The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke

Acute Stroke Clinical Trial

— CLOQS  

Official title:

The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148602
• Other study ID #: UTSP Innovation
• Status: Completed
• Phase: N/A
• First received: June 17, 2010
• Last updated: December 7, 2015
• Start date: June 2010
• Est. completion date: April 2012

Study information

• Verified date: December 2015
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3452
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network - Toronto Western Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	St. Michael's Hospital, Toronto, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No