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Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Kevin Dombkowski, University of Michigan
ClinicalTrials.gov Identifier:
NCT01431183
First received: September 6, 2011
Last updated: September 7, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Seasonal Influenza Vaccination
 Behavioral: Mailed influenza vaccination reminder notice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • seasonal influenza vaccination [ Time Frame: up to 4 months following reminder notification ] [ Designated as safety issue: No ]
    Receipt of 1 or more dose of seasonal influenza vaccine, either trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV)


Secondary Outcome Measures:
  • invalid mailing address [ Time Frame: up to 4 months following reminder notification ] [ Designated as safety issue: No ]
    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


Enrollment: 3618
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   24 Months to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431183

Locations
United States, Michigan
University of Michigan, Child Health Evaluation and Research Unit
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Kevin J Dombkowski, DrPH, MS University of Michigan
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kevin Dombkowski, Research Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01431183     History of Changes
Other Study ID Numbers: 5U01IP000132
Study First Received: September 6, 2011
Last Updated: September 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
influenza
vaccine
reminder / recall
immunization registry
immunization information systems

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

ClinicalTrials.gov processed this record on May 16, 2013