4 Pillars Toolkit for Adolescent Vaccination

Study Overview
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Brief Summary
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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).

Detailed Description
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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. .

Official Title
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An Enhanced 4 Pillars Toolkit for Increasing Adolescent Immunization: A Randomized Controlled Cluster Trial in Pediatrics and Family Medicine

Conditions
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Adolescent HPV Vaccine, Adolescent Influenza Vaccine

Intervention / Treatment
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* Behavioral: 4 Pillars Toolkit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For clinical sites: inclusion criterion includes an appropriate adolescent population: e.g., adolescents aged 11 to 17 years currently using an EMR having and keeping immunization data within a EMR or registry. Exclusion Criteria: For clinical sites: the exclusion criteria is consistent SOP use for the vaccines being studied or known much higher than average immunization rates.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: Toolkit<br>4 Pillars Toolkit | Behavioral: 4 Pillars Toolkit<br>* 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).<br>|
| No Intervention: No Intervention: Standard practice<br>11 Clinical Practices [control sites] | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Influenza, Tdap, MCV, vaccination, adolescents