Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2016
CompletedStudy Start
First participant enrolled
September 13, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 27, 2017
July 1, 2017
9 months
September 8, 2016
July 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Day 0
Secondary Outcomes (2)
Number of children who receive influenza vaccination during the influenza vaccine season
Up to 7 months
Number of parents who anticipate influenza vaccination during the influenza vaccine season
Up to 7 months
Study Arms (3)
Local educational data
EXPERIMENTALLocal-based educational handout
National educational data
EXPERIMENTALNational-based educational handout
Usual care
NO INTERVENTIONNo educational information other than provided as usual care by health care providers
Interventions
Participants in this arm receive educational information regarding influenza vaccination based on local educational information.
Participants in this arm receive educational information regarding influenza vaccination based on national educational information.
Eligibility Criteria
You may qualify if:
- Age at least 6 months
You may not qualify if:
- Receipt of influenza vaccination that season
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 31292219DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Stockwell, MD MPH
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics and Population and Family Health
Study Record Dates
First Submitted
September 8, 2016
First Posted
September 20, 2016
Study Start
September 13, 2016
Primary Completion
May 31, 2017
Study Completion
June 1, 2017
Last Updated
July 27, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share