Effect of rural trauma team development on outcomes of motorcycle related injuries: A protocol for a multi-center cluster randomized controlled clinical trial (The MOTOR trial)

BackgroundInjury is a global health concern whose mortality disproportionately impact low-income countries. Compelling evidence from high-income countries show that rural trauma team development courses (RTTDC) increase clinicians knowledge. There is a dearth of evidence from controlled clinical trials to demonstrate the effect of RTTDC on process and patient outcomes. We document a protocol 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. MethodsThis 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 control for confounding due to injury mechanisms and severity. In parallel to the trial, we shall establish a motorcycle trauma outcome registry (MOTOR) in consultation with community traffic police. DiscussionOur results could inform the design, implementation, and scalability of future rural trauma teams and education programs. Trial registrationRetrospectively registered with Pan African Clinical Trial Registry (PACTR202308851460352) on 17 August 2023. Ethics and disseminationEthical approval was obtained from Uganda National Council for Science and Technology (Ref: SS 5082) prior recruitment. The findings, anonymized datasets and code for analysis will be published publicly. Protocol VersionV (2023). Administrative informationHL (principal investigator, and corresponding author) was enhanced with a personal research loan from Uganda Medical Association to support this study. JPP is supported by the Academy of Finland (grant no 17379) and the Maire Taponen Foundation. The study sponsors did not have any role in the design, writing or decision to submit the protocol for publication. MAM is the study biostatistician, RS and PK are onsite study overseers whereas TB, JPP and MLW are offsite study supervisors. O_TBL View this table: org.highwire.dtl.DTLVardef@121bdc4org.highwire.dtl.DTLVardef@31938borg.highwire.dtl.DTLVardef@cd8ddaorg.highwire.dtl.DTLVardef@11bf409org.highwire.dtl.DTLVardef@3286b9_HPS_FORMAT_FIGEXP M_TBL C_TBL