From Innovation to Solutions: Childhood Influenza Vaccination Planning
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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||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|
- Primary Outcome [ Time Frame: 3/1/2011-2/29/2012 ] [ Designated as safety issue: No ]Influenza vaccination rates in each arm at the end of year 1
- Effectiveness Score [ Time Frame: End of February 2012 ] [ Designated as safety issue: No ]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).
|Study Start Date:||October 2010|
|Study Completion Date:||November 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: Intervention Group Year 1
The 4 Pillars Immunization Toolkit along with donated vaccines for early season vaccination, staff education and support.
Behavioral: 4 Pillars Immunization Toolkit
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.
No Intervention: Control Group Year 1
Control sites will not receive assistance with increasing influenza vaccination in Year 1, they will follow guidelines for usual care.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664793
|United States, Pennsylvania|
|University of Pittsburgh, School of Medicine, Deparment of Family Medicine and Clinical Epidemiology|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Richard Zimmerman, MD, MPH||University of Pittsburgh, School of Medicine, Department of Family Medicine and Clinical Epidemiology|
|Study Director:||Chyongchiou Lin, PhD||University of Pittsburgh|