Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-28 @ 5:33 AM
Study NCT ID:
NCT02478593
Status:
WITHDRAWN
Last Update Posted:
2021-10-06
First Post:
2015-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Patient Education on Benzodiazepine Use in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'insufficient funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2015-06-16', 'studyFirstSubmitQcDate': '2015-06-17', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Benzodiazepine or non-benzodiazepine hypnotic medication use', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Proportion of subjects using benzodiazepine or non-benzodiazepine hypnotic medication (such as zolpidem)'}], 'secondaryOutcomes': [{'measure': 'Patient attempt to discontinuing benzodiazepine', 'timeFrame': '1 month and 6 months post-intervention', 'description': 'Novel patient reported measure regarding attempts to discontinue medication'}, {'measure': 'Patient knowledge regarding benzodiazepines', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'Novel patient reported measure regarding knowledge of the potential risks and benefits of benzodiazepines'}, {'measure': 'Belief about Medicines Questionnaire (BMQ)', 'timeFrame': 'Baseline and 6 months post-intervention', 'description': 'This is a validated instrument assessing patient beliefs regarding medication efficacy and safety'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Education', 'Geriatric', 'Benzodiazepine', 'Prevalence'], 'conditions': ['Anxiety', 'Insomnia']}, 'referencesModule': {'references': [{'pmid': '16950371', 'type': 'RESULT', 'citation': 'Simon GE, Ludman EJ. Outcome of new benzodiazepine prescriptions to older adults in primary care. Gen Hosp Psychiatry. 2006 Sep-Oct;28(5):374-8. doi: 10.1016/j.genhosppsych.2006.05.008.'}, {'pmid': '25733718', 'type': 'RESULT', 'citation': 'Charlesworth CJ, Smit E, Lee DS, Alramadhan F, Odden MC. Polypharmacy Among Adults Aged 65 Years and Older in the United States: 1988-2010. J Gerontol A Biol Sci Med Sci. 2015 Aug;70(8):989-95. doi: 10.1093/gerona/glv013. Epub 2015 Mar 1.'}, {'pmid': '23836694', 'type': 'RESULT', 'citation': 'Weng MC, Tsai CF, Sheu KL, Lee YT, Lee HC, Tzeng SL, Ueng KC, Chen CC, Chen SC. The impact of number of drugs prescribed on the risk of potentially inappropriate medication among outpatient older adults with chronic diseases. QJM. 2013 Nov;106(11):1009-15. doi: 10.1093/qjmed/hct141. Epub 2013 Jul 8.'}, {'pmid': '22376003', 'type': 'RESULT', 'citation': 'Fick DM, Semla TP. 2012 American Geriatrics Society Beers Criteria: new year, new criteria, new perspective. J Am Geriatr Soc. 2012 Apr;60(4):614-5. doi: 10.1111/j.1532-5415.2012.03922.x. Epub 2012 Feb 29. No abstract available.'}, {'pmid': '25208536', 'type': 'RESULT', 'citation': "Billioti de Gage S, Moride Y, Ducruet T, Kurth T, Verdoux H, Tournier M, Pariente A, Begaud B. Benzodiazepine use and risk of Alzheimer's disease: case-control study. BMJ. 2014 Sep 9;349:g5205. doi: 10.1136/bmj.g5205."}, {'pmid': '22371848', 'type': 'RESULT', 'citation': "Kripke DF, Langer RD, Kline LE. Hypnotics' association with mortality or cancer: a matched cohort study. BMJ Open. 2012 Feb 27;2(1):e000850. doi: 10.1136/bmjopen-2012-000850. Print 2012."}, {'pmid': '25517224', 'type': 'RESULT', 'citation': 'Olfson M, King M, Schoenbaum M. Benzodiazepine use in the United States. JAMA Psychiatry. 2015 Feb;72(2):136-42. doi: 10.1001/jamapsychiatry.2014.1763.'}, {'pmid': '19727256', 'type': 'RESULT', 'citation': 'Cascade E, Kalali AH. Use of benzodiazepines in the treatment of anxiety. Psychiatry (Edgmont). 2008 Sep;5(9):21-2.'}, {'pmid': '17356959', 'type': 'RESULT', 'citation': "Cook JM, Marshall R, Masci C, Coyne JC. Physicians' perspectives on prescribing benzodiazepines for older adults: a qualitative study. J Gen Intern Med. 2007 Mar;22(3):303-7. doi: 10.1007/s11606-006-0021-3."}, {'pmid': '19929029', 'type': 'RESULT', 'citation': 'Kaur S, Mitchell G, Vitetta L, Roberts MS. Interventions that can reduce inappropriate prescribing in the elderly: a systematic review. Drugs Aging. 2009;26(12):1013-28. doi: 10.2165/11318890-000000000-00000.'}, {'pmid': '15385274', 'type': 'RESULT', 'citation': 'Crotty M, Halbert J, Rowett D, Giles L, Birks R, Williams H, Whitehead C. An outreach geriatric medication advisory service in residential aged care: a randomised controlled trial of case conferencing. Age Ageing. 2004 Nov;33(6):612-7. doi: 10.1093/ageing/afh213. Epub 2004 Sep 22.'}, {'pmid': '21262782', 'type': 'RESULT', 'citation': 'Loganathan M, Singh S, Franklin BD, Bottle A, Majeed A. Interventions to optimise prescribing in care homes: systematic review. Age Ageing. 2011 Mar;40(2):150-62. doi: 10.1093/ageing/afq161. Epub 2011 Jan 24.'}, {'pmid': '8610730', 'type': 'RESULT', 'citation': 'Hanlon JT, Weinberger M, Samsa GP, Schmader KE, Uttech KM, Lewis IK, Cowper PA, Landsman PB, Cohen HJ, Feussner JR. A randomized, controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy. Am J Med. 1996 Apr;100(4):428-37. doi: 10.1016/S0002-9343(97)89519-8.'}, {'pmid': '16776793', 'type': 'RESULT', 'citation': 'Simon SR, Smith DH, Feldstein AC, Perrin N, Yang X, Zhou Y, Platt R, Soumerai SB. Computerized prescribing alerts and group academic detailing to reduce the use of potentially inappropriate medications in older people. J Am Geriatr Soc. 2006 Jun;54(6):963-8. doi: 10.1111/j.1532-5415.2006.00734.x.'}, {'pmid': '11250852', 'type': 'RESULT', 'citation': 'van Eijk ME, Avorn J, Porsius AJ, de Boer A. Reducing prescribing of highly anticholinergic antidepressants for elderly people: randomised trial of group versus individual academic detailing. BMJ. 2001 Mar 17;322(7287):654-7. doi: 10.1136/bmj.322.7287.654.'}, {'pmid': '24733354', 'type': 'RESULT', 'citation': 'Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014 Jun;174(6):890-8. doi: 10.1001/jamainternmed.2014.949.'}, {'pmid': '10661603', 'type': 'RESULT', 'citation': "Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999 Dec;47(6):555-67. doi: 10.1016/s0022-3999(99)00057-4."}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this research is to develop and test strategies to decrease potentially inappropriate medication use among the elderly.', 'detailedDescription': 'Specifically, the purpose of the study is to determine whether direct patient education is effective in decreasing benzodiazepine use in seniors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women\n* Full benefit members living in a SASH facility\n* 60 years old or older\n* Using at least 1 active short/medium/long acting benzodiazepine at time of recruitment\n\nExclusion Criteria:\n\n* Inability to provide consent\n* Inability to communicate in English\n* Diagnosis of severe mental illness, dementia, seizure disorder'}, 'identificationModule': {'nctId': 'NCT02478593', 'briefTitle': 'Impact of Patient Education on Benzodiazepine Use in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Impact of Patient Education on Benzodiazepine Use in the Elderly', 'orgStudyIdInfo': {'id': '00000485'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Group to receive educational booklet regarding risk/benefits of Benzodiazepine.', 'interventionNames': ['Behavioral: Educational booklet']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Group to receive educational booklet regarding risk/benefits of exercise.'}], 'interventions': [{'name': 'Educational booklet', 'type': 'BEHAVIORAL', 'description': 'Participants in the intervention group will receive an 8-page booklet that includes a list of generic and brand benzodiazepine names, benzodiazepine medication knowledge test, information about the associated risks of benzodiazepine use, and a list of safe alternative to their potentially inappropriate medication, as well as a stepwise tapering method. Recommendations to discuss decreasing use of benzodiazepines with physicians as well as to consult physicians before stopping any medication are also advised in the booklet. Participants in the control group will receive a booklet, produced by the Centers for Disease Control and Prevention, containing information regarding the important of exercise for seniors.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Charles MacLean, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Primary Care Internal Medicine, Department of Medicine Associate Dean for Primary Care', 'investigatorFullName': 'Charles MacLean, MD', 'investigatorAffiliation': 'University of Vermont'}}}}