title: 'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Unexpected obstetric emergencies threaten the safety of pregnant women. As emergencies are rare, they are difficult to learn. Therefore, simulation-based medical education (SBME) seems relevant. In non-systematic reviews on SBME, medical simulation has been suggested to be associated with improved learner outcomes. However, many questions on how SBME can be optimized remain unanswered. One unresolved issue is how 'in situ simulation' (ISS) versus 'off site simulation' (OSS) impact learning. ISS means simulation-based training in the actual patient care unit (in other words, the labor room and operating room). OSS means training in facilities away from the actual patient care unit, either at a simulation centre or in hospital rooms that have been set up for this purpose.
  
  
  METHODS
  The objective of this randomized trial is to study the effect of ISS versus OSS on individual learning outcome, safety attitude, motivation, stress, and team performance amongst multi-professional obstetric-anesthesia teams.The trial is a single-centre randomized superiority trial including 100 participants. The inclusion criteria were health-care professionals employed at the department of obstetrics or anesthesia at Rigshospitalet, Copenhagen, who were working on shifts and gave written informed consent. Exclusion criteria were managers with staff responsibilities, and staff who were actively taking part in preparation of the trial. The same obstetric multi-professional training was conducted in the two simulation settings. The experimental group was exposed to training in the ISS setting, and the control group in the OSS setting. The primary outcome is the individual score on a knowledge test. Exploratory outcomes are individual scores on a safety attitudes questionnaire, a stress inventory, salivary cortisol levels, an intrinsic motivation inventory, results from a questionnaire evaluating perceptions of the simulation and suggested changes needed in the organization, a team-based score on video-assessed team performance and on selected clinical performance.
  
  
  CONCLUSIONS
  The perspective is to provide new knowledge on contextual effects of different simulation settings.
  
  
  BACKGROUND
  ClincialTrials.gov NCT01792674.
authors.affiliation: Department of Obstetrics, Department of Anaesthesia and Juliane Marie Centre for Children, Women and Reproduction, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark. jette.led.soerensen@regionh.dk
authors.forename: Jette Led
authors.initials: JL
authors.lastname: Sørensen
authors.forename: Cees
authors.initials: C
authors.lastname: Van der Vleuten
authors.forename: Jane
authors.initials: J
authors.lastname: Lindschou
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.forename: Doris
authors.initials: D
authors.lastname: Østergaard
authors.forename: Vicki
authors.initials: V
authors.lastname: LeBlanc
authors.forename: Marianne
authors.initials: M
authors.lastname: Johansen
authors.forename: Kim
authors.initials: K
authors.lastname: Ekelund
authors.forename: Charlotte Krebs
authors.initials: CK
authors.lastname: Albrechtsen
authors.forename: Berit Woetman
authors.initials: BW
authors.lastname: Pedersen
authors.forename: Hanne
authors.initials: H
authors.lastname: Kjærgaard
authors.forename: Pia
authors.initials: P
authors.lastname: Weikop
authors.forename: Bent
authors.initials: B
authors.lastname: Ottesen
mesh_terms: D001291:Attitude of Health Personnel; D002983:Clinical Competence; D003198:Computer Simulation; D003299:Cooperative Behavior; D003718:Denmark; D004502:Education, Medical, Continuing / Q000379:methods*; D004630:Emergencies; D005260:Female; D006126:Group Processes; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D033183:Interdisciplinary Communication; D008348:Manikins; D009042:Motivation; D013513:Obstetric Surgical Procedures / Q000009:adverse effects / Q000193:education*; D010348:Patient Care Team / Q000458:organization & administration; D016544:Patient Simulation; D011247:Pregnancy; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013315:Stress, Psychological / Q000209:etiology*; D011795:Surveys and Questionnaires; D013647:Task Performance and Analysis; D014741:Video Recording; D017132:Workplace