Clinical trial NCT02165722: 4 Pillars Toolkit for Adolescent Vaccination
Official title: An Enhanced 4 Pillars Toolkit for Increasing Adolescent Immunization: A Randomized Controlled Cluster Trial in Pediatrics and Family Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent HPV Vaccine
Adolescent Influenza Vaccine
Keywords: Influenza
HPV
Tdap
MCV
vaccination
adolescents
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Merck Sharp & Dohme LLC
First posted: 2014-06-17
Enrollment: 22
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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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Eligibility criteria: 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.

Primary outcomes:
measure: Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age
timeFrame: Baseline period to post-intervention
measure: Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age
timeFrame: Baseline period to post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, School of Medicine, Department of Family Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Richard K Zimmerman, MD, MPH, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.