NCT01159093

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23,675

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 12, 2015

Status Verified

August 1, 2011

Enrollment Period

1 year

First QC Date

July 7, 2010

Last Update Submit

March 11, 2015

Conditions

Keywords

Clinical Decision Support Systems

Outcome Measures

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).

    Monthly, up to 1 year

Secondary Outcomes (1)

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

    Monthly, up to 1 year

Study Arms (4)

Family Decision Support

EXPERIMENTAL

Families will receive informational vaccine reminder telephone calls.

Behavioral: Family Decision Support

Clinical Decision Support

EXPERIMENTAL

In this treatment arm, clinicians receive the decision support at the point of care within an electronic health record.

Behavioral: Clinician Decision Support

Family DS+ Clinician DS

EXPERIMENTAL

Families will receive informational vaccine reminder calls and their clinicians will receive electronic health record-based decision support for immunizations.

Behavioral: Family Decision SupportBehavioral: Clinician Decision SupportOther: Family Decision Support and Clinician Decision Support

Control

OTHER

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

Other: Control

Interventions

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

Also known as: Clinical Decision Support, Family Focused Intervention
Family DS+ Clinician DSFamily 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
Clinical Decision SupportFamily DS+ Clinician DS

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
Family DS+ Clinician DS
ControlOTHER

Usual care

Control

Eligibility Criteria

Age11 Years - 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Alexander G Fiks, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2010

First Posted

July 9, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 12, 2015

Record last verified: 2011-08

Locations