Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT04288193
Status:
WITHDRAWN
Last Update Posted:
2022-05-25
First Post:
2020-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation of a Pharmacist-Driven Antipsychotic Deprescribing Initiative in the PACE Setting: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Change in personnel, unable to begin project.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-05-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify barriers and enablers to implementation of antipsychotic deprescribing initiative.', 'timeFrame': 'Three months', 'description': 'Qualitative'}], 'secondaryOutcomes': [{'measure': 'Implement changes in antipsychotic prescribing to patients in the PACE population.', 'timeFrame': 'Three months', 'description': 'Quantitative and Qualitative'}, {'measure': 'Measure the number of antipsychotic re-initiations in the PACE population.', 'timeFrame': 'Three months', 'description': 'Quantitative'}, {'measure': 'Measure changes in antipsychotic dosing for the PACE population.', 'timeFrame': 'Three months', 'description': 'Quantitative'}, {'measure': 'Identify the number of adverse drug withdrawal events (ADWEs) in the PACE population.', 'timeFrame': 'Three months', 'description': 'Quantitative and Qualitative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'antipsychotic', 'bpsd', 'deprescribing'], 'conditions': ['Behavioral and Psychiatric Symptoms of Dementia', 'Insomnia']}, 'referencesModule': {'references': [{'pmid': '18771457', 'type': 'BACKGROUND', 'citation': 'Bain KT, Holmes HM, Beers MH, Maio V, Handler SM, Pauker SG. Discontinuing medications: a novel approach for revising the prescribing stage of the medication-use process. J Am Geriatr Soc. 2008 Oct;56(10):1946-52. doi: 10.1111/j.1532-5415.2008.01916.x. Epub 2008 Sep 2.'}, {'pmid': '17637610', 'type': 'BACKGROUND', 'citation': 'Jeste DV, Blazer D, Casey D, Meeks T, Salzman C, Schneider L, Tariot P, Yaffe K. ACNP White Paper: update on use of antipsychotic drugs in elderly persons with dementia. Neuropsychopharmacology. 2008 Apr;33(5):957-70. doi: 10.1038/sj.npp.1301492. Epub 2007 Jul 18.'}, {'pmid': '19280680', 'type': 'BACKGROUND', 'citation': 'Feng Z, Hirdes JP, Smith TF, Finne-Soveri H, Chi I, Du Pasquier JN, Gilgen R, Ikegami N, Mor V. Use of physical restraints and antipsychotic medications in nursing homes: a cross-national study. Int J Geriatr Psychiatry. 2009 Oct;24(10):1110-8. doi: 10.1002/gps.2232.'}, {'type': 'BACKGROUND', 'citation': 'Yan J. FDA extends black-box warning to all antipsychotics. Psychiatric News. 2008;43:1-27.'}, {'type': 'BACKGROUND', 'citation': 'US Government Accountability Office. Antipsychotic drug use: HHS has initiatives to reduce use among older adults in nursing homes, but should expand efforts to other settings. Washington, DC: US Government Accountability Office; 2015.'}, {'type': 'BACKGROUND', 'citation': 'U.S. Food and Drug Administration. Information for healthcare professionals: conventional antipsychotics. Silver Spring, MD: Center for Drug Evaluation and Research. 2008.'}, {'pmid': '21682938', 'type': 'BACKGROUND', 'citation': 'Wetzels RB, Zuidema SU, de Jonghe JF, Verhey FR, Koopmans RT. Prescribing pattern of psychotropic drugs in nursing home residents with dementia. Int Psychogeriatr. 2011 Oct;23(8):1249-59. doi: 10.1017/S1041610211000755. Epub 2011 Jun 20.'}, {'type': 'BACKGROUND', 'citation': 'U.S. Food and Drug Administration. Public health advisory:deaths with antipsychotics in elderly patients with behavioral disturbances. Silver Spring, MD: Center for Drug Evaluation and Research. 2005.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to determine the feasibility of implementing an antipsychotic deprescribing initiative that is driven by pharmacists working collaboratively with the Program of All-inclusive Care for the Elderly (PACE) interdisciplinary team.', 'detailedDescription': 'No individual antipsychotic has been approved by the U.S. Food and Drug Administration (FDA) for treating insomnia or behavioral and psychological symptoms of dementia (BPSD). Despite these medications being associated with significant harms, a considerable portion of older adults are prescribed antipsychotics for treatment of insomnia or BPSD. The aim of this study is to determine the feasibility of a pharmacist-driven antipsychotic deprescribing initiative in a community-based practice setting known as Program of All-inclusive Care for the Elderly (PACE). Our primary objective is to assess and describe the implementation process, including barriers and enablers to implementation. Our secondary objectives are to quantify and describe changes in antipsychotic prescribing following implementation; evaluate and report on antipsychotic re-initiations or changes in dosing; and evaluate and report on adverse drug withdrawal events (ADWEs) following antipsychotic deprescribing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Program of All-inclusive Care for the Elderly (PACE) is a Medicare-Medicaid program that provides comprehensive medical and supportive services to individuals \\>55 years of age who are certified by their state as needing nursing home care but are able to live safely in the community through PACE, as an alternative to institutionalization.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant enrolled in a PACE organization during the implementation time period;\n* PACE organization contractually receiving pharmacy services from CareKinesis during the implementation time period; and,\n* Participant's prescriber determines that the participant could potentially benefit from deprescribing the antipsychotic.\n\nExclusion Criteria:\n\n* A diagnosis of bipolar disorder, schizophrenia, schizo-affective disorder, acute delirium, Tourette's syndrome, tic disorders, autism, intellectual disability, developmental delay, obsessive-compulsive disorder, alcoholism, cocaine abuse, Parkinson's disease psychosis, or major depressive disorder for which the antipsychotic is specifically prescribed as adjunctive treatment;\n* Participant's prescriber determines that the participant would likely not benefit or could be harmed from deprescribing the antipsychotic; and,\n* Participant, or healthcare decision-maker on behalf of the participant (e.g., caregiver) refuses to participate in the deprescribing initiative."}, 'identificationModule': {'nctId': 'NCT04288193', 'briefTitle': 'Implementation of a Pharmacist-Driven Antipsychotic Deprescribing Initiative in the PACE Setting: A Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tabula Rasa HealthCare'}, 'officialTitle': 'Implementation of a Pharmacist-Driven Antipsychotic Deprescribing Initiative in the Program of All-inclusive Care for the Elderly (PACE) Setting: A Pilot Study', 'orgStudyIdInfo': {'id': 'RPH-APDP-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trinity Health LIFE New Jersey PACE', 'description': 'Participants enrolled in Trinity Health LIFE New Jersey PACE facility who received an antipsychotic medication for the treatment of BPSD or insomnia', 'interventionNames': ['Drug: Recommendation to Deprescribe']}], 'interventions': [{'name': 'Recommendation to Deprescribe', 'type': 'DRUG', 'description': 'Recommendation to Deprescribe', 'armGroupLabels': ['Trinity Health LIFE New Jersey PACE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08109', 'city': 'Pennsauken', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Trinity Health LIFE, New Jersey', 'geoPoint': {'lat': 39.95622, 'lon': -75.05795}}], 'overallOfficials': [{'name': 'Veronique Michaud, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tabula Rasa HealthCare'}, {'name': 'Anna Furman, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tabula Rasa HealthCare'}, {'name': 'Adriana Matos, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tabula Rasa HealthCare'}, {'name': 'Nishita Amin, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tabula Rasa HealthCare'}, {'name': 'Briana Skalski, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tabula Rasa HealthCare'}, {'name': 'Sweilem Al Rihani, PhD, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tabula Rasa HealthCare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tabula Rasa HealthCare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}