InfluenzaNCT02584036
Project IMPACT Immunizations (IMProving America's Communities Together)
An observational study of Influenza, run by American Pharmacists Association Foundation at 8 sites in United States.
Trial summary
The primary objective of this study is to evaluate how implementing an innovative care model that provides the pharmacist access to a patient's vaccine history at the point-of-care impacts the pharmacist's ability to identify unmet vaccination needs and increase vaccination rates for routinely recommended adult… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Vaccine administration by a pharmacist, Unmet vaccination needs identified and met and Vaccination forecast review and patient education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 1,080 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients receiving an influenza vaccine
Who may be able to join
- Individuals eligible to be enrolled in the study include any person at least 18 years of age receiving an influenza vaccination from a participating pharmacy site.
Who cannot join
- n/a
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Quality Food Centers #101
Belfair, Washington, 98528
Cheney-Owl Pharmacy
Cheney, Washington, 99004
Kirk's Pharmacy
Eatonville, Washington, 98328
Quality Food Centers #851
Edmonds, Washington, 98020
Lopez Island Pharmacy
Lopez Island, Washington, 98261
Kelley-Ross Pharmacy
Seattle, Washington, 98104
ReliantRx
Spokane, Washington, 99207
Tieton Village Drug
Yakima, Washington, 98902
About this study
The primary objective of this study is to evaluate how implementing an innovative care model that provides the pharmacist access to a patient's vaccine history at the point-of-care impacts the pharmacist's ability to identify unmet vaccination needs and increase vaccination rates for routinely recommended adult vaccinations.
Read the detailed description
This is a multi-site, observational study investigating the impact of implementing an innovative care model on the pharmacist's ability to identify unmet vaccination needs and increase vaccination rates for routinely recommended adult vaccinations. The innovative care model enables the pharmacist to utilize a bi-directional IIS to assess patients' vaccination histories, identify unmet vaccination needs, and document the care provided. Data will be collected in the bi-directional IIS. Aggregate de-identified data will be reported to the researchers at the midpoint and conclusion of the study. The project duration has been established to allow sufficient time for each pharmacy to implement the innovative care model and monitor each pharmacy for a 6-month study period. The American Pharmacists Association (APhA) Foundation has an a priori intent to publish the project results.
- Conditions
- Influenza
- Being tested
- Vaccine administration by a pharmacist, Unmet vaccination needs identified and met, Vaccination forecast review and patient education
- Keywords
- influenza, vaccine, public health, preventable disease, vaccine history, point-of-care
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine administration by a pharmacistBiological
Administration, number and types, of vaccine(s) by a pharmacist
Unmet vaccination needs identified and metBehavioural
Identification of unmet vaccination needs and having those needs met
Vaccination forecast review and patient educationBehavioural
Pharmacist review of the vaccination forecast and patient education on his/her vaccine needs
| Study group | Role | What they receive |
|---|---|---|
| Receiving Influenza Vaccine | Patients who receive an influenza vaccine at a participating pharmacy site will be eligible to: a) receive a vaccination forecast review, b) be evaluated for unmet vaccination needs, c) receive patient education, and d) have vaccination needs met. Receives: Biological: Vaccine administration by a pharmacist; Behavioral: Unmet vaccination needs identified and met; Behavioral: Vaccination forecast review and patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and types of vaccines administered
Measured: Change from baseline rates at 6 months
Number of unmet vaccination needs identified and met
Measured: through study completion, an average of 6 months
Number of times the pharmacist reviewed the vaccination forecast and educated the patient on his/her vaccine needs
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Pharmacists Association Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin M Bluml, BPharm, Principal investigator, American Pharmacists Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584036
- Sponsor's protocol ID
- 015
- Status last verified
- Jul 2016
- First submitted
- 20 Oct 2015
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project IMPACT Immunizations (IMProving America's Communities Together)
- ClinicalTrials.gov ID
- NCT02584036
- Acronym / sponsor ID
- 015
- Conditions
- Influenza
- Keywords
- influenza, vaccine, public health, preventable disease, vaccine history, point-of-care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- American Pharmacists Association FoundationUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate how implementing an innovative care model that provides the pharmacist access to a patient's vaccine history at the point-of-care impacts the pharmacist's ability to identify unmet vaccination needs and increase vaccination rates for routinely recommended adult vaccinations.
Detailed description
This is a multi-site, observational study investigating the impact of implementing an innovative care model on the pharmacist's ability to identify unmet vaccination needs and increase vaccination rates for routinely recommended adult vaccinations. The innovative care model enables the pharmacist to utilize a bi-directional IIS to assess patients' vaccination histories, identify unmet vaccination needs, and document the care provided. Data will be collected in the bi-directional IIS. Aggregate de-identified data will be reported to the researchers at the midpoint and conclusion of the study. The project duration has been established to allow sufficient time for each pharmacy to implement the innovative care model and monitor each pharmacy for a 6-month study period. The American Pharmacists Association (APhA) Foundation has an a priori intent to publish the project results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving Influenza Vaccine | – | Biological: Vaccine administration by a pharmacist, Behavioral: Unmet vaccination needs identified and met, Behavioral: Vaccination forecast review and patient educationPatients who receive an influenza vaccine at a participating pharmacy site will be eligible to: a) receive a vaccination forecast review, b) be evaluated for unmet vaccination needs, c) receive patient education, and d) have vaccination needs met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving an influenza vaccine
Key inclusion criteria (1 listed)
- Individuals eligible to be enrolled in the study include any person at least 18 years of age receiving an influenza vaccination from a participating pharmacy site.
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| Vaccine administration by a pharmacistAdministration, number and types, of vaccine(s) by a pharmacist | Biological | Receiving Influenza Vaccine |
| Unmet vaccination needs identified and metIdentification of unmet vaccination needs and having those needs met | Behavioural | Receiving Influenza Vaccine |
| Vaccination forecast review and patient educationPharmacist review of the vaccination forecast and patient education on his/her vaccine needs | Behavioural | Receiving Influenza Vaccine |
Primary outcome
Number and types of vaccines administered
Time frame: Change from baseline rates at 6 months
Number of unmet vaccination needs identified and met
Time frame: through study completion, an average of 6 months
Number of times the pharmacist reviewed the vaccination forecast and educated the patient on his/her vaccine needs
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
Related trials for Influenza
Not yet recruitingPhase 2/3
Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza
Influenza, Human
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Not yet recruiting
Family Physician Nudges for Influenza Vaccination Among Older Adults
Influenza Vaccination
Recruiting
Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections
COVID-19 Respiratory Infection, Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
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.
Benjamin M Bluml, BPharm principal investigator
American Pharmacists Association
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by American Pharmacists Association Foundation at 8 sites 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 1 inclusion and 1 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number and types of vaccines administered (time frame: Change from baseline rates at 6 months). The study lists 3 primary outcomes in all. 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 12 Jul 2016.