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NCT02584036 Clinical Trial

Project IMPACT Immunizations (IMProving America's Communities Together)

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02584036
Other study ID # 015
Secondary ID
Status Completed
Phase N/A
First received October 20, 2015
Last updated July 11, 2016
Start date October 2015
Est. completion date July 2016

Study information
Verified date July 2016
Source American Pharmacists Association Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
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 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.

Recruitment information / eligibility
Status Completed
Enrollment 1080
Est. completion date July 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
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 receiving an influenza vaccination from a participating pharmacy site.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• Vaccine administration by a pharmacist
Administration, number and types, of vaccine(s) 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 Quality Food Centers #101 Belfair Washington
United States Cheney-Owl Pharmacy Cheney Washington
United States Kirk's Pharmacy Eatonville Washington
United States Quality Food Centers #851 Edmonds Washington
United States Lopez Island Pharmacy Lopez Island Washington
United States Kelley-Ross Pharmacy Seattle Washington
United States ReliantRx Spokane Washington
United States Tieton Village Drug Yakima Washington

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 Number and types of vaccines administered Change from baseline rates at 6 months No
Primary Number of unmet vaccination needs identified and met through study completion, an average of 6 months No
Primary Number of times the pharmacist reviewed the vaccination forecast and educated the patient on his/her vaccine needs through study completion, an average of 6 months No
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