JMIR Publications

ABSTRACT

Background:

Injury is a global health concern whose mortality disproportionately impact low- and middle-income countries (LMICs). Compelling evidence from observational studies in high-income countries show that trauma education programs such as rural trauma team development courses (RTTDC) increase clinicians’ knowledge for injury care. There is a dearth of such evidence from controlled clinical trials to demonstrate the effect of RTTDC on process and patient outcomes in LMICs context.

Objective:

We document a protocol and methods for a multi-center cluster randomized controlled clinical trial which aims to examine the impact of RTTDC on process and patient outcomes of motorcycle-related injuries in African low-resource settings.

Methods:

This will be a two-armed parallel multiple period cluster randomized controlled clinical trial in Uganda, where rural trauma team development training is not routinely conducted. We shall recruit regional referral hospitals and include road traffic injured patients, interns, medical trainees, and road traffic law enforcement professionals who serve as trauma care frontliners. Three hospitals will be cluster randomized to RTTDC (intervention group) and the remaining three to standard care (control group). The primary outcomes will be prehospital interval from accident scene to arrival at emergency department, and referral-exit interval from the time the referral decision is made to hospital exist in hours as a measure of process improvement. The secondary outcomes will be all cause mortality, and morbidity of neurological, and orthopedic injuries based on the Glasgow Outcome Scale and Trauma Outcome Measure Scores respectively at 90-days post injury. All outcomes will be measured as final values. We shall compare baseline characteristics and outcomes both at individual, and at cluster level as intervention versus control group. We shall use the mixed effects regression models in Stata 15.0 to report any absolute or relative differences along with 95% CIs. We shall perform subgroup analyses to evaluate and control confounding due to injury mechanisms and injury severity. In parallel to the trial, we shall establish a motorcycle trauma outcome (MOTOR) registry in consultation with community traffic police.

Results:

The anticipated outcomes of this trial is to unveil how a locally contextualized rural trauma team development program impact organisational efficiency in terms of prehospital and referral exit intervals in a continent challenged with limited infrastructure and human resource. More importantly, the study will uncover how rural trauma team coordination impact clinical outcomes such as morbidity and mortality of neurological and orthopedic injuries which are the key targets for strengthening trauma systems in LMICs where prehospital care is embryonic.

Conclusions:

Our results could inform the design, implementation, and scalability of future rural trauma teams and trauma education programs in LMICs. Clinical Trial: Retrospectively registered with Pan African Clinical Trial Registry (PACTR202308851460352) on 17 August 2023. Ethical approval was obtained from Uganda National Council for Science and Technology (Ref: SS 5082) prior recruitment.