Safer AnalGEsia (SAGE) Trial

The SAGE intervention is a GP-facing intervention which involves • Training for GPs in deprescribing skills including communication training (using the motivational interviewing approach) and access to evidence-based deprescribing resources such as tapering algorithms; • To assist the deprescribing process for their patients, GPs can (at no cost to the patient) conduct a long GP consultation; refer to trained physiotherapists for the provision of evidence-based, psychologically-informed physiotherapy sessions; provide alternate pain management options for patients at no cost to them; and patient education if needed. GP training To support GPs in communicating medication-related harms with patient-participants and provide tapering strategies informed by the evidence, we will use a communication support bundle, which will be packaged and delivered during an out-reach visit to GP. The communication bundle comprises the NPS MedicineWise “Opioids: Communication Videos alongside an educational video developed by the research team featuring an experienced GP, which will be presented during the face-to-face training with the study GPs. Together, the videos discuss conversations between GPs and patients, and outlines 'motivational interviewing', the recommended evidence-based communication approach for these conversations, including its underlying ethos, four main principles (empathy, developing discrepancy, rolling with resistance, supporting self-efficacy) and five key skills (open ended questioning, affirmations, reflections, summarisations, elicit shared understanding). Whilst the NPS MedicineWise communication videos discuss tapering in the context of opioid medicines, the messages presented are applicable to other high-risk medicine classes, including benzodiazepines and gabapentinoids. The training will be delivered to study GPs face-to-face (in extreme circumstances, the training may be delivered via video call, i.e. Zoom). During this training, GPs will also be given access to trusted, up-to-date deprescribing resources developed by our partners, e.g. “Medicines Conversation Guide” and Opioid Deprescribing Guideline to support safe tapering of the target medicine(s). GPs will also be given access to trusted tapering algorithms for opioids, gabapentinoids and benzodiazepines e.g. those developed by NPS MedicineWise, The National Health Service (NHS) and Royal Australian College of General Practitioners. The resources offer GPs guidance on safe dose reduction, tailoring the deprescribing plan to the patient-participant, monitoring for withdrawal symptoms, making dose adjustments, and supporting patient-participants to identify and report withdrawal symptoms. Deprescribing support Long GP Consultation: The multifaceted deprescribing intervention will involve a trial-funded “longer” GP consultation. This consultation aligns with standard GP consultation time of a Medicare “Level C” consult (which is at least 20-minutes to less than 40 minutes in duration). This consultation will be provided once and scheduled within 6 weeks of identifying regular patient use of the target medicine and receiving patient consent. The “longer” consultation is intended to support the effective management of chronic conditions and will facilitate a deep discussion about strategies to taper the high-risk medicine (informed by the resources developed by the team). GPs will be asked not to charge Medicare for the consultation in addition to the remuneration they will receive as part of their involvement on the trial. Participant education GPs in the intervention arm will be trained to offer education and psychologically-informed guidance on the target high-risk medicine(s). GPs will be asked to discuss with the patient-participant the use and tapering of the target high-risk medicine, using the guidance provided in the Medicines Conversation Guide, Opioid Deprescribing Guide and tapering guides, and provide education. The education, delivered verbally during consultations with study GPs and phsyiotherapists, combines evidence-based messages on judicious use, harms, and safe disposal of opioids with management strategies endorsed in international back and/or neck pain guidelines, e.g. advice to stay active and avoid bed rest. These strategies assist with pain relief and can speed recovery from back and/or neck pain. Patients will be encouraged to ask questions about pain, discuss a pain management plan, including a tapering plan, and set achievable goals around this. Consumer Medicines Information leaflet provided by study team Each patient-participant in the trial will be provided with a Consumer Medicines Information (CMI) leaflet for the target-high risk medicine currently being used for the chronic back and/or neck pain following the baseline contact. The appropriate CMI will be determined during the baseline contact between the researcher and the patient-participant and provided by the study team. Further, a letter accompanying the CMI leaflets will also be provided by the study team, advising patient-participants to discuss any queries or concerns regarding the CMI leaflets with their doctor or pharmacist. Alternate pain management assistance To further support the tapering process, the trial will provide heat wraps, topical diclofenac gel and referral for psychologically informed physiotherapy sessions. GP training will include training in the study protocol and process (<60min) for all GPs and training associated with the intervention for those randomised to the intervention group (one ~60min session). This training will happen before they start recruiting patient participants. Training will be delivered by the study team (trained researchers with a background in public health, pharmacy etc) and preferentially conducted face-to-face to deliver all relevant materials which could be either one-on-one or in groups (group size will depend on the number of eligible GPs in the practice). GPs will continue to have access to all materials and ongoing support throughout the trial. GP can contact the study team for more information at any point during the trial. The total duration of the study period for each GP will be as long as their involvement in the recruitment of participants. The overall duration of site participation in the trial will be 5 years (subject to extension depending on recruitment rate).

The SAGE intervention is a GP-facing intervention which involves • Training for GPs in deprescribing skills including communication training (using the motivational interviewing approach) and access to evidence-based deprescribing resources such as tapering algorithms; • To assist the deprescribing process for their patients, GPs can (at no cost to the patient) conduct a long GP consultation (trial-funded); refer to trained physiotherapists for the provision of evidence-based, psychologically-informed physiotherapy sessions; provide alternate pain management options (at no cost to the patient). GP training To support GPs in communicating medication-related harms with patient-participants and provide tapering strategies informed by the evidence, we will use a communication support bundle comprising videos, communication support guidance documents and tapering algorithms, which will be packaged and delivered during an out-reach visit to each recruited GP practice. The communication support bundle comprises the NPS MedicineWise “Opioids: Communication Videos alongside an educational video developed by the research team featuring an experienced GP, which will be presented during the face-to-face training with the study GPs. Together, the videos discuss conversations between GPs and patients, and described 'motivational interviewing', the recommended evidence-based communication approach for these conversations, including its underlying ethos, four main principles (empathy, developing discrepancy, rolling with resistance, supporting self-efficacy) and five key skills (open ended questioning, affirmations, reflections, summarisations, elicit shared understanding). While the NPS MedicineWise communication videos discuss tapering in the context of opioid medicines, we will explain to GPs that the messages presented are applicable to other high-risk medicine classes, including benzodiazepines and gabapentinoids. During this training, GPs will also be given access to trusted, up-to-date deprescribing resources developed by our partners, e.g. “Medicines Conversation Guide” and Opioid Deprescribing Guideline and other deprescribing resources hosted on the New South Wales Therapeutic Advisory Group Website ((https://www.nswtag.org.au/deprescribing-tools/) to support safe tapering of the target medicine(s). GPs will also be given access to trusted tapering algorithms for opioids, gabapentinoids and benzodiazepines e.g. those developed by NPS MedicineWise, The National Health Service (NHS) and Royal Australian College of General Practitioners. The resources offer GPs guidance on safe dose reduction, tailoring the deprescribing plan to the patient-participant, monitoring for withdrawal symptoms, making dose adjustments, and supporting patient-participants to identify and report withdrawal symptoms. Where outreach and delivery of the communication support bundle cannot feasibly occur face-to-face, they may be conducted via video call, (e.g. Zoom). Deprescribing support Long GP Consultation: The multifaceted deprescribing intervention will involve a trial-funded “longer” GP consultation payment at the rate of an Australian Medicare Benefits Schedule Item 36 "Level C" concultation (20 to 40 minutes in duration). This consultation will be provided once and scheduled within 2 weeks of identifying regular patient use of the target medicine and receiving patient consent. The “longer” consultation is intended to support the effective management of chronic conditions and is intended to facilitate a deep discussion about strategies to taper the high-risk medicine (informed by the resources developed by the team). GPs will be asked not to charge Medicare for the consultation in addition to the remuneration they will receive as part of their involvement on the trial. GPs will be asked to discuss with the patient-participant the use and tapering of the target high-risk medicine, using the guidance provided in the Medicines Conversation Guide, Opioid Deprescribing Guide and tapering guides, and provide verbal education. Study physiotherapists will be asked to provide patient participants with verbal education. The education combines evidence-based messages on judicious use, harms, and safe disposal of opioids with management strategies endorsed in international back and/or neck pain guidelines, e.g. advice to stay active and avoid bed rest. These strategies assist with pain relief and can speed recovery from back and/or neck pain. Patients will be encouraged by their treating GPs to ask questions about pain, discuss a pain management plan, including a tapering plan, and set achievable goals. Consumer Medicines Information leaflet provided by study team Each patient-participant in the trial will be provided with a Consumer Medicines Information (CMI) leaflet for the target-high risk medicine currently being used for the chronic back and/or neck pain following the baseline contact. The appropriate CMI will be determined during the baseline contact between the researcher and the patient-participant and provided by the study team. Further, a letter accompanying the CMI leaflets will also be provided by the study team, advising patient-participants to discuss any queries or concerns regarding the CMI leaflets with their doctor or pharmacist. Alternate pain management assistance To reduce reliance on the high-risk medicine and further support the tapering process, GPs can provide patient-participants with heat wraps, topical diclofenac gel and referral for psychologically-informed physiotherapy sessions at no cost (funded by the trial). GP training will include training in the study protocol and process (<60min) for all GPs and training associated with the intervention for those randomised to the intervention group (one ~60min session). This training will happen before they start recruiting patient participants. Training will be delivered by the study team (trained researchers with a background in public health, pharmacy etc) and preferentially conducted face-to-face to deliver all relevant materials which could be either one-on-one or in groups (group size will depend on the number of eligible GPs in the practice). GPs will continue to have access to all materials and ongoing support throughout the trial. GP can contact the study team for more information at any point during the trial. The total duration of the study period for each GP will be as long as their involvement in the recruitment of participants. The overall duration of site participation in the trial will be 5 years (subject to extension depending on recruitment rate).