Improving the Wellbeing of people with Opioid Treated CHronic pain; I-WOTCH

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.