Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-27 @ 12:48 PM
Study NCT ID:
NCT05155150
Status:
UNKNOWN
Last Update Posted:
2023-04-10
First Post:
2021-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient reported experience measure (PREM)', 'timeFrame': 'Within 3 months of family meeting', 'description': "Patient and/or relative's experience (measured using the CollaboRATE)"}], 'secondaryOutcomes': [{'measure': 'Patient reported outcome measure (PROM)', 'timeFrame': 'After 3 months and after 1 year', 'description': 'Quality of life, measured using the EuroQol five-dimensional questionnaire (EQ-5D-5L). The Dutch EQ-5D-5L index ranges from -0.446 to 1, with a higher score indicating a better health related quality of life.'}, {'measure': "ICU professionals' experiences", 'timeFrame': 'Two months before inclusion first patient and two months after inclusion last patient', 'description': 'Measured using the Ethical Decision-Making Climate Questionnaire (EDMCQ). The EDMCQ consists of three parts: interdisciplinary collaboration and communication (5-point Likert Scale ranging from strongly disagree to strongly agree), leadership by physicians (5-point Likert Scale ranging from never to always) and ethical environment (4-point Likert Scale ranging from strongly disagree to strongly agree). These three parts cover a total of seven factors. Factor scores range from 1-5 or 1-4, with higher scores reflecting more positive views.'}, {'measure': 'Patient reported outcome measure (PROM)', 'timeFrame': 'After 3 months and after 1 year', 'description': 'Anxiety and depression, measured using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of two components (anxiety and depression), with each score ranging from 0-21. A higher score indicates more severe symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Share decision making', 'Intensive Care Unit', 'Quality of life'], 'conditions': ['Intensive Care Unit Syndrome', 'Patient Engagement']}, 'referencesModule': {'references': [{'pmid': '39992444', 'type': 'DERIVED', 'citation': 'Porter LL, Simons KS, van der Hoeven JG, van den Boogaard M, Zegers M. Discussing expected long-term quality of life in the ICU: effect on experiences and outcomes of patients, family, and clinicians-a randomized clinical trial. Intensive Care Med. 2025 Mar;51(3):478-489. doi: 10.1007/s00134-025-07812-5. Epub 2025 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of incorporation of outcome information in the Intensive Care Unit (ICU) decision-making process on patient and family reported outcomes and experiences of patients, relatives and ICU clinicians in a randomized clinical trial design in the Jeroen Bosch Ziekenhuis and Radboudumc in the Netherlands.', 'detailedDescription': "Background Due to advances in critical care medicine, more patients survive their critical illness. However, many Intensive Care Unit (ICU) survivors suffer from physical, cognitive and/or mental problems impacting patients' quality of life (QoL). Because of a lack of long-term outcome information, ICU physicians make decisions regarding ICU treatment based on their clinical experience and intuition. Moreover, patients and relatives are often not involved in the decision-making process.\n\nTo improve the ICU decision-making process and to make it more substantiated, the use of patient-reported outcome measures (PROMs) is of utmost importance. Therefore, the Radboudumc, in collaboration with six regional hospitals, including Jeroen Bosch Ziekenhuis (JBZ), set up a large-scale prospective cohort study, MONITOR-IC (www.monitor-ic.nl), to study long-term outcomes of ICU survivors', their QoL and their needs.\n\nThis research sets out to evaluate the effect of incorporation of outcome information in the ICU decision-making process on patient and family reported outcomes and experiences of patients, relatives and ICU clinicians in a randomized clinical trial design in the Jeroen Bosch Ziekenhuis and Radboudumc in the Netherlands.\n\nMethods A prediction model for long-term QoL was previously developed using physiological, pathological, drug and treatment data from patients' electronic health record combined with PROMs from one centre of the MONITOR-IC. It was externally validated with the data of six other centres and an E-health tool was developed, incorporating this prediction model. For this research, the E-health tool will be incorporated in family meetings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the ICU for 12 hours or more\n* Patients (or their legal representative) provide written informed consent\n\nExclusion Criteria:\n\n* Patients admitted to the ICU due to a COVID-19 infection\n* Moribund patients'}, 'identificationModule': {'nctId': 'NCT05155150', 'briefTitle': 'Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information', 'orgStudyIdInfo': {'id': '112002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Providing patient-reported outcome: patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting)', 'interventionNames': ['Behavioral: Providing patient-reported outcome']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Family meetings take place as usual.'}], 'interventions': [{'name': 'Providing patient-reported outcome', 'type': 'BEHAVIORAL', 'description': 'Patients receive personalized information on expected quality of life one year after ICU during ICU admission (during a family meeting)', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marieke Zegers, PhD', 'role': 'CONTACT', 'email': 'Marieke.Zegers@radboudumc.nl', 'phone': '0031243619269'}, {'name': 'Mark van den Boogaard, PhD', 'role': 'CONTACT', 'email': 'Mark.vandenBoogaard@radboudumc.nl'}], 'facility': 'Radboud university medical centre', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '5223GZ', 'city': "'s-Hertogenbosch", 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Koen Simons, MD, PhD', 'role': 'CONTACT', 'email': 'k.simons@jbz.nl'}], 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}], 'centralContacts': [{'name': 'Marieke Zegers, PhD', 'role': 'CONTACT', 'email': 'Marieke.Zegers@radboudumc.nl', 'phone': '0031243619269'}, {'name': 'Mark van den Boogaard, PhD', 'role': 'CONTACT', 'email': 'Mark.vandenBoogaard@radboudumc.nl'}], 'overallOfficials': [{'name': 'Marieke Zegers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intensive Care, Radboud university medical center'}, {'name': 'Koen Simons, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intensive Care, Jeroen Bosch Ziekenhuis'}, {'name': 'Mark Van den Boogaard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intensive Care, Radboud university medical center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jeroen Bosch Ziekenhuis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD and Principal Investigator', 'investigatorFullName': 'Marieke Zegers', 'investigatorAffiliation': 'Radboud University Medical Center'}}}}