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From Innovation to Solutions: Childhood Influenza Vaccination Planning

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University of Pittsburgh

Status

Completed

Conditions

Influenza

Treatments

Behavioral: 4 Pillars Immunization Toolkit

Study type

Interventional

Funder types

Other

Identifiers

NCT01664793
1U01IP000321-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

87,665 patients

Sex

All

Ages

6 months to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

87,665 participants in 2 patient groups

Intervention Group Year 1
Experimental group
Description:
The 4 Pillars Immunization Toolkit along with donated vaccines for early season vaccination, staff education and support.
Treatment:
Behavioral: 4 Pillars Immunization Toolkit
Control Group Year 1
No Intervention group
Description:
Control sites will not receive assistance with increasing influenza vaccination in Year 1, they will follow guidelines for usual care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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