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Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

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ClinicalTrials.gov Identifier: NCT01431183
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : September 9, 2011
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Kevin Dombkowski, University of Michigan

Brief Summary:
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 or disease Intervention/treatment
Seasonal Influenza Vaccination Behavioral: Mailed influenza vaccination reminder notice

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3618 participants
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
Study Start Date : October 2008
Primary Completion Date : February 2009
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. 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



Information from the National Library of Medicine

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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)

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

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 Posted: September 9, 2011    Key Record Dates
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