'In Situ Simulation' Versus 'Off Site Simulation' in Obstetric Emergencies

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Rigshospitalet

Status

Completed

Conditions

Education
Simulation
'In Situ Simulation'
Obstetrics

Treatments

Other: In situ simulation
Other: Off site simulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01792674
ob-an-op-simulation-trial

Details and patient eligibility

About

Care for pregnant is a field where unexpected emergencies occur, however emergencies are rare and hence competences difficult to learn. Therefore, it can be relevant to use simulation-based medical education. Many questions on how simulation can optimise learning remain unanswered. A major question is how simulation settings as 'in situ simulation' (i.e. in the actual patient care unit) versus 'off site simulation' (i.e. in training rooms or simulation center) impact learning. Objectives: To study the effect of 'in situ simulation' versus 'off site simulation' on learning outcome, safety-attitudes, team performance and clinical performance in the simulated setting plus stress and motivational inducing effect of simulation settings. Design: Randomised trial. Primary outcome: Written knowledge-test. Exploratory outcomes: Safety Attitudes Questionnaire, team- and clinical performance score, validated stress inventory, salivary cortisol, Intrinsic Motivation Inventory and questionnaire on perceptions of the simulation and organisational changes needed. Perspective: To provide new knowledge on contextual effects of different simulation settings.

Full description

Background: Care for pregnant and delivering women is a field where unexpected emergencies, as for example emergency caesarean sectio, postpartum bleeding or severe preeclampsia, that may potentially harm both mother and baby, occur. Obstetric emergencies are rare and hence by nature difficult to learn in real life. Therefore, it can be relevant with simulation-based medical education, i.e., training with mannequins and scenarios. In non-systematic reviews it is concluded that repetitive medical simulations are associated with improved learner outcomes. However, many questions on how simulation can optimise learning in emergencies remain unanswered; e.g., how different kinds of simulation settings as 'in situ simulation' versus 'off site simulation' impact learning at the individual and the team level. Objectives: In a randomised trial on authentic obstetric-anaesthesia teams to study the effect of 'in situ simulation' versus 'off site simulation' on participants learning outcome, safety-attitudes, team performance plus motivational and stress inducing effect of different simulation settings and the potential association with learning and performance. Interventions: The experimental intervention is training in 'in situ simulation' which means training in the actual patient care unit, in this situation the labour suite and operation theatre. The control group will receive the same training 'off site simulation', i.e., in training rooms away from the actual patient care unit. In the two different simulation settings, the same scenarios will be conducted and the participants will comprise of authentic teams of specialised obstetricians or obstetric trainees in their final training year, trainee obstetricians, midwifes, auxiliary nurses, specialised anaesthetists or anaesthesia trainees in their final training year, trainee anaesthetists, anaesthesia nurses, and surgical nurses. Design and trial size: Single-centre investigator-initiated randomised superiority trial. We have chosen to calculate the required sample size based on experiences about knowledge tests. We assume a standard deviation at 24%, and a difference in the experimental and control means at 17%. With alpha set at 0.05, beta set at 0.80 and intraclass correlation at 0,05 the sample size added up to 93 participants. It is planned to include 100 participants. Outcomes: Primary outcome: 1) Knowledge by written test as multiple choice questions. Exploratory outcomes: 1) Safety Attitudes Questionnaire SAQ). 2) Team performance score measured by Team Emergency Assessment Measure (TEAM). 3) Clinical performance in the simulated setting. 4) Salivary cortisol. 5) Validated stress inventory (Stress-Trait Anxiety Inventory (STAI-1) and cognitive appraisal). 6) Intrinsic Motivation Inventory (IMI). 7) Questionnaire to evaluate participants' perceptions of the simulation, the debriefing, and changes needed at the organisational level. Time schedule: 2 years with start planning 1st of April 2012. Randomisation will start after approval from the Regional Ethics Committee and the Danish Data Protection Agency. The intervention with 'in situ simulation' versus 'on site simulation' described in this protocol will be scheduled spring 2013.

Enrollment

97 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Health-care professionals (specialised obstetricians, trainee obstetricians, midwifes, auxiliary nurses, specialised anaesthetists, trainee anaesthetists, anaesthesia nurses, and surgical nurses) employed at the Obstetric or Anaesthesia departments at Rigshospitalet and trainee doctors having part of their training programme at Juliane Marie Centre for children, women and reproduction, Rigshospitalet.
  • Participants shall work in the evening-, night- and weekend-shift duties with some of their work in labour ward
  • Provide signed informed consent before randomisation

Exclusion criteria

  • Manager with staff responsibilities. Staff taking part in planning of the intervention.
  • Lack of informed consent

Trial design

97 participants in 2 patient groups

In situ simulation
Experimental group
Description:
'In situ simulation' which is training in the actual patient care unit, in this situation the labour suite and operation theatre
Treatment:
Other: In situ simulation
Off site simulation
Active Comparator group
Description:
The control group will receive the same training 'off site simulation', i.e., in training rooms away from the actual patient care unit.
Treatment:
Other: Off site simulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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