Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-02-11 @ 7:58 PM
Study NCT ID:
NCT05423795
Status:
UNKNOWN
Last Update Posted:
2022-06-21
First Post:
2022-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Stepped wedge design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-14', 'studyFirstSubmitDate': '2022-06-14', 'studyFirstSubmitQcDate': '2022-06-14', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'at hospital discharge (up to 28 days)'}], 'secondaryOutcomes': [{'measure': 'Number of changes based on expert opinion', 'timeFrame': 'at 28 days'}, {'measure': 'Number of invasive diagnostic tests used', 'timeFrame': 'at 28 days'}, {'measure': 'Number of non-invasive diagnostic tests used', 'timeFrame': 'at 28 days'}, {'measure': 'Proportion of patients with non-invasive ventilation and/or high flow oxygen', 'timeFrame': 'at 28 days'}, {'measure': 'Proportion of patients in whom the cause for ICU admission remained undetermined', 'timeFrame': 'at 28 days'}, {'measure': 'Number of days without life-supporting interventions', 'timeFrame': 'at 28 days'}, {'measure': 'Number of anti-microbial agents', 'timeFrame': 'at 28 days'}, {'measure': 'Number of blood transfusions', 'timeFrame': 'at 28 days'}, {'measure': 'Number of chemotherapy', 'timeFrame': 'at 28 days'}, {'measure': 'Proportion of patients with antibiotic de-escalation', 'timeFrame': 'at 28 days'}, {'measure': 'Duration of antibiotic therapy', 'timeFrame': 'up to 28 days'}, {'measure': 'Length of ICU stay', 'timeFrame': 'at hospital discharge (up to 28 days)'}, {'measure': 'Proportion of ICU-acquired events', 'timeFrame': 'at 28 days'}, {'measure': 'Satisfaction of patients, intensivists, primary physicians, and expert.', 'timeFrame': 'at 28 days', 'description': 'Satisfaction will be assessed using a visual analog scale (VAS). The VAS is a scale ranging from 0 to 10, with a higher score indicating greater satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Active Malignancies', 'Life Threatening Complication of the Malignancy or Its Treatments']}, 'descriptionModule': {'briefSummary': 'Admission to the intensive care unit (ICU) is a common event in patients treated for solid tumors or hematologic malignancies. A volume-outcome relationship has been shown in these patients, with a mortality rate decreasing from 70% in low-volume centres to 30-40% in high-volume centres.\n\nWe hypothesize that providing the low-volume centres with assistance from experts working in high-volume centres for the management of critically-ill cancer patients can bring down mortality to the values seen in high-volume centres.\n\nThe main objective of this study is to evaluate whether combining three knowledge-transfer methods (videoconference-based forum, educational sessions, and dissemination of published work) increases the survival of cancer patients managed in low-volume centres to the values seen in high-volume centres.\n\nThe main endpoint is all-cause mortality at hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients (\\> 18 years old)\n2. Active malignancy;\n3. ICUs seeking for an advice must admit fewer than 30 patients with active cancer per year;\n4. Patients has been urgently admitted in the ICU for a life threatening complication of the malignancy or its treatments.\n\nExclusion Criteria:\n\n1. Isolated HIV infection or AIDS;\n2. ICU admission complicating scheduled surgery,\n3. Treatment-limitation decisions at admission;\n4. No coverage by the French statutory health insurance system,\n5. Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT05423795', 'acronym': 'EXPERT-IS', 'briefTitle': 'A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU : A Stepped Wedge Cluster-randomised Trial', 'orgStudyIdInfo': {'id': 'P 150954J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Comparator Arm', 'description': 'Classic expertise (as routinely performed in the participating ICU)', 'interventionNames': ['Other: Standard of care arm']}, {'type': 'EXPERIMENTAL', 'label': 'Telemedicine-based intervention', 'description': 'Telemedicine-based expert advice.', 'interventionNames': ['Other: Telemedicine-based intervention']}], 'interventions': [{'name': 'Telemedicine-based intervention', 'type': 'OTHER', 'description': 'Telemedicine-based intervention Multifaceted intervention including daily videoconferences with audit and feedback, educational interventions, and dissemination of published works', 'armGroupLabels': ['Telemedicine-based intervention']}, {'name': 'Standard of care arm', 'type': 'OTHER', 'description': 'Classic expertise (as routinely performed in the participating ICU)', 'armGroupLabels': ['Comparator Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Elie AZOULAY, Pr', 'role': 'CONTACT', 'email': 'elie.azoulay@aphp.fr', 'phone': '+33142499421'}, {'name': 'Matthieu Resche-Rigon, Pr', 'role': 'CONTACT', 'email': 'matthieu.resche-rigon@u-paris.fr', 'phone': '+33142499742'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}