Back to resultsInfluenza Vaccine Randomized Educational Trial: Adult
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
Eligibility Criteria
Inclusion Criteria:
- visit to study site at time of intervention
Exclusion Criteria:
- prior receipt of influenza vaccine 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
National educational
Usual care
Arm Description
Adult patients in this arm receive educational information regarding influenza vaccination based on local data
Adult patients in this arm receive educational information regarding influenza vaccination based on national data
No educational information other than provided as usual care by health care providers
Outcomes
Primary Outcome Measures
Number of participants who receive influenza vaccination on day of intervention
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
Receipt of influenza vaccination by April 2017
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02907645
Brief Title
Influenza Vaccine Randomized Educational Trial: Adult
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 6, 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaccination, Influenza
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local educational
Arm Type
Experimental
Arm Description
Adult patients in this arm receive educational information regarding influenza vaccination based on local data
Arm Title
National educational
Arm Type
Experimental
Arm Description
Adult patients in this arm receive educational information regarding influenza vaccination based on national data
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
Adult patients in this arm receive educational information regarding influenza vaccination based on local data
Intervention Type
Behavioral
Intervention Name(s)
National educational information
Intervention Description
Adult patients in this arm receive educational information regarding influenza vaccination based on national data
Primary Outcome Measure Information:
Title
Number of participants who receive influenza vaccination on day of intervention
Description
Receipt of influenza vaccination on the day of the educational intervention
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Number of participants who receive Influenza vaccination by the end of the influenza vaccine season
Description
Receipt of influenza vaccination by April 2017
Time Frame
Up to 7 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
visit to study site at time of intervention
Exclusion Criteria:
prior receipt of influenza vaccine 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
Learn more about this trial
Influenza Vaccine Randomized Educational Trial: Adult
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