The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke
| Tracking Information | |||||
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| First Received Date ICMJE | June 17, 2010 | ||||
| Last Updated Date | July 19, 2011 | ||||
| Start Date ICMJE | June 2010 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Improved door-to-CT and door-to-needle times. [ Time Frame: 18 months ] [ Designated as safety issue: No ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01148602 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke | ||||
| Official Title ICMJE | The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Acute Stroke | ||||
| Intervention ICMJE | Other: LED countdown timer
We will attach a large, "in-your-face" red LED stopwatch-clock 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.
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | September 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01148602 | ||||
| Other Study ID Numbers ICMJE | UTSP Innovation | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Richard Swartz, Sunnybrook Health Sciences Centre | ||||
| Study Sponsor ICMJE | Sunnybrook Health Sciences Centre | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Sunnybrook Health Sciences Centre | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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