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Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial

Abstract

Introduction A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). A definitive randomised controlled trial (impact trial) is required to assess the clinical and cost effectiveness of the new model before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design.

Methods/analysis This feasibility trial is designed to test the methods of a multicentre, cluster-randomised (stepped- wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a 5-month period; in the initial period acting as the controls (normal care), and in the second period acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a 6-week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory). Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed.

Ethics and dissemination Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Patient recruitment will commence in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at professional meetings.

Trial registration number ISRCTN95571506; Pre-results.

  • blunt chest wall trauma
  • prognostic model
  • feasibility trial
  • stepped-wedge randomised trial

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors All authors of the paper have contributed to the design of the trial. CB wrote this protocol and all other authors edited and made revisions for intellectual content. PE, HH FL, JG and SJ have been involved in the background development and validation work leading up to this trial. For the protocol development, PE, FL, RB, SJ and JG provided the Emergency Medicine expertise, SG provided the health economic expertise, AW provided the statistical expertise, HH provided patient reported outcomes expertise, HH and ZA and overall methodological expertise and CON developed and wrote the qualitative aspects of the protocol. All authors have read and approved the final manuscript for publication.

  • Funding This trial is supported by a Research for Patient and Public Benefit (RfPPB) Grant by Health and Care Research Wales. Project reference: 1193.

  • Disclaimer The funding sources have no role in the design of this trial. The views expressed are those of the author(s) and not necessarily those of the NHS, Health and Care Research Wales, the NIHR or the Department of Health

  • Competing interests None declared.

  • Ethics approval Wales REC 6.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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