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

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: Influenza
• Intervention / Treatment: Behavioral: Unmet vaccination needs identified and met; Behavioral: Vaccination forecast review and patient education; Biological: Vaccine administration by a pharmacist

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

Study Locations

• United States
  • 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

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

How is the study designed?

Number of groups / cohorts

1

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.	Behavioral: Unmet vaccination needs identified and met; Identification of unmet vaccination needs and having those needs met; Behavioral: Vaccination forecast review and patient education; Pharmacist review of the vaccination forecast and patient education on his/her vaccine needs; Biological: Vaccine administration by a pharmacist; 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	Change from baseline rates	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of vaccines administered	Change from baseline rates	6 months
Types of vaccines administered	Change from baseline rates	6 months
Number of unmet vaccination needs that were identified and met	Measured through study completion	6 months

Collaborators and Investigators

• Sponsor: American Pharmacists Association Foundation
• Investigators: Principal Investigator: Benjamin M Bluml, BPharm, American Pharmacists Association Foundation

Study record dates

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

• Keywords: vaccine; public health; point-of-care; preventable disease; vaccine history
• 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