Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT05410366
Status:
WITHDRAWN
Last Update Posted:
2023-03-13
First Post:
2022-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safe Harbors in Emergency Medicine, Specific Aim 3
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Pursuing an alternative clinical trial', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2022-06-02', 'studyFirstSubmitQcDate': '2022-06-02', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'June 15, 2022 - March 31, 2024', 'description': 'Press Ganey scores, Consumer Assessment of Healthcare Providers and Systems (CAHPS), aggregate number of patient complaints'}, {'measure': 'Patient cost', 'timeFrame': 'June 15, 2022 - March 31, 2024', 'description': 'Aggregate out of pocket patient costs'}, {'measure': 'Patient charges', 'timeFrame': 'June 15, 2022 - March 31, 2024', 'description': 'Aggregate patient charges'}, {'measure': 'Adverse event reporting', 'timeFrame': 'June 15, 2022 - March 31, 2024', 'description': 'Aggregate number of reports per patient per condition'}], 'primaryOutcomes': [{'measure': 'Radiation exposure', 'timeFrame': 'June 15, 2022 - March 31, 2024', 'description': 'Aggregate ED radiologic imaging - X-ray or CT scan and MRI'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'June 15, 2022 - March 31, 2024', 'description': 'Aggregate ED length of stay defined as provider evaluation to disposition'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Safe harbors', 'Emergency department', 'Liability'], 'conditions': ['Low Back Pain', 'Headache', 'Head Injury, Minor']}, 'referencesModule': {'references': [{'pmid': '33728420', 'type': 'BACKGROUND', 'citation': 'Blumstein JF, McMichael BJ, Storrow AB. Constraints on Medical Liability Through Malpractice Safe Harbors. JAMA Health Forum. 2020;1(8):e200961. doi: 10.1001/jamahealthforum.2020.0961. Epub 2020 Aug 14. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Many patients who present to the emergency department (ED) receive a vast array of diagnostic tests, some of which might not be useful. Providers often feel obligated to order so many tests to protect themselves against the risk of being sued. The investigators believe if a standard of care providing legal protection for certain clinical conditions were agreed upon and followed, unnecessary testing would significantly decrease in the ED, which, in turn, would improve patient safety, augment the quality of care delivered, and increase patient satisfaction.', 'detailedDescription': 'Overutilization of healthcare resources often has negative implications. The Choosing Wisely campaign, an initiative of the American Board of Internal Medicine, was proposed to help patients and caregivers engage in shared conversations to reduce overuse of potentially harmful tests and procedures. However, the Choosing Wisely campaign\'s lack of linkage to medical liability considerations has substantially reduced its impact.\n\nFor instance, excessive medical imaging and its associated radiation exposure inflicts a measurably real and significant risk of carcinogenesis, drives costs, and therefore is a significant Choosing Wisely target. This is a particularly important consideration in the emergency care setting, frequently cited as an extremely utilization rich environment due to the higher inherent risk of missed pathology and the isolation of clinical care.\n\nThe investigators hypothesize a special type of predetermined standard of care (a "safe harbor") can be defined based upon medical evidence, and upon consultation among multiple experts and advisors, for a selected number of clinical conditions within the specialty of emergency medicine (EM). Furthermore, a state-based, federally-contracted and legally-recognized Quality Improvement Organization (QIO) could adopt the "safe harbor" and, in doing so, establish the standard of care in the context of a legal liability claim. Practitioners who meet such a standard and implement it appropriately satisfy their obligation under the law of medical malpractice.\n\nUltimately, defining provider liability through this predetermined, or ex ante, standard of care, may result in a significant reduction in healthcare resource utilization within EM. Through this reduction, the quality of care would not decrease and a measurable reduction in radiation exposure would occur. Moreover, these predefined standards of care would improve communication between patient and provider during the clinical transaction.\n\nA team of Vanderbilt University medicine, law, economics, and clinical faculty will undertake this. The investigators have summoned a broad group of technical experts and advisors and defined safe harbors for a narrow set of distinct clinical conditions within EM. These safe harbors will be presented for review and approval by the appropriate QIO. Specific Aim 3 will advance the safe harbor demonstration to EM practitioners at Vanderbilt University Medical Center and determine the effects on radiation exposure, length of stay, patient satisfaction, patient costs, charges, and adverse event reporting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Vanderbilt University Medical Center emergency department patients. Comparator Northwestern University emergency department patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult emergency department patients presenting with a chief complaint of 1) low back pain, 2) headache, or 3) minor head injury.\n\nExclusion Criteria:\n\n* Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT05410366', 'briefTitle': 'Safe Harbors in Emergency Medicine, Specific Aim 3', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Safely Improving Emergency Diagnostic Testing Through Clinical Safe Harbors', 'orgStudyIdInfo': {'id': 'AHRQ R18HS025931'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Emergency department (ED) patients', 'description': 'Adult emergency department patients presenting with a chief complaint of 1) low back pain, 2) headache, or 3) minor head injury.', 'interventionNames': ['Other: Safe harbor clinical practice guideline']}], 'interventions': [{'name': 'Safe harbor clinical practice guideline', 'type': 'OTHER', 'description': 'A safe harbor is a special type of clinical practice guideline which, under existing federal law, may serve as the legal standard of care, not just evidence of the standard of care. If a patient with a safe harbor condition satisfies all safe harbor inclusion criteria and does not meet any exclusion criteria, no imaging is required, and the patient may be discharged with specific instructions. If a patient is excluded from the safe harbor, then imaging decisions are per customary practice. The safe harbor clinical practice guidelines are provided to treating ED physicians, but they are not obligated to use them. The safe harbor pathways do not limit the diagnostic and therapeutic approach patients and physicians undertake during a clinical encounter. They have the liberty in this decision to proceed jointly down a clinical pathway most appropriate to the individual clinical circumstance.', 'armGroupLabels': ['Emergency department (ED) patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37027', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Alan B Storrow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Alan Storrow', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}