A pragmatic, two-arm, parallel randomised controlled trial comparing a virtual care referral pathway with usual paramedic care for back pain in ambulance service: Redesigning Ambulance Management for Back-pain Outcomes the RAMBO trial

Trial paramedics will randomly allocate patients via REDCap, to receive either virtual care (intervention group) by Sydney Virtual Hospital or usual care (control group) by a paramedic/s. Patients allocated to the intervention group will be transferred by the paramedic to the virtualADULTS service, where the patient will be triaged, screened for appropriateness and accepted by a nurse into virtualADULTS. The patient’s details will then be registered into the electronic system and the virtual care clinician will begin their clinical assessment of the patient, supported by the on-scene paramedic. The process from call to completion of clinical assessment is anticipated to take ~30 minutes. If the emergency physician confirms that the patient is suitable to remain at home and receive virtual care, the paramedic will discharge the patient and responsibility for ongoing management will transfer to the virtualADULTS service. This may include onward referral to other Sydney Virtual services (e.g. Back@Home). Clinical care will be provided in accordance with the Australian Low Back Pain Clinical Care Standards and may include prescribing medications, ordering pathology or radiology investigations as required, and arranging follow-up (often done by virtualADULTS nurses) the same day and/or next day to assess the patient’s progress. If the virtualADULTS emergency physician determines that the patient is not suitable for virtual care and requires in-person medical assessment, the paramedic will immediately resume care as per standard practice, including transport to the ED or referral to the GP as clinically indicated. Patients randomised to the virtual care pathway who are subsequently escalated to in-person care will be analysed in the group to which they were originally assigned. Recruited NSW Ambulance service clinicians will receive ongoing education and training regarding the trial and associated processes, including screening patients, randomisation, initiating the referral to Sydney Virtual, and transfer of care initially and throughout the study period to ensure awareness and confidence in using the virtual care referral pathway to manage people with back pain is achieved. Initial training will be conducted during the two months prior to the anticipated trial start, followed by ad-hoc training on an ongoing basis. The virtualADULTS triage/screening/clinician review will occur via a dedicated ambulance device managed by the attending paramedic. Participants who are eligible and accepted by the virtualADULTS service will be phoned on their own device by the virtual care clinician, to provide care, prescriptions and ongoing referrals. Every patient enrolled in this study will be followed for a period of 42 days with short online patient-reported outcome measure surveys at day 3, 7, 14 and 42. Patients, regardless of the group in which they were allocated, will be verbally invited to participate in qualitative interviews, retrospectively, by involved clinicians (e.g. paramedic or virtual clinician). Patient qualitative interviews will occur between Day 3 and Day 42 after being attending by a paramedic for their back pain. VirtualADULT clinicians (i.e. emergency physicians) and recruited paramedics will also be invited to participate in qualitative interviews. The referral pathway between NSW Ambulance and virtualADULTS is an existing care pathway within NSW Ambulance. However, there is currently no specific referral pathway for back pain. A dedicated pathway will be established prior to commencement of recruitment for the trial. Various methods will be employed to monitor trial process adherence including through data validation quarterly audits, monitoring visits, annual study reports and as required reporting of protocol deviations.