Clinical Decision Unit (CDU) - Evaluation of a Novel Appr... | NCT00497393

Studies
Clinical Decision Unit (CDU) - Evaluation of a Novel Approach to Address Emergency Department Overcrowding

NCT00497393

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Sep 12, 2008Estimated

Enrollment

6,217Actual

Phase

Phase 4

Conditions

Acute Illness

Interventions

Clinical Decision Unit

Countries

Canada

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

Sep 2008

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

Jul 2007

Primary Completion Date

Aug 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Jul 5, 2007

First Submission Date that Met QC Criteria

Jul 5, 2007

First Posted Date

Jul 6, 2007Estimated

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

Sep 11, 2008

Last Update Posted Date

Sep 12, 2008Estimated

Name	Class
Capital Health, Canada	OTHER

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

This randomized controlled trial will introduce a Clinical Decision Unit (CDU) into the University of Alberta Hospital Emergency Department(ED)and assess the influence on ED length of stay, patients who leave without being seen, and other ED Overcrowding outcomes.

Detailed Description

The study will take place over a 6-week period that will be spilt into three-two-week blocks. Using computerized blocks of 2 weeks, days of the week will be randomly allocated so that each day of the week receives one intervention (CDU) and one control day for the study period. The CDU involves transforming an ED bed location to a 6-chair internal waiting room with 2 adjacent beds assigned to act as assessment and treatment locations. Patients will transition between the chair and stretcher to optimize the use of ED space.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6,217Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	regular use of the 2-bed areas in the Emergency department	Behavioral: Clinical Decision Unit

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinical Decision Unit	Behavioral	a dedicated 2-bed area to see patients and then rotate them back into the waiting room area for labs and diagnostic imaging.	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total ED length of stay		in the Emergency Department

Secondary Outcomes

Measure	Description	Time Frame
Left without being seen (LWBS) rates		in the Emergency Department
nurse and physician satisfaction		following Emergency Department shift
ambulance turnaround times (time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Only adult patients (>17 years of age) presenting to the University of Alberta Hospital Emergency Department (UAH ED), during the study interval will be included in the evaluation.

Exclusion Criteria:

Direct admits/Pediatric patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

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

Name	Affiliation	Role
Michael Bullard, MD	University of Alberta Hospital, Edmonton, Alberta, T6G 2B7, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta Hospital		Edmonton	Alberta	T6G 2B7	Canada

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies
D003441	Crowding

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D013037	Spatial Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000076542	Clinical Observation Units

Ancestor Terms

ID	Term
D006757	Hospital Units
D006268	Health Facilities
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided