From Innovation to Solutions: Childhood Influenza Vaccination Planning

Not Applicable

Completed

• Conditions: Influenza
• Interventions: Behavioral: 4 Pillars Immunization Toolkit

• Registration Number: NCT01664793
• Lead Sponsor: University of Pittsburgh

Brief Summary

The purpose of this study is to increase childhood influenza vaccination rates using the FDA licensed influenza vaccines according to national guidelines in a randomized cluster trial in which primary care offices are randomized to intervention or control with the control group receiving the intervention in the second year.

Detailed Description

The investigators will conduct a stratified, randomized cluster trial of 20 diverse primary care practices to compare influenza vaccination rates in intervention and control sites. Intervention sites will use a package of newly developed and evidence-based techniques that will be tailored to their practice structure and culture, called the 4 Pillars Immunization Toolkit, in addition to receiving donated vaccine for early season vaccination. Control practices will not receive such assistance but will receive the intervention in the second year.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-14
• Primary Completion: 2013-02
• Study Completion: 2013-11
• Results First Submitted: 2014-05-27
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-21
• Last Update Submitted: 2014-11-21
• Results First Posted: 2014-11-24
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87665

Inclusion Criteria

Not provided

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Exclusion Criteria

For children: Severe egg allergy or allergy to influenza vaccine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group Year 1	4 Pillars Immunization Toolkit	The 4 Pillars Immunization Toolkit along with donated vaccines for early season vaccination, staff education and support.

Primary Outcome Measures

Name	Time	Method
Primary Outcome	3/1/2011-2/29/2012	Influenza vaccination rates in each arm at the end of year 1

Secondary Outcome Measures

Name	Time	Method
Effectiveness Score	End of February 2012	Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).

Trial Locations

Locations (1)

University of Pittsburgh, School of Medicine, Deparment of Family Medicine and Clinical Epidemiology; 🇺🇸 Pittsburgh, Pennsylvania, United States