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Comparative Tests of Flu Vaccination Phone Messages

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ClinicalTrials.gov Identifier: NCT03332992
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : May 15, 2018
Sponsor:
Collaborators:
Emmi Solutions
University of Iowa
University of Utah
Information provided by (Responsible Party):
Brian Zikmund-Fisher, University of Michigan

Brief Summary:
This project is a partnership between Emmi Solutions, a private company that delivers health promotion messages to employees of client organizations, and the University of Michigan and affiliated academic investigators. In particular, Emmi sends out pre-recorded and interactive telephone calls on behalf of their healthcare clients to promote influenza vaccination each Fall. The collaboration will design various scripts (based on established risk communication, behavior change, and behavioral economic principles) to be pre-recorded and sent out on these calls on a randomized basis (with approval by client organizations), with the number of arms to vary based on the size of each client's participant list (to ensure sufficient statistical power within each client's sample). Emmi will deliver the calls and track individual responses to questions posed during the call. Emmi will then provide a de-identified dataset to the academic research team for analysis to determine whether any scripts provided greater or lesser effects to people's their motivations to get a flu vaccination.

Condition or disease Intervention/treatment Phase
Influenza, Human Behavioral: Viral changes Behavioral: Protect others Behavioral: General intentions Behavioral: Behavioral intentions Behavioral: Accountability Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparative Tests of Flu Vaccination Phone Messages
Actual Study Start Date : November 11, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Viral changes + General intentions
Script language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a general question asking whether the respondent intends to get a flu shot (general intentions).
Behavioral: Viral changes
Telephone script language provided pre-questions regarding the fact that influenza viruses change each year

Behavioral: General intentions
Question language asking about general interest in getting influenza vaccination

Experimental: Viral changes + Behavioral intentions
Script language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a question asking when / where the respondent will get a flu shot (behavioral intention).
Behavioral: Viral changes
Telephone script language provided pre-questions regarding the fact that influenza viruses change each year

Behavioral: Behavioral intentions
Question language asking individual to make specific plans to be vaccinated

Experimental: Viral changes + Accountability
Script language discusses a) that previous years' shots do not protect against current year influenza (viral changes) and b) poses a question that implies the patient's care team will be notified of intent to vaccinate (accountability to providers).
Behavioral: Viral changes
Telephone script language provided pre-questions regarding the fact that influenza viruses change each year

Behavioral: Accountability
Question language asking individual whether their care team can learn about their vaccination intentions

Experimental: Protect others + General intentions
Script language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a general question asking whether the respondent intends to get a flu shot (general intentions).
Behavioral: Protect others
Telephone script language provided pre-questions emphasizing the need to protect vulnerable others

Behavioral: General intentions
Question language asking about general interest in getting influenza vaccination

Experimental: Protect others + Behavioral intentions
Script language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a question asking when / where the respondent will get a flu shot (behavioral intention).
Behavioral: Protect others
Telephone script language provided pre-questions emphasizing the need to protect vulnerable others

Behavioral: Behavioral intentions
Question language asking individual to make specific plans to be vaccinated

Experimental: Protect others + Accountability
Script language discusses a) that getting the flu shot protects others who can get particularly sick (protect others) and b) poses a question that implies the patient's care team will be notified of intent to vaccinate (accountability to providers).
Behavioral: Protect others
Telephone script language provided pre-questions emphasizing the need to protect vulnerable others

Behavioral: Accountability
Question language asking individual whether their care team can learn about their vaccination intentions




Primary Outcome Measures :
  1. Vaccination intentions (Time 1) [ Time Frame: Day 1 (Assessed during the intervention telephone call) ]
    Question (language being manipulated) asking whether respondent intends to vaccinate


Secondary Outcome Measures :
  1. Documented influenza vaccination [ Time Frame: Within 6 months / during 2017-2018 influenza season ]
    Documentation (when available from Emmi Solutions' clients) via clients' employee records that influenza vaccination occurred



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient of client organizations of Emmi Solutions
  • Provided a phone number to their care team

Exclusion Criteria:


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): NCT03332992


Locations
United States, Illinois
Emmi Solutions
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
University of Michigan
Emmi Solutions
University of Iowa
University of Utah
Investigators
Principal Investigator: Brian J Zikmund-Fisher, PhD University of Michigan
  Study Documents (Full-Text)

Documents provided by Brian Zikmund-Fisher, University of Michigan:

Responsible Party: Brian Zikmund-Fisher, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03332992     History of Changes
Other Study ID Numbers: HUM00135995
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: 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