Abstract
BACKGROUND: Safer Births Bundle of Care (SBBC) is a continuous quality improvement (CQI) program, implemented in 30 facilities in Tanzania, resulting in a 75% reduction in maternal deaths. Simulation training was introduced as a component of the CQI efforts, targeting individual and team skills, focusing on identified clinical needs. OBJECTIVE: The aim of this study was to describe the frequency of documented simulation sessions and the number of recurrent participants and associations with changes in maternal death. METHODS: SBBC was a stepped-wedge cluster randomised implementation study in 30 facilities in 5 regions of Tanzania from 2020 through 2023. The SimBegin® facilitator training program was introduced to train facilitators and support implementation of a training cascade. Fifteen selected healthcare workers were trained in three levels of SimBegin® to become facilitators (level 1) and mentors (level 2). Eight were trained to become instructors (level 3). In total, 90 local facilitators were trained to review local clinical data, run simulation sessions, and document in logbooks. Clinical data were collected from patient files by independent data collectors and looped back to the facilities on a weekly basis. Training interventions were planned, conducted, and evaluated based on identified gaps. Output measures were the frequency of simulation sessions, the number of recurring participants, and maternal death within 7 days postpartum the following month. RESULTS: Overall, 281,165 parturient women were included in this study. The SBBC implementation period was 24-32 months, and 1280 simulation sessions were documented. Maternal deaths declined from 240/100,000 births in the baseline to 60/100,000 after the start of SBBC. There was an association between the frequency of simulation sessions and the reduction in maternal deaths (23% reduction per each unit increase on the log scale, P = 0.0018), and between the number of recurring participants and the reduction in maternal deaths (16% reduction per each unit increase on the log scale, P = 0.0006). CONCLUSION: This study documents a significant and clinically relevant association between the frequency of and participation in simulation sessions and the reduction of maternal deaths the following month. TRIAL REGISTRATION: SBBC main protocol ISRCTN Registry: ISRCTN30541755. Prospectively registered 12.10.2020.