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Influenza Vaccine Randomized Educational Trial: Adult

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907645
First Posted: September 20, 2016
Last Update Posted: July 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Melissa Stockwell, Columbia University
  Purpose

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.


Condition Intervention
Vaccination Influenza Behavioral: Local educational information Behavioral: National educational information

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research

Resource links provided by NLM:


Further study details as provided by Melissa Stockwell, Columbia University:

Primary Outcome Measures:
  • Number of participants who receive influenza vaccination on day of intervention [ Time Frame: Day 0 ]
    Receipt of influenza vaccination on the day of the educational intervention


Secondary Outcome Measures:
  • Number of participants who receive Influenza vaccination by the end of the influenza vaccine season [ Time Frame: Up to 7 months ]
    Receipt of influenza vaccination by April 2017


Enrollment: 222
Actual Study Start Date: October 6, 2016
Study Completion Date: June 1, 2017
Primary Completion Date: May 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Local educational
Adult patients in this arm receive educational information regarding influenza vaccination based on local data
Behavioral: Local educational information
Adult patients in this arm receive educational information regarding influenza vaccination based on local data
Experimental: National educational
Adult patients in this arm receive educational information regarding influenza vaccination based on national data
Behavioral: National educational information
Adult patients in this arm receive educational information regarding influenza vaccination based on national data
No Intervention: Usual care
No educational information other than provided as usual care by health care providers

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • visit to study site at time of intervention

Exclusion Criteria:

  • prior receipt of influenza vaccine that season
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907645


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Melissa Stockwell, MD MPH Columbia University
  More Information

Responsible Party: Melissa Stockwell, Associate Professor of Pediatrics and Population and Family Health, Columbia University
ClinicalTrials.gov Identifier: NCT02907645     History of Changes
Other Study ID Numbers: AAAR0289
First Submitted: September 8, 2016
First Posted: September 20, 2016
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs