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Trial record 6 of 156 for:    Recruiting, Not yet recruiting, Available Studies | "Influenza, Human"

Comparative Tests of Flu Vaccination Phone Messages

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ClinicalTrials.gov Identifier: NCT03332992
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : January 12, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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
Influenza, Human Behavioral: Viral changes Behavioral: Protect others Behavioral: General intentions Behavioral: Behavioral intentions Behavioral: Accountability

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750000 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
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

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): NCT03332992


Contacts
Contact: Brian J Zikmund-Fisher, PhD 734-936-9179 bzikmund@umich.edu

Locations
United States, Illinois
Emmi Solutions Recruiting
Chicago, Illinois, United States, 60606
Contact: Ilana Shalowitz         
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:
More Information

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: January 12, 2018
Last Verified: January 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