The RESHAP-ED trial investigates whether a PCP pathway reduces time spent in EDs compared to the traditional medical/nursing pathway. This will be the first large, high-quality randomised controlled trial assessing the (cost) effectiveness and acceptability of a PCP pathway in EDs. The RESHAP-ED trial was designed to minimise service disruption.
RESHAPE-ED (ACTRN1263000782639) is a pragmatic multi-centre trial conducted across six public hospital EDs in Australia, recruiting patients with simple musculoskeletal conditions. The primary outcome is ED length of stay; secondary outcomes include the acceptability, feasibility, and (cost) effectiveness of the PCP pathway, along with patient experiences. Analyses will adhere to intention-to-treat principles, using linear regression to calculate the adjusted mean difference in ED length of stay. Understanding ED service processes is vital for minimising disruption during the trial.
Pragmatic Approaches
To minimise service disruption, we hired trial physiotherapists to deliver interventions and handle trial procedures, alleviating the burden on existing ED staff. ED length of stay data is being extracted from electronic medical records, while patient-reported outcomes is being collected via text messages and online questionnaires.
Learning
We determined that obtaining written consent for randomisation in busy EDs is impractical. The HREC waived individual randomisation consent because we are comparing two existing care pathways. Aligning trial procedures with standard ED practices, such as screening patients via the FirstNet system and triage notes, is essential. Eligibility criteria were designed to match conditions relevant to physiotherapy practice, and assessments and treatments will adhere to established clinical guidelines. Trial outcomes will be collected without disrupting healthcare services.
Challenges
Setting up and initiating the trial has been particularly challenging at regional sites or those with limited previous trial experience.
Trial Progress
Four EDs are actively recruiting for the trial. Of 2,250 participants screened, 965 out of 1,370 (trial target) are enrolled as at 3rd October 2024. Primary outcome response rate is currently 99.7%.
Embedding a clinical trial in an emergency department is complex. We employed various strategies for successful implementation, gaining insights from ED clinicians, patients, and experienced researchers.
As a pragmatic trial, this intervention occurs in real-world ED settings, allowing for the immediate application of results. This approach may enhance access to appropriate care while ensuring minimal service disruption. If the PCP pathway proves (cost) effective, it could lead to increased funding and expanded physiotherapy roles in primary-contact settings. Additionally, findings may inform updates to emergency medicine and physiotherapy practice guidelines.
Primary-contact physiotherapy
Emergency department
