- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03332992
Comparative Tests of Flu Vaccination Phone Messages
May 13, 2018 updated by: Brian Zikmund-Fisher, University of Michigan
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
7206
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60606
- Emmi Solutions
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient of client organizations of Emmi Solutions
- Provided a phone number to their care team
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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).
|
Telephone script language provided pre-questions regarding the fact that influenza viruses change each year
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).
|
Telephone script language provided pre-questions regarding the fact that influenza viruses change each year
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).
|
Telephone script language provided pre-questions regarding the fact that influenza viruses change each year
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).
|
Question language asking about general interest in getting influenza vaccination
Telephone script language provided pre-questions emphasizing the need to protect vulnerable others
|
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).
|
Question language asking individual to make specific plans to be vaccinated
Telephone script language provided pre-questions emphasizing the need to protect vulnerable others
|
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).
|
Question language asking individual whether their care team can learn about their vaccination intentions
Telephone script language provided pre-questions emphasizing the need to protect vulnerable others
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaccination intentions (Time 1)
Time Frame: Day 1 (Assessed during the intervention telephone call)
|
Question (language being manipulated) asking whether respondent intends to vaccinate
|
Day 1 (Assessed during the intervention telephone call)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Within 6 months / during 2017-2018 influenza season
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian J Zikmund-Fisher, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 11, 2017
Primary Completion (ACTUAL)
April 30, 2018
Study Completion (ACTUAL)
April 30, 2018
Study Registration Dates
First Submitted
October 30, 2017
First Submitted That Met QC Criteria
November 1, 2017
First Posted (ACTUAL)
November 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
May 15, 2018
Last Update Submitted That Met QC Criteria
May 13, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00135995
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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