Aim:
To describe the pragmatic approach used to embed the RESHAP-ED trial in routine emergency department (ED) practice in Australia, including the learnings and the challenges encountered.
Method:
RESHAP-ED is a randomised controlled trial comparing primary-contact physiotherapy with standard care for musculoskeletal conditions in six Hospital EDs in NSW.
Results:
Pragmatic approaches
RESHAPE-ED was designed to minimise impact on participating EDs. An important step was funding the trial physiotherapists from the MRFF grant. These additional staff provide the trial intervention and complete the trial procedures (e.g. enrolment and randomisation) so we are not imposing on the existing ED staff. The primary outcome, ED length of stay, is extracted from electronic medical records, and patient-reported outcomes are collected after discharge via text message invitation (Twilio) and online questionnaire (REDCap).
Learning
We learnt that it is not practical to obtain written consent for randomisation in the busy ED setting. The HREC allowed a waiver of consent for individual randomisation (since we are comparing two standards of care)
We also learned the importance of aligning trial procedures with those of the ED to ensure minimal disruption. For example the screening of patients matches the usual process the physiotherapists use to select their patients (i.e. screen FirstNet system and read triage notes). We have also drafted inclusion and exclusion criteria to match health conditions that fall within the scope of current physiotherapy practice in the emergency department. Assessment and treatments are delivered as usual based on New South Wales and Australian clinical guidelines for musculoskeletal conditions. Trial outcomes are collected without service disruption.
Challenges
Site set up and initiation has been more challenging at regional sites or sites with little previous trial experience.
Conclusion:
Embedding a clinical trial in an emergency department is a complex process. We employed a variety of strategies to ensure the successful implementation of this trial, which involved a significant amount of learning and various challenges.