- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03372967
Project IMPACT Immunizations (IMProving America's Communities Together) Scaled Demonstration
December 12, 2019 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 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 Type
Observational
Enrollment (Actual)
6234
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
-
-
Iowa
-
Atlantic, Iowa, United States, 50022
- Walmart Pharmacy
-
Carlisle, Iowa, United States, 50047
- Medicap Pharmacy
-
Coralville, Iowa, United States, 52241
- NuCara Pharmacy
-
Eagle Grove, Iowa, United States, 50533
- Eagle Pharmacy
-
Eldora, Iowa, United States, 50627
- Medicap Pharmacy
-
Indianola, Iowa, United States, 50125
- Medicap Pharmacy
-
Iowa City, Iowa, United States, 52240
- Towncrest Pharmacy
-
Iowa City, Iowa, United States, 52245
- Hy-Vee Pharmacy
-
Knoxville, Iowa, United States, 50138
- Walmart Pharmacy
-
Maquoketa, Iowa, United States, 52060
- Osterhaus Pharmacy
-
Marion, Iowa, United States, 52302
- Hy-Vee Pharmacy
-
Pella, Iowa, United States, 50219
- Walmart Pharmacy
-
Pleasant Hill, Iowa, United States, 50327
- NuCara Pharmacy
-
Traer, Iowa, United States, 50675
- NuCara Pharmacy
-
W. Union, Iowa, United States, 52175
- NuCara Pharmacy
-
Waterloo, Iowa, United States, 50702
- Greenwood Pharmacy
-
Waverly, Iowa, United States, 50677
- Meyer Pharmacy
-
West Des Moines, Iowa, United States, 50265
- Hy-Vee Pharmacy
-
Winterset, Iowa, United States, 50273
- Montross Pharmacy
-
-
Washington
-
Bellevue, Washington, United States, 98005
- Safeway Pharmacy
-
Issaquah, Washington, United States, 98029
- Safeway Pharmacy
-
Redmond, Washington, United States, 98053
- Albertsons Sav-On Pharmacy
-
-
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
Probability Sample
Study Population
Adults eligible to receive vaccinations for preventable diseases
Description
Inclusion Criteria:
- 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.
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 |
---|---|
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.
|
Identification of unmet vaccination needs and having those needs met
Pharmacist review of the vaccination forecast and patient education on his/her vaccine needs
Administration, number and types, of vaccines by a pharmacist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in vaccination rates for routinely recommended adult vaccinations
Time Frame: 6 months
|
Change from baseline rates
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of vaccines administered
Time Frame: 6 months
|
Change from baseline rates
|
6 months
|
Types of vaccines administered
Time Frame: 6 months
|
Change from baseline rates
|
6 months
|
Number of unmet vaccination needs that were identified and met
Time Frame: 6 months
|
Measured through study completion
|
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 Foundation
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 (Actual)
December 12, 2017
Primary Completion (Actual)
November 20, 2019
Study Completion (Actual)
November 20, 2019
Study Registration Dates
First Submitted
December 5, 2017
First Submitted That Met QC Criteria
December 8, 2017
First Posted (Actual)
December 14, 2017
Study Record Updates
Last Update Posted (Actual)
December 13, 2019
Last Update Submitted That Met QC Criteria
December 12, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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