Trial Outcomes & Findings for Assessing Choice in the Employer Setting (ACES) Study (NCT NCT00808808)
NCT ID: NCT00808808
Last Updated: 2013-11-20
Results Overview
Recruitment status
COMPLETED
Target enrollment
4411 participants
Primary outcome timeframe
30Sep2008 through 23Dec2008
Results posted on
2013-11-20
Participant Flow
Potential employers estimated to have at least 60 employees were contacted to determine their interest in participating in the study and were offered an influenza vaccine clinic on site at no cost. A screening questionnaire to determine eligibility was completed. Sites were excluded according to the study inclusion and exclusion criteria.
Participant milestones
| Measure |
Arm A (Control)
A control arm of usual care offering TIV with baseline advertisement
|
Arm B (Choice)
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
|
Arm C (Choice Plus)
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
|
|---|---|---|---|
|
Overall Study
STARTED
|
4078
|
3757
|
4387
|
|
Overall Study
Vaccinated
|
1392
|
1489
|
2132
|
|
Overall Study
COMPLETED
|
1261
|
1320
|
1830
|
|
Overall Study
NOT COMPLETED
|
2817
|
2437
|
2557
|
Reasons for withdrawal
| Measure |
Arm A (Control)
A control arm of usual care offering TIV with baseline advertisement
|
Arm B (Choice)
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
|
Arm C (Choice Plus)
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
|
|---|---|---|---|
|
Overall Study
Vaccinated; survey not completed
|
131
|
169
|
302
|
|
Overall Study
Employee was not vaccinated.
|
2686
|
2268
|
2255
|
Baseline Characteristics
Assessing Choice in the Employer Setting (ACES) Study
Baseline characteristics by cohort
| Measure |
Arm A (Control)
n=1392 Participants
A control arm of usual care offering TIV with baseline advertisement
|
Arm B (Choice)
n=1489 Participants
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
|
Arm C (Choice Plus)
n=2132 Participants
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
|
Total
n=5013 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to 49 years
|
983 participants
n=5 Participants
|
988 participants
n=7 Participants
|
1398 participants
n=5 Participants
|
3369 participants
n=4 Participants
|
|
Age, Customized
≥ 50 years
|
409 participants
n=5 Participants
|
501 participants
n=7 Participants
|
734 participants
n=5 Participants
|
1644 participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
748 participants
n=5 Participants
|
814 participants
n=7 Participants
|
808 participants
n=5 Participants
|
2370 participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
644 participants
n=5 Participants
|
675 participants
n=7 Participants
|
1324 participants
n=5 Participants
|
2643 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30Sep2008 through 23Dec2008Population: All employees at participating sites, including those who were vaccinated and those who were not
Outcome measures
| Measure |
Arm A (Control)
n=4078 Participants
A control arm of usual care offering TIV with baseline advertisement
|
Arm B (Choice)
n=3757 Participants
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
|
Arm C (Choice Plus)
n=4387 Participants
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
|
|---|---|---|---|
|
Overall Vaccination Rate, All Ages
|
41.6 Percentage of participants
|
45.1 Percentage of participants
|
51.0 Percentage of participants
|
PRIMARY outcome
Timeframe: 30Sep2008 through 23Dec2008Population: All vaccinated employees at participating sites, including those who completed surveys and those who did not
Outcome measures
| Measure |
Arm A (Control)
n=983 Participants
A control arm of usual care offering TIV with baseline advertisement
|
Arm B (Choice)
n=988 Participants
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
|
Arm C (Choice Plus)
n=1398 Participants
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
|
|---|---|---|---|
|
Overall Vaccination Rate, Employees 18 to 49 Years of Age
|
38.5 Percentage of participants
|
40.9 Percentage of participants
|
46.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 2007-2008 season through 2008-2009 seasonPopulation: All vaccinated employees at participating sites, including those who completed surveys and those who did not
Rate difference by arm from baseline to intervention season
Outcome measures
| Measure |
Arm A (Control)
n=1392 Participants
A control arm of usual care offering TIV with baseline advertisement
|
Arm B (Choice)
n=1489 Participants
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
|
Arm C (Choice Plus)
n=2132 Participants
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
|
|---|---|---|---|
|
Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in the Total Population
|
4.7 percentage points
|
4.8 percentage points
|
12.7 percentage points
|
SECONDARY outcome
Timeframe: 2007-2008 season through 2008-2009 seasonPopulation: All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not
Rate difference by arm from baseline to intervention season
Outcome measures
| Measure |
Arm A (Control)
n=983 Participants
A control arm of usual care offering TIV with baseline advertisement
|
Arm B (Choice)
n=988 Participants
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
|
Arm C (Choice Plus)
n=1398 Participants
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
|
|---|---|---|---|
|
Change in Influenza Vaccination Rate From Baseline Season to Intervention Season in Employees 18-49 Years of Age
|
3.7 percentage points
|
2.4 percentage points
|
9.7 percentage points
|
SECONDARY outcome
Timeframe: 30Sep2008 through 23Dec2008Population: All vaccinated employees 18-49 years of age at participating sites, including those who completed surveys and those who did not
Outcome measures
| Measure |
Arm A (Control)
n=983 Participants
A control arm of usual care offering TIV with baseline advertisement
|
Arm B (Choice)
n=988 Participants
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
|
Arm C (Choice Plus)
n=1398 Participants
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
|
|---|---|---|---|
|
Percent of Eligible Participants 18-49 Years of Age Choosing FluMist During Intervention Season
|
0.8 percent
|
19.1 percent
|
26.8 percent
|
SECONDARY outcome
Timeframe: 30Sep2008 through 23Dec2008Population: All participants who completed surveys and were eligible to receive FluMist
Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as white
Outcome measures
| Measure |
Arm A (Control)
n=399 Participants
A control arm of usual care offering TIV with baseline advertisement
|
Arm B (Choice)
n=1990 Participants
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
|
Arm C (Choice Plus)
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
|
|---|---|---|---|
|
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Race
|
67.8 percent
|
71.8 percent
|
—
|
SECONDARY outcome
Timeframe: 30Sep2008 through 23Dec2008Population: All participants who completed surveys and were eligible to receive FluMist
Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as college graduates.
Outcome measures
| Measure |
Arm A (Control)
n=399 Participants
A control arm of usual care offering TIV with baseline advertisement
|
Arm B (Choice)
n=1990 Participants
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
|
Arm C (Choice Plus)
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
|
|---|---|---|---|
|
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Education
|
73.4 percent
|
52.8 percent
|
—
|
SECONDARY outcome
Timeframe: 30Sep2008 through 23Dec2008Population: All participants who completed surveys and were eligible to receive FluMist
Percent of participants 18-49 years of age who chose FluMist vs TIV for influenza vaccination and who self-identified as male.
Outcome measures
| Measure |
Arm A (Control)
n=399 Participants
A control arm of usual care offering TIV with baseline advertisement
|
Arm B (Choice)
n=1990 Participants
An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
|
Arm C (Choice Plus)
An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
|
|---|---|---|---|
|
Characteristics of Participants 18-49 Years of Age Choosing FluMist vs TIV: Gender
|
49.9 percent
|
49.7 percent
|
—
|
Adverse Events
Arm A (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B (Choice)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm C (Choice Plus)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.The principal investigators (PIs) also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER