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Giving Immunizations Through Vaccine Education (GIVE)

This study has been completed.
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01159093
First received: July 7, 2010
Last updated: August 12, 2011
Last verified: August 2011
History of Changes

July 7, 2010
August 12, 2011
May 2010
May 2011   (final data collection date for primary outcome measure)
Rate of HPV vaccination among girls actively cared for at participating sites [ Time Frame: Monthly, up to 1 year ] [ Designated as safety issue: No ]
The outcome will be assessed monthly, until study completion (1 year).
Rate of HPV vaccination among girls actively cared for at participating sites [ Time Frame: Monthly, until study completion (1 year) ] [ Designated as safety issue: No ]
The outcome will be assessed monthly, until study completion (1 year).
Complete list of historical versions of study NCT01159093 on ClinicalTrials.gov Archive Site
Rates of meningococcal and tetanus, diphtheria, and pertussis vaccines among girls in the study [ Time Frame: Monthly, up to 1 year ] [ Designated as safety issue: No ]
The outcome will be assessed monthly, until study completion (1 year).
Rates of meningococcal and tetanus, diphtheria, and pertussis vaccines among girls in the study [ Time Frame: Monthly, until study completion (1 year) ] [ Designated as safety issue: No ]
The outcome will be assessed monthly, until study completion (1 year).
Not Provided
Not Provided
 
Giving Immunizations Through Vaccine Education
Using Health Information Technology to Improve Healthcare Quality in Primary Care Practices and in Transitions Between Care Settings

This study will test the effectiveness of clinician-focused health IT-based decision support, family-focused health IT-based decision support, and a combination of both efforts, in increasing HPV and other adolescent vaccine rates among adolescent girls. We hypothesize that a combination of clinician-focused clinical decision support and family-focused decision support will be most effective.
  • Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.
  • Family-focused intervention includes vaccine reminders and informational telephone calls prompted by the electronic health record.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
HPV Vaccines
  • Behavioral: Family Decision Support
    Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.
    Other Names:
    • Family Decision Support
    • Clinical Decision Support
    • Family Focused Intervention
  • Behavioral: Clinician Decision Support
    Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.
    Other Names:
    • Clinical Decision Support
    • Clinician Focused Intervention
  • Other: Family Decision Support and Clinician Decision Support
    This will be a combination of the family-focused decision support (telephone reminder calls) and clinician-focused decision support (clinical alerts).
    Other Names:
    • Family Decision Support
    • Clinician Decision Support
  • Other: Control
    Usual care
  • Experimental: Family Decision Support
    Families will receive informational vaccine reminder telephone calls.
    Intervention: Behavioral: Family Decision Support
  • Experimental: Clinical Decision Support
    In this treatment arm, clinicians receive the decision support at the point of care within an electronic health record.
    Intervention: Behavioral: Clinician Decision Support
  • Experimental: Family DS+ Clinician DS
    Families will receive informational vaccine reminder calls and their clinicians will receive electronic health record-based decision support for immunizations.
    Interventions:
    • Behavioral: Family Decision Support
    • Behavioral: Clinician Decision Support
    • Other: Family Decision Support and Clinician Decision Support
  • No Intervention: Control
    This group will receive regular primary care with no decision support.
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23675
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All clinicians practicing at participating sites
  • Parents with an eligible adolescent girl
  • Adolescent girls
  • Ages 11-17
  • Has a visit at one of the primary care centers within the last 15 months.
  • Has not completed the teen vaccine series

Exclusion Criteria:

  • None
Female
11 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01159093
09-00-7352, AHRQ
No
Dr. Alexander G. Fiks, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Alexander G Fiks, MD, MSCE Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
August 2011

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