Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT06357195
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2024-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antipsychotic/Benzodiazepine', 'timeFrame': 'From admission to discharge, up to 30 days', 'description': 'Name of medication used'}, {'measure': 'Clinical Indication', 'timeFrame': 'From admission to discharge, up to 30 days', 'description': 'Reason for antipsychotic or benzodiazepine administration'}], 'secondaryOutcomes': [{'measure': 'Length of Stay', 'timeFrame': 'From admission to discharge, up to 30 days', 'description': 'Number of hours spent in the ED, number of days spent during hospital admission'}, {'measure': 'Disposition', 'timeFrame': 'From admission to discharge, up to 30 days', 'description': 'Discharge location order'}, {'measure': 'Code Status', 'timeFrame': 'From admission to discharge, up to 30 days', 'description': 'Resuscitation orders at the time of admission and discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergency Psychiatric', 'Cognition Disorder', 'Movement Disorders', 'Antipsychotics and Neuroleptics Toxicity', 'Dementia With Lewy Bodies', 'Alteration in Mental Status', 'Behavior', 'Aging']}, 'referencesModule': {'references': [{'pmid': '31519472', 'type': 'BACKGROUND', 'citation': "Taylor JP, McKeith IG, Burn DJ, Boeve BF, Weintraub D, Bamford C, Allan LM, Thomas AJ, O'Brien JT. New evidence on the management of Lewy body dementia. Lancet Neurol. 2020 Feb;19(2):157-169. doi: 10.1016/S1474-4422(19)30153-X. Epub 2019 Sep 10."}, {'pmid': '21747029', 'type': 'BACKGROUND', 'citation': 'Weintraub D, Chen P, Ignacio RV, Mamikonyan E, Kales HC. Patterns and trends in antipsychotic prescribing for Parkinson disease psychosis. Arch Neurol. 2011 Jul;68(7):899-904. doi: 10.1001/archneurol.2011.139.'}, {'pmid': '30930058', 'type': 'BACKGROUND', 'citation': 'Spears CC, Besharat A, Monari EH, Martinez-Ramirez D, Almeida L, Armstrong MJ. Causes and outcomes of hospitalization in Lewy body dementia: A retrospective cohort study. Parkinsonism Relat Disord. 2019 Jul;64:106-111. doi: 10.1016/j.parkreldis.2019.03.014. Epub 2019 Mar 23.'}, {'pmid': '35612546', 'type': 'BACKGROUND', 'citation': "Hill JD, Schmucker AM, Siman N, Goldfeld KS, Cuthel AM, Chodosh J, Bouillon-Minois JB, Grudzen CR. Emergency and post-emergency care of older adults with Alzheimer's disease/Alzheimer's disease related dementias. J Am Geriatr Soc. 2022 Sep;70(9):2582-2591. doi: 10.1111/jgs.17833. Epub 2022 May 25."}, {'pmid': '37662063', 'type': 'BACKGROUND', 'citation': 'Russek NS, Skappak C, Scheuermeyer F, Brousseau AA, McLeod SL, Melady D, Spencer M. Pharmacological Management of Agitation and Delirium in Older Adults: a Survey of Practices in Canadian Emergency Departments. Can Geriatr J. 2023 Sep 1;26(3):405-409. doi: 10.5770/cgj.26.666. eCollection 2023 Sep.'}, {'pmid': '28592453', 'type': 'BACKGROUND', 'citation': "McKeith IG, Boeve BF, Dickson DW, Halliday G, Taylor JP, Weintraub D, Aarsland D, Galvin J, Attems J, Ballard CG, Bayston A, Beach TG, Blanc F, Bohnen N, Bonanni L, Bras J, Brundin P, Burn D, Chen-Plotkin A, Duda JE, El-Agnaf O, Feldman H, Ferman TJ, Ffytche D, Fujishiro H, Galasko D, Goldman JG, Gomperts SN, Graff-Radford NR, Honig LS, Iranzo A, Kantarci K, Kaufer D, Kukull W, Lee VMY, Leverenz JB, Lewis S, Lippa C, Lunde A, Masellis M, Masliah E, McLean P, Mollenhauer B, Montine TJ, Moreno E, Mori E, Murray M, O'Brien JT, Orimo S, Postuma RB, Ramaswamy S, Ross OA, Salmon DP, Singleton A, Taylor A, Thomas A, Tiraboschi P, Toledo JB, Trojanowski JQ, Tsuang D, Walker Z, Yamada M, Kosaka K. Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium. Neurology. 2017 Jul 4;89(1):88-100. doi: 10.1212/WNL.0000000000004058. Epub 2017 Jun 7."}], 'seeAlsoLinks': [{'url': 'https://research.ncl.ac.uk/diamondlewy/managementtoolkit/', 'label': 'DIAMOND-Lewy Management Toolkit'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about current practices for the acute neuropsychiatric management of older adults during emergency department (ED) visits. Researchers will compare current standard of care practices with implemented guideline practice to see if standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations. The main questions this study aims to answer are:\n\n* How many older adults are receiving antipsychotics or benzodiazepines during emergency department visits?\n* Why are older adults receiving antipsychotics or benzodiazepines during emergency department visits?\n* How many older adults who receive antipsychotics or benzodiazepines during emergency department visits have an underlying cognitive or movement disorder?\n* What effects does administration of antipsychotics or benzodiazepines during emergency department visits have on patient outcomes in older adults and adults with neurocognitive disorders?\n* Does implementation of standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations?', 'detailedDescription': "Lewy Body Dementia (LBD) is the second most common type of dementia next to Alzheimer's Dementia, but many patients with this disease go undiagnosed or misdiagnosed. A clinical feature of this disease is sensitivity to certain medications such as antipsychotics and benzodiazepines, which can potentially worsen their symptoms and/or increase the risk of death. With neuropsychiatric symptoms being the leading cause for acute hospital visits in patients with LBD, over a third of patients receive antipsychotics in the hospital, a third end up needing a higher level of care after discharge, and a third of patients with dementia end up dying within the first year after an ED visit. Currently, there is not enough data for the best pharmacologic management of acute behavioral disturbances in older patients, but we do have international LBD guidelines that we can start to implement.\n\nSince the ED is a place with high usage of antipsychotics/benzodiazepines, the purpose of this study is to measure the proportion of older patients who are receiving these medications during an ED visit. Of the older patients who received these medications, this study will measure which fraction of the patients might have an underlying diagnosis of dementia or movement disorder. The goal is to implement new hospital guidelines to help reduce the usage of these medications in older patients, thus the study will measure the proportion of older patients receiving these medications before and after the new hospital guidelines are implemented. The study will also directly measure the treatment knowledge of providers working in the ED by having them answer a clinical scenario/patient case question before and after the guidelines are presented to them. The ultimate goal of this study is to help improve patient outcomes in older people who visit the hospital by avoiding medications that could be potentially harmful to their health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '54 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Older adults \\>54 years old who receive antipsychotics or benzodiazepines in the ED and older adults \\>54 years old who have underlying neurocognitive disorders and receive antipsychotics or benzodiazepines in the ED.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 54\n* Received antipsychotic/benzodiazepine in the ED\n* Have clinical signs or symptoms of underlying cognitive or movement disorders\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06357195', 'briefTitle': 'DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Implementation of DIAMOND-Lewy Guidelines for Emergency Department Antipsychotic Use in Older Patients With Cognitive and Movement Disorders', 'orgStudyIdInfo': {'id': '2024H0075'}}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Neurology and Psychiatry, Division Director of Cognitive Neurology', 'investigatorFullName': 'Douglas Scharre', 'investigatorAffiliation': 'Ohio State University'}}}}