From Innovation to Solutions: Childhood Influenza Vaccination Planning

Study Overview
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Brief Summary
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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
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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.

Official Title
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From Innovation to Solutions: Autodialers, Use of Early Autumn Physicals and Vaccination Assessment as a Vital Sign to Increase Childhood Influenza Vaccination in Diverse Settings

Conditions
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Influenza

Intervention / Treatment
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* Behavioral: 4 Pillars Immunization Toolkit


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: For children: attendance at the selected health care center within the last year and age >/=6 months thru 18 years. Exclusion Criteria: For children: Severe egg allergy or allergy to influenza vaccine

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group Year 1<br>The 4 Pillars Immunization Toolkit along with donated vaccines for early season vaccination, staff education and support. | Behavioral: 4 Pillars Immunization Toolkit<br>* Pillar 1: Convenient Vaccination Services; Pillar 2: Patient notification about the importance of vaccination and availability of convenient services; Pillar 3: Enhanced Office Systems; Pillar 4: Motivation: Office immunization champion tracks progress towards a goal; Early delivery of donated vaccines for disadvantaged children, staff education, support of effort by research staff.<br>|
| No Intervention: Control Group Year 1<br>Control sites will not receive assistance with increasing influenza vaccination in Year 1, they will follow guidelines for usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome | Influenza vaccination rates in each arm at the end of year 1 | 3/1/2011-2/29/2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness Score | 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). | End of February 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, vaccination, strategies, children/adolescents