NCT01792674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

January 30, 2013

Last Update Submit

December 17, 2015

Conditions

EducationObstetricsSimulation'In Situ Simulation'

Keywords

EducationPatient simulationIn situ simulationStress

Outcome Measures

Primary Outcomes (1)

  • Knowledge test by written test as multiple-choice questions (MCQ).

    The intervention will be applied on ten training days. Each training day will include training of one authentic team consisting of ten health care professionals.

    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 (8)

  • Exploratory outcomes: Safety Attitudes Questionnaire (SAQ).

    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.

  • Exploratory outcomes: Team Emergency Assessment Measure (TEAM).

    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.

  • Exploratory outcomes: Video assessment: Clinical performance in the simulated setting.

    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.

  • Exploratory outcome: Salivary cortisol

    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.

  • Exploratory outcome: State-Trait Anxiety Inventory (STAI-1).

    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.

  • +3 more secondary outcomes

Study Arms (2)

In situ simulation

EXPERIMENTAL

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

Other: In situ simulation

Off site simulation

ACTIVE COMPARATOR

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

Other: Off site simulation

Interventions

In situ simulationOTHER
In situ simulation
Off site simulationOTHER
Off site simulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Juliane Marie Centre for Children, Women and Reproduction

Copenhagen, 2100, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 33325570DERIVED

  • 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.

    PMID: 26443654DERIVED

  • 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.

    PMID: 23870501DERIVED

Related Links

Study Officials

  • Jette Led Sørensen, MD, MMEd

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Consultant Obstetric Gynecologist, MMEd, Associate Professor

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 15, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

DK(1)