Back to resultsInfluenza Vaccine Attitudes, Intent, and Receipt: Pediatric
Primary Purpose
Vaccination, Influenza
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Local educational information
National educational information
Sponsored by
About this trial
This is an interventional health services research trial for Vaccination focused on measuring influenza, vaccination
Eligibility Criteria
Inclusion Criteria:
- Age at least 6 months
Exclusion Criteria:
- Receipt of influenza vaccination that season
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Local educational data
National educational data
Usual care
Arm Description
Local-based educational handout
National-based educational handout
No educational information other than provided as usual care by health care providers
Outcomes
Primary Outcome Measures
Number of children who receive influenza vaccination on day of intervention
Receipt of influenza vaccination by the child on the day of the educational intervention
Secondary Outcome Measures
Number of children who receive influenza vaccination during the influenza vaccine season
Receipt of influenza vaccination by the child by April 2017
Number of parents who anticipate influenza vaccination during the influenza vaccine season
Parents report planned receipt of influenza vaccination by themselves by April 2017
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02907580
Brief Title
Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric
Official Title
Influenza Vaccine Attitudes, Intent, and Receipt
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 13, 2016 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older. Recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal. In an effort to educate parents and patients, public health entities and physicians give informational handouts in various forms. However, recent publications have found that pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further studies on vaccine related public health communication is needed. Few, if any, studies have analyzed the relationship between influenza vaccine attitudes and intention with actual vaccine receipt in the pediatric population. These results will help to understand the relationship between parent's vaccine perception and the intent to vaccinate versus the child's receipt of the influenza vaccine, as well as to optimize educational information given to families regarding the influenza vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccination, Influenza
Keywords
influenza, vaccination
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local educational data
Arm Type
Experimental
Arm Description
Local-based educational handout
Arm Title
National educational data
Arm Type
Experimental
Arm Description
National-based educational handout
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
No educational information other than provided as usual care by health care providers
Intervention Type
Behavioral
Intervention Name(s)
Local educational information
Intervention Description
Participants in this arm receive educational information regarding influenza vaccination based on local educational information.
Intervention Type
Behavioral
Intervention Name(s)
National educational information
Intervention Description
Participants in this arm receive educational information regarding influenza vaccination based on national educational information.
Primary Outcome Measure Information:
Title
Number of children who receive influenza vaccination on day of intervention
Description
Receipt of influenza vaccination by the child on the day of the educational intervention
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Number of children who receive influenza vaccination during the influenza vaccine season
Description
Receipt of influenza vaccination by the child by April 2017
Time Frame
Up to 7 months
Title
Number of parents who anticipate influenza vaccination during the influenza vaccine season
Description
Parents report planned receipt of influenza vaccination by themselves by April 2017
Time Frame
Up to 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age at least 6 months
Exclusion Criteria:
Receipt of influenza vaccination that season
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Stockwell, MD MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31292219
Citation
Scott VP, Opel DJ, Reifler J, Rikin S, Pethe K, Barrett A, Stockwell MS. Office-Based Educational Handout for Influenza Vaccination: A Randomized Controlled Trial. Pediatrics. 2019 Aug;144(2):e20182580. doi: 10.1542/peds.2018-2580. Epub 2019 Jul 10.
Results Reference
derived
Learn more about this trial
Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric
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