Effectiveness of primary-contact physiotherapy in managing musculoskeletal conditions in emergency departments: Statistical analysis plan for the RESHAP-ED trial

The RESHAP-ED1 trial is a pragmatic, multicentre, two-arm, parallel randomised controlled trial which aims to test the effectiveness of primary-contact physiotherapy for musculoskeletal pain when compared to the traditional doctor/nurse pathway, on patient flow (i.e. length of stay) in the emergency department. The objective of this trial is to compare two approaches to physiotherapy involvement in the assessment and management of patients who present to emergency departments with simple musculoskeletal problems that are both standard of care in Australian emergency departments. The primary health services outcome is emergency department length of stay defined as the period between when a patient presents at an emergency department, and when that person is recorded as having physically departed the emergency department. The primary outcome will be analysed using a generalised linear mixed effects model with a fixed effect of intervention (primary-contact physiotherapy vs control) and a random effect for hospital. The statistical analysis plan pre-specifies the method of analysis for primary, secondary and safety outcomes and key variables collected in the trial. Secondary, and subgroup group analyses have been pre-specified as well.