Study is Open to Seniors Age 50 or OlderPhase 4PPVPNCT01944462
Impact and Cost of a Pharmacist Pneumococcal Vaccination Program With PNEUMOVAX® 23 at an Urban Senior Center
A Phase 4 study testing Pharmacist Pneumococcal Vaccine Program (PPVP) in people with Study is Open to Seniors Age 50 or Older, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Study is Open to Seniors Age 50 or Older
- What is being tested?
- Pharmacist Pneumococcal Vaccine Program (PPVP)
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 27Show fewer
- 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
Who cannot join
- Exclusions to the PPVP program: none
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center in the Park
Philadelphia, Pennsylvania, 19144
About this study
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
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.
- Conditions
- Study is Open to Seniors Age 50 or Older
- Being tested
- Pharmacist Pneumococcal Vaccine Program (PPVP)
- Keywords
- pneumococcal vaccine, pharmacist vaccination, Pneumovax 23, pneumococcal vaccine polyvalent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist Pneumococcal Vaccine Program (PPVP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Pneumococcal Vaccine Program (PPVP) | Experimental | Individuals receiving the PPVP intervention which consists of the educational program delivered on site at the collaborating senior center. Receives: Behavioral: Pharmacist Pneumococcal Vaccine Program (PPVP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-test, 3 months
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Study is Open to Seniors Age 50 or OlderStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Pizzi, PharmD, MPH, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944462
- Sponsor's protocol ID
- Merck IISP ID 50926
- Acronym
- PPVP
- Status last verified
- May 2017
- First submitted
- 5 Sep 2013
- Last updated
- 3 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01944462
- Acronym / sponsor ID
- PPVP / Merck IISP ID 50926
- Conditions
- Study is Open to Seniors Age 50 or Older
- Keywords
- pneumococcal vaccine, pharmacist vaccination, Pneumovax 23, pneumococcal vaccine polyvalent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Posted 3 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Pneumococcal Vaccine Program (PPVP) | Experimental | Behavioral: Pharmacist Pneumococcal Vaccine Program (PPVP)Individuals receiving the PPVP intervention which consists of the educational program delivered on site at the collaborating senior center. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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
Key exclusion criteria (5 listed)
- Exclusions to the PPVP program: none
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Pharmacist Pneumococcal Vaccine Program (PPVP) |
Primary outcome
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.
5 secondary outcomes
Trust in Pharmacists as Vaccine Providers
Time frame: Baseline, post-test (immediately following intervention), 3 months
Activation
Time frame: 3 months
Satisfaction With PPPP
Time frame: 3 months
Intervention Cost
Time frame: 3 months
Pharmacist Satisfaction
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- US Centers for Disease Control. Vaccine Information Statement on Pneumococcal Polysaccharide Vaccine.Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Pizzi, PharmD, MPH principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pharmacist Pneumococcal Vaccine Program (PPVP) in people with Study is Open to Seniors Age 50 or Older, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge and Awareness of Pneumococcal Disease (time frame: Baseline, post-test, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.