Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO2): study protocol for a cluster randomised trial

Gabriel Birgand, Thomas Haudebourg, Leslie Grammatico-Guillon, Léa Ferrand, Leila Moret, François Gouin, Nicolas Mauduit, Christophe Leux, Yannick Le Manach, Didier Lepelletier, Elsa Tavernier, Jean-Christophe Lucet, Bruno Giraudeau, Gabriel Birgand, Thomas Haudebourg, Leslie Grammatico-Guillon, Léa Ferrand, Leila Moret, François Gouin, Nicolas Mauduit, Christophe Leux, Yannick Le Manach, Didier Lepelletier, Elsa Tavernier, Jean-Christophe Lucet, Bruno Giraudeau

Abstract

Background: Inappropriate staff behaviour during surgical procedures may disrupt the surgical performance and compromise patient safety. We developed an innovative monitoring and feedback system combined with an adaptive approach to optimise staff behaviour intraoperatively and prevent post-operative complications (POC) in orthopaedic surgery.

Methods/design: This protocol describes a parallel-group, cluster randomised, controlled trial with orthopaedic centre as the unit of randomisation. The intervention period will last 6 months and will be based on the monitoring of two surrogates of staff behaviour: the frequency of doors opening and the level of noise. Both will be collected from incision to wound closure, using wireless sensors and sonometers, and recorded and analysed on a dedicated platform (Livepulse®). Staff from centres randomised to the intervention arm will be informed in real time on their own data through an interactive dashboard available in each operating room (OR), and a posteriori for hip and knee replacement POC. Aggregated data from all centres will also be displayed for benchmarking. A lean method will be applied in each centre by a local multidisciplinary team to analyse baseline situations, determine the target condition, analyse the root cause(s), and take countermeasures. The education and awareness of participants on the impact of their behaviour on patient safety will assist the quality improvement process. The control centres will be blinded to monitoring data and quality improvement approaches. The primary outcome will be any POC occurring during the 30 days post operation. We will evaluate this outcome using local and national routinely collected data from hospital discharge and disease databases. Thirty orthopaedic centres will be randomised for a total of 9945 hip and knee replacement surgical procedures.

Discussion: The field of human factors and behaviour in the OR seems to offer potential room for improvement. An intervention providing goal-setting, monitoring, feedback and action planning may reduce the traffic flow and interruptions/distractions of the surgical team during procedures, preventing subsequent POCs. The results of this trial will provide important data on the impact of OR staff behaviour on patient safety, and promote best practice during surgical procedures.

Trial registration: ClinicalTrials.gov, NCT03158181 .

Keywords: Behaviour; Complications; Doors opening; Noise; Surgery; Surgical site infection.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Timeline cluster: graphical tool to identify risk of bias in cluster randomised trials [47]
Fig. 2
Fig. 2
Trial schedule of enrolment, interventions, and assessments (as recommended by Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Additional file 1)
Fig. 3
Fig. 3
Description of data collected, data sources and key variables for the merging according to levels. OR, operating room; eCRF, electronic case report form; ICD-10, International Statistical Classification of Diseases and Related Health Problems, 10th Revision; POC, post-operative complication

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