Investigating the effect of a mHealth assisted allied health opioid tapering intervention on daily opioid use for chronic pain: the MOTION-Pilot randomised controlled trial

This project investigates an mHealth assisted allied health intervention for opioid tapering (mHealth Intervention). Components of this intervention include: 1) Pain ROADMAP monitoring Pain ROADMAP was designed by our research team to help people with chronic pain to accurately identify which activities cause pain flare-ups. Pain ROADMAP monitors physical activity, symptoms and behaviour over the course of a week. People with pain wear a commercially available TGA approved activity monitor (Actigraph) and enter data into our bespoke mobile phone app. This app functions as an electric diary and records self-reported pain ratings, pain medication intake and activity participation throughout the day. The app reminds participants to enter their medication and diary data through push notification every waking hour. In addition, the app alerts participants through push notifications to enter pain intensity ratings every waking hour using a 0–10 numerical rating scale. It is estimated that data entry takes approximately 15 minutes in total per day across multiple data entries. After participants have completed their one week monitoring period, their data is uploaded to our online portal where the data is analysed. The portal produces summary statistics for the week such as average pain intensity, percentage of time spent on productive tasks, and oral morphine equivalent daily dose (oMEDD) to monitor progress over time. In additional, a visual record of each day is produced associating specific activities with pain flare-ups using our published algorithm. The analysed output is used by clinicians to give feedback to clients/patients to help them reduce their pain flare ups, improve productivity and achieve their therapy goals. As part of this trial, participants will receive 3 x 1-week Pain ROADMAP monitoring periods and feedback appointments that are interspersed over a 25-week treatment block. Participants will be loan a phone with the Pain ROADMAP app installed and an Actigraph activity monitor for all monitoring periods. Data analytics from the Pain ROADMAP platform will be used to ascertain adherence to monitoring procedures as part of an assessment of treatment fidelity. 2) Individual occupational therapy treatment The occupational therapist uses the Pain ROADMAP data to provide feedback on the daily activities that are most likely contributing to pain flare ups and to monitor progress over time. For this trial, the occupational therapist will work with participants randomised to the mHealth Intervention group to reduce the frequency and severity of pain flare ups by adapting pain provoking activities and optimising routines. Examples of activity adaptions include breaking up a pain-provoking activity (mowing the lawn for 20 mins in the morning and 20 mins in the afternoon), using assistive equipment (long handle garden tools) or changing one’s posture while doing a task (sitting while doing meal preparation). The occupational therapist will also help participants set functional goals, develop graded functional activity programs for goals and develop individualised flare up management plans. Examples of exercises for graded functional activity programs include: “start walking 15 mins every day” and “cook dinner for family once a week”. Participants randomised to the mHealth intervention group will receive 8 sessions with the occupational therapist (1 assessment session and 7 active treatment sessions) over a 25-week treatment block. All sessions will be 60 minutes in length and occur approximately once every two-three weeks. The occupational therapist will document any deviations from the treatment protocol at the end of each treatment session using a custom-made case report form. Both attendance records and allied health practitioner documentation will be scrutinised by the research team to ascertain deviations from the treatment protocol as part of an assessment of treatment fidelity. 3) Individual pharmacy treatment The pharmacy sessions will focus on education about opioid-related harm, advice on how to best reduce opioid dose and supported supervised tapering. Treatment will be informed by the Australian Commission on Safety and Quality in Health Care (ACSQHC) and NPS MedicineWise guidelines and resources. As education will be tailored to the participant, generic education materials will not be provided. Tapering advice may include ceasing certain opioid medications in the context of less flare ups (PRN Endone), opioid rotation (rotating Targin to Buprenorphine), or a gradual reduction in dose over time (5-10% decrease in oMEDD every 2-4 weeks). The pharmacist will use Pain ROADMAP data to understand how participants take their medications, why participants may be taking extra medication and typical patterns of pain throughout the day. Pain ROADMAP data also be used to monitor progress and provide feedback on pain levels in the context of medication changes . All treatment decision will be made in consultation with the participant, their pain specialist, and their primary care physician. Participants randomised to the mHealth intervention group will receive 8 sessions with the pharmacist (1 assessment session and 7 active treatment sessions) over a 25-week treatment block. All sessions will be 60 minutes in length and occur approximately once every two-three weeks. The pharmacist will document any deviations from the treatment protocol at the end of each treatment session using a custom-made case report form. Both attendance records and allied health practitioner documentation will be scrutinised by the research team to ascertain deviations from the treatment protocol as part of an assessment of treatment fidelity. Mode of delivery Participants will have the option to either complete their treatment over telehealth or onsite at the Tess Cramond Pain and Research Centre. The Queensland Health telehealth portal will be used for telehealth sessions. Telehealth participants will be mailed their monitoring equipment and a pre-paid Australian Post parcel satchel to return their equipment after their monitoring is completed. A hard copy app manual and links to videos of app demonstrations will be given or mailed to participants during their first appointment.