Journal Article

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

Eldabe, Sam, Iglesias Urrutia, Cynthia Paola, Seers, Kate, Shaw, Jane, Balasubramanian, Shyam, Mistry, Dipesh, Betteley, Lauren, Taylor, Stephanie, Tysall, Colin, Alleyne, Sharisse, Noyes, Jennifer, Carnes, Dawn, Lall, Ranjit, Furlan, Andrea D, Nichols, Vivien P, Sandhu, Harbinder K, Underwood, Martin, Rahman, Anisur, Booth, Katie, Manca, Andrea, Withers, Emma J, Tang, Nicole K Y, Abraham, Charles, Haywood, Kirstie

2019

Overview

IntroductionChronic 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 analysisA 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 disseminationFull 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.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Activities of Daily Living / Analgesics, Opioid - therapeutic use / Back pain / behavioural interventions / chronic non-malignant pain / Chronic Pain - therapy / Cost analysis / Cost-Benefit Analysis / Design / Evidence-based medicine / Health Resources - statistics & numerical data / Health services / Humans / Intervention / Multicenter Studies as Topic / Narcotics / opioids / Pain management / Pain Management - economics / Pain Management - methods / Pain Measurement / Patient Reported Outcome Measures / Patient-centered care / Patient-Centred Medicine / Pragmatic Clinical Trials as Topic / Primary care / process evaluation / Quality of Life / Questionnaires / Randomized Controlled Trials as Topic / RCT / Research Design / Self Efficacy / self-management / Sleep / tapering / Ulcers / Well being / Withholding Treatment