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4 Pillars Toolkit for Adolescent Vaccination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02165722
Recruitment Status : Completed
First Posted : June 17, 2014
Results First Posted : July 30, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborators:
Pfizer
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Richard Zimmerman, 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).

Condition or disease Intervention/treatment Phase
Adolescent HPV Vaccine Adolescent Influenza Vaccine Behavioral: 4 Pillars Toolkit Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Shot

Arm Intervention/treatment
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]



Primary Outcome Measures :
  1. Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age [ Time Frame: 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.

  2. Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age [ Time Frame: 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.



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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165722


Locations
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United States, Pennsylvania
University of Pittsburgh, School of Medicine, Department of Family Medicine
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Pfizer
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Richard K Zimmerman, MD, MPH, MA University of Pittsburgh
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Richard Zimmerman, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02165722    
Other Study ID Numbers: PRO13070205
First Posted: June 17, 2014    Key Record Dates
Results First Posted: July 30, 2018
Last Update Posted: August 28, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Zimmerman, University of Pittsburgh:
Influenza
HPV
Tdap
MCV
vaccination
adolescents
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases