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Improving Otitis Media Care With Clinical Decision Support (OMHIT)

Primary Purpose

Otitis Media

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
3-Part Intervention
4-Part Intervention
1-part intervention
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media focused on measuring Electronic Health Record, Clinical Decision Support, Otitis Media

Eligibility Criteria

2 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

HIT Intervention without feedback

HIT Intervention with feedback

Feedback only

Arm Description

Usual Care

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

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

1 part intervention: Physician Feedback

Outcomes

Primary Outcome Measures

Quality of otitis media care.

Secondary Outcome Measures

Clinician adoption of intervention and Resource Utilization

Full Information

First Posted
December 19, 2007
Last Updated
June 15, 2012
Sponsor
Children's Hospital of Philadelphia
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT00581711
Brief Title
Improving Otitis Media Care With Clinical Decision Support
Acronym
OMHIT
Official Title
Improving Otitis Media Care With EHR-based Clinical Decision Support and Feedback
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
Electronic Health Record, Clinical Decision Support, Otitis Media

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55779 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Care
Arm Title
HIT Intervention without feedback
Arm Type
Experimental
Arm Description
3-Part Intervention: Training, Otitis Media Episode Grouper, Clinical Decision Support
Arm Title
HIT Intervention with feedback
Arm Type
Experimental
Arm Description
4-Part Intervention: Training, Episode Grouper, Clinical Decision Support, and Physician Feedback.
Arm Title
Feedback only
Arm Type
Experimental
Arm Description
1 part intervention: Physician Feedback
Intervention Type
Other
Intervention Name(s)
3-Part Intervention
Intervention Description
A combination of training, an otitis media episode grouper, and clinical decision support.
Intervention Type
Other
Intervention Name(s)
4-Part Intervention
Intervention Description
A combination of clinician training, an otitis media episode grouper, clinical decision support, and feedback.
Intervention Type
Other
Intervention Name(s)
1-part intervention
Intervention Description
Provision of feedback on otitis media quality indicators
Primary Outcome Measure Information:
Title
Quality of otitis media care.
Time Frame
18 Months
Secondary Outcome Measure Information:
Title
Clinician adoption of intervention and Resource Utilization
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher B Forrest, MD, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23478860
Citation
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.
Results Reference
derived

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Improving Otitis Media Care With Clinical Decision Support

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