Spread and scale of an electronic deprescribing software to improve health outcomes of older adults living in nursing homes: study protocol for a stepped wedge cluster randomized trial

Marc-Eric Nadeau, Justine L Henry, Todd C Lee, Émilie Bortolussi-Courval, Carole Goodine, Emily G McDonald, Marc-Eric Nadeau, Justine L Henry, Todd C Lee, Émilie Bortolussi-Courval, Carole Goodine, Emily G McDonald

Abstract

Background: Medication overload or problematic polypharmacy is a major problem causing widespread harm, particularly to older adults. Taking multiple medications increases the risk of potentially inappropriate medications (PIMs), and residents in long-term care (LTC) are frequently prescribed 10 or more medications at once. One strategy to address this problem is for the physician and/or pharmacist to perform regular medication reviews; however, this process can be complicated and time-consuming. With a prescription review, medications may be decreased, changed, or stopped altogether. MedReviewRx is a software that runs an analysis using deprescribing rules to produce a report to guide medication reviews addressing medication overload for residents in LTC.

Methods: This study will employ a mixed methods effectiveness-implementation hybrid type 2 study design. To measure effectiveness, a stepped wedge cluster randomized trial design is planned, which allows us to approximate a randomized clinical trial. Approximately 1000 residents living in LTC will be recruited from five facilities in New Brunswick. The study will begin with 3 months of baseline data on rates of deprescribing. Thereafter, every 3 months a new cluster will enter the intervention mode. The intervention consists of medication reviews augmented with the MedReviewRx software, which will be used by staff and clinicians in the facilities. The estimated study duration is 18 months and the main outcome will be the proportion of patients with one or more PIMs deprescribed (reduced/stopped or changed to a safer alternative) in the 90 days following a prescription review. The goal is to study the impact of MedReviewRx on medication overload among older adults living in LTC. In typical fashion of a stepped wedge cluster randomized trial, each cluster acts as an internal control (before and after) as well as a control for the other clusters (external control). Qualitative data collected will include resident/caregiver attitudes towards deprescribing and semi-structured interviews with staff working in the long-term care homes.

Discussion: This study design addresses issues with seasonality and allows all clusters to participate in the intervention, which is an advantage when the intervention is related to quality improvement. This study will provide valuable information on PIM use, cost savings, and facilitators and challenges associated with medication reviews and deprescribing. This study represents an important step towards understanding and promoting tools to guide safe and rational reduction of PIM use among older adults.

Trial registration: NCT04762303 , Registered February 21, 2021.

Keywords: Adverse drug event; Deprescribing; Long-term care; Medication review; Medication use; Nursing home; Older adults; Polypharmacy; Prescription check-up.

Conflict of interest statement

Dr. McDonald and Dr. Lee are co-owners of the MedSafer software that powers the application in this study and jointly own the company MedSafer CORP. Both physicians also receive salary support from the Fond de recherche santé Québec.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Sample screenshot of MedReviewRx App
Fig. 2
Fig. 2
Sample screenshots of MedReviewRx App

References

    1. Eliminating medication overload: A national action plan. Working Group on Medication Overload. Brookline: The Lown Institute; 2020.
    1. Canadian Institute for Health Information . Drug Use Among Seniors in Canada, 2016. Ottawa: CIHI; 2018. p. 41.
    1. Maher RL, Hanlon JT, Hajjar ER. Clinical Consequences of Polypharmacy in Elderly. Expert Opin Drug Saf. 2014;13(1) Available from: .
    1. Kim J, Parish AL. Polypharmacy and Medication Management in Older Adults. Nurs Clin North Am. 2017;52(3):457–468. doi: 10.1016/j.cnur.2017.04.007.
    1. Brath H, Mehta N, Savage RD, Gill SS, Wu W, Bronskill SE, et al. What Is Known About Preventing, Detecting, and Reversing Prescribing Cascades: A Scoping Review. J Am Geriatr Soc. 2018;66(11):2079–2085. doi: 10.1111/jgs.15543.
    1. Lavan AH, Gallagher P. Predicting risk of adverse drug reactions in older adults. Ther Adv Drug Saf. 2016;7(1):11–22. doi: 10.1177/2042098615615472.
    1. By the American Geriatrics Society 2015 Beers Criteria Update Expert Panel American Geriatrics Society 2015 Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2015;63(11):2227–2246. doi: 10.1111/jgs.13702.
    1. O’Mahony D, O’Sullivan D, Byrne S, O’Connor MN, 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. Choosing Wisely Canada [Internet]. Choosing Wisely Canada. [cited 2021 Apr 12]. Available from:
    1. Gallagher P, Barry P, O’Mahony D. Inappropriate prescribing in the elderly. J Clin Pharm Ther. 2007;32(2):113–121. doi: 10.1111/j.1365-2710.2007.00793.x.
    1. Gutiérrez-Valencia M, Izquierdo M, Cesari M, Casas-Herrero Á, Inzitari M, Martínez-Velilla N. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018;84(7):1432–1444. doi: 10.1111/bcp.13590.
    1. Thompson W, Farrell B. Deprescribing: What Is It and What Does the Evidence Tell Us? Can J Hosp Pharm. 2013;66(3):201–202.
    1. McDonald E, Wu P, Rashidi B, Forster A, Huang A, Pilote L, et al. The MedSafer Study: A Controlled Trial of an Electronic Decision Support Tool for Deprescribing in Acute Care: THE MEDSAFER STUDY. Journal of the American Geriatrics Society. 2019;27:67.
    1. AnAgingStrategyForNB.pdf [Internet]. [cited 2021 Apr 12]. Available from:
    1. Hemming K, Kasza J, Hooper R, Forbes A, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. International Journal of Epidemiology. 2020;49(3):979–995. doi: 10.1093/ije/dyz237.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006;3(2):77–101. doi: 10.1191/1478088706qp063oa.
    1. Kim H, Park Y-H, Jung Y, Choi H, Lee S, Kim G-S, et al. Evaluation of a technology-enhanced integrated care model for frail older persons: protocol of the SPEC study, a stepped-wedge cluster randomized trial in nursing homes. BMC Geriatrics. 2017;17(1):88. doi: 10.1186/s12877-017-0459-7.
    1. van der Sluijs R, Fiddelers AAA, Waalwijk JF, Reitsma JB, Dirx MJ, den Hartog D, et al. The impact of the Trauma Triage App on pre-hospital trauma triage: design and protocol of the stepped-wedge, cluster-randomized TESLA trial. Diagnostic and Prognostic Research. 2020;4(1):10. doi: 10.1186/s41512-020-00076-1.
    1. Barker D, D’Este C, Campbell MJ, McElduff P. Minimum number of clusters and comparison of analysis methods for cross sectional stepped wedge cluster randomised trials with binary outcomes: A simulation study. Trials. 2017;18(1):119. doi: 10.1186/s13063-017-1862-2.
    1. Woertman W, de Hoop E, Moerbeek M, Zuidema SU, Gerritsen DL, Teerenstra S. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. 2013;66(7):752–758. doi: 10.1016/j.jclinepi.2013.01.009.

Source: PubMed

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