Developing a complex multi-modal self-management behaviour change intervention for Improving the Wellbeing of people with Opioid-Treated CHronic pain: which theories, processes and materials are required?

Problem

In Britain, approximately 10 million people live with pain; the limited data on prescribing patterns show that there were 16 million opioid prescriptions in 2015, costing >£200million. Yet evidence suggests that opioids are only effective in the short-term; thereafter most patients experience tolerance and some develop opioid-induced hyperalgesia. Opioid side effects and withdrawal symptoms can be overwhelming to patients, their family and society: little support is available for people considering opioid withdrawal. Structured, group-based, psycho-educational self-management interventions help people to better manage their daily lives with persistent pain, but few specifically target patients considering opioid withdrawal.The Improving the Wellbeing of people with Opioid-Treated CHronic pain (I-WOTCH) study aims to enable people with persistent non-malignant pain to self-manage their pain better, reduce opioid use and improve their quality of life. We report the complex intervention-development approaches, the pilot process evaluation, and the patient-facing materials required.

Approach

Using MRC guidance, we applied our learning from a previous study to inform our new intervention, including additional content about opioids, and an opioid tapering regime. The multi-modal intervention materials have been adapted in response to feedback from the nurses and lay facilitators who have delivered the pilot I-WOTCH intervention. We are working with our patient and public involvement group and representatives on the Trial Management Group. We describe the iterative development, and the formative process evaluation results of the pilot phase, which have led to the further refinement of the new intervention and final materials.

Findings

The I-WOTCH intervention uses the biopsychosocial model, including the psychological theories of self-efficacy, social learning, and cognitive behaviour-change. Three, full-day sessions are co-delivered by a specifically trained nurse and a lay facilitator with experience of opioid withdrawal. Sessions cover pain and opioid pathways, partnership working with health professionals, communication skills, relaxation tools, action planning and problem solving (including managing setbacks).These aim to increase self-confidence and motivation. Participants are offered a one-to-one nurse session to agree a tailored opioid tapering programme, and follow-up telephone calls. Participants will additionally receive course handouts, a DVD and a mindfulness CD (or access electronic downloads). Both active and control arm participants will receive a My Opioid Manager book – a patient education tool (untested in the UK) - and a relaxation CD.

Consequences

This work highlights the context-specific theoretical considerations that necessarily underpin behaviour-change interventions and outlines the pragmatics of designing appropriate content involving multi-modal delivery media (paper, electronic, audio-visual), in collaboration with multiple stakeholders. We present examples of our intervention materials.By sharing the insights that we have gained from this process, other intervention developers can anticipate, implement and succeed in designing their intervention to optimise its persuasiveness, feasibility, relevance and benefit to participants.