Acute StrokeCLOQSNCT01148602
The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke
A study testing LED stopwatch-clock timers in people with Acute Stroke, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
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". Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Stroke
- What is being tested?
- LED stopwatch-clock timers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,452 participants
- Where
- 3 sitesCanada
- Study dates
- Jun 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients who present to the emergency room with acute stroke for consideration of treatment with tPA.
Who cannot join
- Patients presenting to the emergency room (door time) more than 4.5 hours after symptom onset
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4n 3M5
St. Michael's Hospital
Toronto, Ontario
University Health Network - Toronto Western Hospital
Toronto, Ontario
About this study
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.
Read the 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.
- Conditions
- Acute Stroke
- Being tested
- LED stopwatch-clock timers
- Keywords
- Acute stroke, Emergency departments, Quality Improvement, Improved Processes, tPA, door-to-needle, door-to-treatment
- Medical subject headings
- Stroke, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED stopwatch-clock timersOther
Also called Clocks, CLOQS, Clock, LED countdown timer
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.
| Study group | Role | What they receive |
|---|---|---|
| 'Off Clock' | No intervention | Stopwatch timers will NOT be used for "off clock" weeks, so patients presenting with hyperacute stroke will be managed normally without the visual timer. |
| 'On Clock" | Active comparator | 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. Receives: Other: LED stopwatch-clock timers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, Unity Health Toronto
- Responsible party
- Principal investigator, Dr. Richard H. Swartz, Sunnybrook Health Sciences Centre
- Investigators
- Richard Swartz, MD, Principal investigator, University of Toronto Stroke Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148602
- Sponsor's protocol ID
- UTSP Innovation
- Acronym
- CLOQS
- Status last verified
- Dec 2015
- First submitted
- 17 Jun 2010
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke
- ClinicalTrials.gov ID
- NCT01148602
- Acronym / sponsor ID
- CLOQS / UTSP Innovation
- Conditions
- Acute Stroke
- Keywords
- Acute stroke, Emergency departments, Quality Improvement, Improved Processes, tPA, door-to-needle, door-to-treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,452 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, Unity Health Toronto
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'Off Clock' | No intervention | –Stopwatch timers will NOT be used for "off clock" weeks, so patients presenting with hyperacute stroke will be managed normally without the visual timer. |
| 'On Clock" | Active comparator | Other: LED stopwatch-clock timersLED 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who present to the emergency room with acute stroke for consideration of treatment with tPA.
Key exclusion criteria (1 listed)
- Patients presenting to the emergency room (door time) more than 4.5 hours after symptom onset
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LED stopwatch-clock timersAlso: Clocks, CLOQS, Clock, LED countdown timerWe 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 | 'On Clock" |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Swartz, MD principal investigator
University of Toronto Stroke Program
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED stopwatch-clock timers in people with Acute Stroke, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved door-to-CT and door-to-needle times. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.