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Clinical Trials/NCT00581711
NCT00581711CompletedPhase 3

Improving Otitis Media Care With EHR-based Clinical Decision Support and Feedback

Children's Hospital of Philadelphia1 site in 1 country55,779 target enrollmentStarted: December 1, 2007Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
55,779
Locations
1
Primary Endpoint
Quality of otitis media care.

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Months to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • •There are no exclusion criteria. All CHOP primary care pediatric and ENT sites are eligible for participation. Data for all clinicians providing OM care and data on all OM encounters will be included in our data set.

Arms & Interventions

Feedback only

Experimental

1 part intervention: Physician Feedback

Intervention: 1-part intervention (Other)

Control

No Intervention

Usual Care

HIT Intervention without feedback

Experimental

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

Intervention: 3-Part Intervention (Other)

HIT Intervention with feedback

Experimental

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

Intervention: 4-Part Intervention (Other)

Outcomes

Primary Outcomes

Quality of otitis media care.

Time Frame: 18 Months

Secondary Outcomes

  • Clinician adoption of intervention and Resource Utilization(18 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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