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From Innovation to Solutions: Childhood Influenza Vaccination Planning

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4 Pillars Immunization Toolkit
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza, vaccination, strategies, children/adolescents

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group Year 1

Control Group Year 1

Arm Description

The 4 Pillars Immunization Toolkit along with donated vaccines for early season vaccination, staff education and support.

Control sites will not receive assistance with increasing influenza vaccination in Year 1, they will follow guidelines for usual care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
August 2, 2012
Last Updated
November 21, 2014
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01664793
Brief Title
From Innovation to Solutions: Childhood Influenza Vaccination Planning
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, vaccination, strategies, children/adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87665 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group Year 1
Arm Type
Experimental
Arm Description
The 4 Pillars Immunization Toolkit along with donated vaccines for early season vaccination, staff education and support.
Arm Title
Control Group Year 1
Arm Type
No Intervention
Arm Description
Control sites will not receive assistance with increasing influenza vaccination in Year 1, they will follow guidelines for usual care.
Intervention Type
Behavioral
Intervention Name(s)
4 Pillars Immunization Toolkit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Outcome
Description
Influenza vaccination rates in each arm at the end of year 1
Time Frame
3/1/2011-2/29/2012
Secondary Outcome Measure Information:
Title
Effectiveness Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Zimmerman, MD, MPH
Organizational Affiliation
University of Pittsburgh, School of Medicine, Department of Family Medicine and Clinical Epidemiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chyongchiou Lin, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
University of Pittsburgh, School of Medicine, Deparment of Family Medicine and Clinical Epidemiology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25113138
Citation
Nowalk MP, Lin CJ, Hannibal K, Reis EC, Gallik G, Moehling KK, Huang HH, Allred NJ, Wolfson DH, Zimmerman RK. Increasing childhood influenza vaccination: a cluster randomized trial. Am J Prev Med. 2014 Oct;47(4):435-43. doi: 10.1016/j.amepre.2014.07.003. Epub 2014 Aug 8.
Results Reference
background
PubMed Identifier
24793941
Citation
Zimmerman RK, Nowalk MP, Lin CJ, Hannibal K, Moehling KK, Huang HH, Matambanadzo A, Troy J, Allred NJ, Gallik G, Reis EC. Cluster randomized trial of a toolkit and early vaccine delivery to improve childhood influenza vaccination rates in primary care. Vaccine. 2014 Jun 17;32(29):3656-63. doi: 10.1016/j.vaccine.2014.04.057. Epub 2014 Apr 29.
Results Reference
background

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From Innovation to Solutions: Childhood Influenza Vaccination Planning

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