This trial is active, not recruiting.

Conditions adolescent hpv vaccine, adolescent influenza vaccine
Treatment 4 pillars toolkit
Sponsor University of Pittsburgh
Collaborator Pfizer
Start date September 2013
End date May 2016
Trial size 21 participants
Trial identifier NCT02165722, PRO13070205


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
4 Pillars Toolkit
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)
11 Clinical Practices [control sites]

Primary Outcomes

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. Year 2: June 1, 2015 thru February 28, 2016.

Eligibility Criteria

Male or female participants from 11 years up to 17 years old.

Inclusion Criteria: - For clinical sites: inclusion criterion includes 1. an appropriate adolescent population: e.g., adolescents aged 11 to 17 years 2. currently using an EMR 3. 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.

Additional Information

Official title An Enhanced 4 Pillars Toolkit for Increasing Adolescent Immunization: A Randomized Controlled Cluster Trial in Pediatrics and Family Medicine
Principal investigator Richard K Zimmerman, MD, MPH, MA
Description 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. .
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Pittsburgh.