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NCT03372967 Clinical Trial

Project IMPACT Immunizations (IMProving America's Communities Together) Scaled Demonstration

Influenza Clinical Trial

Official title:
Project IMPACT Immunizations (IMProving America's Communities Together) Scaled Demonstration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03372967
Other study ID # 018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 12, 2017
Est. completion date November 20, 2019

Study information
Verified date December 2019
Source American Pharmacists Association Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 vaccinations.

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.

Recruitment information / eligibility
Status Completed
Enrollment 6234
Est. completion date November 20, 2019
Est. primary completion date November 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Vaccine administration by a pharmacist
Administration, number and types, of vaccines by a pharmacist
Behavioral:
• Unmet vaccination needs identified and met
Identification of unmet vaccination needs and having those needs met
• Vaccination forecast review and patient education
Pharmacist review of the vaccination forecast and patient education on his/her vaccine needs

Locations
Country Name City State
United States Walmart Pharmacy Atlantic Iowa
United States Safeway Pharmacy Bellevue Washington
United States Medicap Pharmacy Carlisle Iowa
United States NuCara Pharmacy Coralville Iowa
United States Eagle Pharmacy Eagle Grove Iowa
United States Medicap Pharmacy Eldora Iowa
United States Medicap Pharmacy Indianola Iowa
United States Hy-Vee Pharmacy Iowa City Iowa
United States Towncrest Pharmacy Iowa City Iowa
United States Safeway Pharmacy Issaquah Washington
United States Walmart Pharmacy Knoxville Iowa
United States Osterhaus Pharmacy Maquoketa Iowa
United States Hy-Vee Pharmacy Marion Iowa
United States Walmart Pharmacy Pella Iowa
United States NuCara Pharmacy Pleasant Hill Iowa
United States Albertsons Sav-On Pharmacy Redmond Washington
United States NuCara Pharmacy Traer Iowa
United States NuCara Pharmacy W. Union Iowa
United States Greenwood Pharmacy Waterloo Iowa
United States Meyer Pharmacy Waverly Iowa
United States Hy-Vee Pharmacy West Des Moines Iowa
United States Montross Pharmacy Winterset Iowa

Sponsors (1)
Lead Sponsor Collaborator
American Pharmacists Association Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in vaccination rates for routinely recommended adult vaccinations Change from baseline rates 6 months
Secondary Number of vaccines administered Change from baseline rates 6 months
Secondary Types of vaccines administered Change from baseline rates 6 months
Secondary Number of unmet vaccination needs that were identified and met Measured through study completion 6 months
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