CClinicalTrials.gg
CompletedNCT01159093GIVEUpdated Mar 12, 2015

Giving Immunizations Through Vaccine Education

An interventional study of Family Decision Support and Clinician Decision Support in HPV Vaccines, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to female participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-03-12.

Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
23,675
Allocation
Randomized
Ages
11 Years to 17 Years
Sex
Female
01

Study summary

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.

Read the 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.
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Conditions studied

  • HPV Vaccines

Keywords

  • Clinical Decision Support Systems
03

In context

Lead sponsor

Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23,675 participants (actual)

Study arms

  • Experimental
    Family Decision Support

    Families will receive informational vaccine reminder telephone calls.

    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.

    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.

    Behavioral: Family Decision Support · Behavioral: Clinician Decision Support · Other: Family Decision Support and Clinician Decision Support

  • Other
    Control

    This group will receive regular primary care with no decision support.

    Other: Control

Interventions

  • BehavioralFamily Decision Support

    Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.

    Also known as: Clinical Decision Support, Family Focused Intervention

  • BehavioralClinician Decision Support

    Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.

    Also known as: Clinical Decision Support, Clinician Focused Intervention

  • OtherFamily 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).

    Also known as: Family Decision Support, Clinician Decision Support

  • OtherControl

    Usual care

06

What researchers measure

Primary outcomes

  1. Rate of HPV vaccination among girls actively cared for at participating sites

    The outcome will be assessed monthly, until study completion (1 year).

    Time frame: Monthly, up to 1 year

Secondary outcomes

  1. Rates of meningococcal and tetanus, diphtheria, and pertussis vaccines among girls in the study

    The outcome will be assessed monthly, until study completion (1 year).

    Time frame: Monthly, up to 1 year

07

Study locations

1 site
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19103, United States
08

References and documents

Publications

  • Mayne SL, duRivage NE, Feemster KA, Localio AR, Grundmeier RW, Fiks AG. Effect of decision support on missed opportunities for human papillomavirus vaccination. Am J Prev Med. 2014 Dec;47(6):734-44. doi: 10.1016/j.amepre.2014.08.010. Epub 2014 Nov 18. PubMed 25455116 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01159093
Lead sponsor
Children's Hospital of Philadelphia
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Responsible party
Sponsor
First posted
Jul 9, 2010
Start date
May 2010
Primary completion
May 2011
Completion
May 2011
Last update
Mar 12, 2015

Study contacts

Alexander G Fiks, MD, MSCE
principal investigator · Children's Hospital of Philadelphia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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