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Comparative Tests of Flu Vaccination Phone Messages

Primary Purpose

Influenza, Human

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Viral changes
Protect others
General intentions
Behavioral intentions
Accountability
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza, Human

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Emmi Solutions

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Viral changes + General intentions

Viral changes + Behavioral intentions

Viral changes + Accountability

Protect others + General intentions

Protect others + Behavioral intentions

Protect others + Accountability

Arm Description

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).

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).

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Vaccination intentions (Time 1)
Question (language being manipulated) asking whether respondent intends to vaccinate

Secondary Outcome Measures

Documented influenza vaccination
Documentation (when available from Emmi Solutions' clients) via clients' employee records that influenza vaccination occurred

Full Information

First Posted
October 30, 2017
Last Updated
May 13, 2018
Sponsor
University of Michigan
Collaborators
Emmi Solutions, University of Iowa, University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03332992
Brief Title
Comparative Tests of Flu Vaccination Phone Messages
Official Title
Comparative Tests of Flu Vaccination Phone Messages
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 11, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Emmi Solutions, University of Iowa, University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Viral changes + General intentions
Arm Type
Experimental
Arm Description
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).
Arm Title
Viral changes + Behavioral intentions
Arm Type
Experimental
Arm Description
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).
Arm Title
Viral changes + Accountability
Arm Type
Experimental
Arm Description
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).
Arm Title
Protect others + General intentions
Arm Type
Experimental
Arm Description
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).
Arm Title
Protect others + Behavioral intentions
Arm Type
Experimental
Arm Description
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).
Arm Title
Protect others + Accountability
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Viral changes
Intervention Description
Telephone script language provided pre-questions regarding the fact that influenza viruses change each year
Intervention Type
Behavioral
Intervention Name(s)
Protect others
Intervention Description
Telephone script language provided pre-questions emphasizing the need to protect vulnerable others
Intervention Type
Behavioral
Intervention Name(s)
General intentions
Intervention Description
Question language asking about general interest in getting influenza vaccination
Intervention Type
Behavioral
Intervention Name(s)
Behavioral intentions
Intervention Description
Question language asking individual to make specific plans to be vaccinated
Intervention Type
Behavioral
Intervention Name(s)
Accountability
Intervention Description
Question language asking individual whether their care team can learn about their vaccination intentions
Primary Outcome Measure Information:
Title
Vaccination intentions (Time 1)
Description
Question (language being manipulated) asking whether respondent intends to vaccinate
Time Frame
Day 1 (Assessed during the intervention telephone call)
Secondary Outcome Measure Information:
Title
Documented influenza vaccination
Description
Documentation (when available from Emmi Solutions' clients) via clients' employee records that influenza vaccination occurred
Time Frame
Within 6 months / during 2017-2018 influenza season

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient of client organizations of Emmi Solutions Provided a phone number to their care team Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Zikmund-Fisher, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emmi Solutions
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparative Tests of Flu Vaccination Phone Messages

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