Influenza Vaccine Randomized Educational Trial: Adult

NCT02907645 | Completed

• 1 other identifier: AAAR0289
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 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 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. The purpose of this study is to compare the effectiveness of pro-vaccine messages of local data, pro-vaccine messages of national data, and no educational message on patient's receipt of the influenza vaccine. These results will help to understand the relationship between patient education and the intent to vaccinate and receipt of the influenza vaccine as well as to optimize educational information given to patients regarding the influenza vaccine.

Conditions

Vaccination; Influenza

Outcome Measures

Primary Outcomes (1)

• Number of participants who receive influenza vaccination on day of intervention

  Receipt of influenza vaccination on the day of the educational intervention

  Day 0

Secondary Outcomes (1)

• Number of participants who receive Influenza vaccination by the end of the influenza vaccine season

  Up to 7 months

Study Arms (3)

Local educational

EXPERIMENTAL

Adult patients in this arm receive educational information regarding influenza vaccination based on local data

Behavioral: Local educational information

National educational

EXPERIMENTAL

Adult patients in this arm receive educational information regarding influenza vaccination based on national data

Behavioral: National educational information

Usual care

NO INTERVENTION

No educational information other than provided as usual care by health care providers

Interventions

Local educational information BEHAVIORAL

Adult patients in this arm receive educational information regarding influenza vaccination based on local data

Local educational

National educational information BEHAVIORAL

Adult patients in this arm receive educational information regarding influenza vaccination based on national data

National educational

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• visit to study site at time of intervention

You may not qualify if:

• prior receipt of influenza vaccine that season

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory 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: October 6, 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

US (1)