FIT Study (Functional Outcomes In Trauma Study)

NCT04074382 | Active Not Recruiting

• 3 other identifiers: OR19/12340125706419/YH/0280
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patient Reported Outcome Measures; Recovery of Function; Rehabilitation; Disability Evaluation; Trauma Centers; Trauma Severity Indices; Advanced Trauma Life Support Care; Multiple Trauma/Injuries; Wounds and Injuries; Orthopedic Disorder; Surgery

Keywords

Patient Reported Outcome Measures; Recovery of Function; Rehabilitation; Disability Evaluation; Trauma Centers; Trauma Severity Indices; Advanced Trauma Life Support Care; Multiple Trauma/Injuries; Wounds and Injuries; Orthopedic Disorder; Surgery

Outcome Measures

Primary Outcomes (1)

• Physical Component Score of SF-36v2 - PROM

  The primary aim of this project will be to assess the impact of major trauma, especially polytrauma, on the physical aspect of functional outcome, the change over time and trends in this data, assessed by the physical component score (PCS) of the SF-36 as our primary outcome measure. The SF-36 is a 36 item form, developed in 1990 based on work from the Rand corporation's Medical Outcomes Study in the 1970's is a widely used and validated measure of general function, covering eight domains (physical functioning, role limitations due to physical and emotional problems, bodily pain, social functioning, general mental health, vitality, general health perceptions). It has been extensively validated globally, and used in a large number of functional outcome studies which will allow broad comparison with our study group. We will use the Physical Component Score as our primary outcome measure

  As per description: 0-10 years after trauma. We will aim to collect this data in phase 1 and phase 2.

Secondary Outcomes (5)

• Trauma and Outcomes Profile (TOP) - PROM

  As per description: 0-10 years after trauma. We will aim to collect this data in phase 1 and phase 2.

• HADS: Hospital Anxiety and Depression Score - PROM

  As per description: 0-10 years after trauma. We will aim to collect this data in phase 1 and phase 2.

• EQ-5D: Euroqol 5 Dimensions Scale

  As per description: 0-10 years after trauma. We will aim to collect this data in phase 1 and phase 2.

• Leeds Trauma Questionnaire - PROM/PREM

  As per description: 0-10 years after trauma. We will aim to collect this data in phase 1 and phase 2.

• Qualitative Interview Outcomes

  As per description: 0-10 years after trauma. We will aim to collect this data in phase 1.

Other Outcomes (2)

• Work Status

  As per description: 0-10 years after trauma. We will aim to collect this data in phase 1 and phase 2.

• Social and Care Status

  As per description: 0-10 years after trauma. We will aim to collect this data in phase 1 and phase 2.

Study Arms (2)

Prospective Cohort

Prospective cohort (Phase 1, and Phase 2 Group A: explained in detailed description earlier) We will recruit and consent patients on the ward in the first few weeks following their admission for major trauma when the consultant in charge of their care feels that they are physically and emotionally/mentally ready and appropriate to take part in the study. A member of the research team will ask whether they want to take part in the study and offer them the participant information sheet. If happy to take part, the patient will have an account set up on the online questionnaire service we will be using called QTool. The consent form will be completed online at baseline along with the initial baseline PROM questionnaires. This group of people will then be sent reminders at 3, 6, 9 and 12 months to complete follow-up questionnaires, up to 28 days before or after these timepoints. They will then enter Phase 2 (Group A).

Other: Online Questionnaires; Other: Qualitative Interviews

Retrospective Cohort

Retrospective cohort (Phase 1/2): Patients between 1 to 10 years following their major trauma will be identified using a database. We will randomly select which of these patients to include in our study, using computer software, to reduce selection bias, and those selected will be sent a recruitment pack in the post. We have calculated that we need at least 320 patients in the retrospective cohort to show any important changes. This group of patients will only complete the questionnaires once in phase 1, and once per year up to 10 years after their trauma in phase 2 (Group B).

Other: Online Questionnaires; Other: Qualitative Interviews

Interventions

Online Questionnaires OTHER

We will use online questionnaires to complete research into functional outcomes after trauma

Prospective Cohort; Retrospective Cohort

Qualitative Interviews OTHER

We will undertake qualitative interviews (remote or face to face) to shed more light on reasons for functional outcomes after trauma

Prospective Cohort; Retrospective Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at Leeds Teaching Hospitals, who sustained/sustain major trauma (with priority for inclusion given to polytrauma) - to assess functional outcomes in these patients

You may qualify if:

• Injury Severity Score \>15
• Age 18-65

You may not qualify if:

• Impaired capacity of patient or proxy (dementia, significantly reduced cognitive ability)
• Patient not deemed to be in a physical or mental state to provide consent
• Any isolated head injury
• Involvement in another study, and these would adversely impact one another
• No access to internet linked device to complete questionnaires
• Poor grasp of English language
• Patient deceased

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds teaching Hospitals

Leeds, West Yorkshire, LS13EX, United Kingdom

Location

Related Publications (12)

• Balogh ZJ, Varga E, Tomka J, Suveges G, Toth L, Simonka JA. The new injury severity score is a better predictor of extended hospitalization and intensive care unit admission than the injury severity score in patients with multiple orthopaedic injuries. J Orthop Trauma. 2003 Aug;17(7):508-12. doi: 10.1097/00005131-200308000-00006.

  PMID: 12902789 BACKGROUND

• Abajas Bustillo R, Amo Setien FJ, Ortego Mate MDC, Segui Gomez M, Dura Ros MJ, Leal Costa C. Predictive capability of the injury severity score versus the new injury severity score in the categorization of the severity of trauma patients: a cross-sectional observational study. Eur J Trauma Emerg Surg. 2020 Aug;46(4):903-911. doi: 10.1007/s00068-018-1057-x. Epub 2018 Dec 8.

  PMID: 30535521 BACKGROUND

• Boyd CR, Tolson MA, Copes WS. Evaluating trauma care: the TRISS method. Trauma Score and the Injury Severity Score. J Trauma. 1987 Apr;27(4):370-8.

  PMID: 3106646 BACKGROUND

• Palmer C. Major trauma and the injury severity score--where should we set the bar? Annu Proc Assoc Adv Automot Med. 2007;51:13-29.

  PMID: 18184482 BACKGROUND

• Moran CG, Lecky F, Bouamra O, Lawrence T, Edwards A, Woodford M, Willett K, Coats TJ. Changing the System - Major Trauma Patients and Their Outcomes in the NHS (England) 2008-17. EClinicalMedicine. 2018 Aug 5;2-3:13-21. doi: 10.1016/j.eclinm.2018.07.001. eCollection 2018 Aug-Sep.

  PMID: 31193723 BACKGROUND

• Lefering R, Tecic T, Schmidt Y, Pirente N, Bouillon B, Neugebauer E; POLO Chart Study Group. Quality of life after multiple trauma: validation and population norm of the Polytrauma Outcome (POLO) chart. Eur J Trauma Emerg Surg. 2012 Aug;38(4):403-15. doi: 10.1007/s00068-011-0149-7. Epub 2011 Sep 14.

  PMID: 26816121 BACKGROUND

• Zwingmann J, Hagelschuer P, Langenmair E, Bode G, Herget G, Sudkamp NP, Hammer T. Lower Health-Related Quality of Life in Polytrauma Patients: Long-Term Follow-Up After Over 5 Years. Medicine (Baltimore). 2016 May;95(19):e3515. doi: 10.1097/MD.0000000000003515.

  PMID: 27175646 BACKGROUND

• Falkenberg L, Zeckey C, Mommsen P, Winkelmann M, Zelle BA, Panzica M, Pape HC, Krettek C, Probst C. Long-term outcome in 324 polytrauma patients: what factors are associated with posttraumatic stress disorder and depressive disorder symptoms? Eur J Med Res. 2017 Oct 30;22(1):44. doi: 10.1186/s40001-017-0282-9.

  PMID: 29084612 BACKGROUND

• Zeckey C, Hildebrand F, Pape HC, Mommsen P, Panzica M, Zelle BA, Sittaro NA, Lohse R, Krettek C, Probst C. Head injury in polytrauma-Is there an effect on outcome more than 10 years after the injury? Brain Inj. 2011;25(6):551-9. doi: 10.3109/02699052.2011.568036.

  PMID: 21534733 BACKGROUND

• Attenberger C, Amsler F, Gross T. Clinical evaluation of the Trauma Outcome Profile (TOP) in the longer-term follow-up of polytrauma patients. Injury. 2012 Sep;43(9):1566-74. doi: 10.1016/j.injury.2011.01.002. Epub 2011 Jan 20.

  PMID: 21255778 BACKGROUND

• Spreadborough S, Radford K, das Nair R, Brooks A, Duffy M. A study of outcomes of patients treated at a UK major trauma centre for moderate or severe injuries one to three years after injury. Clin Rehabil. 2018 Mar;32(3):410-418. doi: 10.1177/0269215517730862. Epub 2017 Sep 20.

  PMID: 28929802 BACKGROUND

• Folkard SS, Bloomfield TD, Page PRJ, Wilson D, Ricketts DM, Rogers BA. Factors affecting planned return to work after trauma: A prospective descriptive qualitative and quantitative study. Injury. 2016 Dec;47(12):2664-2670. doi: 10.1016/j.injury.2016.09.040. Epub 2016 Sep 30.

  PMID: 27712904 BACKGROUND

MeSH Terms

Conditions

Multiple Trauma; Wounds and Injuries; Musculoskeletal Diseases

Study Officials

• Peter Giannoudis, MD

  Leeds Teaching Hospitals

  STUDY CHAIR

• Paul Andrzejowski, BMBS

  Leeds Teaching Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 30, 2019
• Study Start: August 10, 2020
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2032
• Last Updated: August 13, 2020

Record last verified: 2019-08

Locations

GB (1)