Overview

This trial is active, not recruiting.

Condition study is open to seniors age 50 or older
Treatment pharmacist pneumococcal vaccine program (ppvp)
Phase phase 4
Sponsor Thomas Jefferson University
Start date January 2014
End date November 2014
Trial size 200 participants
Trial identifier NCT01944462, Merck IISP ID 50926

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Individuals receiving the PPVP intervention which consists of the educational program delivered on site at the collaborating senior center.
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.

Primary Outcomes

Measure
Knowledge and awareness of pneumococcal disease
time frame: Baseline, 1 month, 3 months
Activation
time frame: 3 months

Secondary Outcomes

Measure
Trust in pharmacists as vaccine providers
time frame: Baseline, 3 months
Satisfaction with PPVP
time frame: 3 months
Intervention cost
time frame: 3 months
Pharmacist activation
time frame: 3 months

Eligibility Criteria

Male or female participants at least 50 years old.

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)

Additional Information

Official title 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
Principal investigator Laura Pizzi, PharmD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Thomas Jefferson University.