Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT01148602
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2010-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050881', 'term': 'E1A-Associated p300 Protein'}], 'ancestors': [{'id': 'D050880', 'term': 'p300-CBP Transcription Factors'}, {'id': 'D051548', 'term': 'Histone Acetyltransferases'}, {'id': 'D000070837', 'term': 'Lysine Acetyltransferases'}, {'id': 'D000123', 'term': 'Acetyltransferases'}, {'id': 'D000217', 'term': 'Acyltransferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014157', 'term': 'Transcription Factors'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3452}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-07', 'studyFirstSubmitDate': '2010-06-17', 'studyFirstSubmitQcDate': '2010-06-21', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved door-to-CT and door-to-needle times.', 'timeFrame': '18 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute stroke', 'Emergency departments', 'Quality Improvement', 'Improved Processes', 'tPA', 'door-to-needle', 'door-to-treatment'], 'conditions': ['Acute Stroke']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who present to the emergency room with acute stroke for consideration of treatment with tPA.\n\nExclusion Criteria:\n\n* Patients presenting to the emergency room (door time) more than 4.5 hours after symptom onset'}, 'identificationModule': {'nctId': 'NCT01148602', 'acronym': 'CLOQS', 'briefTitle': 'The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'The CLOQS Trial - Countdown Lights to Optimize Quality in Stroke', 'orgStudyIdInfo': {'id': 'UTSP Innovation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': "'Off Clock'", 'description': 'Stopwatch timers will NOT be used for "off clock" weeks, so patients presenting with hyperacute stroke will be managed normally without the visual timer.'}, {'type': 'ACTIVE_COMPARATOR', 'label': '\'On Clock"', 'description': '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.', 'interventionNames': ['Other: LED stopwatch-clock timers']}], 'interventions': [{'name': 'LED stopwatch-clock timers', 'type': 'OTHER', 'otherNames': ['Clocks', 'CLOQS', 'Clock', 'LED countdown timer'], 'description': '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.', 'armGroupLabels': ['\'On Clock"']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4n 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network - Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Richard Swartz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto Stroke Program'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Health Network, Toronto', 'class': 'OTHER'}, {'name': 'Unity Health Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dr. Richard H. Swartz', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}