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A Realist Evaluation of Patients' Decisions to Deprescribe in the EMPOWER Trial

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A Realist Evaluation of Patients' Decisions to Deprescribe in the EMPOWER Trial BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-015959 on 4 May 2017. Downloaded from A realist evaluation of patients' decisions to deprescribe in the EMPOWER trial ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2017-015959 Article Type: Research Date Submitted by the Author: 12-Jan-2017 Complete List of Authors: Martin, Philippe; Centre de recherche de l'Institut universitaire de gériatrie de Montréal, Tannenbaum, Cara; Université de Montréal, <b>Primary Subject Geriatric medicine Heading</b>: Secondary Subject Heading: Health services research, Patient-centred medicine, Addiction Keywords: deprescribing, benzodiazepines, realist evaluation, mechanisms, EMPOWER http://bmjopen.bmj.com/ on September 24, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 37 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-015959 on 4 May 2017. Downloaded from 1 2 3 1 A realist evaluation of patients' decisions to deprescribe in the EMPOWER trial 4 5 a,b b,c 6 2 Philippe Martin, BSc , Cara Tannenbaum, MD MSc 7 8 9 3 10 11 a 12 4 Doctoral Student, Faculty of Pharmacy, Université de Montréal, Montreal, PQ Canada 13 14 15 b For peer review only 16 5 Institut Universitaire de Gériatrie de Montréal, Montreal, PQ Canada 17 18 c 19 6 Professor and Michel Saucier Endowed Chair, Université de Montréal, Faculties of Medicine 20 21 22 7 and Pharmacy, Montreal, PQ, Canada. 23 24 25 8 26 27 9 Corresponding Author: 28 29 10 Philippe Martin, B. Sc. 30 31 32 11 Institut Universitaire de Gériatrie de Montréal, 33 http://bmjopen.bmj.com/ 34 12 Faculties of Pharmacy and Medicine, 35 36 37 13 Université de Montréal, Montréal, Quebec, Canada 38 39 14 4545 Queen Mary Road 40 41 15 Montreal, QC H3W 1W5 on September 24, 2021 by guest. Protected copyright. 42 43 44 16 E-mail : [email protected] 45 46 17 Tel: 514-340-3540 ext: 4728 47 48 18 Fax: 514-340-2117 49 50 51 19 Alternate Corresponding Author: [email protected] 52 53 20 Word Count: Abstract (262 words), Main text (2877 words) 54 55 21 56 57 58 59 60 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 37 BMJ Open: first published as 10.1136/bmjopen-2017-015959 on 4 May 2017. Downloaded from 1 2 3 22 Funding statement: This work was supported by Operating Grant OTG-88591 from the 4 5 6 23 Canadian Institutes of Health Research (CIHR). Philippe Martin received a doctoral bursary 7 8 24 from the FRQS. Cara Tannenbaum was supported by a Senior Scientist Career Award from the 9 10 11 25 FRQS. The above funding organizations had no role in the design and conduct of the study; 12 13 26 collection, management, analysis, and interpretation of the data; preparation, review, or approval 14 15 27 of the manuscript;For or the decision peer to submit review the manuscript for publication.only 16 17 18 28 19 20 29 Data sharing statement: Dataset is available upon request to the corresponding author. 21 22 23 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 24, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 37 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-015959 on 4 May 2017. Downloaded from 1 2 3 30 STRUCTURED ABSTRACT: 4 5 6 31 BACKGROUND AND OBJECTIVES: Successful mechanisms for engaging patients in the 7 8 32 deprescribing process remain unknown. We sought to determine in which contexts the 9 10 11 33 EMPOWER deprescribing intervention triggered older adults’: (1) motivation to deprescribe by 12 13 34 increasing knowledge and concern about benzodiazepines; (2) capacity to taper by augmenting 14 15 35 self-efficacy; andFor (3) opportunities peer to discuss review and receive support only from a healthcare provider to 16 17 18 36 deprescribe. 19 20 37 DESIGN: A realist evaluation using a sequential mixed methods approach, conducted alongside 21 22 38 the EMPOWER randomized clinical trial 23 24 25 39 SETTING: Community, Quebec, Canada. 26 27 40 PARTICIPANTS: 261 older chronic benzodiazepine consumers, who received the EMPOWER 28 29 41 intervention and had complete 6 month follow up data. 30 31 32 42 INTERVENTION: Mailed deprescribing brochure on benzodiazepines. 33 http://bmjopen.bmj.com/ 34 43 MEASUREMENTS: Motivation (change in knowledge test score; change in beliefs about the 35 36 37 44 risk-benefits of benzodiazepines, measured with the Beliefs about Medicines questionnaire; 38 39 45 intent to discuss deprescribing); Capacity (self-efficacy for tapering) and Opportunity (support 40 41 46 from a physician or pharmacist) on September 24, 2021 by guest. Protected copyright. 42 43 44 47 RESULTS: The intervention triggered an intent to deprescribe among 167 (n=64%) participants 45 46 48 (mean age 74.6 years + 6.3, 72% women). Participants intending to deprescribe had improved 47 48 49 knowledge (risk difference, 58.50% [95% CI, 46.98%-67.44%]), increased concern about taking 49 50 51 50 benzodiazepines (risk difference, 67.67% [95% CI, 57.36%-74.91%]), and higher self-efficacy 52 53 51 for tapering (risk difference, 56.90% [95% CI, 45.41%-65.77%]). Contexts where the 54 55 52 deprescribing mechanisms failed included lack of support from a health care provider, 56 57 58 59 60 3 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 37 BMJ Open: first published as 10.1136/bmjopen-2017-015959 on 4 May 2017. Downloaded from 1 2 3 53 intolerance to withdrawal symptoms, perceived poor health, and psychological reliance on 4 5 6 54 benzodiazepines. 7 8 55 CONCLUSION: Deprescribing interventions that systematically target patient motivation and 9 10 11 56 capacity to deprescribe are successful to the extent that healthcare providers are supportive, and 12 13 57 that patients do not have internal competing motivations to remain on drug therapy. 14 15 58 For peer review only 16 17 18 59 Key words: deprescribing, benzodiazepines, realist evaluation, mechanisms, EMPOWER 19 20 60 ClinicalTrials.gov identifier is NCT01148186 21 61 22 62 23 24 25 63 26 64 ARTICLE SUMMARY: 27 65 28 66 STRENGTHS AND LIMITATIONS OF THE STUDY: 29 30 67 • Use of a mixed methods approach enabled us to explore the breadth, depth, and 31 68 complexity of the patient’s experience of deprescribing. 32 69 • Use of the realist evaluation allowed us to investigate how the mechanisms underlying 33 70 deprescribing interventions interact with specific contexts to yield positive or negative http://bmjopen.bmj.com/ 34 71 outcomes 35 36 72 • This study was conducted alongside a large cluster randomized clinical trial. 37 73 38 39 40 41 on September 24, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 4 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 37 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2017-015959 on 4 May 2017. Downloaded from 1 2 3 74 INTRODUCTION 4 5 6 75 Deprescribing refers to the collaborative process of tapering, discontinuing, stopping, or 7 8 76 withdrawing medications in order to reduce adverse drug events and improve outcomes.1-5 9 10 1 3 6 11 77 Deprescribing has many steps , with one key component being the engagement of patients in 12 1 7-15 13 78 shared decision-making. Research suggests that older adults have conflicted feelings about 14 15 79 medications4 14: For78% of older peer adults believe review that medications onlyare necessary to improve health, 16 17 18 80 but at the same time, 68% would like to reduce their current medication use, with 92% willing to 19 20 81 stop a regular medication if advised to do so by their physician14. 21 22 82 23 24 25 83 A better understanding of the mechanisms that trigger patient motivation and capacity to 26 27 84 engage in the deprescribing process could reduce the use of potentially inappropriate medications 28 29 85 in older adults. The aim of realist evaluation is to reveal how an intervention might generate 30 31 32 86 different outcomes in different circumstances, and how different mechanisms work in particular 33 http://bmjopen.bmj.com/ 34 87 contexts, by enabling or motivating participants to make different choices 16. Educational 35 36 37 88 strategies to increase patients’ knowledge, beliefs, and motivation are hypothesized to influence 38 10 39 89 deliberate action on the part of the patient to curtail the use of a drug . However, what works, 40 41 90 for whom, under which circumstances and why, are questions that have never been explored on September 24, 2021 by guest. Protected copyright. 42 43 44 91 systematically from the patient’s point of view. Recent reviews on deprescribing call for a 45 46 92 realistic evaluation of large deprescribing trials to investigate how the mechanisms underlying 47 48 93 deprescribing interventions interact with specific contexts to yield positive or negative 49 50 17 18 51 94 outcomes. The EMPOWER trial, which demonstrated a number-needed-to-treat of 4 for the 52 53 95 effectiveness of mailing a benzodiazepine deprescribing brochure on complete cessation of 54 55 56 57 58 59 60 5 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 37 BMJ Open: first published as 10.1136/bmjopen-2017-015959 on 4 May 2017.
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