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NCT02478593 Clinical Trial

Impact of Patient Education on Benzodiazepine Use in the Elderly

Anxiety Clinical Trial

Official title:
Impact of Patient Education on Benzodiazepine Use in the Elderly

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02478593
Other study ID # 00000485
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date January 2019

Study information
Verified date April 2019
Source University of Vermont
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Specifically, the purpose of the study is to determine whether direct patient education is effective in decreasing benzodiazepine use in seniors.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Men and women - Full benefit members living in a SASH facility - 60 years old or older - Using at least 1 active short/medium/long acting benzodiazepine at time of recruitment Exclusion Criteria: - Inability to provide consent - Inability to communicate in English - Diagnosis of severe mental illness, dementia, seizure disorder

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Educational booklet
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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Vermont

References & Publications (17)

Billioti de Gage S, Moride Y, Ducruet T, Kurth T, Verdoux H, Tournier M, Pariente A, Bégaud B. Benzodiazepine use and risk of Alzheimer's disease: case-control study. BMJ. 2014 Sep 9;349:g5205. doi: 10.1136/bmj.g5205. — View Citation

Cascade E, Kalali AH. Use of benzodiazepines in the treatment of anxiety. Psychiatry (Edgmont). 2008 Sep;5(9):21-2. — View 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. — View 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. — View 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. Epub 2004 Sep 22. — View 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. — View 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 polyp — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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 — View 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: 10.100 — View 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. — View 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 — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Patient attempt to discontinuing benzodiazepine Novel patient reported measure regarding attempts to discontinue medication 1 month and 6 months post-intervention
Secondary Patient knowledge regarding benzodiazepines Novel patient reported measure regarding knowledge of the potential risks and benefits of benzodiazepines Baseline and 6 months post-intervention
Secondary Belief about Medicines Questionnaire (BMQ) This is a validated instrument assessing patient beliefs regarding medication efficacy and safety Baseline and 6 months post-intervention
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