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
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: 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 October 23, 2014