NCT02907580

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

September 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

September 8, 2016

Last Update Submit

July 26, 2017

Conditions

Keywords

influenzavaccination

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

EXPERIMENTAL

Local-based educational handout

Behavioral: Local educational information

National educational data

EXPERIMENTAL

National-based educational handout

Behavioral: National educational information

Usual care

NO INTERVENTION

No 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.

Local educational data

Participants in this arm receive educational information regarding influenza vaccination based on national educational information.

National educational data

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Melissa Stockwell, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

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

Locations