The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke

Study Overview
=================
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.

Official Title
-----------------
The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke

Conditions
-----------------
Acute Stroke

Intervention / Treatment
-----------------
* Other: LED stopwatch-clock timers


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 'Off Clock'<br>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<br>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<br>* 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.<br>* Other names: LED countdown timer;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute stroke, Emergency departments, Quality Improvement, Improved Processes, tPA, door-to-needle, door-to-treatment