Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT03599856
Status:
UNKNOWN
Last Update Posted:
2019-02-04
First Post:
2018-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TraceBook: the Clinical Proof of Concept on the Intensive Care.
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-01', 'size': 1631583, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-12T11:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'A prospective single center (Catharina Hospital Eindhoven) controlled before-and-after study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2018-06-29', 'studyFirstSubmitQcDate': '2018-07-24', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Checked items', 'timeFrame': '24 hours (each day)', 'description': 'The percentage of daily checked checkable items overall and items requiring an intervention per patient.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '9 months', 'description': 'Intensive Care mortality'}, {'measure': 'Mortality', 'timeFrame': '9 months', 'description': '30 day mortality'}, {'measure': 'Mortality', 'timeFrame': '9 months', 'description': '90 day mortality'}, {'measure': 'Length of stay', 'timeFrame': '9 months', 'description': 'Length of stay at the intensive care'}, {'measure': 'Ventilator days', 'timeFrame': '9 months', 'description': 'Number of days with use of mechanical ventilator (per patient and overall per period)'}, {'measure': 'Sedation days', 'timeFrame': '9 months', 'description': 'Number of patient days with a Richmond Agitation-Sedation Scale (score -5 till +4) between -5 and -1 as worse outcome.'}, {'measure': 'Daily intensive care medication alerts', 'timeFrame': '4 months', 'description': 'Number of daily intensive care medication alerts for the pharmacist.'}, {'measure': "Pharmacists' interventions", 'timeFrame': '4 months', 'description': "Types of pharmacists' interventions based on the daily intensive care medication alerts"}, {'measure': 'Number of gastro-intestinal bleedings', 'timeFrame': '4 months', 'description': 'The number of patients during each period with hematemesis or melena, not being the reason of admission.'}, {'measure': 'Ventilator and hospital associated pneumonia on the intensive care.', 'timeFrame': '4 months', 'description': 'The number of patients during each period with ventilator and hospital associated pneumonia, not being the reason of admission.'}, {'measure': 'Central-venous-catheter-related bloodstream infections.', 'timeFrame': '4 months', 'description': 'The number of patients during each period with central-venous-catheter-related bloodstream infections, not being the reason of admission.'}, {'measure': 'Incorrect prescribed anticoagulation or thrombosis prophylaxis.', 'timeFrame': '4 months', 'description': 'Number of patient days where anticoagulation or thrombosis prophylaxis is prescribed incorrect based on local protocol.'}, {'measure': 'Incorrect prescribed proton pump inhibitors', 'timeFrame': '4 months', 'description': 'Number of patient days where proton pump inhibitors are prescribed incorrect based on local protocol.'}, {'measure': 'Incorrect prescribed selective digestive decontamination', 'timeFrame': '4 months', 'description': 'Number of patient days where selective digestive decontamination is prescribed incorrect based on local protocol.'}, {'measure': 'Spontaneous breathing trials', 'timeFrame': '4 months', 'description': 'Number of spontaneous breathing trials when required based on local protocol in weaning patients'}, {'measure': 'Sedation wake up calls', 'timeFrame': '4 months', 'description': 'Number of sedation wake up calls when required based on local protocol'}, {'measure': 'Intravenous sedatives use', 'timeFrame': '4 months', 'description': 'Number of patient days with the use of intravenous sedatives (eg Propofol, Midazolam)'}, {'measure': 'Opiates use', 'timeFrame': '4 months', 'description': 'Number of patient days with the use of opiates overall and in patients with low Visual Analogue Scale scores (\\<4).'}, {'measure': 'Antibiotics use', 'timeFrame': '4 months', 'description': 'Number of patient days with the use of antibiotics overall and when not required based on local protocol.'}, {'measure': 'Complication registration', 'timeFrame': '4 months', 'description': 'Number of complications that were discussed within 24hrs and registered.'}, {'measure': 'Energy deficit', 'timeFrame': '4 months', 'description': 'Number of patient days with energy deficit of \\>250.'}, {'measure': 'Automatically checked items', 'timeFrame': '4 months', 'description': 'Number of items that where or could have been checked automatically during each period.'}, {'measure': 'User experience outcomes', 'timeFrame': '6 months', 'description': 'Attrakdiff questionnaire after both periods Technology Acceptance Model 2 (TAM2) based questionnaire Semi-structured interview'}, {'measure': 'Hedonic and pragmatic quality', 'timeFrame': '6 months', 'description': 'Attrakdiff questionnaire'}, {'measure': 'User acceptance', 'timeFrame': '6 months', 'description': 'Technology Acceptance Model 2 (TAM2) based questionnaire after both periods to compare paper checklist and electronic health records with digital checklist and electronic health records.'}, {'measure': 'User experience', 'timeFrame': '6 months', 'description': 'Semi-structured interview after the intervention period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Checklist', 'Intensive Care Unit', 'Clinical decision support systems', 'Medical errors', 'Patient safety'], 'conditions': ['Critical Illness', 'Safety Issues']}, 'referencesModule': {'references': [{'pmid': '28854530', 'type': 'RESULT', 'citation': 'De Bie AJR, Nan S, Vermeulen LRE, Van Gorp PME, Bouwman RA, Bindels AJGH, Korsten HHM. Intelligent dynamic clinical checklists improved checklist compliance in the intensive care unit. Br J Anaesth. 2017 Aug 1;119(2):231-238. doi: 10.1093/bja/aex129.'}, {'pmid': '33213832', 'type': 'DERIVED', 'citation': 'De Bie AJR, Mestrom E, Compagner W, Nan S, van Genugten L, Dellimore K, Eerden J, van Leeuwen S, van de Pol H, Schuling F, Lu X, Bindels AJGH, Bouwman ARA, Korsten EHHM. Intelligent checklists improve checklist compliance in the intensive care unit: a prospective before-and-after mixed-method study. Br J Anaesth. 2021 Feb;126(2):404-414. doi: 10.1016/j.bja.2020.09.044. Epub 2020 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'The effectiveness of current checklists is hampered by lack of acceptance and compliance. Recently, a new type of checklist with dynamic properties has been created to provide more specific checklist items for each individual patient. The proof of concept of this dynamic clinical checklist (DCC; BJA 2017 (DOI: 10.1093/bja/aex129)) was tested in a simulation trial with improved outcomes and high acceptance scores. The purpose of this study is to investigate if the outcomes of this real-life clinical proof of concept study are similar with the outcomes of the simulation trial for the intensive care unit (ICU) ward.', 'detailedDescription': 'Method A prospective single center (Catharina Hospital Eindhoven) controlled before-and-after study.\n\nThe before period will be used as control group in which ward rounds and nurse handovers will be observed by the investigators for two months. Then TraceBook will be introduced and clinicians, ICU doctors and nurses, will be able to use checklists of TraceBook for ward rounds, their shifts and handovers in which they will be observed for two months. The goal is at least 120 observations per period.\n\nEndpoints The primary outcome is the percentage of items that were checked per ward rounds and nurse handovers during the before and the after implementation period. Secondary outcomes will be clinical outcomes of admitted patients, pharmacist specific outcomes, specific checkable item related outcomes, and user experience and acceptance scores.\n\nHypothesis TraceBook, with the use of digital dynamic checklists, improves compliance to care processes on the intensive care with a high user acceptance score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physicians working on the ICU\n* All admitted patients on the ICU during the study periods.\n\nExclusion Criteria:\n\n* Physicians objecting participation in the trial'}, 'identificationModule': {'nctId': 'NCT03599856', 'acronym': 'TraceBook', 'briefTitle': 'TraceBook: the Clinical Proof of Concept on the Intensive Care.', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': 'TraceBook: the Clinical Proof of Concept on the Intensive Care.', 'orgStudyIdInfo': {'id': 'nWMO-2018.61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '"Before" control group', 'description': 'Control group with observation of current local standard of care with paper checklist available at the bedside during the ICU rounds of the ICU physicians (as usual)'}, {'type': 'EXPERIMENTAL', 'label': '"After" Intervention group', 'description': "An mini Ipad providing TraceBook' intelligent dynamic clinical checklists during the ICU rounds of the ICU physicians.", 'interventionNames': ['Other: TraceBook']}], 'interventions': [{'name': 'TraceBook', 'type': 'OTHER', 'otherNames': ['Dynamic clinical checklist'], 'description': 'TraceBook offers the user intelligent dynamic clinical checklist that shows patient specific items to a specific user while being context aware.', 'armGroupLabels': ['"After" Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}], 'overallOfficials': [{'name': 'Erik Korsten, Prof MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Catharina Ziekenhuis Eindhoven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD is available if researchers ask for it.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eindhoven University of Technology', 'class': 'OTHER'}, {'name': 'Philips Electronics Nederland B.V. acting through Philips CTO organization', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician-scientist', 'investigatorFullName': 'Ashley De Bie', 'investigatorAffiliation': 'Catharina Ziekenhuis Eindhoven'}}}}