Trial Outcomes & Findings for From Innovation to Solutions: Childhood Influenza Vaccination Planning (NCT NCT01664793)
NCT ID: NCT01664793
Last Updated: 2014-11-24
Results Overview
Influenza vaccination rates in each arm at the end of year 1
COMPLETED
NA
87665 participants
3/1/2011-2/29/2012
2014-11-24
Participant Flow
Participant milestones
| Measure |
Intervention Group
Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the Intervention group; n=49,039.
Intervention sites will use the 4 Pillars toolkit along with early season vaccine to promote increases in childhood influenza vaccination.
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Control Group
Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the control group; n=38,626. They will receive the 4 Pillars Toolkit and early season vaccine in Year 2.
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|---|---|---|
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Overall Study
STARTED
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49039
|
38626
|
|
Overall Study
COMPLETED
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49039
|
38626
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
From Innovation to Solutions: Childhood Influenza Vaccination Planning
Baseline characteristics by cohort
| Measure |
Intervention Group
n=43293 Participants
Children in 10 diverse pediatric and family medicine practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
|
Control Group
n=38306 Participants
Children in 10 diverse pediatric and family practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
|
Total
n=81599 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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7.3 years
STANDARD_DEVIATION 4.8 • n=93 Participants
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7.1 years
STANDARD_DEVIATION 5.2 • n=4 Participants
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7.2 years
STANDARD_DEVIATION 5 • n=27 Participants
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Sex: Female, Male
Female
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21560 Participants
n=93 Participants
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18540 Participants
n=4 Participants
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40100 Participants
n=27 Participants
|
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Sex: Female, Male
Male
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21733 Participants
n=93 Participants
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19766 Participants
n=4 Participants
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41499 Participants
n=27 Participants
|
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Region of Enrollment
United States
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43293 children at sites
n=93 Participants
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38306 children at sites
n=4 Participants
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81599 children at sites
n=27 Participants
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PRIMARY outcome
Timeframe: 3/1/2011-2/29/2012Influenza vaccination rates in each arm at the end of year 1
Outcome measures
| Measure |
Intervention Group
n=49039 Participants
Children seen in 10 diverse pediatric and family medicine practices between 3/1/2011 and 2/29/2012.
|
Control Group
n=38626 Participants
Children with a visit between 3/1/2011 and 2/29/2012 in 10 diverse pediatric and family practices.
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|---|---|---|
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Primary Outcome
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26432 participants vaccinated out of all
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19352 participants vaccinated out of all
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SECONDARY outcome
Timeframe: End of February 2012Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Children seen in 10 diverse pediatric and family medicine practices between 3/1/2011 and 2/29/2012.
|
Control Group
Children with a visit between 3/1/2011 and 2/29/2012 in 10 diverse pediatric and family practices.
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|---|---|---|
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Effectiveness Score
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75 units on a scale
Standard Deviation 14
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—
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Adverse Events
Intervention Group
Control Group
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
- Publication restrictions are in place