Trial record 6 of 56 for:    pillar

4 Pillars Toolkit for Adolescent Vaccination

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02165722
First received: June 13, 2014
Last updated: June 16, 2014
Last verified: October 2013
  Purpose

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 Intervention
Adolescent HPV Vaccine
Adolescent Influenza Vaccine
Behavioral: 4 Pillars Toolkit

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Age-based criteria will be used: 11-17 years for HPV and influenza vaccination rates.


Estimated Enrollment: 21
Study Start Date: September 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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]

Detailed 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.

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  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02165722

Locations
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
Investigators
Principal Investigator: Richard K Zimmerman, MD, MPH, MA University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02165722     History of Changes
Other Study ID Numbers: PRO13070205
Study First Received: June 13, 2014
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Influenza
HPV
Tdap
MCV
vaccination
adolescents

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014