NCT01664793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87,665

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 24, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

2.3 years

First QC Date

August 2, 2012

Results QC Date

May 27, 2014

Last Update Submit

November 21, 2014

Conditions

Influenza

Keywords

influenzavaccinationstrategieschildren/adolescents

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome

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

    3/1/2011-2/29/2012

Secondary Outcomes (1)

  • Effectiveness Score

    End of February 2012

Study Arms (2)

Intervention Group Year 1

EXPERIMENTAL

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

Behavioral: 4 Pillars Immunization Toolkit

Control Group Year 1

NO INTERVENTION

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

Interventions

4 Pillars Immunization ToolkitBEHAVIORAL

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 Group Year 1

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • For children: attendance at the selected health care center within the last year and age \>/=6 months thru 18 years.

You may not qualify if:

  • For children: Severe egg allergy or allergy to influenza vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • 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.

    PMID: 25113138BACKGROUND

  • 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.

    PMID: 24793941BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Limitations and Caveats

2 offices of 1 practice were randomized to each arm potentially causing carryover of the intervention.

Results Point of Contact

Title
Richard K. Zimmerman
Organization
University of Pittsburgh
zimmer@pitt.edu
412-383-2355

Study Officials

  • Richard Zimmerman, MD, MPH

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

    PRINCIPAL INVESTIGATOR

  • Chyongchiou Lin, PhD

    University of Pittsburgh

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 14, 2012

Study Start

October 1, 2010

Primary Completion

February 1, 2013

Study Completion

November 1, 2013

Last Updated

November 24, 2014

Results First Posted

November 24, 2014

Record last verified: 2014-11

Locations

US(1)