Study is Open to Seniors Age 50 or Older
Conditions
Keywords
pneumococcal vaccine, pharmacist vaccination, Pneumovax 23, pneumococcal vaccine polyvalent
Brief summary
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 1. PPVP will result in improved knowledge and awareness in older minorities in the senior center setting (primary hypothesis); 2. Participants who are vaccinated through the project will experienced increased trust in receiving vaccines from a pharmacist; 3. Participants will be satisfied with and trust the PV information provided by pharmacists in the PPVP; 4. PPVP is an efficient approach to educating patients in the senior center based on its costs; 5. Participating pharmacists will be activated to implement PPVP learnings in their practice.
Interventions
BEHAVIORALPharmacist 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.
Sponsors
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
A. Inclusions for PPVP: 1. Age ≥ 50 years old 2. Can attend a 1.5-hour session at CIP 3. Cognitively intact based on responses to an Abbreviated Mental Test Score (AMTS) of ≥7 (see Appendix for AMTS instrument) 4. Can speak and read English at ≥4th grade level as evidenced by ability to read a brief passage 5. Access to a telephone B. Inclusions to receive the optional pneumococcal vaccination: Patient meets ≥1 of the following criteria for receiving their first pneumococcal vaccination: 1. All adults age 65 years and older who have not had the vaccine previously 2. Age 50-64 years with any of the following conditions: 1. Cigarette smokers age 19 years and older 2. Chronic cardiovascular disease (e.g., congestive heart failure, cardiomyopathies; excluding hypertension) 3. Chronic pulmonary disease (including COPD and emphysema, and for adults ages 19 years and older, asthma) 4. Diabetes mellitus 5. Alcoholism 6. Chronic liver disease, cirrhosis 7. Candidate for or recipient of cochlear implant 8. Functional or anatomic asplenia (e.g., sickle cell disease, splenectomy) 9. Immunocompromising conditions or on immunosuppressive therapy 10. Chronic renal failure or nephrotic syndrome OR Patient meets ≥1 of the following criteria for receiving a booster dose of the pneumococcal vaccination: 1. Adults age 65 years and older who received their first dose for any indication when they were younger than age 65 years. 2. Adults age 50-64 who have not received the vaccine for ≥5 years and have one of the following conditions: 1. Functional or anatomic asplenia (including persons with sickle cell disease or splenectomy patients); 2. Chronic renal failure (including dialysis patients) or nephrotic syndrome; 3. Immunocompromising conditions or on immunosuppressive therapy
Exclusion criteria
A. Exclusions to the PPVP program: none B. Exclusions to receiving the optional pneumococcal vaccine: 1. Participant has a history of allergic reaction to pneumococcal vaccine 2. Participant has a history of allergic reaction to any component of any vaccine 3. Participant with moderate or severe illness (these individuals will be advised to speak to their doctor regarding the vaccine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge and Awareness of Pneumococcal Disease | Baseline, post-test, 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trust in Pharmacists as Vaccine Providers | Baseline, post-test (immediately following intervention), 3 months | 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). |
| Activation | 3 months | Activation was measured as number of participants having taken action at 3 months or planning action at baseline, post-test, and 3 months. |
| Satisfaction With PPPP | 3 months | 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. |
| Intervention Cost | 3 months | 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. |
| Pharmacist Satisfaction | 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment and program coordination were completed from January to November 2014, through partnerships with local churches and senior centers.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| PPPP Participants One group (pre/post design) receiving the PPPP intervention | 203 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| PPPP Educational Program | Lost to Follow-up | 60 |
Baseline characteristics
| Characteristic | PPPP Participants |
|---|---|
| Age, Continuous | 74.4 years STANDARD_DEVIATION 8.955 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 163 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 38 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 203 participants |
| Sex/Gender, Customized Gender, customized Female | 152 Participants |
| Sex/Gender, Customized Gender, customized Male | 23 Participants |
| Sex/Gender, Customized Gender, customized No response / prefer not to answer | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Baseline, post-test, 3 months
Population: Intention-to-treat (ITT) sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPPP Participants | Knowledge and Awareness of Pneumococcal Disease | Baseline knowledge score (max score 28) | 13.90 scores on a scale | Standard Deviation 6.725 |
| PPPP Participants | Knowledge and Awareness of Pneumococcal Disease | Post-test knowledge score (max score 28) | 20.41 scores on a scale | Standard Deviation 6.254 |
| PPPP Participants | Knowledge and Awareness of Pneumococcal Disease | 3 month knowledge score (max score 28) | 21.43 scores on a scale | Standard Deviation 4.524 |
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.
Time frame: 3 months
Population: Intention-to-Treat (ITT) sample, subset not reporting positive history of pneumococcal vaccination at baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PPPP Participants | Activation | Actions taken at 3 months | 77 Participants |
| PPPP Participants | Activation | Actions planned at baseline | 41 Participants |
| PPPP Participants | Activation | Actions planned at post-test | 91 Participants |
| PPPP Participants | Activation | Actions planned at 3 months | 27 Participants |
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPPP Participants | Intervention Cost | 162.43 $/participant |
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.
Time frame: 3 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PPPP Participants | Pharmacist Satisfaction | Satisfaction with live action skit | Agree | 18 Participants |
| PPPP Participants | Pharmacist Satisfaction | Satisfaction with live action skit | Disagree | 1 Participants |
| PPPP Participants | Pharmacist Satisfaction | Satisfaction with live action skit | No response | 1 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP successfully educated participnts | Agree | 19 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP successfully educated participnts | Disagree | 1 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP successfully educated participnts | No response | 0 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP successfully built trust | Agree | 17 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP successfully built trust | Disagree | 2 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP successfully built trust | No response | 1 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP successfully increased acceptance | Agree | 19 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP successfully increased acceptance | Disagree | 1 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP successfully increased acceptance | No response | 0 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP decreased barriers to vaccination | Agree | 20 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP decreased barriers to vaccination | Disagree | 0 Participants |
| PPPP Participants | Pharmacist Satisfaction | Belief that PPPP decreased barriers to vaccination | No response | 0 Participants |
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.
Time frame: 3 months
Population: Intention-to-treat (ITT) sample
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| PPPP Participants | Satisfaction With PPPP | Satisfied with content | No response | 116 Participants |
| PPPP Participants | Satisfaction With PPPP | Satisfied with content | Completely Agree | 69 Participants |
| PPPP Participants | Satisfaction With PPPP | Satisfied with content | Somewhat agree | 3 Participants |
| PPPP Participants | Satisfaction With PPPP | Satisfied with content | Somewhat disagree | 1 Participants |
| PPPP Participants | Satisfaction With PPPP | Satisfied with content | Completely disagree | 1 Participants |
| PPPP Participants | Satisfaction With PPPP | Engaged or interested in the program | Completely Agree | 70 Participants |
| PPPP Participants | Satisfaction With PPPP | Engaged or interested in the program | Somewhat agree | 4 Participants |
| PPPP Participants | Satisfaction With PPPP | Engaged or interested in the program | Somewhat disagree | 0 Participants |
| PPPP Participants | Satisfaction With PPPP | Engaged or interested in the program | Completely disagree | 0 Participants |
| PPPP Participants | Satisfaction With PPPP | Engaged or interested in the program | No response | 116 Participants |
| PPPP Participants | Satisfaction With PPPP | Program helped learn about pneumonia & vaccination | Completely Agree | 110 Participants |
| PPPP Participants | Satisfaction With PPPP | Program helped learn about pneumonia & vaccination | Somewhat agree | 26 Participants |
| PPPP Participants | Satisfaction With PPPP | Program helped learn about pneumonia & vaccination | Somewhat disagree | 3 Participants |
| PPPP Participants | Satisfaction With PPPP | Program helped learn about pneumonia & vaccination | Completely disagree | 0 Participants |
| PPPP Participants | Satisfaction With PPPP | Program helped learn about pneumonia & vaccination | No response | 51 Participants |
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).
Time frame: Baseline, post-test (immediately following intervention), 3 months
Population: Intention-to-Treat (ITT) sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PPPP Participants | Trust in Pharmacists as Vaccine Providers | Baseline | 1.79 units on a scale | Standard Deviation 0.51 |
| PPPP Participants | Trust in Pharmacists as Vaccine Providers | Post-Test | 1.55 units on a scale | Standard Deviation 0.47 |
| PPPP Participants | Trust in Pharmacists as Vaccine Providers | 3 Months | 1.80 units on a scale | Standard Deviation 0.43 |