NCT01148602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

1.8 years

First QC Date

June 17, 2010

Last Update Submit

December 7, 2015

Conditions

Keywords

Acute strokeEmergency departmentsQuality ImprovementImproved ProcessestPAdoor-to-needledoor-to-treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

'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.

Other: LED stopwatch-clock timers

Interventions

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.

Also known as: Clocks, CLOQS, Clock, LED countdown timer
'On Clock"

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who present to the emergency room with acute stroke for consideration of treatment with tPA.

You may not qualify if:

  • Patients presenting to the emergency room (door time) more than 4.5 hours after symptom onset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4n 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

University Health Network - Toronto Western Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

StrokeEmergencies

Interventions

E1A-Associated p300 Protein

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

p300-CBP Transcription FactorsHistone AcetyltransferasesLysine AcetyltransferasesAcetyltransferasesAcyltransferasesTransferasesEnzymesEnzymes and CoenzymesTranscription FactorsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Richard Swartz, MD

    University of Toronto Stroke Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 22, 2010

Study Start

June 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations