4 Pillars Toolkit for Adolescent Vaccination
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).
Adolescent HPV Vaccine
Adolescent Influenza Vaccine
Behavioral: 4 Pillars Toolkit
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||An Enhanced 4 Pillars Toolkit for Increasing Adolescent Immunization: A Randomized Controlled Cluster Trial in Pediatrics and Family Medicine|
- Adolescent vaccination rates for HPV and Influenza [ Time Frame: Baseline year (for background data): June 1, 2013 thru February 28, 2014. Year 1: June 1, 2014 thru February 28, 2015. ] [ Designated as safety issue: No ]Age-based criteria will be used: 11-17 years for HPV and influenza vaccination rates.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Intervention: Toolkit
4 Pillars Toolkit
Behavioral: 4 Pillars Toolkit
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).
No Intervention: No Intervention: Standard practice
11 Clinical Practices [control sites]
This intervention is a stratified randomized cluster trial in about 21 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02165722
|United States, Pennsylvania|
|University of Pittsburgh, School of Medicine, Department of Family Medicine|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Richard K Zimmerman, MD, MPH, MA||University of Pittsburgh|