Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-03 @ 10:52 AM
Study NCT ID:
NCT03268967
Status:
UNKNOWN
Last Update Posted:
2018-03-09
First Post:
2017-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Data analysis'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Before and after interventional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-08', 'studyFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU length of stay (LOS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Days admitted at the ICU using registre data'}], 'secondaryOutcomes': [{'measure': 'Hospital length of stay (LOS)', 'timeFrame': 'At Hospital discharge within one-year before and after the intervention implementation', 'description': 'Days admitted to the hospital using registre data'}, {'measure': 'Line Sepsis', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Treatment package of number of the line sepsis after ICU admission covering the number of patients with line sepsis using registre data on Lactat \\<1 hour, bacteria samples ≤1 hour taken, time between diagnosis of sepsis and taken bacteria samples, time between diagnosis and given antibiotics measured by registre data'}, {'measure': 'Ventilated associated pneumonia (VAP)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of VAP measured by registre data'}, {'measure': 'Re-intubations', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Number of re-intubations measured by registre data'}, {'measure': '30-days Mortality', 'timeFrame': '30 days through study completion, an average of 1 year', 'description': '30-days mortality rates after ICU discharge measured by registre data'}, {'measure': '90-days Mortality', 'timeFrame': '90 days through study completion, an average of 1 year', 'description': '90-days mortality rates after ICU discharge measured by registre data'}, {'measure': 'Staff turn-over', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Staff turn-over before and after the intervention measured by registre data'}, {'measure': 'Sick Leave', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Sick leave amongst staff members measured by registre data'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intensive care', 'crisis resource management', 'simulation training', 'before and after study'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'Admission to the intensive care unit (ICU) is vital for surviving critical illness. An admission to ICU without having a consistent structure, structured review of the patient and a solid team organization lead to unclear communication and responsibility. Factors that correlate with patient acceptance and safety, morbidity and mortality. The hypothesize was that a structured admission can improve patients safety, reduce delays in treatment, reduce ICU length of stay, and improve mortality rate. The overall objective was to optimize patient safety, and effectively use available resources to reduce admission time, delays in treatment and procedures and mortality by using both quantitative and qualitative methods.', 'detailedDescription': 'The quantitative before-data is a one-year observational period prior to the intervention measured by different perspectives; patients and staff outcomes.\n\nAfter the intervention, was qualititive data collected from participants, who received simulation training.\n\nThe quantitative after-data is a one-year observational period post-intervention with same outcomes as before starting the intervention.\n\nData is already collected registry data from hospital quality assurance board. Data will be compared before and after with assessor blinded analysis. Missing data will not be replaced but reported as missing.\n\nThe investigators will try to compare the results with data from an approximately comparative ICU in Denmark due to the implementation of a new patient management system called the Health Portal.\n\nThe statistical analysis plan is based on descriptive and comparative analyses of the group before and after the trial. The quantitative results are explained in in-depths description from participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU admissions\n\nExclusion Criteria:\n\n* None\n* Drop-out are deaths'}, 'identificationModule': {'nctId': 'NCT03268967', 'briefTitle': 'Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)', 'organization': {'class': 'OTHER', 'fullName': 'Hillerod Hospital, Denmark'}, 'officialTitle': 'Optimized Admission to the Intensive Care Unit by Using Crisis Resource Management (CRM)', 'orgStudyIdInfo': {'id': '113581'}, 'secondaryIdInfos': [{'id': '113581', 'type': 'OTHER_GRANT', 'domain': 'Trygfonden'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Structured Admission procedure', 'description': 'After implementation of a structured admission procedure to all ICU patients inspired by principles of Crisis Resource Management, Closed loop communication, action cards, and staff simulation training', 'interventionNames': ['Behavioral: Structured admission procedure']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': "Randomly admission procedure to all ICU patients based on the clinicians' evaluation prior implementation of the intervention."}], 'interventions': [{'name': 'Structured admission procedure', 'type': 'BEHAVIORAL', 'otherNames': ['Standard Care'], 'description': 'A structured ICU admission was inspired by principles of Crisis Resource Management and simulation training of ICU staff members. The Principles of Crisis Resource Management consisted of a treatment manual, a learning video, clear precise communication tool based on Identification-Situation-Background-Analysis-Recommendations (ISBAR) and Closed loop, actions cards, and ABCDE-evaluation of the patient including debriefing, and training in the simulation environment.', 'armGroupLabels': ['Structured Admission procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4300', 'city': 'Holbæk', 'country': 'Denmark', 'facility': 'Department of Anaestesiology', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Holbaek Sygehus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD, Principal Investigator', 'investigatorFullName': 'Janet Froulund Jensen', 'investigatorAffiliation': 'Hillerod Hospital, Denmark'}}}}