From Innovation to Solutions: Childhood Influenza Vaccination Planning

University of Pittsburgh87,665 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

87,665

Conditions

Influenza

Interventions

4 Pillars Immunization ToolkitBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Pittsburgh, School of Medicine, Deparment of Family Medicine and Clinical Epidemiology

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Primary Outcome

Influenza vaccination rates in each arm at the end of year 1

Time frame: 3/1/2011-2/29/2012

Secondary Outcomes

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).

Time frame: End of February 2012

Data from ClinicalTrials.gov

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