Impact and Cost of a Pharmacist Pneumococcal Vaccination Program With PNEUMOVAX® 23 at an Urban Senior Center

Study Overview
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Brief Summary
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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 PPVP will result in improved knowledge and awareness in older minorities in the senior center setting (primary hypothesis); Participants who are vaccinated through the project will experienced increased trust in receiving vaccines from a pharmacist; Participants will be satisfied with and trust the PV information provided by pharmacists in the PPVP; PPVP is an efficient approach to educating patients in the senior center based on its costs; Participating pharmacists will be activated to implement PPVP learnings in their practice.

Official Title
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Impact and Cost of a Pharmacist Pneumococcal Vaccination Program With PNEUMOVAX® 23 at an Urban Senior Center for Adults Aged 65 Years or Older or Those With Defined Risk Factors for Invasive Pneumococcal Disease

Conditions
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Study is Open to Seniors Age 50 or Older

Intervention / Treatment
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* Behavioral: Pharmacist Pneumococcal Vaccine Program (PPVP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. Inclusions for PPVP: Age ≥ 50 years old Can attend a 1.5-hour session at CIP Cognitively intact based on responses to an Abbreviated Mental Test Score (AMTS) of ≥7 (see Appendix for AMTS instrument) Can speak and read English at ≥4th grade level as evidenced by ability to read a brief passage 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: All adults age 65 years and older who have not had the vaccine previously Age 50-64 years with any of the following conditions: Cigarette smokers age 19 years and older Chronic cardiovascular disease (e.g., congestive heart failure, cardiomyopathies; excluding hypertension) Chronic pulmonary disease (including COPD and emphysema, and for adults ages 19 years and older, asthma) Diabetes mellitus Alcoholism Chronic liver disease, cirrhosis Candidate for or recipient of cochlear implant Functional or anatomic asplenia (e.g., sickle cell disease, splenectomy) Immunocompromising conditions or on immunosuppressive therapy Chronic renal failure or nephrotic syndrome 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: Functional or anatomic asplenia (including persons with sickle cell disease or splenectomy patients); Chronic renal failure (including dialysis patients) or nephrotic syndrome; Immunocompromising conditions or on immunosuppressive therapy Exclusion Criteria: A. Exclusions to the PPVP program: none B. Exclusions to receiving the optional pneumococcal vaccine: Participant has a history of allergic reaction to pneumococcal vaccine Participant has a history of allergic reaction to any component of any vaccine Participant with moderate or severe illness (these individuals will be advised to speak to their doctor regarding the vaccine)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist Pneumococcal Vaccine Program (PPVP)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumococcal vaccine, pharmacist vaccination, Pneumovax 23, pneumococcal vaccine polyvalent