4 Pillars Toolkit for Adolescent Vaccination

Not Applicable

Completed

• Conditions: Adolescent Influenza Vaccine; Adolescent HPV Vaccine
• Interventions: Behavioral: 4 Pillars Toolkit

• Registration Number: NCT02165722
• Lead Sponsor: University of Pittsburgh

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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Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-17
• Primary Completion: 2016-06
• Study Completion: 2016-12
• Results First Submitted: 2017-05-08
• Results First Submitted QC: 2017-10-24
• Status Verified: 2018-07
• Results First Posted: 2018-07-30
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Toolkit	4 Pillars Toolkit	4 Pillars Toolkit

Primary Outcome Measures

Name	Time	Method
Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age	Baseline period to post-intervention	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.
Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age	Baseline period to post-intervention	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.

Trial Locations

Locations (1)

University of Pittsburgh, School of Medicine, Department of Family Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States