Improving Otitis Media Care With Clinical Decision Support (OMHIT)
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|ClinicalTrials.gov Identifier: NCT00581711|
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : June 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media||Other: 3-Part Intervention Other: 4-Part Intervention Other: 1-part intervention||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55779 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Otitis Media Care With EHR-based Clinical Decision Support and Feedback|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
No Intervention: Control
Experimental: HIT Intervention without feedback
3-Part Intervention: Training, Otitis Media Episode Grouper, Clinical Decision Support
Other: 3-Part Intervention
A combination of training, an otitis media episode grouper, and clinical decision support.
Experimental: HIT Intervention with feedback
4-Part Intervention: Training, Episode Grouper, Clinical Decision Support, and Physician Feedback.
Other: 4-Part Intervention
A combination of clinician training, an otitis media episode grouper, clinical decision support, and feedback.
Experimental: Feedback only
1 part intervention: Physician Feedback
Other: 1-part intervention
Provision of feedback on otitis media quality indicators
- Quality of otitis media care. [ Time Frame: 18 Months ]
- Clinician adoption of intervention and Resource Utilization [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581711
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Christopher B Forrest, MD, PhD||Children's Hospital of Philadelphia|