Giving Immunizations Through Vaccine Education (GIVE)

This study has been completed.
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention
HPV Vaccines
Behavioral: Family Decision Support
Behavioral: Clinician Decision Support
Other: Family Decision Support and Clinician Decision Support
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Using Health Information Technology to Improve Healthcare Quality in Primary Care Practices and in Transitions Between Care Settings

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 23675
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family Decision Support
Families will receive informational vaccine reminder telephone calls.
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
Experimental: Clinical Decision Support
In this treatment arm, clinicians receive the decision support at the point of care within an electronic health record.
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
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.
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
No Intervention: Control
This group will receive regular primary care with no decision support.
Other: Control
Usual care

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159093

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Alexander G Fiks, MD, MSCE Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Dr. Alexander G. Fiks, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01159093     History of Changes
Other Study ID Numbers: 09-00-7352, AHRQ
Study First Received: July 7, 2010
Last Updated: August 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Clinical Decision Support Systems

ClinicalTrials.gov processed this record on April 23, 2014