Embedding digitally enabled, single case experiments in general practice to support self-management and shared decision-making with patients with persistent pain

Personalised, non-drug single case experimental design trials of self-managed activity chosen by patient from a list of options available locally and affordable for the patient. The list of suggested options will be revised at intervals during the study to ensure it is updated and options remain available at the time of patient enrolment. We will not pre-specify a particular list of options in this protocol as we expect availability to change over the course of the study, and options suggested by the patient will also be considered if suitable. Options are likely to include group or individual walking programs, chair yoga, park Tai Chi, mindfulness practice, personalised exercise program, online pain management module, and online cognitive-behavioural therapy. None of these activities is designed specifically for the study, and all are publicly available, with the exception of a personalised exercise program (which is likely to require an exercise physiologist or physiotherapist assessment and prescription). Online options are openly accessible and ideally free of charge. Some activities may be sponsored by local government or councils. The patient's GP will indicate suitable options for the patient. The list will also be reviewed at intervals by a physiotherapist with expertise in persistent pain, who is a member of the research team. Specific examples of online options recommended by the physiotherapist include MindSpot via https://www.mindspot.org.au/treatment/our-courses/pain-course/, SmilingMind via https://www.smilingmind.com.au/smiling-mind-app, and myWhiplash Navigator via https://mywhiplash.com.au/. A brief description of these options is as follows: MIndSpot is a self-guided course including 5 lessons with the option of online, weekly therapist support, providing education and management strategies for cycles of persistent pain; SmilingMind is a self-guided app providing education and strategies for mindfulness practice and meditation; myWhiplash Navigator is a self-directed online program to guide people on how best to recover from a whiplash injury. Patients rate symptoms on a daily basis at baseline and during intervention, using a mobile phone app called StudyU, over a period of 8-10 weeks. StudyU is the digital enabler of the patient's single case experiment testing the effectiveness of their chosen, self-managed activity. Participants will download the StudyU app on to their mobile phone and a personalised study will be set up for them by the study manager. StudyU has been developed to assist with single case experiments in various settings and patient groups, so it has not been developed specifically for this study, although the researchers are collaborating with the developers to improve design features for patients with persistent pain. StudyU produces a clinical report at the conclusion of each experiment, which is sent to the patient and their GP, so that the two can discuss activity effectiveness and make shared decisions about ongoing care. Patients will be encouraged to persist with their selected activity for 6-8 weeks, in order to test effectiveness. On completion of one experiment, they may choose to conduct another experiment to test the effectiveness of a different activity. The frequency and duration of activities will vary depending on the activity chosen by the patient, and will be self-paced and self-managed. Options involving physical activity are likely to last from 10 - 50 minutes, undertaken from daily (or most days) to 2-3 times per week. Options involving mindfulness practice are likely to be of shorter duration and up to several times a day. Options involving online modules will also be self-paced, and guided by the module design. Online activities will not be accessed through the StudyU app, but patients will use the StudyU app to rate their pain and its impact during their experiment. Patients will record their own adherence to planned activities.