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From Innovation to Solutions: Childhood Influenza Vaccination Planning

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Zimmerman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01664793
First received: August 2, 2012
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

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 Intervention
Influenza
Behavioral: 4 Pillars Immunization Toolkit

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).


Enrollment: 87665
Study Start Date: October 2010
Study Completion Date: November 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664793

Locations
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
Investigators
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
  More Information

Additional Information:
No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Zimmerman, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01664793     History of Changes
Other Study ID Numbers: 1 U01 IP000321-01
Study First Received: August 2, 2012
Results First Received: May 27, 2014
Last Updated: November 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
influenza
vaccination
strategies
children/adolescents

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014