Assessing Choice in the Employer Setting (ACES) Study

Study Overview
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Brief Summary
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The purpose of this study is to determine, among adults and in the total population, the effects of offering a choice of FluMist or trivalent inactivated vaccine (TIV) in the employer setting when compared to a control group.

Detailed Description
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The primary objective is to determine, among adults in the 18-49 year old population and in the total population, the effects of offering a choice of FluMist or TIV with and without enhanced advertisement/added incentive on the overall influenza vaccination rates in the employer setting when compared to a control group.

Official Title
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Assessing Choice in the Employer Setting (ACES Study): An Observational Study to Assess the Impact of Offering Intranasal Vaccine on Influenza Vaccination Rates in the Employer Setting

Conditions
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Healthy

Intervention / Treatment
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* Biological: Choice of TIV or FluMist with baseline advertisement
* Other: Choice of TIV or FluMist with enhanced advertisement and incentives
* Biological: Control - Usual care offering TIV only with baseline advertisement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for employer sites: Located in the United States Has not previously offered FluMist in an employee vaccination program in the past or FluMist represented less than 5% of all vaccine received at past programs Data are available that will allow for a reliable estimate of the employee (total and 18-49 year old populations) vaccination rate for the 2007-2008 influenza season

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A (Control)<br>A control arm of usual care offering TIV with baseline advertisement | Biological: Control - Usual care offering TIV only with baseline advertisement<br>* A control arm of usual care offering TIV with baseline advertisement<br>|
| Arm B (Choice)<br>An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist | Biological: Choice of TIV or FluMist with baseline advertisement<br>* An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist<br>|
| Arm C (Choice Plus)<br>An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination | Other: Choice of TIV or FluMist with enhanced advertisement and incentives<br>* An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Vaccination Rate, All Ages |  | 30Sep2008 through 23Dec2008 | 
| Overall Vaccination Rate, Employees 18 to 49 Years of Age |  | 30Sep2008 through 23Dec2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population | Rate difference by arm from baseline to intervention season | 2007-2008 season through 2008-2009 season | 
| Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age | Rate difference by arm from baseline to intervention season | 2007-2008 season through 2008-2009 season | 
| Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season |  | 30Sep2008 through 23Dec2008 | 
| Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race | Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white | 30Sep2008 through 23Dec2008 | 
| Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education | Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates. | 30Sep2008 through 23Dec2008 | 
| Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender | Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male. | 30Sep2008 through 23Dec2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FluMist, TIV, vaccination rates