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AnxietyNCT02478593

Impact of Patient Education on Benzodiazepine Use in the Elderly

A study testing Educational booklet in people with Anxiety and Insomnia, run by University of Vermont.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Anxiety, Insomnia
What is being tested?
Educational booklet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2015to Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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

Read the detailed description

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

Conditions
Anxiety, Insomnia
Being tested
Educational booklet
Keywords
Education, Geriatric, Benzodiazepine, Prevalence
Medical subject headings
Anxiety Disorders, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational bookletBehavioural

    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.

Study groups in NCT02478593
Study groupRoleWhat they receive
Experimental groupExperimentalGroup to receive educational booklet regarding risk/benefits of Benzodiazepine.
Receives: Behavioral: Educational booklet
Control groupNo interventionGroup to receive educational booklet regarding risk/benefits of exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Benzodiazepine or non-benzodiazepine hypnotic medication use

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

    Measured: Baseline and 6 months post-intervention

Secondary outcomes (3)

  1. Patient attempt to discontinuing benzodiazepine

    Novel patient reported measure regarding attempts to discontinue medication

    Measured: 1 month and 6 months post-intervention

  2. Patient knowledge regarding benzodiazepines

    Novel patient reported measure regarding knowledge of the potential risks and benefits of benzodiazepines

    Measured: Baseline and 6 months post-intervention

  3. Belief about Medicines Questionnaire (BMQ)

    This is a validated instrument assessing patient beliefs regarding medication efficacy and safety

    Measured: Baseline and 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2015 (estimated)
  2. Study startJun 2015 (estimated)
  3. Primary completionJan 2019
  4. Study completionJan 2019

Why it stopped: insufficient funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02478593
Sponsor's protocol ID
00000485
Status last verified
Apr 2019
First submitted
16 Jun 2015
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16950371

  • 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.

    PubMed 25733718

  • 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.

    PubMed 23836694

  • 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.

    PubMed 22376003

  • 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.

    PubMed 25208536

  • 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.

    PubMed 22371848

  • 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.

    PubMed 25517224

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

    PubMed 19727256

  • 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.

    PubMed 17356959

  • 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.

    PubMed 19929029

  • 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.

    PubMed 15385274

  • 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.

    PubMed 21262782

  • 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.

    PubMed 8610730

  • 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.

    PubMed 16776793

  • 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.

    PubMed 11250852

Questions about this trial

What is this clinical trial studying?

A study testing Educational booklet in people with Anxiety and Insomnia, run by University of Vermont.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Benzodiazepine or non-benzodiazepine hypnotic medication use (time frame: Baseline and 6 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02478593, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.

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