From Innovation to Solutions: Childhood Influenza Vaccination Planning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01664793
Recruitment Status : Completed
First Posted : August 14, 2012
Results First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Information provided by (Responsible Party):
Richard Zimmerman, 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.

Condition or disease Intervention/treatment Phase
Influenza Behavioral: 4 Pillars Immunization Toolkit Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 87665 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Primary Outcome [ Time Frame: 3/1/2011-2/29/2012 ]
    Influenza vaccination rates in each arm at the end of year 1

Secondary Outcome Measures :
  1. Effectiveness Score [ Time Frame: 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01664793

United States, Pennsylvania
University of Pittsburgh, School of Medicine, Deparment of Family Medicine and Clinical Epidemiology
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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

Responsible Party: Richard Zimmerman, Professor, University of Pittsburgh Identifier: NCT01664793     History of Changes
Other Study ID Numbers: 1U01IP000321-01 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2012    Key Record Dates
Results First Posted: November 24, 2014
Last Update Posted: November 24, 2014
Last Verified: November 2014

Keywords provided by Richard Zimmerman, University of Pittsburgh:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs