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 wellbeing, mood and productivity of those affected. Opioids are increasingly being prescribed to manage this type of pain, but the increasing risk of other disabling symptoms, and their effectiveness for this type of pain has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in patients with chronic pain. . Methods and analysis: A pragmatic, multi–centre, 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 CD). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The twoprimary outcomes are activities of daily living (measured by PROMIS Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events, and NHS health care resource use. Participants are followed up at four, eight, 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 40-77). We will undertake an NHS perspective cost-effectiveness analysis using Quality Adjusted Life Years. Ethics: Full approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on September 13th, 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 19th December 2018. Dissemination: Publication of results in peer reviewed journals, including the development and theoretical framework of the intervention, 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: This trial is registered with an International Standard Randomised Controlled Trial Number (ISRCTN) Register. ISRCTN number: 49470934 (06 Feb 2017