Back to resultsSeasonal Influenza Vaccination Reminders for Children With High-risk Conditions
Primary Purpose
Seasonal Influenza Vaccination
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mailed influenza vaccination reminder notice
Sponsored by
About this trial
This is an interventional health services research trial for Seasonal Influenza Vaccination focused on measuring influenza, vaccine, reminder / recall, immunization registry, immunization information systems
Eligibility 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)
Sites / Locations
- University of Michigan, Child Health Evaluation and Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
mailed reminder notice
No reminder notice
Arm Description
Seasonal influenza vaccination reminder sent by postal mail
No seasonal influenza vaccination reminder sent by postal mail
Outcomes
Primary Outcome Measures
seasonal influenza vaccination
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
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
Full Information
NCT ID
NCT01431183
First Posted
September 6, 2011
Last Updated
September 7, 2011
Sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT01431183
Brief Title
Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions
Official Title
Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza Vaccination
Keywords
influenza, vaccine, reminder / recall, immunization registry, immunization information systems
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3618 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mailed reminder notice
Arm Type
Active Comparator
Arm Description
Seasonal influenza vaccination reminder sent by postal mail
Arm Title
No reminder notice
Arm Type
No Intervention
Arm Description
No seasonal influenza vaccination reminder sent by postal mail
Intervention Type
Behavioral
Intervention Name(s)
Mailed influenza vaccination reminder notice
Intervention Description
Influenza vaccination reminder sent by postal mail
Primary Outcome Measure Information:
Title
seasonal influenza vaccination
Description
Receipt of 1 or more dose of seasonal influenza vaccine, either trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV)
Time Frame
up to 4 months following reminder notification
Secondary Outcome Measure Information:
Title
invalid mailing address
Description
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
Time Frame
up to 4 months following reminder notification
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin J Dombkowski, DrPH, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan, Child Health Evaluation and Research Unit
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22176850
Citation
Dombkowski KJ, Harrington LB, Dong S, Clark SJ. Seasonal influenza vaccination reminders for children with high-risk conditions: a registry-based randomized trial. Am J Prev Med. 2012 Jan;42(1):71-5. doi: 10.1016/j.amepre.2011.09.028.
Results Reference
derived
Learn more about this trial
Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions
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