InfluenzaNCT03372967
Project IMPACT Immunizations (IMProving America's Communities Together) Scaled Demonstration
An observational study of Influenza, run by American Pharmacists Association Foundation at 22 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
- 6,234 participants
- Where
- 22 sitesUnited States
- Study dates
- 12 Dec 2017to 20 Nov 2019
- 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: Adults eligible to receive vaccinations for preventable diseases
Who may be able to join
- Individuals eligible to be enrolled in the study include any person at least 18 years of age who is eligible for a comprehensive vaccination history review as determined by the pharmacist.
Who cannot join
- n/a
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Walmart Pharmacy
Atlantic, Iowa, 50022
Safeway Pharmacy
Bellevue, Washington, 98005
Medicap Pharmacy
Carlisle, Iowa, 50047
NuCara Pharmacy
Coralville, Iowa, 52241
Eagle Pharmacy
Eagle Grove, Iowa, 50533
Medicap Pharmacy
Eldora, Iowa, 50627
Medicap Pharmacy
Indianola, Iowa, 50125
Towncrest Pharmacy
Iowa City, Iowa, 52240
Hy-Vee Pharmacy
Iowa City, Iowa, 52245
Safeway Pharmacy
Issaquah, Washington, 98029
Walmart Pharmacy
Knoxville, Iowa, 50138
Osterhaus Pharmacy
Maquoketa, Iowa, 52060
Hy-Vee Pharmacy
Marion, Iowa, 52302
Walmart Pharmacy
Pella, Iowa, 50219
NuCara Pharmacy
Pleasant Hill, Iowa, 50327
Albertsons Sav-On Pharmacy
Redmond, Washington, 98053
NuCara Pharmacy
Traer, Iowa, 50675
Greenwood Pharmacy
Waterloo, Iowa, 50702
Meyer Pharmacy
Waverly, Iowa, 50677
Hy-Vee Pharmacy
West Des Moines, Iowa, 50265
NuCara Pharmacy
West Union, Iowa, 52175
Montross Pharmacy
Winterset, Iowa, 50273
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 multi-site study will use a pre-post design with a population-based comparison group to investigate 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. 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
- preventable disease, vaccine, public health, 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 vaccines 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 |
|---|---|---|
| Comprehensive Vaccination History Review | Patients who receive a comprehensive vaccination history review 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.
Change in vaccination rates for routinely recommended adult vaccinations
Change from baseline rates
Measured: 6 months
Secondary outcomes (3)
Number of vaccines administered
Change from baseline rates
Measured: 6 months
Types of vaccines administered
Change from baseline rates
Measured: 6 months
Number of unmet vaccination needs that were identified and met
Measured through study completion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start12 Dec 2017
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
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
- 6,234 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 Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372967
- Sponsor's protocol ID
- 018
- Status last verified
- Dec 2019
- First submitted
- 5 Dec 2017
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project IMPACT Immunizations (IMProving America's Communities Together) Scaled Demonstration
- ClinicalTrials.gov ID
- NCT03372967
- Acronym / sponsor ID
- 018
- Conditions
- Influenza
- Keywords
- preventable disease, vaccine, public health, vaccine history, point-of-care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,234 participants (actual)
- Lead sponsor
- American Pharmacists Association FoundationUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 14 Dec 2017 (actual)
- 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 multi-site study will use a pre-post design with a population-based comparison group to investigate 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. 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 |
|---|---|---|
| Comprehensive Vaccination History Review | – | Biological: Vaccine administration by a pharmacist, Behavioral: Unmet vaccination needs identified and met, Behavioral: Vaccination forecast review and patient educationPatients who receive a comprehensive vaccination history review 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
- Adults eligible to receive vaccinations for preventable diseases
Key inclusion criteria (1 listed)
- Individuals eligible to be enrolled in the study include any person at least 18 years of age who is eligible for a comprehensive vaccination history review as determined by the pharmacist.
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 vaccines by a pharmacist | Biological | Comprehensive Vaccination History Review |
| Unmet vaccination needs identified and metIdentification of unmet vaccination needs and having those needs met | Behavioural | Comprehensive Vaccination History Review |
| Vaccination forecast review and patient educationPharmacist review of the vaccination forecast and patient education on his/her vaccine needs | Behavioural | Comprehensive Vaccination History Review |
Primary outcome
Change in vaccination rates for routinely recommended adult vaccinations
Time frame: 6 months
Change from baseline rates
3 secondary outcomes
Number of vaccines administered
Time frame: 6 months
Types of vaccines administered
Time frame: 6 months
Number of unmet vaccination needs that were identified and met
Time frame: 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 13 Dec 2019.
- Individual participant dataSharing planned: No
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Post Influenza
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 Foundation
22 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 22 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 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Change in vaccination rates for routinely recommended adult vaccinations (time frame: 6 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 13 Dec 2019; AzTrials last refreshed its copy on 1 Nov 2026.