Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trial

Introduction The US opioid crisis and increasing prescription rates in Europe suggest inappropriate risk perceptions and behaviours of people who prescribe, take or advise on opioids: physicians, patients and pharmacists. Findings from cognitive and decision science in areas other than drug safety s...

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Main Authors: Odette Wegwarth, Joerg J Meerpohl, Norbert Donner-Banzhoff, Claudia Spies, Christine Schmucker, Erika Schulte, Edris Nury, Dirk Brockmann, Stefan Wind, Eva Goebel, Wolf-Dieter Ludwig, Ralph Hertwig
Format: Article
Language:English
Published: BMJ Publishing Group 2020-09-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/9/e037642.full
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author Odette Wegwarth
Joerg J Meerpohl
Norbert Donner-Banzhoff
Claudia Spies
Christine Schmucker
Erika Schulte
Edris Nury
Dirk Brockmann
Stefan Wind
Eva Goebel
Wolf-Dieter Ludwig
Ralph Hertwig
author_facet Odette Wegwarth
Joerg J Meerpohl
Norbert Donner-Banzhoff
Claudia Spies
Christine Schmucker
Erika Schulte
Edris Nury
Dirk Brockmann
Stefan Wind
Eva Goebel
Wolf-Dieter Ludwig
Ralph Hertwig
author_sort Odette Wegwarth
collection DOAJ
description Introduction The US opioid crisis and increasing prescription rates in Europe suggest inappropriate risk perceptions and behaviours of people who prescribe, take or advise on opioids: physicians, patients and pharmacists. Findings from cognitive and decision science in areas other than drug safety suggest that people’s risk perception and behaviour can differ depending on whether they learnt about a risk through personal experience or description. Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA) is the first-ever conducted trial that aims at investigating the effects of these two modes of learning on individuals’ risk perception and behaviour in the long-term administration of WHO-III opioids in chronic non-cancer pain.Methods and analysis ERONA—an exploratory, randomised controlled online survey intervention trial with two parallel arms—will examine the opioid-associated risk perception and behaviour of four groups involved in the long-term administration of WHO-III opioids: (1) family physicians, (2) physicians specialised in pain therapy, (3) patients with chronic (≥3 months) non-cancer pain and (4) pharmacists who regularly dispense narcotic substances. Participants will be randomly assigned to one of two online risk education interventions, description based or experiencebased. Both interventions will present the best medical evidence available. Participants will be queried at baseline and after intervention on their risk perception of opioids’ benefit–harm ratio, their medical risk literacy and their current/intended risk behaviour (in terms of prescribing, taking or counselling, depending on study group). A follow-up will occur after 9 months, when participants will be queried on their actual risk behaviour. The study was developed by the authors and will be conducted by the market research institution IPSOS Health.Ethics and dissemination The study was approved by the Institutional Review Board of the Max Planck Institute for Human Development. Results will be disseminated through peer-reviewed journals, conference presentations and social media.Trial registration number DRKS00020358.
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spelling doaj-art-37f54d15babd4ec7af116b9c65960cf72025-01-09T04:45:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-037642Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trialOdette Wegwarth0Joerg J Meerpohl1Norbert Donner-Banzhoff2Claudia Spies3Christine Schmucker4Erika Schulte5Edris Nury6Dirk Brockmann7Stefan Wind8Eva Goebel9Wolf-Dieter Ludwig10Ralph Hertwig11Adpative Rationality, Max-Planck-Institute for Human Development, Berlin, GermanyInstitute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Centre of the University of Freiburg, Faculty of Medicine, University of Freiburg, Breisacher Straße 153, 79110 Freiburg, GermanyDepartment of Primary Care, University of Marburg, Marburg, GermanyDepartment of Anesthesiology and Operative Intensive Care Medicine, Charité—Universitätsmedizin Berlin, Berlin, GermanyInstitute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Baden-Württemberg, GermanyDepartment of Anesthesiology and Operative Intensive Care Medicine, Charité, Universitaetsmedizin Berlin, Berlin, GermanyInstitute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, GermanyInstitute for Theoretical Biology and Integrative Research, Humboldt University of Berlin, Berlin, GermanyBerlin Chamber of Pharmacists, Berlin, GermanyBerlin Chamber of Pharmacists, Berlin, GermanyDrug Commission of the German Medical Association, Berlin, GermanyCenter for Adaptive Rationality, Max-Planck-Institut für Bildungsforschung, Berlin, GermanyIntroduction The US opioid crisis and increasing prescription rates in Europe suggest inappropriate risk perceptions and behaviours of people who prescribe, take or advise on opioids: physicians, patients and pharmacists. Findings from cognitive and decision science in areas other than drug safety suggest that people’s risk perception and behaviour can differ depending on whether they learnt about a risk through personal experience or description. Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA) is the first-ever conducted trial that aims at investigating the effects of these two modes of learning on individuals’ risk perception and behaviour in the long-term administration of WHO-III opioids in chronic non-cancer pain.Methods and analysis ERONA—an exploratory, randomised controlled online survey intervention trial with two parallel arms—will examine the opioid-associated risk perception and behaviour of four groups involved in the long-term administration of WHO-III opioids: (1) family physicians, (2) physicians specialised in pain therapy, (3) patients with chronic (≥3 months) non-cancer pain and (4) pharmacists who regularly dispense narcotic substances. Participants will be randomly assigned to one of two online risk education interventions, description based or experiencebased. Both interventions will present the best medical evidence available. Participants will be queried at baseline and after intervention on their risk perception of opioids’ benefit–harm ratio, their medical risk literacy and their current/intended risk behaviour (in terms of prescribing, taking or counselling, depending on study group). A follow-up will occur after 9 months, when participants will be queried on their actual risk behaviour. The study was developed by the authors and will be conducted by the market research institution IPSOS Health.Ethics and dissemination The study was approved by the Institutional Review Board of the Max Planck Institute for Human Development. Results will be disseminated through peer-reviewed journals, conference presentations and social media.Trial registration number DRKS00020358.https://bmjopen.bmj.com/content/10/9/e037642.full
spellingShingle Odette Wegwarth
Joerg J Meerpohl
Norbert Donner-Banzhoff
Claudia Spies
Christine Schmucker
Erika Schulte
Edris Nury
Dirk Brockmann
Stefan Wind
Eva Goebel
Wolf-Dieter Ludwig
Ralph Hertwig
Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trial
BMJ Open
title Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trial
title_full Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trial
title_fullStr Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trial
title_full_unstemmed Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trial
title_short Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trial
title_sort experiencing the risk of overutilising opioids among patients with chronic non cancer pain in ambulatory care erona the protocol of an exploratory randomised controlled trial
url https://bmjopen.bmj.com/content/10/9/e037642.full
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