PharmD, MPH principal investigator

Rutgers University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 1 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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)). 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 NCT03239665, which also lists 35 linked publications.

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 1 Jul 2020.