Trial Outcomes & Findings for Impact and Cost of a Pharmacist Pneumococcal Vaccination Program With PNEUMOVAX® 23 at an Urban Senior Center (NCT NCT01944462)
NCT ID: NCT01944462
Last Updated: 2018-01-03
Results Overview
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.
COMPLETED
PHASE4
203 participants
Baseline, post-test, 3 months
2018-01-03
Participant Flow
Recruitment and program coordination were completed from January to November 2014, through partnerships with local churches and senior centers.
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.
Participant milestones
| Measure |
PPPP Participants
One group (pre/post design) receiving the PPPP intervention
|
|---|---|
|
PPPP Educational Program
STARTED
|
203
|
|
PPPP Educational Program
Baseline
|
203
|
|
PPPP Educational Program
Post-Test
|
187
|
|
PPPP Educational Program
3 Month Follow-Up
|
143
|
|
PPPP Educational Program
COMPLETED
|
143
|
|
PPPP Educational Program
NOT COMPLETED
|
60
|
|
Optional Vaccination
STARTED
|
20
|
|
Optional Vaccination
COMPLETED
|
20
|
|
Optional Vaccination
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
PPPP Participants
One group (pre/post design) receiving the PPPP intervention
|
|---|---|
|
PPPP Educational Program
Lost to Follow-up
|
60
|
Baseline Characteristics
Impact and Cost of a Pharmacist Pneumococcal Vaccination Program With PNEUMOVAX® 23 at an Urban Senior Center
Baseline characteristics by cohort
| Measure |
PPPP Participants
n=203 Participants
One group (pre/post design) receiving the PPPP intervention
|
|---|---|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 8.955 • n=5 Participants
|
|
Sex/Gender, Customized
Gender, customized · Female
|
152 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender, customized · Male
|
23 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender, customized · No response / prefer not to answer
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
203 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, post-test, 3 monthsPopulation: Intention-to-treat (ITT) sample
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.
Outcome measures
| Measure |
PPPP Participants
n=190 Participants
One group (pre/post design) receiving the PPPP intervention
|
|---|---|
|
Knowledge and Awareness of Pneumococcal Disease
Baseline knowledge score (max score 28)
|
13.90 scores on a scale
Standard Deviation 6.725
|
|
Knowledge and Awareness of Pneumococcal Disease
Post-test knowledge score (max score 28)
|
20.41 scores on a scale
Standard Deviation 6.254
|
|
Knowledge and Awareness of Pneumococcal Disease
3 month knowledge score (max score 28)
|
21.43 scores on a scale
Standard Deviation 4.524
|
SECONDARY outcome
Timeframe: Baseline, post-test (immediately following intervention), 3 monthsPopulation: Intention-to-Treat (ITT) sample
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).
Outcome measures
| Measure |
PPPP Participants
n=190 Participants
One group (pre/post design) receiving the PPPP intervention
|
|---|---|
|
Trust in Pharmacists as Vaccine Providers
Baseline
|
1.79 units on a scale
Standard Deviation 0.51
|
|
Trust in Pharmacists as Vaccine Providers
Post-Test
|
1.55 units on a scale
Standard Deviation 0.47
|
|
Trust in Pharmacists as Vaccine Providers
3 Months
|
1.80 units on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-Treat (ITT) sample, subset not reporting positive history of pneumococcal vaccination at baseline
Activation was measured as number of participants having taken action at 3 months or planning action at baseline, post-test, and 3 months.
Outcome measures
| Measure |
PPPP Participants
n=113 Participants
One group (pre/post design) receiving the PPPP intervention
|
|---|---|
|
Activation
Actions taken at 3 months
|
77 Participants
|
|
Activation
Actions planned at baseline
|
41 Participants
|
|
Activation
Actions planned at post-test
|
91 Participants
|
|
Activation
Actions planned at 3 months
|
27 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat (ITT) sample
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.
Outcome measures
| Measure |
PPPP Participants
n=190 Participants
One group (pre/post design) receiving the PPPP intervention
|
|---|---|
|
Satisfaction With PPPP
Satisfied with content · Completely Agree
|
69 Participants
|
|
Satisfaction With PPPP
Satisfied with content · Somewhat agree
|
3 Participants
|
|
Satisfaction With PPPP
Satisfied with content · Somewhat disagree
|
1 Participants
|
|
Satisfaction With PPPP
Satisfied with content · Completely disagree
|
1 Participants
|
|
Satisfaction With PPPP
Satisfied with content · No response
|
116 Participants
|
|
Satisfaction With PPPP
Engaged or interested in the program · Completely Agree
|
70 Participants
|
|
Satisfaction With PPPP
Engaged or interested in the program · Somewhat agree
|
4 Participants
|
|
Satisfaction With PPPP
Engaged or interested in the program · Somewhat disagree
|
0 Participants
|
|
Satisfaction With PPPP
Engaged or interested in the program · Completely disagree
|
0 Participants
|
|
Satisfaction With PPPP
Engaged or interested in the program · No response
|
116 Participants
|
|
Satisfaction With PPPP
Program helped learn about pneumonia & vaccination · Completely Agree
|
110 Participants
|
|
Satisfaction With PPPP
Program helped learn about pneumonia & vaccination · Somewhat agree
|
26 Participants
|
|
Satisfaction With PPPP
Program helped learn about pneumonia & vaccination · Somewhat disagree
|
3 Participants
|
|
Satisfaction With PPPP
Program helped learn about pneumonia & vaccination · Completely disagree
|
0 Participants
|
|
Satisfaction With PPPP
Program helped learn about pneumonia & vaccination · No response
|
51 Participants
|
SECONDARY outcome
Timeframe: 3 monthsMeasures 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".
Outcome measures
| Measure |
PPPP Participants
n=203 Participants
One group (pre/post design) receiving the PPPP intervention
|
|---|---|
|
Intervention Cost
|
162.43 $/participant
|
SECONDARY outcome
Timeframe: 3 monthsPharmacists 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.
Outcome measures
| Measure |
PPPP Participants
n=20 Participants
One group (pre/post design) receiving the PPPP intervention
|
|---|---|
|
Pharmacist Satisfaction
Satisfaction with live action skit · Agree
|
18 Participants
|
|
Pharmacist Satisfaction
Satisfaction with live action skit · Disagree
|
1 Participants
|
|
Pharmacist Satisfaction
Satisfaction with live action skit · No response
|
1 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP successfully educated participnts · Agree
|
19 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP successfully educated participnts · Disagree
|
1 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP successfully educated participnts · No response
|
0 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP successfully built trust · Agree
|
17 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP successfully built trust · Disagree
|
2 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP successfully built trust · No response
|
1 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP successfully increased acceptance · Agree
|
19 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP successfully increased acceptance · No response
|
0 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP decreased barriers to vaccination · Agree
|
20 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP decreased barriers to vaccination · Disagree
|
0 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP decreased barriers to vaccination · No response
|
0 Participants
|
|
Pharmacist Satisfaction
Belief that PPPP successfully increased acceptance · Disagree
|
1 Participants
|
Adverse Events
PPPP Participants - Vaccine Recipients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Laura T. Pizzi, PharmD, MPH; Principal Investigator
Thomas Jefferson University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60