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The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke (CLOQS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01148602
First Posted: June 22, 2010
Last Update Posted: December 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University Health Network, Toronto
St. Michael's Hospital, Toronto
Information provided by (Responsible Party):
Dr. Richard H. Swartz, Sunnybrook Health Sciences Centre
  Purpose
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.

Condition Intervention
Acute Stroke Other: LED stopwatch-clock timers

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke

Further study details as provided by Dr. Richard H. Swartz, Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Improved door-to-CT and door-to-needle times. [ Time Frame: 18 months ]
    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.


Enrollment: 3452
Study Start Date: June 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 'Off Clock'
Stopwatch timers will NOT be used for "off clock" weeks, so patients presenting with hyperacute stroke will be managed normally without the visual timer.
Active Comparator: 'On Clock"
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.
Other: LED stopwatch-clock timers
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.
Other Names:
  • Clocks
  • CLOQS
  • Clock
  • LED countdown timer

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.
  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148602


Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4n 3M5
St. Michael's Hospital
Toronto, Ontario, Canada
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
University Health Network, Toronto
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Richard Swartz, MD University of Toronto Stroke Program
  More Information

Responsible Party: Dr. Richard H. Swartz, Dr., Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01148602     History of Changes
Other Study ID Numbers: UTSP Innovation
First Submitted: June 17, 2010
First Posted: June 22, 2010
Last Update Posted: December 9, 2015
Last Verified: December 2015

Keywords provided by Dr. Richard H. Swartz, Sunnybrook Health Sciences Centre:
Acute stroke
Emergency departments
Quality Improvement
Improved Processes
tPA
door-to-needle
door-to-treatment

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases