Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
Department of Pain Medicine, James Cook University Hospital, Middlesbrough, UK.
BMJ Open. 2022 Mar 16;12(3):e053725. doi: 10.1136/bmjopen-2021-053725.
To describe the design, development and pilot of a multicomponent intervention aimed at supporting withdrawal of opioids for people with chronic non-malignant pain for future evaluation in the Improving the Wellbeing of people with Opioid Treated CHronic pain (I-WOTCH) randomised controlled trial.
The I-WOTCH intervention draws on previous literature and collaboration with stakeholders (patient and public involvement). Intervention mapping and development activities of Behaviour Change Taxonomy are described.
The intervention development was conducted by a multidisciplinary team with clinical, academic and service user perspectives. The team had expertise in the development and testing of complex health behaviour interventions, opioid tapering and pain management in primary and secondary care, I.T programming, and software development-to develop an opioid tapering App.
The I-WOTCH trial participants are adults (18 years and over) with chronic non-malignant pain using strong opioids for at least 3 months and on most days in the preceding month.
A multicomponent self-management support package to help people using opioids for chronic non-malignant pain reduce opioid use.
Receiving information on the impact of long-term opioid use, and potential adverse effects were highlighted as important facilitators in making the decision to reduce opioids. Case studies of those who have successfully stopped taking opioids were also favoured as a facilitator to reduce opioid use. Barriers included the need for a 'trade-off to fill the deficit of the effect of the drug'. The final I-WOTCH intervention consists of an 8-10 week programme incorporating: education; problem-solving; motivation; group and one to one tailored planning; reflection and monitoring. A detailed facilitator manual was developed to promote consistent delivery of the intervention across the UK.
We describe the development of an opioid reduction intervention package suitable for testing in the I-WOTCH randomised controlled trial.
ISRCTN49470934.
描述一项多组分干预措施的设计、开发和试点,旨在为未来在改善接受阿片类药物治疗的慢性疼痛患者的幸福感(I-WOTCH)随机对照试验中支持慢性非恶性疼痛患者阿片类药物戒断提供支持。
I-WOTCH 干预措施借鉴了先前的文献和与利益相关者(患者和公众参与)的合作。描述了行为改变分类学的干预映射和开发活动。
干预措施的开发由具有临床、学术和服务用户观点的多学科团队进行。该团队在开发和测试复杂的健康行为干预措施、初级和二级保健中的阿片类药物逐渐减量和疼痛管理、IT 编程和软件开发方面具有专业知识-开发阿片类药物逐渐减量应用程序。
I-WOTCH 试验参与者为年龄在 18 岁及以上、使用强阿片类药物至少 3 个月且在前一个月的大多数日子都在使用的慢性非恶性疼痛患者。
提供有关长期使用阿片类药物的影响和潜在不良反应的信息,被强调为做出减少阿片类药物使用的决定的重要促进因素。成功停止使用阿片类药物的案例研究也被认为是减少阿片类药物使用的促进因素。障碍包括需要“权衡以弥补药物效果的不足”。最终的 I-WOTCH 干预措施包括一个 8-10 周的计划,包括:教育;解决问题;动机;小组和一对一量身定制的计划;反思和监测。制定了详细的促进者手册,以促进在英国各地一致提供干预措施。
我们描述了一种适合在 I-WOTCH 随机对照试验中测试的阿片类药物减少干预包的开发。
ISRCTN49470934。