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From Innovation to Solutions: Childhood Influenza Vaccination Planning

NCT ID: NCT01664793

Last Updated: 2014-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87665 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Group Year 1

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

Group Type EXPERIMENTAL

4 Pillars Immunization Toolkit

Intervention Type BEHAVIORAL

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.

Control Group Year 1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Richard Zimmerman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Zimmerman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

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

Chyongchiou Lin, PhD

Role: STUDY_DIRECTOR

University of Pittsburgh

Locations

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

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25113138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24793941 (View on PubMed)

Other Identifiers

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1U01IP000321-01

Identifier Type: NIH

Identifier Source: org_study_id

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