Impact of Patient Education on Benzodiazepine Use in the Elderly

NCT02478593 | Withdrawn

• 1 other identifier: 00000485
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall goal of this research is to develop and test strategies to decrease potentially inappropriate medication use among the elderly.

Conditions

Anxiety; Insomnia

Keywords

Education; Geriatric; Benzodiazepine; Prevalence

Outcome Measures

Primary Outcomes (1)

• Benzodiazepine or non-benzodiazepine hypnotic medication use

  Proportion of subjects using benzodiazepine or non-benzodiazepine hypnotic medication (such as zolpidem)

  Baseline and 6 months post-intervention

Secondary Outcomes (3)

• Patient attempt to discontinuing benzodiazepine

  1 month and 6 months post-intervention

• Patient knowledge regarding benzodiazepines

  Baseline and 6 months post-intervention

• Belief about Medicines Questionnaire (BMQ)

  Baseline and 6 months post-intervention

Study Arms (2)

Experimental group

EXPERIMENTAL

Group to receive educational booklet regarding risk/benefits of Benzodiazepine.

Behavioral: Educational booklet

Control group

NO INTERVENTION

Group to receive educational booklet regarding risk/benefits of exercise.

Interventions

Educational booklet BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• Full benefit members living in a SASH facility
• years old or older
• Using at least 1 active short/medium/long acting benzodiazepine at time of recruitment

You may not qualify if:

• Inability to provide consent
• Inability to communicate in English
• Diagnosis of severe mental illness, dementia, seizure disorder

Sponsors & Collaborators

• University of Vermont: lead

Related Publications (17)

• 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: 16950371 RESULT

• 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: 25733718 RESULT

• 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: 23836694 RESULT

• 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: 22376003 RESULT

• 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: 25208536 RESULT

• 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: 22371848 RESULT

• 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: 25517224 RESULT

• Cascade E, Kalali AH. Use of benzodiazepines in the treatment of anxiety. Psychiatry (Edgmont). 2008 Sep;5(9):21-2.

  PMID: 19727256 RESULT

• 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: 17356959 RESULT

• 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: 19929029 RESULT

• 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: 15385274 RESULT

• 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: 21262782 RESULT

• 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: 8610730 RESULT

• 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: 16776793 RESULT

• 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: 11250852 RESULT

• 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: 24733354 RESULT

• 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.

  PMID: 10661603 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Charles MacLean, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Primary Care Internal Medicine, Department of Medicine Associate Dean for Primary Care

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: October 6, 2021

Record last verified: 2019-04