Improving Otitis Media Care With Clinical Decision Support

NCT ID: NCT00581711

Last Updated: 2012-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 55779 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-09-30

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.

Detailed Description

Context The high prevalence of Otitis Media (OM) and its enormous cost make it a prime target for cost-effective and evidence-based strategies for disease management.

Objectives

This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes 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. The specific aims are:

Aim 1: To develop and pilot test the OM health IT intervention; Aim 2: To examine the overall effect of the health IT intervention and the independent contribution of physician feedback on quality of OM care (primary outcomes); Aim 3: To assess the effects of the intervention on the secondary outcomes of health care resource utilization and clinician adoption of the health IT.

Study Design/Settings/Participants A cluster randomized trial and multi-level statistical modeling will be used to estimate health IT intervention effects on study outcomes. The proposed project will be conducted in the Children's Hospital of Philadelphia's (CHOP) health care system. The heath IT intervention will be tested in the Pediatric Research Consortium (PeRC), which includes 28 primary care practices in the CHOP network, both urban and suburban, and the CHOP ENT clinical sites. Randomization and implementation of the intervention will occur at the practice level. Study outcomes of quality of care and resource utilization will be reported at the levels of the practice, individual practitioner, and episode-of-care (patient-level).

Study Measures Our main study measures include the quality of otitis media care provided during episodes of OM.

Our secondary outcomes include measurement of clinician adoption of the health IT intervention and resource use.

Conditions

Otitis Media

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

HIT Intervention without feedback

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

Group Type: EXPERIMENTAL

3-Part Intervention

Intervention Type: OTHER

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

HIT Intervention with feedback

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

Group Type: EXPERIMENTAL

4-Part Intervention

Intervention Type: OTHER

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

Feedback only

1 part intervention: Physician Feedback

Group Type: EXPERIMENTAL

1-part intervention

Intervention Type: OTHER

Provision of feedback on otitis media quality indicators

Interventions

3-Part Intervention

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

Intervention Type: OTHER

4-Part Intervention

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

Intervention Type: OTHER

1-part intervention

Provision of feedback on otitis media quality indicators

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All CHOP primary care pediatric and ENT practice sites are eligible for inclusion in this study. We expect 35,000 patients to receive care for otitis media by CHOP clinicians at these sites during the study period however, they are not the subjects of this research.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher B Forrest, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23478860 (View on PubMed)

Other Identifiers

1R18HS017042-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

2007-10-5555

Identifier Type: -

Identifier Source: org_study_id