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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to test whether or not the 4 Pillars Immunization Toolkit increases adolescent vaccination rates, particularly influenza and human papillomavirus (HPV) but also tetanus, diphtheria and pertussis (Tdap), and meningococcal conjugate (MCV) vaccination rates. The vaccines are all FDA licensed vaccines and to be used according to national guidelines. The investigators will conduct a randomized cluster trial of this toolkit in diverse primary care practices with electronic medical records (EMRs).
This intervention is a stratified randomized cluster trial in about 22 diverse primary care practices. These practices will be randomly assigned to be intervention or control sites to test this 4 Pillars Immunization Toolkit intervention package of evidence-based techniques tailored to their practice structure and culture; the specialties are split between pediatric and family medicine practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Toolkit | Experimental | 4 Pillars Toolkit |
|
| No Intervention: Standard practice | No Intervention | 11 Clinical Practices [control sites] |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 Pillars Toolkit | Behavioral | Behavioral: Pillar 1: Convenient Vaccination Services (e.g. use every visit [chronic and acute] as an opportunity to vaccinate; use express vaccination clinics and dedicated vaccination stations; use influenza vaccination as an opportunity to vaccinate for other vaccines). Behavioral: Pillar 2: Patient Notification (e.g. use electronic reminders and social media for vaccination reminders; use physician recommendations). Behavioral: Pillar 3: Enhanced Office Systems (e.g. implement Standing Order Programs; use EMR prompts; add vaccination status as a vital sign when rooming). Behavioral: Pillar 4: Motivation (e.g. establish an office Immunization Champion to track goal progress, aided by research team feedback). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age | Change in cumulative vaccination rates from baseline to end of year 1 for HPV series initiation (e.g., receipt of first dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015. | Baseline period to post-intervention |
| Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age | Change in cumulative vaccination rates from baseline to end of year 1 for HPV series completion (e.g., receipt of third dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015. | Baseline period to post-intervention |
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Inclusion Criteria:
For clinical sites: inclusion criterion includes
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard K Zimmerman, MD, MPH, MA | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh, School of Medicine, Department of Family Medicine | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27876200 | Result | Zimmerman RK, Moehling KK, Lin CJ, Zhang S, Raviotta JM, Reis EC, Humiston SG, Nowalk MP. Improving adolescent HPV vaccination in a randomized controlled cluster trial using the 4 Pillars practice Transformation Program. Vaccine. 2017 Jan 3;35(1):109-117. doi: 10.1016/j.vaccine.2016.11.018. Epub 2016 Nov 18. | |
| 28947346 | Derived |
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Cluster randomized trial where units reflect clinical practices enrolled. Numbers of participants who started and ended study reflect the longitudinal analytic data set of patients who had a visit during both the baseline and intervention periods.
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Sites | 9 Clinical practices (intervention sites) used the 4 Pillars Toolkit to increase vaccination rates from baseline to end of year 1. Two practices dropped out of the intervention (11-2=9). Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015). The 4 Pillars Toolkit is built around 4 pillars which include evidence-based strategies to increase vaccination rates: Pillar 1: Convenient Vaccination Services Pillar 2: Patient Notification Pillar 3: Enhanced Office Systems Pillar 4: Motivation |
| FG001 | Control Sites | 11 Clinical Practices [control sites] were not actively intervened upon. Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Sites | Clinical practices: 9 Clinical practices (intervention sites) used the 4 Pillars Toolkit to increase vaccination rates from baseline to end of year 1. Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age | Change in cumulative vaccination rates from baseline to end of year 1 for HPV series initiation (e.g., receipt of first dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015. | HPV series initiation stratified by age of 11-13 years and 14-17 years of age. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015. | Posted | Number | percent change in vaccination rates | Baseline period to post-intervention |
|
Baseline period to post-intervention
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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 Sites | Clinical practices: 9 Clinical practices (intervention sites) used the 4 Pillars Toolkit to increase vaccination rates from baseline to end of year 1. Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015). |
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Limitations include: unequal distribution of baseline characteristics, possible influence of a ceiling effect, modest length (9 months) of the intervention limited ability to observe differences in HPV series completion rates between groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard K. Zimmerman, MD, MPH, MA | University of Pittsburgh | 412-383-2354 | 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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| Zimmerman RK, Raviotta JM, Nowalk MP, Moehling KK, Reis EC, Humiston SG, Lin CJ. Using the 4 Pillars Practice Transformation Program to increase adolescent human papillomavirus, meningococcal, tetanus-diphtheria-pertussis and influenza vaccination. Vaccine. 2017 Oct 27;35(45):6180-6186. doi: 10.1016/j.vaccine.2017.09.039. Epub 2017 Sep 22. |
| Control Sites |
Clinical practices: 11 Clinical Practices [control sites] were not actively intervened upon but continued their standard clinical practices regarding provision of vaccinations. Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015). |
| BG002 | Total | Total of all reporting groups |
| percent of participants aged 11-13 years |
|
| Sex/Gender, Customized | Number | percent of female participants |
|
| Race/Ethnicity, Customized | Number | percent of Non-white participants |
|
| Commercial health insurance, % | Number | percent of participants privt insurance |
|
| OG001 | Control Group: HPV Series Initiation 11-13 Years of Age | Practices: Represents 11 clinical practices Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015). Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015. |
| OG002 | Intervention Group: HPV Series Initiation 14-17 Years of Age | Practices: Represents 9 clinical practices Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015). Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015. |
| OG003 | Control Group: HPV Series Initiation 14-17 Years of Age | Practices: Represents 11 clinical practices Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015). Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015. |
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|
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| Primary | Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age | Change in cumulative vaccination rates from baseline to end of year 1 for HPV series completion (e.g., receipt of third dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015. | Posted | Number | percent change in vaccination rates | Baseline period to post-intervention |
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| 0 |
| 4,942 |
| 0 |
| 4,942 |
| EG001 | Control Sites | Clinical practices: 11 Clinical Practices [control sites] were not actively intervened upon but continued their standard clinical practices regarding provision of vaccinations. Patients: Adolescents aged 11-17 years of age who had a visit during both the baseline (7/1/2013 to 6/30/2014) and intervention periods (7/1/2014 to 3/31/2015). | 0 | 5,919 | 0 | 5,919 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Chi-squared | >0.05 | Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05. | Other | Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention. |
| Chi-squared | >0.05 | Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05. | Other | Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics. |
| Chi-squared | >0.05 | Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05. | Other | Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics. |