FIT Study (Functional Outcomes In Trauma Study)

Why? There is not much information in the UK on how well patients who sustain major trauma function afterwards. Major trauma is defined as significant injuries with a calculated 'injury severity score' (ISS) over 15. The ISS is calculated based on how many parts of the body are injured and how badly injured these are, up to a maximum score of 75 (fatal). We feel that learning more about how these people cope afterwards, and what influences this will allow us to improve the care we can deliver in the future, which will hopefully lead to better outcomes. What? We propose to implement the FIT (Functional outcomes In Trauma) study to assess how well patients function physically, psychologically and socially, and get back to activities of daily living, work and participation in recreational activities following major trauma. Who? Major trauma patients: 2 cohorts: prospectively going forwards in time (from baseline to 12 months after trauma) and retrospectively going backwards in time (patients between 2-10 years after trauma). Where? Leeds General Infirmary. How? We will do this by collecting data from questionnaires completed by patients (also known as PROMS, or Patient Reported Outcome Measures), using an online questionnaire service developed at the University of Leeds, called QTool. These will offer the participants the chance to tell us how they are doing across lots of areas, with both tick-box multiple choice questions and open-ended questions to explain how they are doing and what influences this. We will also interview a random selection of patients in further detail to discuss how their trauma has affected them, how they found the study, how we could improve it. Afterwards we will send participants a copy of what we have learnt from the study and aim to publish it in a scientific journal. Timeline/Phase overview: The FIT Study will consist of 2 phases. Phase 1 will last for 2 years in total (12 months for prospective study cohort recruitment and 12 months follow-up for these patients) during which time data will be collected from the retrospective cohort as well. Following this there will be a full analysis of the data, after which phase 2 of the FIT Study will begin. Patients enrolled into phase 1 of the study will be given the option of consenting to being contacted annually to complete the same set of online PROMs, which will comprise phase 2 of the study. We will also continue active recruitment into both prospective and retrospective arms of the study in phase 2. We plan to continue data collection on an annual basis up to 10 years post trauma in phase 2 of the study for patients in both cohorts. We hope to incorporate elements of the FIT Study into future routine care with what we learn from the FIT Study, and develop our own unique Patient Reported Outcome Measure tool, with the overall aim of improving patient care and outcomes.

NCT Number	NCT04074382
Lead Sponsor	The Leeds Teaching Hospitals NHS Trust
Conditions	Patient Reported Outcome Measures, Recovery of Function, Rehabilitation, Disability Evaluation, Trauma Centers, Trauma Severity Indices, Advanced Trauma Life Support Care, Multiple Trauma/Injuries +3 more
Enrollment	440 participants
Start Date	2020-08-10
Primary Completion	2031-09 (estimated)
Study Completion	2032-09 (estimated)
Updated on ClinicalTrials.gov	2020-08-13