4 Pillars Toolkit for Adolescent Vaccination

NCT02165722

Last updated date
Study Location
University of Pittsburgh, School of Medicine, Department of Family Medicine
Pittsburgh, Pennsylvania, 15261, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adolescent HPV Vaccine, Adolescent Influenza Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
11-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Adolescent HPV Vaccine, Adolescent Influenza Vaccine4 Pillars Toolkit for Adolescent Vaccination
NCT02165722
  1. Pittsburgh, Pennsylvania
ALL GENDERS
11 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 4 Pillars Toolkit for Adolescent Vaccination
Official Title  ICMJE An Enhanced 4 Pillars Toolkit for Increasing Adolescent Immunization: A Randomized Controlled Cluster Trial in Pediatrics and Family Medicine
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Adolescent HPV Vaccine
  • Adolescent Influenza Vaccine
Intervention  ICMJE 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).

Study Arms  ICMJE
  • Experimental: Intervention: Toolkit
    4 Pillars Toolkit
    Intervention: Behavioral: 4 Pillars Toolkit
  • No Intervention: No Intervention: Standard practice
    11 Clinical Practices [control sites]
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2017)
22
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2014)
21
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 11 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02165722
Other Study ID Numbers  ICMJE PRO13070205
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Richard Zimmerman, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE
  • Pfizer
  • Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator:Richard K Zimmerman, MD, MPH, MAUniversity of Pittsburgh
PRS Account University of Pittsburgh
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP