Effectiveness of a blended care programme for the discontinuation of benzodiazepine use for sleeping problems in primary care: study protocol of a cluster randomised trial, the Big Bird trial

Kristien Coteur, Marc Van Nuland, Marc Vanmeerbeek, Gilles Henrard, Sibyl Anthierens, Kris Van den Broeck, An De Sutter, Hanne Creupelandt, Dirk Devroey, Roel Van Overmeire, Anne-Marie Offermans, Nadine Kacenelenbogen, Annouschka Laenen, Catharina Mathei, Kristien Coteur, Marc Van Nuland, Marc Vanmeerbeek, Gilles Henrard, Sibyl Anthierens, Kris Van den Broeck, An De Sutter, Hanne Creupelandt, Dirk Devroey, Roel Van Overmeire, Anne-Marie Offermans, Nadine Kacenelenbogen, Annouschka Laenen, Catharina Mathei

Abstract

Introduction: Problematic benzodiazepine use is a global health issue. Although the adverse side effects of long-term use of benzodiazepines are well known, it remains difficult to implement interventions for discontinuation in primary care. Considering the success of blended care for the treatment of sleeping disorders and the support of substance use disorders, evidence suggests that a blended care approach, combining face-to-face consultations with the general practitioner with web-based self-learning by the patient, is beneficial for the discontinuation of chronic benzodiazepine use for primary insomnia in general practice. Therefore, the aim of this study is to evaluate the effectiveness of such an approach for the discontinuation of benzodiazepine and zolpidem, zopiclone and zaleplon drugs ((z-)BZD) use in the long term and evaluate the implementation process.

Methods and analysis: This study is a multicentre, pragmatic, cluster randomised controlled trial with 1200 patients, included by 120 general practitioners. Allocation to usual or blended care happens at the level of the general practice in a 1:1 ratio using a block randomisation system stratified per language. The study population consists of adult primary care patients who have been using (z-)BZD for primary insomnia on a daily basis for at least 6 months. Primary outcome measure is the proportion of patients that discontinued (z-)BZD at 12 months assessed by toxicological screening for (z-)BZD in urine. Secondary outcomes include discontinuation of (z-)BZD at 6 months, quality of life and the number of defined daily doses of (z-)BZD prescribed. Data will be collected using a study-specific online platform and analysed using the intention-to-treat approach. The process of implementing blended care will be evaluated in a nested study.

Ethics and dissemination: This trial was approved by the Ethics Committee for Research of UZ/KU Leuven (ref. S61194). Study results will be disseminated via open-access, peer-reviewed publications and conference presentations.

Trial registration number: NCT03937180.

Keywords: primary care; public health; sleep medicine; telemedicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart of trial design summary.
Figure 2
Figure 2
Flow chart of trial procedures. BZD, benzodiazepine and zolpidem, zopiclone and zaleplon; GP, general practitioner.

References

    1. Thomas RE. Benzodiazepine use and motor vehicle accidents. systematic review of reported association. Can Fam Physician 1998;44:799–808.
    1. Leipzig RM, Cumming RG, Tinetti ME. Drugs and falls in older people: a systematic review and meta-analysis: I. psychotropic drugs. J Am Geriatr Soc 1999;47:30–9. 10.1111/j.1532-5415.1999.tb01898.x
    1. Glass J, Lanctôt KL, Herrmann N, et al. . Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ 2005;331:1169 10.1136/bmj.38623.768588.47
    1. Barker MJ, Greenwood KM, Jackson M, et al. . Cognitive effects of long-term benzodiazepine use. CNS Drugs 2004;18:37–48. 10.2165/00023210-200418010-00004
    1. Billioti de Gage S, Begaud B, Bazin F, et al. . Benzodiazepine use and risk of dementia: prospective population based study. BMJ 2012;345:e6231 10.1136/bmj.e6231
    1. Belleville G. Mortality hazard associated with anxiolytic and hypnotic drug use in the National population health survey. Can J Psychiatry 2010;55:558–67. 10.1177/070674371005500904
    1. Kripke DF, Langer RD, Kline LE. Hypnotics' association with mortality or cancer: a matched cohort study. BMJ Open 2012;2:e000850 10.1136/bmjopen-2012-000850
    1. Soyka M. Treatment of benzodiazepine dependence. N Engl J Med 2017;376:1147–57. 10.1056/NEJMra1611832
    1. Zhong G, Wang Y, Zhang Y, et al. . Association between benzodiazepine use and dementia: a meta-analysis. PLoS One 2015;10:e0127836 10.1371/journal.pone.0127836
    1. Takada M, Fujimoto M, Hosomi K. Association between benzodiazepine use and dementia: data mining of different medical databases. Int J Med Sci 2016;13:825–34. 10.7150/ijms.16185
    1. Mugunthan K, McGuire T, Glasziou P. Minimal interventions to decrease long-term use of benzodiazepines in primary care: a systematic review and meta-analysis. Br J Gen Pract 2011;61:e573–8. 10.3399/bjgp11X593857
    1. Canadian Agency for Drugs and Technologies in Health Discontinuation strategies for patients with long-term benzodiazepine use: a review of clinical evidence and guidelines rapid response report: summary with critical appraisal. Ottawa: Canadian Agency for Drugs and Technologies in Health, 2015.
    1. Tannenbaum C, Martin P, Tamblyn R, et al. . Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the empower cluster randomized trial. JAMA Intern Med 2014;174:890–8. 10.1001/jamainternmed.2014.949
    1. Vicens C, Bejarano F, Sempere E, et al. . Comparative efficacy of two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled trial in primary care. Br J Psychiatry 2014;204:471–9. 10.1192/bjp.bp.113.134650
    1. Richards D, Richardson T. Computer-Based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev 2012;32:329–42. 10.1016/j.cpr.2012.02.004
    1. Wilhelmsen M, Lillevoll K, Risør MB, et al. . Motivation to persist with Internet-based cognitive behavioural treatment using blended care: a qualitative study. BMC Psychiatry 2013;13:296 10.1186/1471-244X-13-296
    1. Kaldo V, Jernelöv S, Blom K, et al. . Guided Internet cognitive behavioral therapy for insomnia compared to a control treatment – a randomized trial. Behav Res Ther 2015;71:90–100. 10.1016/j.brat.2015.06.001
    1. Hermes EDA, Rosenheck RA. Implementing computer-based psychotherapy among veterans in outpatient treatment for substance use disorders. Psychiatric Services 2016;67:176–83. 10.1176/appi.ps.201400532
    1. Kawaguchi K, Shimizu Y, Izumi T, et al. . Alcohol related problem in the workplace: trial of a screening and brief intervention program for risky drinking in the workplace, via the Internet. Nihon Arukoru Yakubutsu Igakkai Zasshi 2014;49:369–80.
    1. Ebert DD, Heber E, Berking M, et al. . Self-guided Internet-based and mobile-based stress management for employees: results of a randomised controlled trial. Occup Environ Med 2016;73:315–23. 10.1136/oemed-2015-103269
    1. Carlbring P, Andersson G, Cuijpers P, et al. . Internet-Based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther 2018;47:1–18. 10.1080/16506073.2017.1401115
    1. Klaasen G, Helsen C, Klaasen B, et al. . Afbouwen van chronisch benzodiazepinegebruik: Resultaten van EEN interactieve en patiëntgerichte webmodule. HuisartsNu 2015;5:186–91.
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. EuroQol Group EuroQol--a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199–208. 10.1016/0168-8510(90)90421-9
    1. Babor TF, Higgins-Biddle JC, Saunders JB, et al. . The alcohol use disorders identification test: guidelines for use in primary care. 2nd edn Geneva, Switzerland: World Health Organization, 2001.
    1. Kan CC, Breteler MHM, Timmermans EAY, et al. . Scalability, reliability, and validity of the benzodiazepine dependence self-report questionnaire in outpatient benzodiazepine users. Compr Psychiatry 1999;40:283–91. 10.1016/S0010-440X(99)90129-3
    1. Bastien C, Vallières A, Morin CM. Validation of the insomnia severity index as an outcome measure for insomnia research. Sleep Med 2001;2:297–307. 10.1016/S1389-9457(00)00065-4
    1. Sørensen K, Van den Broucke S, Pelikan JM, et al. . Measuring health literacy in populations: illuminating the design and development process of the European health literacy survey questionnaire (HLS-EU-Q). BMC Public Health 2013;13:1–10. 10.1186/1471-2458-13-948
    1. Ten Wolde GB, Dijkstra A, van Empelen P, et al. . Long-Term effectiveness of computer-generated tailored patient education on benzodiazepines: a randomized controlled trial. Addiction 2008;103:662–70. 10.1111/j.1360-0443.2008.02141.x

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit