Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-01 @ 8:54 PM
Study NCT ID:
NCT04181294
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time Limited Trials to Reduce Non-Beneficial Intensive Care Unit Treatments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Pre- and post study design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2019-10-31', 'studyFirstSubmitQcDate': '2019-11-26', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Key process measure: Family meetings', 'timeFrame': '4 months', 'description': "A convenience sample of family meetings will be examined to determine the proportion of meetings in which key decision-making components (discussion of medical issues, prognosis, risk/benefit of ICU treatments, patients' values and preferences, clinical markers of improvement, recommendations for next steps) were discussed"}], 'primaryOutcomes': [{'measure': 'ICU Length of Stay', 'timeFrame': '4 months', 'description': 'ICU LOS will be collected using the electronic medical record'}], 'secondaryOutcomes': [{'measure': 'Hospital Length of Stay', 'timeFrame': '4 months', 'description': 'Hospital LOS will be collected using the electronic medical record'}, {'measure': 'Days receiving life-sustaining ICU treatments', 'timeFrame': '4 months', 'description': 'Total number of days receiving mechanical ventilation, vasopressor medications, and renal replacement therapy will be collected from the electronic health record'}, {'measure': 'Use of invasive ICU procedures', 'timeFrame': '4 months', 'description': 'Total number of central venous or arterial catheterizations, thoracenteses, paracenteses, lumbar punctures, endoscopies, and attempts at cardiopulmonary resuscitation will be collected using the electronic health record'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Palliative Care', 'Medical Futility', 'Intensive Care'], 'conditions': ['Critical Illness', 'Communication']}, 'referencesModule': {'references': [{'pmid': '33843946', 'type': 'DERIVED', 'citation': 'Chang DW, Neville TH, Parrish J, Ewing L, Rico C, Jara L, Sim D, Tseng CH, van Zyl C, Storms AD, Kamangar N, Liebler JM, Lee MM, Yee HF Jr. Evaluation of Time-Limited Trials Among Critically Ill Patients With Advanced Medical Illnesses and Reduction of Nonbeneficial ICU Treatments. JAMA Intern Med. 2021 Jun 1;181(6):786-794. doi: 10.1001/jamainternmed.2021.1000.'}]}, 'descriptionModule': {'briefSummary': 'Overutilization of intensive care unit (ICU) treatments among patients with advanced medical illnesses and poor prognosis places them at risk for prolonged suffering with minimal anticipated benefit. Improving communication and shared decision-making between providers and patients/family members represents an opportunity to reduce potentially non-beneficial treatments. Time limited trials (TLTs) are agreements between clinicians and patients/surrogate decision-makers to use medical therapies over a defined period of time to observe if patients improve or deteriorate according to agreed-upon clinical outcomes. The objective of this project is to examine whether a quality improvement intervention that uses protocoled time limited trials as the default ICU communication/care planning strategy for patients with advanced medical illnesses will decrease the duration and intensity of non-beneficial ICU treatments without changing hospital mortality.', 'detailedDescription': "Invasive intensive care unit (ICU) treatments for patients with advanced medical illnesses and poor prognoses may prolong suffering with minimal benefit. Unfortunately, the quality of care planning and communication between clinicians and critically-ill patients/families in these situations are highly variable, frequently leading to over-utilization of invasive ICU treatments. Time limited trials (TLTs) are agreements between the clinicians and patients/decision-makers to use certain medical therapies over defined periods of time and evaluate whether patients improve or worsen according to pre-determined clinical parameters. For patients with advanced medical illnesses receiving aggressive ICU treatments, TLTs can promote effective dialogue, develop consensus in decision-making, and set rational boundaries to treatments based on patients' goals of care. The objective of our study is to examine whether a multi-component quality improvement strategy that uses protocoled time limited trials as the default ICU care planning approach for critically-ill patients with advanced medical illnesses will decrease duration and intensity of non-beneficial ICU care without changing hospital mortality.\n\nThis study will be conducted in medical ICUs of 3 public teaching hospitals in Los Angeles County. We will train clinicians to use protocol-enhanced TLTs as the default communication and care planning approach in patients with advanced medical illnesses who receive invasive ICU treatments. Eligible patients will be those considered by treating ICU physicians to be at high risk for non-beneficial treatments according to guidelines from the Society of Critical Care Medicine. ICU physicians will be trained to use the TLT protocol through a curriculum of didactic lectures, case discussions, and simulations utilizing actors as family members in role-playing scenarios. Family meetings will be schedule by trained care managers. The improvement strategy will be implemented sequentially in the 3 participating hospitals, and outcomes will be evaluated using a before-after study design.\n\nKey process outcomes will include frequency, timing, and content of family meetings. The primary clinical outcome will be ICU length of stay. Secondary outcomes will include hospital length of stay, days receiving life-sustaining treatments (mechanical ventilation, vasopressors, and renal replacement therapy), number of attempts at cardiopulmonary resuscitation, frequency of invasive ICU procedures, and disposition from hospitalization."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the medical ICU who are determined on admission by the treating ICU physicians to be at high risk for potentially non-beneficial treatments based on ICU Admission and Triage Guidelines from the Society of Critical Care Medicine\n\nExclusion Criteria:\n\n* Patients who cannot communicate for themselves and do not have surrogate decision-makers'}, 'identificationModule': {'nctId': 'NCT04181294', 'briefTitle': 'Time Limited Trials to Reduce Non-Beneficial Intensive Care Unit Treatments', 'organization': {'class': 'OTHER', 'fullName': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center'}, 'officialTitle': 'Time Limited Trials to Reduce Non-Beneficial Intensive Care Unit Treatments Among Critically-ill Patients With Advanced Medical Illnesses', 'orgStudyIdInfo': {'id': '0311710100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-intervention', 'description': 'Baseline data on patient characteristics and outcomes will be collected for 4 months prior to intervention.', 'interventionNames': ['Behavioral: Usual practice']}, {'type': 'EXPERIMENTAL', 'label': 'Post-intervention', 'description': 'The quality improvement intervention will be conducted sequentially at all 3 medical centers (LAC-USC, Olive View, and Harbor-UCLA Medical Centers). Data on patient characteristics and outcomes will be collected for 4 months after the intervention', 'interventionNames': ['Behavioral: Family meetings using time limited trials as default ICU communication and care planning approach']}], 'interventions': [{'name': 'Family meetings using time limited trials as default ICU communication and care planning approach', 'type': 'BEHAVIORAL', 'description': 'Providers will be trained using didactics, focus groups, and simulations using actors as family members. A TLT protocol and checklist will be used to facilitate family meetings. A coordinator will schedule family meetings. Routine feedback sessions will be held with the local champions.', 'armGroupLabels': ['Post-intervention']}, {'name': 'Usual practice', 'type': 'BEHAVIORAL', 'description': 'Baseline practice of ICU communication and care planning', 'armGroupLabels': ['Pre-intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles County-University of Southern California Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Olive View Medical Center', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '90509', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Los Angeles Department of Health Services', 'class': 'UNKNOWN'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dong Chang', 'investigatorAffiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center'}}}}