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

INTERVENTION: 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 CONDITION: Anaesthesiology ‐ Pain management Chronic Pain; ; Chronic Pain Public Health ‐ Health service research PRIMARY OUTCOME: Any change in oral morphine equivalent daily dose (oMEDD) [The oMEDD value will be estimated by an assessor who will be blinded to the group status of participants. The assessor will review available electronic medication prescription records and conduct a phone interview with participants using a structured interview technique to obtain a best possible medical history (BPMH). The oMEDD value will then be calculated using the Faculty of Pain Medicine ANZCA Opioid Calculator based on the BPMH. Baseline and 6‐months post‐intervention commencement ] INCLUSION CRITERIA: Patients will be eligible to participate in the trial if they: i) have a pain duration equal to or greater than 3 months, ii) are aged 18 ‐ 80 years, iii) have non‐malignant pain, iv) are prescribed opioids, and v) are open to engaging with allied health staff to discuss their pain medications. SECONDARY OUTCOME: Dropout rate [Audit of study enrolment/withdrawal logs. Calculated as percentage of participants who completed 6‐month outcome measures from those who were enrolled. Cumulative data will be assessed at the conclusion of the trial.] Intervention acceptability [7‐point Likert Scale 6‐months post‐intervention commencement ] Opioid tapering self‐efficacy [Visual Analog Scale Baseline and 6‐months post‐intervention commencement ] Overactivity severity [The Overactivity in Persistent Pain Assessment Baseline and 6‐months post‐intervention commencement ] Pain Interference [Brief Pain Inventory Baseline and 6‐months post‐intervention commencement ] Pain Severity [Brief Pain Inventory Baseline and 6‐months post‐intervention commencement ] Recruitment rate [Audit of study enrolment/consent logs. Calculated as average number of participants per month who provided informed consent and were enrolled in the study. Cumulative data will be assessed at the conclusion of the trial.] Self‐reported opioid misuse [Prescription Opioid Misuse Inde XBaseline and 6‐months post‐intervention commencement ] Self‐reported problems related to opioid use [Problems Subscale of Prescription Opioid Difficulties Scale Baseline and 6‐months post‐intervention commencement ] Self‐reported substance use [Recorded by the blinded assessor during the phone interview using the Substance Use section of the interRAI Self‐Assessment for Mental Health. Baseline and 6‐months post‐intervention commencement ] Treatment Fidelity[Data analytics from the Pain ROADMAP platform will be used to ascertain adherence to monitoring procedures. The allied health practitioners 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. Cumulative data will be assessed at the conclusion of the trial.]