Reduction in Clinical Variance Using Targeted Design Chan... | NCT00952471

Studies
Reduction in Clinical Variance Using Targeted Design Changes in Computerized Provider Order Entry Order (CPOE) Sets

NCT00952471

Sponsor

Brian Jacobs

Status

Completed

Last Update Posted

May 21, 2015Estimated

Enrollment

458Actual

Phase

Phase 3

Conditions

Asthma Exacerbation

Interventions

Evidence Based Intervention to order set

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Jul 24, 2009

First Submission Date that Met QC Criteria

Aug 4, 2009

First Posted Date

Aug 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2015

Last Update Posted Date

May 21, 2015Estimated

Name	Class
Siemens Medical	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Selective redesign of order sets using different ways to frame the order and physician decision-making in a computerized provider order entry system could increase adherence to evidence-based care and reduce population-specific variance.

Detailed Description

Variance in ordering of care can be characterized as the lack of uniform use of specific treatments by clinicians for a given medical condition. Unwarranted variance in healthcare has been associated with prolonged length of stay, diminished health and increased cost. Practice variation in the management of asthma can be significant and few investigators have evaluated strategies to reduce this variation. We hypothesized that selective redesign of order sets using different ways to frame the order and physician decision-making in a computerized provider order entry system could increase adherence to evidence-based care and reduce population-specific variance.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

458Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Baseline Period	No Intervention	Patients in the baseline period were cared for using the standard historical electronic order set.
Post Intervention Period	Active Comparator	Patients in the Post intervention period were cared for with evidence-bsed modified order set changes	Other: Evidence Based Intervention to order set

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evidence Based Intervention to order set	Other	The order set was altered to include evidence based care items	Post Intervention Period

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduced variation from in evidence-based care through integrating evidence into the clinician workflow in the EMR system.		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients admitted using an acute asthma exacerbation order set.

Exclusion Criteria:

Patients who did not have either an admission or discharge diagnosis of asthma exacerbation.
In addition, patients admitted to the intensive care unit directly or transferred to the intensive care unit within 24-hours were excluded from analysis.
Finally, patients were excluded from analysis if asthma was not the presenting problem.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center		Cincinnati	Ohio	45229	United States

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided