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

Trials

Jean-Christophe Lucet¹  Thomas Haudebourg²  Gabriel Birgand³  Léa Ferrand⁴  Nicolas Mauduit⁵  Christophe Leux⁵  François Gouin⁶  Leila Moret⁷  Didier Lepelletier⁸  Yannick Le Manach⁹  Elsa Tavernier^1,10  Bruno Giraudeau^1,10  Leslie Grammatico-Guillon^1,11 

[1] 0000 0001 2175 4109, grid.50550.35, Unité d’hygiène et de lutte Contre L’infection Nosocomiale (UHLIN), AP-HP, Paris, France;0000 0004 0472 0371, grid.277151.7, CPias Pays de la Loire, Nantes University Hospital, CHU – Le Tourville, 5, rue du Pr Yves Boquien, 44093, Nantes, cedex, France;0000 0004 0472 0371, grid.277151.7, CPias Pays de la Loire, Nantes University Hospital, CHU – Le Tourville, 5, rue du Pr Yves Boquien, 44093, Nantes, cedex, France;0000 0001 2113 8111, grid.7445.2, Health Protection Research Unit, Imperial College London, London, UK;0000 0004 0472 0371, grid.277151.7, Direction de la Recherche Clinique, Nantes University Hospital, Nantes, France;0000 0004 0472 0371, grid.277151.7, Service D’information Médicale, Nantes University Hospital, Nantes, France;0000 0004 0472 0371, grid.277151.7, Service de Chirurgie Orthopédique, Nantes University Hospital, Nantes, France;0000 0004 0472 0371, grid.277151.7, Service de Santé Publique, Nantes University Hospital, Nantes, France;0000 0004 0472 0371, grid.277151.7, Unité de Gestion du Risque Infectieux, CHU, Nantes, France;0000 0004 0545 1978, grid.415102.3, Perioperative Medicine and Surgical Research Unit, Population Health Research Institute, David Braley Cardiac, Vascular and Stroke Research Institute, 237 Barton St E, L8L 2X2, Hamilton, ON, Canada;0000 0004 1765 1600, grid.411167.4, INSERM CIC 1415, CHRU de Tours, Tours, France;0000 0001 2182 6141, grid.12366.30, Université de Tours, Université de Nantes, INSERM SPHERE U1246, Tours, France;Service de Santé Publique, Unité Régionale d’épidémiologie Hospitalière, CHU, Université de Tours, Tours, France;

关键词: Surgery;    Complications;    Surgical site infection;    Behaviour;    Noise;    Doors opening;   

DOI  :  10.1186/s13063-019-3370-z

来源: publisher

【 摘 要 】

BackgroundInappropriate 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/designThis 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.DiscussionThe 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 registrationClinicalTrials.gov, NCT03158181.

【 授权许可】

CC BY