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| Sponsor: | Children's Hospital of Philadelphia |
|---|---|
| Collaborator: |
Agency for Healthcare Research and Quality (AHRQ) |
| Information provided by: | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT00581711 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Otitis Media |
Other: 3-Part Intervention Other: 4-Part Intervention Other: 1-part intervention |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Improving Otitis Media Care With EHR-based Clinical Decision Support and Feedback |
| Estimated Enrollment: | 35000 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | February 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
Usual Care
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Experimental: HIT Intervention without feedback
3-Part Intervention: Training, Otitis Media Episode Grouper, Clinical Decision Support
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Other: 3-Part Intervention
A combination of training, an otitis media episode grouper, and clinical decision support.
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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.
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|
Experimental: Feedback only
1 part intervention: Physician Feedback
|
Other: 1-part intervention
Provision of feedback on otitis media quality indicators
|
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.
Eligibility| Ages Eligible for Study: | 2 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Christopher Forrest, MD, PhD, The Children's Hospital of Philadlephia |
| ClinicalTrials.gov Identifier: | NCT00581711 History of Changes |
| Other Study ID Numbers: | 2007-10-5555, 1R18HS017042-01 |
| Study First Received: | December 19, 2007 |
| Last Updated: | November 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Electronic Health Record Clinical Decision Support Otitis Media |
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Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases |
