Clinical trial NCT01944462: Impact and Cost of a Pharmacist Pneumococcal Vaccination Program With PNEUMOVAX® 23 at an Urban Senior Center
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Study is Open to Seniors Age 50 or Older
Keywords: pneumococcal vaccine
pharmacist vaccination
Pneumovax 23
pneumococcal vaccine polyvalent
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 203
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Knowledge and Awareness of Pneumococcal Disease
timeFrame: Baseline, post-test, 3 months
Secondary outcomes:
measure: Trust in Pharmacists as Vaccine Providers
timeFrame: Baseline, post-test (immediately following intervention), 3 months
measure: Activation
timeFrame: 3 months
measure: Satisfaction With PPPP
timeFrame: 3 months
measure: Intervention Cost
timeFrame: 3 months
measure: Pharmacist Satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center in the Park
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Laura Pizzi, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References: