What is the effect of a formalised trauma tertiary survey procedure on missed injury rates in multi-trauma patients? Study protocol for a randomised controlled trial

BACKGROUND: Missed injury is commonly used as a quality indicator in trauma care. The trauma tertiary survey (TTS) has been proposed to reduce missed injuries. However a systematic review assessing the effect of the TTS on missed injury rates in trauma patients found only observational studies, only suggesting a possible increase in early detection and reduction in missed injuries, with significant potential biases. Therefore, more robust methods are necessary to test whether implementation of a formal TTS will increase early in-hospital injury detection, decrease delayed diagnosis and decrease missed injuries after hospital discharge. METHODS/DESIGN: We propose a cluster-randomised, controlled trial to evaluate trauma care enhanced with a formalised TTS procedure. Currently, 20 to 25% of trauma patients routinely have a TTS performed. We expect this to increase to at least 75%. The design is for 6,380 multi-trauma patients in approximately 16 hospitals recruited over 24 months. In the first 12 months, patients will be randomised (by hospital) and allocated 1:1 to receive either the intervention (Group 1) or usual care (Group 2). The recruitment for the second 12 months will entail Group 1 hospitals continuing the TTS, and the Group 2 hospitals beginning it to enable estimates of the persistence of the intervention. The intervention is complex: implementation of formal TTS form, small group education, and executive directive to mandate both. Outcome data will be prospectively collected from (electronic) medical records and patient (telephone follow-up) questionnaires. Missed injuries will be adjudicated by a blinded expert panel. The primary outcome is missed injuries after hospital discharge; secondary outcomes are maintenance of the intervention effect, in-hospital missed injuries, tertiary survey performance rate, hospital and ICU bed days, interventions required for missed injuries, advanced diagnostic imaging requirements, readmissions to hospital, days of work and quality of life (EQ-5D-5 L) and mortality. DISCUSSION: The findings of this study may alter the delivery of international trauma care. If formal TTS is (cost-) effective this intervention should be implemented widely. If not, where already partly implemented, it should be abandoned. Study findings will be disseminated widely to relevant clinicians and health funders. TRIAL REGISTRATION: ANZCTR: ACTRN12613001218785, prospectively registered, 5 November 2013 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0733-y) contains supplementary material, which is available to authorized users.