Clinical trial NCT01792674: 'In Situ Simulation' Versus 'Off Site Simulation' in Obstetric Emergencies
Official title: A Randomised Educational Feasibility Trial: 'In Situ Simulation' Versus 'Off Site Simulation' in Obstetric Emergencies and the Effect on Knowledge, Safety-attitudes, Team Performance, Stress, and Motivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Obstetrics
Simulation
'In Situ Simulation'
Keywords: Education
Patient simulation
In situ simulation
Stress
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen Trial Unit, Center for Clinical Intervention Research
First posted: 2013-02-15
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge test by written test as multiple-choice questions (MCQ).
timeFrame: The participants will get a knowledge test at the training day they will participate in. Ten training days will be conducted in a 3 months period
Secondary outcomes:
measure: Exploratory outcomes: Safety Attitudes Questionnaire (SAQ).
timeFrame: The participants will answer the Safety Attitudes Questionnaire (SAQ) 3-6 weeks before and 3-6 weeks after the training day they will participate in. Ten training days will be conducted in a 3 months period.
measure: Exploratory outcomes: Team Emergency Assessment Measure (TEAM).
timeFrame: Video's will be recorded at the ten training days (within a 3 months period) and within approximately 4 months after the video's will be assessed by independent observers.
measure: Exploratory outcomes: Video assessment: Clinical performance in the simulated setting.
timeFrame: Video's will be recorded at the ten training days (within a 3 months period) and within approximately 4 months after be assessed by independent observers.
measure: Exploratory outcome: Salivary cortisol
timeFrame: Participants will have testing for salivary cortisol before and after the two simulated scenarios that will be conducted on the training they will participate in.
measure: Exploratory outcome: State-Trait Anxiety Inventory (STAI-1).
timeFrame: Participants will respond on State-Trait Anxiety Inventory (STAI-1) before and after the two simulated scenarios that will be conducted on the training day they will participate in.
measure: Exploratory outcome: Cognitive appraisal (CA).
timeFrame: Participants will respond on cognitive appraisal (CA) before and after the two simulated scenarios that will be conducted on the training day they will participate in on one training day.
measure: Exploratory outcome: Intrinsic Motivation Inventory (IMI).
timeFrame: The participants will answer on Intrinsic Motivation Inventory (IMI) approximately one week after the training day they will have participated in
measure: Exploratory outcome: Participant's perceptions of the simulations.
timeFrame: The participants will answer on questionnaires about their perceptions of the simulations approximately one week after the training day they will have participated in.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Juliane Marie Centre for Children, Women and Reproduction
Study officials:
affiliation: Juliane Marie Centre for Children, Women and Reproduction , Rigshospitalet, Copenhagen University Hospital
name: Jette Led Sørensen, MD, MMEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fransen AF, van de Ven J, Banga FR, Mol BWJ, Oei SG. Multi-professional simulation-based team training in obstetric emergencies for improving patient outcomes and trainees' performance. Cochrane Database Syst Rev. 2020 Dec 16;12(12):CD011545. doi: 10.1002/14651858.CD011545.pub2.
citation: Sorensen JL, van der Vleuten C, Rosthoj S, Ostergaard D, LeBlanc V, Johansen M, Ekelund K, Starkopf L, Lindschou J, Gluud C, Weikop P, Ottesen B. Simulation-based multiprofessional obstetric anaesthesia training conducted in situ versus off-site leads to similar individual and team outcomes: a randomised educational trial. BMJ Open. 2015 Oct 6;5(10):e008344. doi: 10.1136/bmjopen-2015-008344.
citation: Sorensen JL, Van der Vleuten C, Lindschou J, Gluud C, Ostergaard D, LeBlanc V, Johansen M, Ekelund K, Albrechtsen CK, Pedersen BW, Kjaergaard H, Weikop P, Ottesen B. '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. Trials. 2013 Jul 17;14:220. doi: 10.1186/1745-6215-14-220.