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

NCT ID: NCT01944462

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-11-30

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.

Conditions

Study is Open to Seniors Age 50 or Older

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pharmacist Pneumococcal Vaccine Program (PPVP)

Individuals receiving the PPVP intervention which consists of the educational program delivered on site at the collaborating senior center.

Group Type: EXPERIMENTAL

Pharmacist Pneumococcal Vaccine Program (PPVP)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Pizzi, PharmD, MPH

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Center in the Park

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

Merck IISP ID 50926

Identifier Type: -

Identifier Source: org_study_id