Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

September 7, 2011 updated by: Kevin Dombkowski, University of Michigan
The objective of this study was to assess the feasibility and effectiveness of using a statewide immunization information system (IIS) to send seasonal influenza vaccine reminders from Local Health Departments (LHDs), targeting children with high-risk conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3618

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan, Child Health Evaluation and Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children, 24-60 months
  • current or previous enrollment in Medicaid (Michigan)
  • presence of at least 1 chronic condition, as indicated by the Michigan Care Improvement Registry (MCIR)
  • resident of Kalamazoo, Ottawa, or Kent counties (Michigan)

Exclusion Criteria:

  • receipt of influenza prior to notification date
  • ineligible for reminder/recall notification in the Michigan Care Improvement Registry (MCIR)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mailed reminder notice
Seasonal influenza vaccination reminder sent by postal mail
Behavioral: Mailed influenza vaccination reminder notice
Influenza vaccination reminder sent by postal mail
No Intervention: No reminder notice
No seasonal influenza vaccination reminder sent by postal mail

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
seasonal influenza vaccination
Time Frame: up to 4 months following reminder notification
Receipt of 1 or more dose of seasonal influenza vaccine, either trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV)
up to 4 months following reminder notification

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
invalid mailing address
Time Frame: up to 4 months following reminder notification
Postal mailing address determined to be invalid for mail delivery, either by physical return of mailed reminder notification, or through the United States Postal Service's National Change of Address (NCOA) process
up to 4 months following reminder notification

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Kevin J Dombkowski, DrPH, MS, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 6, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (Estimate)

September 9, 2011

Study Record Updates

Last Update Posted (Estimate)

September 9, 2011

Last Update Submitted That Met QC Criteria

September 7, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5U01IP000132 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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