Comparative Tests of Flu Vaccination Phone Messages
Phase: NA
Conditions: Influenza, Human
Sponsor: University of Michigan

Study Title: Comparative Tests of Flu Vaccination Phone Messages 
Summary of Research Protocol 
October 30, 2017 
 
This project is an unfunded research collaboration between Emmi Solutions, Inc., and a team of academic 
research investigators led by Brian J. Zikmund-Fisher, Ph.D. of the University of Michigan. 
 
Emmi Solutions provides services that educate, support, remind, and ultimately prompt people to take actions 
toward better health on behalf of various clients, which include individual physicians or medical practices, 
hospital systems, and health insurance companies. As part of their service to their clients, Emmi deploys 
outbound, automated, Interactive Voice Response phone calls with the outlined variations to patients identified 
by Emmi’s clients as eligible for the flu vaccine. 
 
This study will begin by gaining consent from specific clients of Emmi Solutions to share de-identified data 
collected on their patient populations with the investigators for the purpose of investigating the effectiveness of 
different telephone scripts at promoting behavioral intentions related to vaccination.  
 
Calls will be made at times and at a rate specified by Emmi’s clients using Emmi’s in-house automatic 
deployment system. Pre-recorded messages that adjust to patient responses will follow interaction outlines, or 
“scripts” developed by Emmi for the purpose of encouraging uptake of seasonal influenza vaccination. Contact 
information and basic demographic information about each patient is provided by the client based on their own 
processes and is confidentially maintained by Emmi as part of their services. 
 
Within each client’s list of patients, Emmi will randomly assign patients to receive different versions of the flu 
call script. Patients of larger clients will be randomized among the full set of experimental arms, while patients 
of smaller clients may be randomized among a smaller subset of arms to ensure statistical power for 
comparisons within each client’s patient set, with the decision to be based on the size of the provided patient 
list. 
 
As part of Emmi’s standard process, each call includes one or more questions that recipients can answer 
during the call (e.g., by saying “yes” to the question). For the calls included in this study, at least one question 
will measure patients’ behavioral intentions to receive an influenza vaccine.  
 
Emmi’s database records each patient’s responses over the course of the call and generates one report of all 
patients’ responses for Emmi’s clients to review. This report includes Protected Health Information, such as 
patient names and phone numbers.  
 
As part of this research, however, Emmi will then de-identify the reports to meet the standards of the Health 
Insurance Portability and Accountability Act and then send the de-identified response reports, as well as linked 
demographic information and call timing data, and send them to the investigators via Secure File Transfer 
Protocol, the preferred trusted protocol used between Emmi and their clients. Each patient record will not 
include any Protected Health Information and will be identified only by a unique identification number. Only 
Emmi will maintain and have access to the mapping algorithm that could enable matching of individual records 
to contact information or other protected health information.  
 
Certain clients of Emmi also have access to other information about their patients, such as data that may 
indicate whether a patient actually obtains an influenza vaccination during the 2017-2018 influenza season. If 
clients share these data with Emmi, Emmi will in turn share with investigators (again, only using the unique 
patient id number and secure file transfer) for inclusion of these variables in analyses. 
 
The research investigators (led by Dr. Zikmund-Fisher) will then conduct statistical analyses to determine if the 
rates of behavioral intentions to vaccinate (and actual vaccination status, when available) differed among the 
study arms. After preliminary bivariate analyses (e.g., chi-squared analyses), logistic regression analyses will 
control for variation among clients (both because client populations vary in unmeasured ways and because call 
timing will be different for different clients) and include available demographic information when possible.