- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02584036
Project IMPACT Immunizations (IMProving America's Communities Together)
July 11, 2016 updated by: American Pharmacists Association Foundation
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
1080
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Belfair, Washington, United States, 98528
- Quality Food Centers #101
-
Cheney, Washington, United States, 99004
- Cheney-Owl Pharmacy
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Eatonville, Washington, United States, 98328
- Kirk's Pharmacy
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Edmonds, Washington, United States, 98020
- Quality Food Centers #851
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Lopez Island, Washington, United States, 98261
- Lopez Island Pharmacy
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Seattle, Washington, United States, 98104
- Kelley-Ross Pharmacy
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Spokane, Washington, United States, 99207
- ReliantRx
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Yakima, Washington, United States, 98902
- Tieton Village Drug
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients receiving an influenza vaccine
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- n/a
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Administration, number and types, of vaccine(s) by a pharmacist
Identification of unmet vaccination needs and having those needs met
Pharmacist review of the vaccination forecast and patient education on his/her vaccine needs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number and types of vaccines administered
Time Frame: Change from baseline rates at 6 months
|
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
|
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
|
through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Benjamin M Bluml, BPharm, American Pharmacists Association
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
October 20, 2015
First Submitted That Met QC Criteria
October 21, 2015
First Posted (Estimate)
October 22, 2015
Study Record Updates
Last Update Posted (Estimate)
July 12, 2016
Last Update Submitted That Met QC Criteria
July 11, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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