NCT03332992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

November 11, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

October 30, 2017

Last Update Submit

May 13, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Vaccination intentions (Time 1)

    Question (language being manipulated) asking whether respondent intends to vaccinate

    Day 1 (Assessed during the intervention telephone call)

Secondary Outcomes (1)

  • Documented influenza vaccination

    Within 6 months / during 2017-2018 influenza season

Study Arms (6)

Viral changes + General intentions

EXPERIMENTAL

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 changesBehavioral: General intentions

Viral changes + Behavioral intentions

EXPERIMENTAL

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 changesBehavioral: Behavioral intentions

Viral changes + Accountability

EXPERIMENTAL

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 changesBehavioral: Accountability

Protect others + General intentions

EXPERIMENTAL

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 othersBehavioral: General intentions

Protect others + Behavioral intentions

EXPERIMENTAL

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 othersBehavioral: Behavioral intentions

Protect others + Accountability

EXPERIMENTAL

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 othersBehavioral: Accountability

Interventions

Viral changesBEHAVIORAL

Telephone script language provided pre-questions regarding the fact that influenza viruses change each year

Viral changes + AccountabilityViral changes + Behavioral intentionsViral changes + General intentions
Protect othersBEHAVIORAL

Telephone script language provided pre-questions emphasizing the need to protect vulnerable others

Protect others + AccountabilityProtect others + Behavioral intentionsProtect others + General intentions

Question language asking about general interest in getting influenza vaccination

Protect others + General intentionsViral changes + General intentions

Question language asking individual to make specific plans to be vaccinated

Protect others + Behavioral intentionsViral changes + Behavioral intentions
AccountabilityBEHAVIORAL

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

Protect others + AccountabilityViral changes + Accountability

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emmi Solutions

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Health Insurance Portability and Accountability Act

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Insurance, HealthInsuranceFinancing, OrganizedEconomicsHealth Care Economics and OrganizationsLegislation as TopicSocial Control, Formal

Study Officials

  • Brian J Zikmund-Fisher, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

November 11, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations