A multi-centre randomised feasibility study evaluating the impact of a prognostic model for management of blunt chest wall trauma patients. STUMBL Trial

Blunt chest wall trauma accounts for over 15% of all trauma admissions worldwide.

Reported mortality ranges between four and 20%. [1] Difficulties in the management of these patients in the Emergency Department (ED) are well recognised, due to the frequent on-set of delayed complications. [1-3] A prognostic model that can assist in the management of this patient group has recently been developed and externally validated by this study team. [4] In order for the model to be used by clinicians in the ED, the completion of a full impact trial is required.

The aim of this trial is to establish the feasibility of a future definitive trial comparing the use of a new prognostic model for the management of blunt chest wall trauma patients in the ED versus conventional management (using no model). To achieve this aim, these objectives will be addressed:

1- Evaluate the infrastructure necessary to perform a future definitive trial, including a Trial Management Group, Trial Steering/Data Management Committee
2- Test the feasibility of the proposed progressive, cluster-randomised design
3- Evaluate and qualitatively explore the compliance of the clinicians in using the prognostic model (and reasons for non-compliance) and adherence to interview schedules/focus groups
4.- Assess the appropriateness of the training manual and consistency of training provided by each principal investigator (PI)
5- Quantify the number of patients required for a full definitive trial through the estimation of the magnitude of effect and necessary parameters, including the margin of error acceptable to achieve the proposed outcomes
6- Assess the processes of patient recruitment, consent and reasons for non-participation
7- Assess the quantity and potential patterns of missing data
8- Test the feasibility of collecting the proposed outcome measures for a full trial, including optimal time points, using the electronic case report form on the MACRO 4 data collection system
9- Decide whether a fully powered, multi-centre randomised trial is indicated by formal assessment of feasibility trial findings against pre-set progression criteria
10- If the full definitive impact trial is indicated then potential research sites across UK will be contacted for participation and a full trial protocol and funding application to the NIHR will be completed.

Study design: A multi-centre, progressive cluster-randomised controlled trial will be completed to compare conventional management of blunt chest wall trauma patients with implementation of the new prognostic model. [5]. Four sites will start the data collection for two months using conventional management (without model). During this period, the PI for each site will train all doctors in the use of the model.

A second two month data collection period will then begin, using the new model. All patients presenting to the ED with blunt chest wall trauma will be eligible for inclusion, excluding non-consenting adults, patients under 18 years of age and patients with immediately life threatening injuries whose management will be dictated by the need for life preserving intervention. Data collection will focus on the feasibility trial objectives.

The potential benefits will be the evaluation of the full impact trial protocol. The long term benefits support prudent healthcare as the aim is to reduce the rate of morbidity, improve quality of life and cost-effectiveness of patient management.