Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04348318
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2020-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advance Directive Implementation and Scientific Evaluation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2050-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2050-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients without predefined health care agents and/or completed advance directives', 'timeFrame': 'at baseline', 'description': "Descriptive analyses will be applied to report the proportion of patients with an advance directive. The core components of the advance directives will be analyzed regarding their translation into clinical practice. Patient and disease related characteristics will be compared between patients with and without advance directives applying the Chi-square and Fisher's exact test (where appropriate) for comparisons of proportions and the Mann-Whitney-U-test for the comparisons of continuous variables."}, {'measure': 'number of adequate translations of directives into clinical practice', 'timeFrame': 'at baseline', 'description': "Descriptive analyses will be applied to report the proportion of patients with an advance directive. The core components of the advance directives will be analyzed regarding their translation into clinical practice. Patient and disease related characteristics will be compared between patients with and without advance directives applying the Chi-square and Fisher's exact test (where appropriate) for comparisons of proportions and the Mann-Whitney-U-test for the comparisons of continuous variables."}], 'secondaryOutcomes': [{'measure': 'In-hospital outcome (defined as survival and return of neurologic function to premorbid baseline)', 'timeFrame': 'at baseline', 'description': "In-hospital outcome (defined as survival and return of neurologic function to premorbid baseline) will be compared between patients with and without advanced directives applying the Chi-square and Fisher's exact test (where appropriate) for comparisons of proportions and the Mann-Whitney-U-test for the comparisons of continuous variables."}, {'measure': 'In-hospital outcome (defined as Glasgow Outcome Score)', 'timeFrame': 'at baseline', 'description': 'scale of patients with brain injuries that groups victims by the objective degree of recovery.The scale consists of five ordinal outcome categories: good recovery (able to live independently, able to return to work or school), moderate disability (able to live independently, unable to return to work or school), severe disability (able to follow commands, unable to live independently), persistent vegetative state (unable to interact with the environment, unresponsive), and death.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['advance directives', 'life-sustaining treatment', 'neurocritical illness'], 'conditions': ['Loss of Capability of Judgement']}, 'referencesModule': {'references': [{'pmid': '41085533', 'type': 'DERIVED', 'citation': 'Baumann SM, Vock D, Kliem PSC, Amacher SA, Erne Y, Grzonka P, Berger S, Lohri M, Hunziker S, Gebhard CE, Nebiker M, Cioccari L, Sutter R. Prevalence, clinical impact and associated patient-centred outcomes of advance directives in Swiss intensive care units: Results from the retrospective ADVISE Study. Swiss Med Wkly. 2025 Sep 24;155:4625. doi: 10.57187/s.4625.'}]}, 'descriptionModule': {'briefSummary': 'This study is to better understand the use of advance directives, their implementation in the intensive care unit, and their effects on outcome. Data from the digital medical records of all consecutive adult patients admitted to the intensive care unit at the University Hospital Basel from 2011 to 2023 are retrospectively extracted. Descriptive analyses will be applied to report the proportion of patients with an advance directive. In-hospital outcome (defined as survival, Glasgow Outcome Score, and return of neurologic function to premorbid baseline) will be compared between patients with and without advanced directives'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include all consecutive adult patients (i.e., ≥18 years of age) treated in the intensive care unit at the University Hospital Basel from 2011 to 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients treated for more than 48 hours in the intensive care unit (post-operative or internal medicine) of the University Hospital Basel in the years 2011-2023\n\nExclusion Criteria:\n\n* Patients with documented refusal of the general consent.\n* Patients who have been treated in the intensive care unit for less than 48 hours'}, 'identificationModule': {'nctId': 'NCT04348318', 'acronym': 'ADVISE', 'briefTitle': 'Advance Directive Implementation and Scientific Evaluation Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Advance Directive Implementation and Scientific Evaluation (ADVISE) Study', 'orgStudyIdInfo': {'id': '2020-00584; me20Sutter2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'health related personal data extraction from digital medical records', 'type': 'OTHER', 'description': 'health related personal data extraction from digital medical records (i.e. patient characteristics; start, end and duration of hospitalization and ICU stay; admitted from another hospital, nursing home or comes with emergency medical Service; formal data of written advance directives; data of unwritten advance directive; information on the contents of the advance directives (regarding life-worthy conditions, health care agents, resuscitation, pain management, artificial nutrition, hydration, surgeries, renal replacement, mechanical circulation, mechanical ventilation, pacemaker, administration of blood products, treatment of infections, organ donation, autopsy); patient history; clinical data; therapeutic features; outcome at discharge; knowledge regarding relatives and their level of information about the advance directives; discussion of euthanasia and self-determination of dying.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarau', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Luca Cioccari, PD Dr. med.', 'role': 'CONTACT'}, {'name': 'Luca Cioccari, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kantonsspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Raoul Sutter, PD Dr. med', 'role': 'CONTACT', 'email': 'raoul.sutter@usb.ch', 'phone': '+41 61 265 25 25'}, {'name': 'Sira Baumann, Cand. med.', 'role': 'CONTACT', 'email': 'sira.baumann@stud.unibas.ch'}, {'name': 'Sarah Tschudin Sutter, Prof. Dr. med', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sira Baumann, Cand. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinic for Intensive Care Medicine, University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Raoul Sutter, PD Dr. med', 'role': 'CONTACT', 'email': 'raoul.sutter@usb.ch', 'phone': '+41 61 87928'}, {'name': 'Sira Baumann, Cand. med.', 'role': 'CONTACT', 'email': 'Cand. med. Sira Maria Baumann <sira.baumann@stud.unibas.ch>'}], 'overallOfficials': [{'name': 'Raoul Sutter, PD Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic for Intensive Care Medicine, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}