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Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01431183
First Posted: September 9, 2011
Last Update Posted: September 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Kevin Dombkowski, University of Michigan
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

Resource links provided by NLM:


Further study details as provided by Kevin Dombkowski, University of Michigan:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   24 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( U.S. NIH Grant/Contract )
First Submitted: September 6, 2011
First Posted: September 9, 2011
Last Update Posted: September 9, 2011
Last Verified: September 2011

Keywords provided by Kevin Dombkowski, 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
Vaccines
Immunologic Factors
Physiological Effects of Drugs