The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke (CLOQS)
Primary Purpose
Acute Stroke
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
LED stopwatch-clock timers
Sponsored by

About this trial
This is an interventional health services research trial for Acute Stroke focused on measuring Acute stroke, Emergency departments, Quality Improvement, Improved Processes, tPA, door-to-needle, door-to-treatment
Eligibility Criteria
Inclusion Criteria:
- All patients who present to the emergency room with acute stroke for consideration of treatment with tPA.
Exclusion Criteria:
- Patients presenting to the emergency room (door time) more than 4.5 hours after symptom onset
Sites / Locations
- Sunnybrook Health Sciences Centre
- St. Michael's Hospital
- University Health Network - Toronto Western Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
'Off Clock'
'On Clock"
Arm Description
Stopwatch timers will NOT be used for "off clock" weeks, so patients presenting with hyperacute stroke will be managed normally without the visual timer.
LED stopwatch-clock timers will be posted for all patients presenting during "ON clock" weeks. All patients presenting with hyperacute stroke will be managed normally with the addition of a visual stopwatch timer.
Outcomes
Primary Outcome Measures
Improved door-to-CT and door-to-needle times.
Improved door-to-CT scan times and door-to-needle treatment times with tPA, with potentially improved response to treatment and reduction in adverse events.
Secondary Outcome Measures
Full Information
NCT ID
NCT01148602
First Posted
June 17, 2010
Last Updated
December 7, 2015
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
University Health Network, Toronto, Unity Health Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01148602
Brief Title
The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke
Acronym
CLOQS
Official Title
The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
University Health Network, Toronto, Unity Health Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To reduce door-to-needle times in acute stroke treatment. Using an organizational behaviour intervention (a large stopwatch), we will post a visual cue to remind all parties that "time is brain". We hypothesize that this simple visual cue will improve door-to-CT scan times and door-to-needle treatment times, and thus improve treatment response, and reduce adverse events.
Detailed Description
We will construct a large, "in-your-face" red LED stopwatch-clock that is the intervention. The clock will be attached to the stretcher of patients presenting for hyperacute stroke treatment (consideration of tissue plasminogen activator (tPA) treatment at the moment of their Emergency department arrival. This will act as a constant visual reminder to all team members (physicians, RN's, CT technologists) of the urgency of the situation. The study will be a block randomization, by week of presentation. All patients presenting during "on" weeks will have a stopwatch timer with them during the hyperacute stroke workup. During "off" weeks, the clocks will not be used.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
Acute stroke, Emergency departments, Quality Improvement, Improved Processes, tPA, door-to-needle, door-to-treatment
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3452 (Actual)
8. Arms, Groups, and Interventions
Arm Title
'Off Clock'
Arm Type
No Intervention
Arm Description
Stopwatch timers will NOT be used for "off clock" weeks, so patients presenting with hyperacute stroke will be managed normally without the visual timer.
Arm Title
'On Clock"
Arm Type
Active Comparator
Arm Description
LED stopwatch-clock timers will be posted for all patients presenting during "ON clock" weeks. All patients presenting with hyperacute stroke will be managed normally with the addition of a visual stopwatch timer.
Intervention Type
Other
Intervention Name(s)
LED stopwatch-clock timers
Other Intervention Name(s)
Clocks, CLOQS, Clock, LED countdown timer
Intervention Description
We will attach a large, "in-your-face" red LED stopwatch-clock timers to the patient's stretcher at the moment of ED arrival to act as a constant visual reminder to all team members (physicians, RN's, CT technologists) of the urgency of the situation.
Primary Outcome Measure Information:
Title
Improved door-to-CT and door-to-needle times.
Description
Improved door-to-CT scan times and door-to-needle treatment times with tPA, with potentially improved response to treatment and reduction in adverse events.
Time Frame
18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients who present to the emergency room with acute stroke for consideration of treatment with tPA.
Exclusion Criteria:
Patients presenting to the emergency room (door time) more than 4.5 hours after symptom onset
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Swartz, MD
Organizational Affiliation
University of Toronto Stroke Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4n 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
University Health Network - Toronto Western Hospital
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke
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