Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05783505
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2023-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011595', 'term': 'Psychomotor Agitation'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter stepped wedge cluster randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2023-01-08', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence rate of falls out of bed', 'timeFrame': '14 days'}, {'measure': 'A secondary Bayesian analysis of the trial including heterogeneity of treatment effect', 'timeFrame': 'To be conducted within one year after study completion', 'description': 'A secondary Bayesian analysis of the trial including heterogeneity of treatment effect'}], 'primaryOutcomes': [{'measure': 'ICU-free days', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Incidence rate of accidentally removed medical devices', 'timeFrame': '14 days'}, {'measure': 'Incidence rate of (self-extubation induced) reintubations', 'timeFrame': '14 days'}, {'measure': 'Days with delirium', 'timeFrame': '14 days', 'description': 'Assessed using the Intensive Care Delirium Screening Checklist (ICDSC), Confusion Assessment Method for the ICU (CAM-ICU), or the Delirium Observation Screening scale for the ward (DOS)'}, {'measure': 'Days with coma', 'timeFrame': '14 days', 'description': 'Assessed using the Richmond Agitation and Sedation Scale (RASS)'}, {'measure': 'Number of delirium- and coma-free days', 'timeFrame': '14 days'}, {'measure': 'Days with physical restraints', 'timeFrame': '14 days'}, {'measure': 'Days with dexmedetomidine (and total administered dose)', 'timeFrame': '14 days'}, {'measure': 'Dexmedetomidine related adverse events (e.g., hypotension, bradycardia) that required intervention', 'timeFrame': '14 days'}, {'measure': 'Days with propofol (and total administered dose)', 'timeFrame': '14 days'}, {'measure': 'Duration of mechanical ventilation in days', 'timeFrame': 'up to 180 days'}, {'measure': 'Hospital length of stay in days', 'timeFrame': 'up to 180 days'}, {'measure': 'Mortality', 'timeFrame': 'at 28 days, 3 months and 12 months'}, {'measure': 'Physical outcome', 'timeFrame': 'at ICU admission, 3, 12 and 24 months', 'description': 'E.g., fatigue, frailty, new or worsened physical problems, assessed using validated questionnaires'}, {'measure': 'Mental outcome', 'timeFrame': 'at ICU admission 3, 12 and 24 months', 'description': 'E.g., post traumatic stress disorder (PTSD), anxiety, depression, assessed using validated questionnaires'}, {'measure': 'Cognitive outcome', 'timeFrame': 'at 3, 12 and 24 months', 'description': 'E.g., cognitive impairment, assessed using a validated questionnaire'}, {'measure': 'Quality of life', 'timeFrame': 'at ICU admission, 3, 12 and 24 months', 'description': 'Assessed using a validated QoL questionnaire'}, {'measure': 'Cost-effectiveness', 'timeFrame': '12 months', 'description': 'Measured by cost per Quality-Adjusted Life Year (QALY)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ICU', 'Agitation', 'Physical Restraints', 'Non-pharmacologic interventions', 'Dexmedetomidine'], 'conditions': ['Agitation,Psychomotor']}, 'referencesModule': {'references': [{'pmid': '38082351', 'type': 'DERIVED', 'citation': 'Kooken RWJ, Tilburgs B, Ter Heine R, Ramakers B, van den Boogaard M; PRAISE study group. A multicomponent intervention program to Prevent and Reduce AgItation and phySical rEstraint use in the ICU (PRAISE): study protocol for a multicenter, stepped-wedge, cluster randomized controlled trial. Trials. 2023 Dec 11;24(1):800. doi: 10.1186/s13063-023-07807-x.'}]}, 'descriptionModule': {'briefSummary': 'Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.', 'detailedDescription': 'Applying physical restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated. Nonetheless, PR are still used in approximately 20-25% of all patients during their intensive care unit (ICU) stay in the Netherlands. The aim of this study is to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints on short- and long-term outcomes and healthcare costs in (expected to become) agitated adult ICU patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult ICU patients (aged ≥18) with an expected ICU stay of \\>24 hours\n* Patients who are (expected to become) agitated within the first 14 days of their ICU admission\n\nExclusion criteria:\n\n* Contra indication for dexmedetomidine use (i.e., AV-block grade 2 or 3 unless a pacemaker is present, uncontrolled hypotension, acute cerebrovascular condition or known/suspected hypersensitivity);\n* Neurological patients with an (expected risk of) increased intracranial pressure;\n* An intoxication as a result of drug abuse (e.g., ethanol, γ-Hydroxybutyrate, opioids, benzodiazepines);\n* Support with Extracorporeal Membrane Oxygenation (ECMO);\n* Difficult airway (e.g., a Cormack and Lehane laryngoscopy grade 4 view or a tumor causing airway obstruction);\n* A high risk of physical aggression towards healthcare professionals;\n* No consent for long term follow up in the MONITOR-IC study;\n* Not able to read or understand the Dutch language and no relatives able to assist;\n* Enrolment in other sedation studies.'}, 'identificationModule': {'nctId': 'NCT05783505', 'acronym': 'PRAISE', 'briefTitle': 'A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': "PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention", 'orgStudyIdInfo': {'id': '2022-16133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Multicomponent intervention program', 'interventionNames': ['Other: Multicomponent intervention program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Standard care'}], 'interventions': [{'name': 'Multicomponent intervention program', 'type': 'OTHER', 'description': 'Non-pharmacological interventions combined with goal directed sedation using dexmedetomidine if needed', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alkmaar', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Wouter de Ruijter, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Noordwest Ziekenhuisgroep', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Bergen op Zoom', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bram Simons, MD', 'role': 'CONTACT'}], 'facility': 'Bravis Ziekenhuis', 'geoPoint': {'lat': 51.495, 'lon': 4.29167}}, {'city': 'Breda', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Thijs Rettig, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Amphia Ziekenhuis', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Helmond', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rens van de Weyer, MD', 'role': 'CONTACT'}], 'facility': 'Elkerliek Ziekenhuis', 'geoPoint': {'lat': 51.48167, 'lon': 5.66111}}, {'city': 'Venlo', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Quirine Habes, MD, PhD', 'role': 'CONTACT'}], 'facility': 'VieCuri Medisch Centrum', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}], 'centralContacts': [{'name': 'Rens Kooken, MSc', 'role': 'CONTACT', 'email': 'rens.kooken@radboudumc.nl', 'phone': '+31 24 361 6735'}, {'name': 'Bram Tilburgs, PhD', 'role': 'CONTACT', 'email': 'bram.tilburgs@radboudumc.nl', 'phone': '+31 24 361 4996'}], 'overallOfficials': [{'name': 'Bram Tilburgs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}, {'name': 'Mark van den Boogaard, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}