Title: Improving the Wellbeing of people with Opioid Treated CHronic pain; I-WOTCH
Funder: Department of Health and Social Care

Abstract: I-WOTCH is definitive randomised controlled trial testing the effectiveness of a multicomponent self-management intervention targeting withdrawal of strong opioids (I-WOTCH) in comparison to ‘potential best usual care’ (i.e. the control intervention) for people living with chronic pain. People using strong opioid drugs for the relief of pain on most days will be recruited from primary care in three locations (North East England, North East London West Midlands). The I-WOTCH intervention consists of three days of a group self-management intervention jointly led by a lay facilitator and an I-WOTCH trained nurse plus one-to-one support from the nurse (face to face and telephone) to support tapering of opioid medication. The aim of the intervention is complete withdrawal from opioids The control intervention will consist of an anglicised version of ‘my opioid manager’ a self-help-booklet to support opioid withdrawal developed in Canada plus a relaxation CD. The primary outcome measure is activities of daily living using The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (8A) developed by the national Institute for Health in the USA. The main secondary outcome is opioid use. Mean difference in daily morphine equivalent dose of opioids taken: based on participant self-report will be used for opioid analysis. We will also report proportion maintaining complete withdrawal and proportion who achieve at least a 50% reduction opioid use and collect data on opioid prescribing from GP records. We will use a package of other secondary patient-reported outcome measures based on international recommendations and the requirements of the brief. These include pain severity, adverse events (opioid withdrawal symptoms), health related quality of life, sleep quality, self-efficacy, and emotional well-being. NHS costs will be collected using a combination of routine records and participant self-reported. The latter will be used also to collect non-NHS costs such as over the counter medications. We will do postal follow up at four, eight, and twelve months. To show a 3.5 points difference on PROMIS-PI-SF-8A at 5% significance with 90% power, allowing for 20% loss to follow-up and clustering effects we plan to recruit 468 participants. We will use hierarchical linear regression models to estimate the treatment effects (with 95% confidence intervals), and will be adjusted for important patient-level covariates. In the pilot stage we will develop an initial model-based cost-effectiveness and value of information analyses of I-WOTCH. The results of our initial analyses will be used to inform the design of the main I-WOTCH trial. We will do a within-trial cost-consequences analysis. In a third stage of the economic analysis we will use the data collected in the main trial to update model structure (if necessary) and parameter to produce an updated estimate of the long term cost-effectiveness of I-WOTCH compared to best usual. This long term model is needed because some of the important benefits of opioid withdrawal (reduced fractures and deaths) are likely to continue to accrue for several years after the end of the follow-up period. In a parallel process evaluation we will track how the intervention is delivered, staff experiences of delivery, possible mediating processes, patients’ perceptions and experiences of participation in the intervention, and assess the intervention fidelity.

Lay abstract: Nearly eight million people in the UK have long-term painful disorders such as low back pain, neck pain, arthritis, fibromyalgia, neuralgia (nerve pain), and pain after surgery. This pain has a major impact on daily living and wellbeing. A substantial minority of those affected are using long-term strong opioid drugs. These include tablets such as tramadol or oxycodone and long-acting patches such as fentanyl or buprenorphine. Morphine is sometimes prescribed. Although opioids can be very effective in the short term they have little effect on long-term pain. In the long term they may lose their pain relieving effects completely; or even cause a paradoxical increase in pain There are concerns about the adverse health impact of strong opioids. Around half of people taking opioids have undesirable side effects; including nausea, vomiting, constipation, sleep disturbance, unusual drowsiness, & reduced mental capacity. In the older population, side effects mean opioid drugs increase both number of broken bones and number of deaths. Over recent years there have been substantial increases in the amount of these drugs prescribed in the UK. There is a need for a proven intervention, targeting opioid use that helps people with long standing pain to get on with their lives without opioid drugs. Participants and recruitment 468 people living with chronic pain treated with strong opioids will be recruited from around 100 general practices to a randomised controlled trial testing the effect of adding a supportive self-management and information/advice about coming off opioid drugs (the I-WOTCH intervention) to best practice paper/on-line advice. Intervention In a previous large study of supportive self-management for people living with chronic pain we found long-term benefits on depression and anxiety. This intervention did not target opioid use. We are adapting this to include opioid specific elements such as education on side effects and providing additional support, to promote withdrawal from opioid drugs. Over a ten week period there will be three days attending a self-management group plus two face to face and two telephone consultations with a specially trained pain nurse. Control Intervention An adaption of ‘My Opioid Manager’, an, electronic/paper guide, to opioid use developed in Canada will be used with a relaxation CD. We will work with patient partners and GPs to ensure it is relevant to the UK context. Outcome Measures Participants will be asked to complete follow-up postal questionnaires four, eight and twelve months after joining the study. Our main outcomes will be how well people can get on with normal activities (e.g. work, family, & social life) and opioid use. To decide if the I-WOTCH intervention represents good value for money we will also collect data on all the NHS Costs associated with their care. Some of the benefits from stopping the use of strong opioid drugs may not be apparent within one year of follow-up; we will therefore estimate the long-term benefits of the I-WOTCH intervention using information from within this trial and what is already known about the effects of opioids on these important outcome. In a parallel interview study we will explore, staff experiences of delivering the interventions, and patients’ perceptions and experiences of participating in the intervention. This will help us to understand how the intervention might work and improve how we deliver the intervention in the future.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: GENERIC HEALTH RELEVANCE