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

NCT ID: NCT01792674

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Education Obstetrics Simulation 'In Situ Simulation'

Keywords

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Education Patient simulation In situ simulation Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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In situ simulation

'In situ simulation' which is training in the actual patient care unit, in this situation the labour suite and operation theatre

Group Type EXPERIMENTAL

In situ simulation

Intervention Type OTHER

Off site simulation

The control group will receive the same training 'off site simulation', i.e., in training rooms away from the actual patient care unit.

Group Type ACTIVE_COMPARATOR

Off site simulation

Intervention Type OTHER

Interventions

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In situ simulation

Intervention Type OTHER

Off site simulation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Jette Led Sorensen

MD, Consultant Obstetric Gynecologist, MMEd, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jette Led Sørensen, MD, MMEd

Role: PRINCIPAL_INVESTIGATOR

Juliane Marie Centre for Children, Women and Reproduction , Rigshospitalet, Copenhagen University Hospital

Locations

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Rigshospitalet, Juliane Marie Centre for Children, Women and Reproduction

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33325570 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26443654 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23870501 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

View Document

Document Type: Qualitative study based on the study population from randomised trial.

View Document

Related Links

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http://rh.dk/simulation-jmc

Related Info

Other Identifiers

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ob-an-op-simulation-trial

Identifier Type: -

Identifier Source: org_study_id