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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group Year 1 | Experimental | The 4 Pillars Immunization Toolkit along with donated vaccines for early season vaccination, staff education and support. |
|
| Control Group Year 1 | No Intervention | Control sites will not receive assistance with increasing influenza vaccination in Year 1, they will follow guidelines for usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 Pillars Immunization Toolkit | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | Influenza vaccination rates in each arm at the end of year 1 | 3/1/2011-2/29/2012 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Richard Zimmerman, MD, MPH | University of Pittsburgh, School of Medicine, Department of Family Medicine and Clinical Epidemiology | Principal Investigator |
| Chyongchiou Lin, PhD | University of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh, School of Medicine, Deparment of Family Medicine and Clinical Epidemiology | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25113138 | Background | Nowalk MP, Lin CJ, Hannibal K, Reis EC, Gallik G, Moehling KK, Huang HH, Allred NJ, Wolfson DH, Zimmerman RK. Increasing childhood influenza vaccination: a cluster randomized trial. Am J Prev Med. 2014 Oct;47(4):435-43. doi: 10.1016/j.amepre.2014.07.003. Epub 2014 Aug 8. | |
| 24793941 | Background | Zimmerman RK, Nowalk MP, Lin CJ, Hannibal K, Moehling KK, Huang HH, Matambanadzo A, Troy J, Allred NJ, Gallik G, Reis EC. Cluster randomized trial of a toolkit and early vaccine delivery to improve childhood influenza vaccination rates in primary care. Vaccine. 2014 Jun 17;32(29):3656-63. doi: 10.1016/j.vaccine.2014.04.057. Epub 2014 Apr 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Children enrolled at family medicine practices and pediatric practices in the year preceding the intervention year for both intervention and control groups who were seen for a visit between 3/1/2010 and 2/28/2011.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | To be eligible, the practice must have had a patient population of children under 19 years old. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Outcome | Influenza vaccination rates in each arm at the end of year 1 | Posted | Number | participants vaccinated out of all | 3/1/2011-2/29/2012 |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children. |
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2 offices of 1 practice were randomized to each arm potentially causing carryover of the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard K. Zimmerman | University of Pittsburgh | 412-383-2355 | zimmer@pitt.edu |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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|
| End of February 2012 |
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.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | children at sites |
|
| Participants |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | End of February 2012 |
|
|
|
| 0 |
| 26,432 |
| 0 |
| 26,432 |
| EG001 | Control Group | Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children. | 0 | 19,352 | 0 | 19,352 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |