NCT00581711

Brief Summary

This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes Otitis Media (OM) care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT physicians working within an integrated physician network that uses a common EHR, and c) tests the additive effects on quality and resource utilization of providing feedback to physicians.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55,779

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2007

Typical duration for phase_3

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

December 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 18, 2012

Status Verified

June 1, 2012

Enrollment Period

2.8 years

First QC Date

December 19, 2007

Last Update Submit

June 15, 2012

Conditions

Keywords

Electronic Health RecordClinical Decision SupportOtitis Media

Outcome Measures

Primary Outcomes (1)

  • Quality of otitis media care.

    18 Months

Secondary Outcomes (1)

  • Clinician adoption of intervention and Resource Utilization

    18 months

Study Arms (4)

Control

NO INTERVENTION

Usual Care

HIT Intervention without feedback

EXPERIMENTAL

3-Part Intervention: Training, Otitis Media Episode Grouper, Clinical Decision Support

Other: 3-Part Intervention

HIT Intervention with feedback

EXPERIMENTAL

4-Part Intervention: Training, Episode Grouper, Clinical Decision Support, and Physician Feedback.

Other: 4-Part Intervention

Feedback only

EXPERIMENTAL

1 part intervention: Physician Feedback

Other: 1-part intervention

Interventions

A combination of training, an otitis media episode grouper, and clinical decision support.

HIT Intervention without feedback

A combination of clinician training, an otitis media episode grouper, clinical decision support, and feedback.

HIT Intervention with feedback

Provision of feedback on otitis media quality indicators

Feedback only

Eligibility Criteria

Age2 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Forrest CB, Fiks AG, Bailey LC, Localio R, Grundmeier RW, Richards T, Karavite DJ, Elden L, Alessandrini EA. Improving adherence to otitis media guidelines with clinical decision support and physician feedback. Pediatrics. 2013 Apr;131(4):e1071-81. doi: 10.1542/peds.2012-1988. Epub 2013 Mar 11.

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Christopher B Forrest, MD, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 28, 2007

Study Start

December 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

June 18, 2012

Record last verified: 2012-06

Locations