A protocol for a randomized controlled trial comparing Sleepwell, EMPOWER, and treatment-as-usual for benzodiazepine receptor agonist discontinuation in older adults: the your answers when needing sleep in New Brunswick (YAWNS NB) study

Andrea L Murphy, Justin P Turner, Malgorzata Rajda, Sandra Magalhaes, Kathleen G Allen, David M Gardner, Andrea L Murphy, Justin P Turner, Malgorzata Rajda, Sandra Magalhaes, Kathleen G Allen, David M Gardner

Abstract

Background: Chronic benzodiazepine receptor agonist (BZRA) use among older adults is a public health concern given cognitive and physical risks. One in four older adults in New Brunswick, Canada, is a long-term user of BZRAs. Previous studies using a direct-to-patient approach as the primary intervention target have shown promise in reducing BZRA use. The Your Answers When Needing Sleep in New Brunswick (YAWNS NB) study aims to reduce the long-term use of BZRAs in older adults and increase the use of cognitive behavioural therapy for insomnia (CBTi), which is the recommended first line treatment.

Methods: The trial (ClinicalTrials.gov registration NCT04406103) is a three arm, open-label, parallel randomized controlled trial in NB, Canada. Eligible participants 65 years and older using BZRAs long-term will be randomly allocated to: the Eliminating Medications through Patient Ownership of End Results (EMPOWER) information package group; the Sleepwell information package group; or treatment-as-usual (TAU). Information packages will be mailed via Canada Post. The primary outcome of BZRA discontinuation at 6 months will be compared across groups. Secondary outcomes include participants with ≥25% BZRA dose reduction, and switching to newly prescribed alternate sedative-hypnotics. Several exploratory outcomes will also be examined.

Discussion: Targeting participants with information packages informing them of appropriate use, dangers, and approaches to reducing BZRA use and increasing CBTi use may be beneficial in a region of Canada with the highest rate of chronic BZRA use in older adults. Comparing information packages and TAU will provide insights into the effectiveness of direct-to-patient interventions for BZRA reduction.

Keywords: Benzodiazepine receptor agonists (BZRAs); Benzodiazepines; Chronic insomnia; Cognitive-behavioural therapy for insomnia (CBTi); EMPOWER; Sedative-hypnotic; Sleepwell; Z-drugs.

Conflict of interest statement

None.

© 2022 The Authors.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram for the YAWNS NB study.

References

    1. Government of Canada SC Population Estimates, Quarterly. 2022. Published December 16, 2021. Accessed April 25.
    1. Canadian Institute for Health Information The Use of Selected Psychotropic Drugs Among Seniors on Public Drug Programs in Canada, 2001 to 2010. 2022. Published online March 2012. Accessed April 25.
    1. Canadian Institute for Health Information Pan-Canadian Trends in the Prescribing of Opioids and Benzodiazepines, 2012 to 2017. 2022. Published online 2018. Accessed April 25.
    1. Canadian Deprescribing Network 2017 Annual Report. 2022. Accessed April 25, 2022.
    1. Canadian Institute of Health Information . 2018. Drug Use among Seniors in Canada, 2016; pp. 1–63.
    1. Huedo-Medina T.B., Kirsch I., Middlemass J., Klonizakis M., Siriwardena A.N. Effectiveness of non-benzodiazepine hypnotics in treatment of adult insomnia: meta-analysis of data submitted to the food and drug administration. BMJ. 2012;345
    1. Holbrook A.M., Crowther R., Lotter A., Cheng C., King D. Meta-analysis of benzodiazepine use in the treatment of insomnia. CMAJ. 2000;162(2):225–233.
    1. Pillai V., Roth T., Roehrs T., Moss K., Peterson E.L., Drake C.L. Effectiveness of benzodiazepine receptor agonists in the treatment of insomnia: an examination of response and remission rates. Sleep. 2016;40(2) doi: 10.1093/sleep/zsw044.
    1. Conn D.K., Hogan D.B., Amdam L., et al. Canadian guidelines on benzodiazepine receptor agonist use disorder among older adults. Can Geriatr J. 2020;23(1):116–122. doi: 10.5770/cgj.23.419.
    1. Qaseem A., Kansagara D., Forciea M.A., Cooke M., Denberg T.D. Clinical Guidelines Committee of the American College of Physicians. Management of Chronic Insomnia Disorder in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2016;165(2):125–133. doi: 10.7326/M15-2175.
    1. Wilt T.J., MacDonald R., Brasure M., et al. Pharmacologic treatment of insomnia disorder: an evidence report for a clinical practice guideline by the American College of Physicians. Ann Intern Med. 2016;165(2):103–112.
    1. Morin C.M., Drake C.L., Harvey A.G., et al. Insomnia disorder. Nat Rev Dis Primers. 2015;1:15026. doi: 10.1038/nrdp.2015.26.
    1. Morin C.M., Vallieres A., Guay B., et al. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009;301(19):2005–2015. doi: 10.1001/jama.2009.682.
    1. American Geriatrics Society American Geriatrics Society 2019 updated AGS beers criteria® for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2019;67(4):674–694. doi: 10.1111/jgs.15767.
    1. Canadian Geriatrics Society Geriatric: Five Tests and Treatments to Question. 2022. Published online November 2020. Accessed April 25.
    1. O’Mahony D., O’Sullivan D., Byrne S., O’Connor M.N., Ryan C., Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015;44(2):213–218. doi: 10.1093/ageing/afu145.
    1. Brandt J., Leong C. Benzodiazepines and z-drugs: an updated review of major adverse outcomes reported on in epidemiologic research. Drugs R D. 2017;17(4):493–507.
    1. Sylvestre M.P., Abrahamowicz M., Capek R., Tamblyn R. Assessing the cumulative effects of exposure to selected benzodiazepines on the risk of fall-related injuries in the elderly. IntPsychogeriatr. 2012;24(4):577–586. doi: 10.1017/S1041610211002031.
    1. Pariente A., Dartigues J.F., Benichou J., Letenneur L., Moore N., Fourrier-Reglat A. Benzodiazepines and injurious falls in community dwelling elders. Drugs Aging. 2008;25(1):61–70. doi: 10.2165/00002512-200825010-00007.
    1. Panneman M.J., Goettsch W.G., Kramarz P., Herings R.M. The costs of benzodiazepine-associated hospital-treated fall injuries in the EU: a Pharmo study. Drugs Aging. 2003;20(11):833–839.
    1. Gray S.L., Dublin S., Yu O., et al. Benzodiazepine use and risk of incident dementia or cognitive decline: prospective population based study. BMJ. 2016;352(Journal Article):i90. doi: 10.1136/bmj.i90.
    1. Billioti de Gage S., Moride Y., Ducruet T., et al. Benzodiazepine use and risk of Alzheimer’s disease: case-control study. BMJ. 2014;349(Journal Article) doi: 10.1136/bmj.g5205.
    1. Nakafero G., Sanders R.D., Nguyen-Van-Tam J.S., Myles P.R. The association between benzodiazepines and influenza-like illness-related pneumonia and mortality: a survival analysis using UK primary care data. Pharmacoepidemiol Drug Saf. 2016;25(11):1263–1273. doi: 10.1002/pds.4028.
    1. Taipale H., Tolppanen A.M., Koponen M., et al. Risk of pneumonia associated with incident benzodiazepine use among community-dwelling adults with Alzheimer disease. CMAJ. 2017;189(14):E519–E529. doi: 10.1503/cmaj.160126.
    1. Nevriana A., Moller J., Laflamme L., Monarrez-Espino J. New, occasional, and frequent use of zolpidem or Zopiclone (alone and in combination) and the risk of injurious road traffic crashes in older adult drivers: a population-based case-control and case-crossover study. CNS Drugs. 2017;31(8):711–722. doi: 10.1007/s40263-017-0445-9.
    1. Sun G., Zhang L., Zhang L., et al. Benzodiazepines or related drugs and risk of pneumonia: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2019;34(4):513–521. doi: 10.1002/gps.5048.
    1. Rudisill T.M., Zhu M., Kelley G.A., Pilkerton C., Rudisill B.R. Medication use and the risk of motor vehicle collisions among licensed drivers: a systematic review. Accid Anal Prev. 2016;96:255–270. doi: 10.1016/j.aap.2016.08.001.
    1. Meuleners L.B., Duke J., Lee A.H., Palamara P., Hildebrand J., Ng J.Q. Psychoactive medications and crash involvement requiring hospitalization for older drivers: a population-based study. J Am Geriatr Soc. 2011;59(9):1575–1580. doi: 10.1111/j.1532-5415.2011.03561.x.
    1. Markota M., Rummans T.A., Bostwick J.M., Lapid M.I. Benzodiazepine use in older adults: dangers, management, and alternative therapies. Mayo Clin Proc. 2016;91(11):1632–1639.
    1. Murphy Y., Wilson E., Goldner E.M., Fischer B. Benzodiazepine use, misuse, and harm at the population level in Canada: a comprehensive narrative review of data and developments since 1995. Clin Drug Investig. 2016;36(7):519–530. doi: 10.1007/s40261-016-0397-8.
    1. Lader M. Benzodiazepines revisited--will we ever learn? Addiction. 2011;106(12):2086–2109. doi: 10.1111/j.1360-0443.2011.03563.x.
    1. Jones C.M., McAninch J.K. Emergency department visits and overdose deaths from combined use of opioids and benzodiazepines. Am J Prev Med. 2015;49(4):493–501. doi: 10.1016/j.amepre.2015.03.040.
    1. Shaw J., Murphy A.L., Turner J., et al. Policies for deprescribing: an international scan of intended and unintended outcomes of limiting sedative-hypnotic use in community-dwelling older adults. Health Policy. 2019;14(4):39–51.
    1. Lynch T., Ryan C., Hughes C.M., et al. Brief interventions targeting long-term benzodiazepine and Z-drug use in primary care: a systematic review and meta-analysis. Addiction. 2022 doi: 10.1111/add.14981.
    1. Ng B.J., Le Couteur D.G., Hilmer S.N. Deprescribing benzodiazepines in older patients: impact of interventions targeting physicians, pharmacists, and patients. Drugs Aging. 2018;35(6):493–521. doi: 10.1007/s40266-018-0544-4.
    1. Cook J.M., Marshall R., Masci C., Coyne J.C. Physicians’ perspectives on prescribing benzodiazepines for older adults: a qualitative study. J Gen Intern Med. 2007;22(3):303–307. doi: 10.1007/s11606-006-0021-3.
    1. Mah L., Upshur R.E.G. Long term benzodiazepine use for insomnia in patients over the age of 60: discordance of patient and physician perceptions. BMC Fam Pract. 2002;3:9. doi: 10.1186/1471-2296-3-9.
    1. Sirdifield C., Anthierens S., Creupelandt H., Chipchase S.Y., Christiaens T., Siriwardena A.N. General practitioners’ experiences and perceptions of benzodiazepine prescribing: systematic review and meta-synthesis. BMC Fam Pract. 2013;14:191. doi: 10.1186/1471-2296-14-191.
    1. 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;174(6):890–898. doi: 10.1001/jamainternmed.2014.949.
    1. Martin P., Tannenbaum C. A realist evaluation of patients’ decisions to deprescribe in the EMPOWER trial. BMJ Open. 2017;7(4):e015959. doi: 10.1136/bmjopen-2017-015959.
    1. Mendes M.A., Smith J.P., Marin J.K., et al. Reducing benzodiazepine prescribing in older veterans: a direct-to-consumer educational brochure. Fed Pract. 2018;35(9):36–43.
    1. Sleepwell. 2022. Published online 2020. Accessed April 25.
    1. Morin C.M., Belleville G., Bélanger L., Ivers H. The insomnia severity index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011;34(5):601–608.
    1. Johns M.W. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14(6):540–545. doi: 10.1093/sleep/14.6.540.
    1. Spitzer R.L., Kroenke K., Williams J.B.W., Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–1097. doi: 10.1001/archinte.166.10.1092.
    1. Saliba D., Elliott M., Rubenstein L.Z., et al. The vulnerable elders survey: a tool for identifying vulnerable older people in the community. J Am Geriatr Soc. 2001;49(12):1691–1699. doi: 10.1046/j.1532-5415.2001.49281.x.
    1. Ware J., Kosinski M., Keller S.D. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–233. doi: 10.1097/00005650-199603000-00003.
    1. Horne R., Weinman J., Hankins M. The beliefs about medicines questionnaire: The development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health. 2020;14(1) doi: 10.1080/08870449908407311. Published 1996. Accessed May 8.
    1. Sekhon M., Cartwright M., Francis J.J. Acceptability of health care interventions: a theoretical framework and proposed research agenda. Br J Health Psychol. 2018;23(3):519–531. doi: 10.1111/bjhp.12295.
    1. SPIRIT Statement: Defining Standard Protocol Items for Clinical Trials | The EQUATOR Network. 2013. Accessed February 10, 2022.
    1. Hoffmann T.C., Glasziou P.P., Boutron I., et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. doi: 10.1136/bmj.g1687.
    1. Schulz K.F., Altman D.G., Moher D., CONSORT Group CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672–677.
    1. MoCA - Cognitive Assessment MoCA – Cognitive Assessment. 2022. Accessed July 26, 2022.
    1. Michie S., Wood C.E., Johnston M., Abraham C., Francis J.J., Hardeman W. Behaviour change techniques: the development and evaluation of a taxonomic method for reporting and describing behaviour change interventions (a suite of five studies involving consensus methods, randomised controlled trials and analysis of qualitative data) Health Technol Assess. 2015;19(99):1–188. doi: 10.3310/hta19990.
    1. Michie S., Richardson M., Johnston M., et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81–95. doi: 10.1007/s12160-013-9486-6.
    1. Carey R.N., Connell L.E., Johnston M., et al. Behavior change techniques and their mechanisms of action: a synthesis of links described in published intervention literature. Ann Behav Med. 2018;53(8):693–707. doi: 10.1093/abm/kay078.
    1. Cane J., O’Connor D., Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012;7:37. doi: 10.1186/1748-5908-7-37.
    1. Michie S., van Stralen M.M., West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6(1):42. doi: 10.1186/1748-5908-6-42.
    1. Study Randomizer [Software Application] 2022. Published online 2017.
    1. Harris P.A., Taylor R., Thielke R., Payne J., Gonzalez N., Conde J.G. Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381.
    1. Harris P.A., Taylor R., Minor B.L., et al. The REDCap consortium: building an international community of software partners. J Biomed Inform. 2019;95
    1. Michie S., Atkins L., West R. 2014. The Behaviour Change Wheel: A Guide to Designing Interventions. Silverback.

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