Influenza
Conditions
Keywords
influenza, vaccination, strategies, children/adolescents
Brief summary
The purpose of this study is to increase childhood influenza vaccination rates using the FDA licensed influenza vaccines according to national guidelines in a randomized cluster trial in which primary care offices are randomized to intervention or control with the control group receiving the intervention in the second year.
Detailed description
The investigators will conduct a stratified, randomized cluster trial of 20 diverse primary care practices to compare influenza vaccination rates in intervention and control sites. Intervention sites will use a package of newly developed and evidence-based techniques that will be tailored to their practice structure and culture, called the 4 Pillars Immunization Toolkit, in addition to receiving donated vaccine for early season vaccination. Control practices will not receive such assistance but will receive the intervention in the second year.
Interventions
BEHAVIORAL4 Pillars Immunization Toolkit
Pillar 1: Convenient Vaccination Services; Pillar 2: Patient notification about the importance of vaccination and availability of convenient services; Pillar 3: Enhanced Office Systems; Pillar 4: Motivation: Office immunization champion tracks progress towards a goal; Early delivery of donated vaccines for disadvantaged children, staff education, support of effort by research staff.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
Yes
Inclusion criteria
For children: attendance at the selected health care center within the last year and age \>/=6 months thru 18 years.
Exclusion criteria
For children: Severe egg allergy or allergy to influenza vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome | 3/1/2011-2/29/2012 | Influenza vaccination rates in each arm at the end of year 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness Score | End of February 2012 | Two 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group 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. | 43,293 |
| Control Group 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. | 38,306 |
| Total | 81,599 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 7.3 years STANDARD_DEVIATION 4.8 | 7.1 years STANDARD_DEVIATION 5.2 | 7.2 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 43293 children at sites | 38306 children at sites | 81599 children at sites |
| Sex: Female, Male Female | 21560 Participants | 18540 Participants | 40100 Participants |
| Sex: Female, Male Male | 21733 Participants | 19766 Participants | 41499 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26,432 | 0 / 19,352 |
| serious Total, serious adverse events | 0 / 26,432 | 0 / 19,352 |
Outcome results
Primary
Primary Outcome
Influenza vaccination rates in each arm at the end of year 1
Time frame: 3/1/2011-2/29/2012
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Primary Outcome | 26432 participants vaccinated out of all |
| Control Group | Primary Outcome | 19352 participants vaccinated out of all |
p-value: <0.05Chi-squared
Secondary
Effectiveness Score
Two 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).
Time frame: End of February 2012
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Effectiveness Score | 75 units on a scale | Standard Deviation 14 |