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

IntroductionA 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/analysisThis 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 disseminationWales 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 numberISRCTN95571506; Pre-results.

Blunt chest trauma in the elderly: an expert practice review

“…An integer score of 26 was selected as the cut-off point, at which the patient was at sufficiently high risk to warrant intensive care admission. Although the score has been externally validated in a multicentre study, the clinical and cost-effectiveness of this score are yet to be proved by an appropriate randomised controlled impact trial 31. There are currently no superior alternative scores published, and if the STUMBL tool is appropriately validated, it could become a very useful component of the assessment of all patients suffering chest wall trauma, including the elderly.…”

Prognostic prediction tools and clinician communication: a qualitative study of the effect of the STUMBL tool on clinical practice

“…STUMBL was a multi-site step wedged feasibility study of the acceptability of using a prognostic model to guide decision making on blunt chest wall trauma in the ED. A total of 177 patients were consented into the study at four sitesthe Royal Gwent Hospital, Musgrove Park Hospital, Salford Royal Hospital and the Manchester Royal Infirmary [11]. The study was undertaken between October 2016 to September 2018, with the qualitative component conducted in the months of February, March and April of 2018.…”

“…In this paper we analyse data collected as part of a study on the feasibility of utilising a PPT in a critical care environment. The STUMBL (STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients) study was a multi-site feasibility trial set up to understand the feasibility of using a PPT in an emergency department (ED) setting with patients presenting with blunt chest wall trauma [11]. The tool takes five risk factors into account [12].…”

“…The model used here has been demonstrated to have excellent discrimination. This trial was only embarked on following this earlier validation work which has shown that clinicians can confidently assess whether the patient with the higher risk prediction using the model will develop complications following blunt chest-wall trauma, compared to the patients with low risk predictions who will not develop complications [11,12]. Nor do we assess the effect of this PPT on patient outcomes (step 5), as this is beyond the remit of the feasibility study.…”

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

“…Every month, one hospital was randomly assigned to the intervention period (using the prognostic model), until all hospitals were intervention sites. Online supplementary file 1 outlines the trial procedure, and the protocol describes the trial in full 14…”