A Phase 4 interventional study of Pharmacist Pneumococcal Vaccine Program (PPVP) in Study is Open to Seniors Age 50 or Older, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-03.
Sponsored by Thomas Jefferson University · Phase 4, Interventional, and Health services research
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
Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
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A. Inclusions for PPVP:
B. Inclusions to receive the optional pneumococcal vaccination:
Patient meets ≥1 of the following criteria for receiving their first pneumococcal vaccination:
Age 50-64 years with any of the following conditions:
OR
Patient meets ≥1 of the following criteria for receiving a booster dose of the pneumococcal vaccination:
Adults age 50-64 who have not received the vaccine for ≥5 years and have one of the following conditions:
Exclusion Criteria:
A. Exclusions to the PPVP program: none
B. Exclusions to receiving the optional pneumococcal vaccine:
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.
Knowledge and Awareness of Pneumococcal Disease
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.
Time frame: Baseline, post-test, 3 months
Trust in Pharmacists as Vaccine Providers
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).
Time frame: Baseline, post-test (immediately following intervention), 3 months
Activation
Activation was measured as number of participants having taken action at 3 months or planning action at baseline, post-test, and 3 months.
Time frame: 3 months
Satisfaction With PPPP
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.
Time frame: 3 months
Intervention Cost
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".
Time frame: 3 months
Pharmacist Satisfaction
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.
Time frame: 3 months
Recruitment and program coordination were completed from January to November 2014, through partnerships with local churches and senior centers.
| Milestone | PPPP Participants |
|---|---|
| Started | 203 |
| Baseline | 203 |
| Post-test | 187 |
| 3 month follow-up | 143 |
| Completed | 143 |
| Not completed | 60 |
| Withdrew: Lost to follow-up | 60 |
| Milestone | PPPP Participants |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| scores on a scale | PPPP Participants |
|---|---|
| Baseline knowledge score (max score 28) | 13.90 ± 6.725 |
| Post-test knowledge score (max score 28) | 20.41 ± 6.254 |
| 3 month knowledge score (max score 28) | 21.43 ± 4.524 |
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).
| units on a scale | PPPP Participants |
|---|---|
| Baseline | 1.79 ± 0.51 |
| Post-Test | 1.55 ± 0.47 |
| 3 Months | 1.80 ± 0.43 |
Activation was measured as number of participants having taken action at 3 months or planning action at baseline, post-test, and 3 months.
| Participants | PPPP Participants |
|---|---|
| Actions taken at 3 months | 77 |
| Actions planned at baseline | 41 |
| Actions planned at post-test | 91 |
| Actions planned at 3 months | 27 |
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.
| Participants | PPPP Participants |
|---|---|
| Satisfied with content — Completely Agree | 69 |
| Satisfied with content — Somewhat agree | 3 |
| Satisfied with content — Somewhat disagree | 1 |
| Satisfied with content — Completely disagree | 1 |
| Satisfied with content — No response | 116 |
| Engaged or interested in the program — Completely Agree | 70 |
| Engaged or interested in the program — Somewhat agree | 4 |
| Engaged or interested in the program — Somewhat disagree | 0 |
| Engaged or interested in the program — Completely disagree | 0 |
| Engaged or interested in the program — No response | 116 |
| Program helped learn about pneumonia & vaccination — Completely Agree | 110 |
| Program helped learn about pneumonia & vaccination — Somewhat agree | 26 |
| Program helped learn about pneumonia & vaccination — Somewhat disagree | 3 |
| Program helped learn about pneumonia & vaccination — Completely disagree | 0 |
| Program helped learn about pneumonia & vaccination — No response | 51 |
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".
| $/participant | PPPP Participants |
|---|---|
| Intervention Cost | 162.43 |
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.
| Participants | Pharmacy Staff |
|---|---|
| Satisfaction with live action skit — Agree | 18 |
| Satisfaction with live action skit — Disagree | 1 |
| Satisfaction with live action skit — No response | 1 |
| Belief that PPPP successfully educated participnts — Agree | 19 |
| Belief that PPPP successfully educated participnts — Disagree | 1 |
| Belief that PPPP successfully educated participnts — No response | 0 |
| Belief that PPPP successfully built trust — Agree | 17 |
| Belief that PPPP successfully built trust — Disagree | 2 |
| Belief that PPPP successfully built trust — No response | 1 |
| Belief that PPPP successfully increased acceptance — Agree | 19 |
| Belief that PPPP successfully increased acceptance — Disagree | 1 |
| Belief that PPPP successfully increased acceptance — No response | 0 |
| Belief that PPPP decreased barriers to vaccination — Agree | 20 |
| Belief that PPPP decreased barriers to vaccination — Disagree | 0 |
| Belief that PPPP decreased barriers to vaccination — No response | 0 |
Collected over Time of vaccination plus 7 days following receipt of vaccine. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PPPP Participants - Vaccine Recipients | — | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | PPPP Participants |
|---|---|
| Mean | 74.4 ± 8.955 |
| Sex/Gender, Customized(Participants) | PPPP Participants |
|---|---|
| Gender, customized — Female | 152 |
| Gender, customized — Male | 23 |
| Gender, customized — No response / prefer not to answer | 28 |
| Race (NIH/OMB)(Participants) | PPPP Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 163 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 38 |
| Region of Enrollment(participants) | PPPP Participants |
|---|---|
| United States | 203 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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