Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01944462
Recruitment Status : Completed
First Posted : September 17, 2013
Results First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Study is Open to Seniors Age 50 or Older Behavioral: Pharmacist Pneumococcal Vaccine Program (PPVP) Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : January 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pharmacist Pneumococcal Vaccine Program (PPVP)
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)
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 Outcome Measures :
  1. Knowledge and Awareness of Pneumococcal Disease [ Time Frame: 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 Outcome Measures :
  1. Trust in Pharmacists as Vaccine Providers [ Time Frame: 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).

  2. Activation [ Time Frame: 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.

  3. Satisfaction With PPPP [ Time Frame: 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.

  4. Intervention Cost [ Time Frame: 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".

  5. Pharmacist Satisfaction [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944462


Locations
Layout table for location information
United States, Pennsylvania
Center in the Park
Philadelphia, Pennsylvania, United States, 19144
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Layout table for investigator information
Principal Investigator: Laura Pizzi, PharmD, MPH Thomas Jefferson University

Additional Information:
Layout table for additonal information
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01944462     History of Changes
Other Study ID Numbers: Merck IISP ID 50926
First Posted: September 17, 2013    Key Record Dates
Results First Posted: January 3, 2018
Last Update Posted: January 3, 2018
Last Verified: May 2017
Keywords provided by Thomas Jefferson University:
pneumococcal vaccine
pharmacist vaccination
Pneumovax 23
pneumococcal vaccine polyvalent
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs