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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist Pneumococcal Vaccine Program (PPVP) | Experimental | Individuals receiving the PPVP intervention which consists of the educational program delivered on site at the collaborating senior center. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist Pneumococcal Vaccine Program (PPVP) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-test, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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:
All adults age 65 years and older who have not had the vaccine previously
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 65 years and older who received their first dose for any indication when they were younger than age 65 years.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Pizzi, PharmD, MPH | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center in the Park | Philadelphia | Pennsylvania | 19144 | United States |
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| Label | URL |
|---|---|
| US Centers for Disease Control. Vaccine Information Statement on Pneumococcal Polysaccharide Vaccine. | View source |
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Pre/post design (no groups). Inclusion criteria were age ≥50; able to attend a 1.5-hour session; cognitively intact (abbreviated mental test score ≥7); speak & read English at ≥4th grade (ability to read a brief passage). Additionally, program attendees wishing to participate in the study signed consent forms prior to the start of the program.
Recruitment and program coordination were completed from January to November 2014, through partnerships with local churches and senior centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | PPPP Participants | One group (pre/post design) receiving the PPPP intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PPPP Educational Program |
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| Optional Vaccination |
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| ID | Title | Description |
|---|---|---|
| BG000 | PPPP Participants | One group (pre/post design) receiving the PPPP intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-to-treat (ITT) sample | Posted | Mean | Standard Deviation | scores on a scale | Baseline, post-test, 3 months |
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Time of vaccination plus 7 days following receipt of vaccine
Vaccine consent form stated risks & benefits of vaccine and instructed individuals suspecting an adverse event (AE) within 7 days post-vaccination to phone a 24-hour investigator hotline for immediate phone evaluation and determination of next steps. In the event of an AE, the VAERS reporting system form VAERS-1 (FDA) would have been utilized.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PPPP Participants - Vaccine Recipients | Subgroup of participants receiving the pneumococcal vaccine (Pneumococcal Vaccine Polyvalent (Pneumovax® 23)) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura T. Pizzi, PharmD, MPH; Principal Investigator | Thomas Jefferson University | 215-955-1159 | laura.pizzi@rutgers.edu |
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| 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. | 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. | 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". | 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. | 3 months |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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One group (pre/post design) receiving the PPPP intervention
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| Secondary | 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). | Intention-to-Treat (ITT) sample | Posted | Mean | Standard Deviation | units on a scale | Baseline, post-test (immediately following intervention), 3 months |
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| Secondary | Activation | Activation was measured as number of participants having taken action at 3 months or planning action at baseline, post-test, and 3 months. | Intention-to-Treat (ITT) sample, subset not reporting positive history of pneumococcal vaccination at baseline | Posted | Count of Participants | Participants | 3 months |
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| Secondary | 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. | Intention-to-treat (ITT) sample | Posted | Count of Participants | Participants | 3 months |
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| Secondary | 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". | Posted | Number | $/participant | 3 months |
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| Secondary | 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. | Posted | Count of Participants | Participants | 3 months |
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| 20 |
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| Title | Measurements |
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| Title |
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| Measurements |
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| Actions planned at 3 months |
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| Completely disagree |
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| No response |
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| Engaged or interested in the program |
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| Program helped learn about pneumonia & vaccination |
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| Belief that PPPP successfully educated participnts |
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| Belief that PPPP successfully built trust |
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| Belief that PPPP successfully increased acceptance |
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| Belief that PPPP decreased barriers to vaccination |
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