Patient empowerment brochures to increase gabapentinoid deprescribing: protocol for the prospective, controlled before-and-after GABA-WHY trial

Jerome Williams, Marc-Alexandre Gingras, Robert Dubé, Todd C Lee, Emily G McDonald, Jerome Williams, Marc-Alexandre Gingras, Robert Dubé, Todd C Lee, Emily G McDonald

Abstract

Background: Off-label use of gabapentinoids is common among patients admitted to hospital medical wards, who are at risk of adverse drug events. In this study, we will assess if educational brochures can increase rates of gabapentinoid deprescription among medical inpatients, compared with usual care.

Methods: We describe the protocol for a prospective before-and-after trial that will take place on 5 medical wards of 2 tertiary care hospitals in Montréal, Canada. The study intervention will include distribution of educational brochures to users of gabapentinoids during hospital admission, as well as short educational sessions for medical staff on safe gabapentinoid prescribing practices. We will include patients with a gabapentinoid prescription before admission who are aged 60 years or older. Exclusion criteria are known seizure disorder, severe cognitive impairment, expected prognosis less than 3 months and inability to read English or French. The primary outcome is the rate of gabapentinoid deprescription at 8 weeks postdischarge. We aim to recruit 160 participants, with a 1:1 distribution between intervention and control groups.

Interpretation: If successful, the use of educational brochures and staff education represents a scalable intervention to reduce gabapentinoid overuse by encouraging deprescription conversations between patients and their health care providers. Results of the study will be disseminated through publication in peer-reviewed journals and presentations at conferences.

Trial registration: ClinicalTrials.gov, no. NCT04855578.

Conflict of interest statement

Competing interests: Todd Lee and Emily McDonald receive salary support from the Fonds de Recherche Québec–Santé and jointly hold the copyright for MedSafer, a deprescribing software that links to the Canadian Deprescribing Network patient empowerment brochures used in this study. Todd Lee also reports funding from the Canadian Institutes of Health Research and the Centre for Aging and Brain Health Innovation. No other competing interests were declared.

© 2022 CMA Impact Inc. or its licensors.

References

    1. Lyrica [product monograph] Kirkland (QC): Pfizer Canada; [accessed 2020 Nov. 15]. revised 2016 Dec 6. Available: .
    1. Neurontin [product monograph] Kirkland (QC): Pfizer Canada; [accessed 2020 Nov. 15]. revised 2018 Feb 22. Available: .
    1. Highlights of prescribing information. Lyrica Silver Spring (MD): US Food and Drug Administration; 2012. [accessed 2020 Nov. 15]. Available: .
    1. Highlights of prescribing information: Neurontin. Silver Spring (MD): US Food and Drug Administration; 2017. [accessed 2020 Nov. 15]. Available: .
    1. Johansen ME. Gabapentinoid use in the United States 2002 through 2015. JAMA Intern Med. 2018;178:292–4.
    1. Medicines use and spending in the US: a review of 2016 and outlook to 2021. Parsippany (NJ): QuintilesIMS Institute; 2017. [accessed 2020 Nov. 16]. Available: .
    1. Kwok H, Khuu W, Fernandes K, et al. Impact of unrestricted access to pregabalin on the use of opioids and other CNS-active medications: a cross-sectional time series analysis. Pain Med. 2017;18:1019–26.
    1. Prescribed drug spending in Canada, 2021: a focus on public drug programs — top 100 drug classes, 2020 data tables. Ottawa: Canadian Institute for Health Information; 2021.
    1. Hamer AM, Haxby DG, McFarland BH, et al. Gabapentin use in a managed medicaid population. J Manag Care Pharm. 2002;8:266–71.
    1. Bennett MI, Laird B, van Litsenburg C, et al. Pregabalin for the management of neuropathic pain in adults with cancer: a systematic review of the literature. Pain Med. 2013;14:1681–8.
    1. Mathieson S, Maher CG, McLachlan AJ, et al. Trial of pregabalin for acute and chronic sciatica. N Engl J Med. 2017;376:1111–20.
    1. Moore A, Derry S, Wiffen P. Gabapentin for chronic neuropathic pain. JAMA. 2018;319:818–9.
    1. Shanthanna H, Gilron I, Rajarathinam M, et al. Benefits and safety of gabapentinoids in chronic low back pain: a systematic review and meta-analysis of randomized controlled trials. PLoS Med. 2017;14:e1002369.
    1. Wiffen PJ, Derry S, Moore AR, et al. Antiepileptic drugs for neuropathic pain and fibromyalgia: an overview of Cochrane reviews. Cochrane Database Syst Rev. 2013;2013:CD010567.
    1. Gingras M-A, Lieu A, Papillon-Ferland L, et al. Retrospective cohort study of the prevalence of off-label gabapentinoid prescriptions in hospitalized medical patients. J Hosp Med. 2019;14:E1–4.
    1. Gomes T, Greaves S, van den Brink W, et al. Pregabalin and the risk for opioid-related death: a nested case-control study. Ann Intern Med. 2018;169:732–4.
    1. Gomes T, Juurlink DN, Antoniou T, et al. Gabapentin, opioids, and the risk of opioid-related death: a population-based nested case-control study. PLoS Med. 2017;14:e1002396.
    1. Wilson MG, Lee TC, Hass A, et al. EMPOWERing hospitalized older adults to deprescribe sedative hypnotics: a pilot study. J Am Geriatr Soc. 2018;66:1186–9.
    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.
    1. Des Jarlais DC, Lyles C, Crepaz N TREND Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Am J Public Health. 2004;94:361–6.
    1. Ross SB, Wu PE, Atique A, et al. Adverse drug events in older adults: review of adjudication methods in deprescribing studies. J Am Geriatr Soc. 2020;68:1594–602.
    1. Tannenbaum C. You may be at risk: you are taking one of the following medications for pain: gabapentin (Neurotin), pregabalin. (Lyrica): Montréal: Institut universitaire de gériatrie de Montréal; 2020. [accessed 2021 Aug. 15]. Available: .
    1. PROMIS Scale v12: global health. Evanston (IL): Northwestern University; 2018. [accessed 2021 Aug. 15]. Available .
    1. PROMIS Scale v20: pain intensity 3a. Evanston (IL): Northwestern University; 2020. [accessed 2021 Aug. 15]. Available .
    1. PROMIS Short Form 2.0: cognitive function 6a. Evanston (IL): Northwestern University; 2016. [accessed 2021 Aug. 15]. Available .
    1. Martin P, Tannenbaum C. Use of the EMPOWER brochure to deprescribe sedative-hypnotic drugs in older adults with mild cognitive impairment. BMC Geriatr. 2017;17:37.

Source: PubMed

3
Iratkozz fel