Testing a support programme for opioid reduction for people with chronic non-malignant pain: the I-WOTCH randomised controlled trial protocol.

Introduction: Chronic non-malignant pain has a major impact on the well-being, mood and productivity of those affected. Opioids are increasingly prescribed to manage this type of pain, but with a risk of other disabling symptoms, when their effectiveness has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in people with chronic pain.
Methods and Analysis: A pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of a group-based multicomponent intervention combined with individualised clinical facilitator led support for the management of chronic non-malignant pain against the control intervention (self-help booklet and relaxation compact disc). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The two primary outcomes are activities of daily living (measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events and National Health Service (NHS) healthcare resource use. Participants are followed up at 4, 8 and 12 months, with a primary endpoint of 12 months. Between-group differences will indicate effectiveness; we are looking for a difference of 3.5 points on our pain interference outcome (scale 40 to 77). We will undertake an NHS perspective cost-effectiveness analysis using quality adjusted life years.
Ethics and Dissemination: Full approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on 13 September, 2016 (16/YH/0325). Appropriate local approvals were sought for each area in which recruitment was undertaken. The current protocol version is 1.6 date 19 December 2018. Publication of results in peer- reviewed journals will inform the scientific and clinical community. We will disseminate results to patient participants and study facilitators in a study newsletter as well as a lay summary of results on the study website.
Trial Registration Number: ISRCTN49470934; Pre-results.
Competing Interests: Competing interests: MU was Chair of the NICE accreditation advisory committee until March 2017 for which he received a fee. He is the chief investigator or co-investigator on multiple previous and current research grants from the UK National Institute for Health Research, Arthritis Research UK and is co-investigator on grants funded by the Australian NHMRC. He is an NIHR Senior Investigator. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is a director and shareholder of Clinvivo Ltd that provides electronic data collection for health services research. He is part of an academic partnership with Serco Ltd related to return to work initiatives. He is a co-investigator on a study receiving support in kind from Orthospace Ltd. He is an editor of the NIHR journal series, and a member of the NIHR Journal Editors Group, for which he receives a fee. SE is investigator on a number of NIHR and industry sponsored studies. He received travel expenses for speaking at conferences from the professional organisations. SE consults for Medtronic, Abbott, Boston Scientific and Mainstay Medical, none in relation to opioids. SE is chair of the BPS Science and Research Committee. SE is deputy Chair of the NIHR CRN Anaesthesia Pain and Perioperative Medicine National Specialty Group. SE’s department has received fellowship funding from Medtronic as well as nurse funding from Abbott. HS is director of Health Psychology Services Ltd, providing psychological services for a range of health related conditions. AF developed an app that is sold in iTunes for US$9.99 (Opioid Manager). The app is owned by the hospital (UHN) where Dr Furlan works, and Dr Furlan does not retain any profits of the sales of this app for herself. KS received grant funding as PI and CoI from NIHR for other projects. She was on the NIHR HS&DR Funding Board until January 2018. NT received grant funding as PI and CoI from NIHR for other projects and current funding as PI from the Medical Research Council.
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