Outcome-based research in Obstetric simulation

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Outcome-based research in Obstetric simulation

• Dr Jo Crofts
• Academic Clinical Lecturer in Obstetrics
• University of Bristol, UK

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Outline

• Why simulation training is required
• 9 years of progress
• Simulation and clinical outcomes
• Characteristics of effective training
• Outcome based research is required
• Future of obstetric simulation

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Childbirth is dangerous
1000 women die every day due to pregnancy and
childbirth complications that could have been
prevented
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The Safety Problem

• 1 12 labours associated with adverse outcomes
• Nielsen P at al, Obstet Gynecol 2007
• 50 adverse outcomes preventable with better care
• CESDI 4th Annual Report. 1997
• CEMD Why Mothers Die. 1998
• CEMACH Saving Mothers Lives 2007

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Very expensive

• NHS Litigation Authority 633 million in settled
  negligence claims 2007-08
• 221 million for Obstetric Claims
• 1 billion for additional bed days to deal with
  preventable harm
• Human costs ?
• House of Commons Health Committee Patient Safety
  Report. 2009

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Training

• Simulated emergencies should be organised to
  improve management of rare obstetric emergencies
• CESDI 4th Annual Report 1997
• CEMD Why Mothers Die 1998
• NHSLA. CNST Maternity Standards 2000
• CEMACH Saving Mothers Lives 2007
• Kings Fund Safer Births everybodys business.
  2008
• Include teamwork training
• To Err is Human building a safer health system.
  2000

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9 years of progress

• 2003
• No objective evaluation
• Difficult to demonstrate any benefit
• Decade after first recommendation - neither a
  national curriculum, nor a system for provision
• Black R Brocklehurst P. BJOG 2003

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Outcome based research
Evidence of Effectiveness Evidence of Effectiveness Evidence of Effectiveness
Level 1 Reaction Satisfaction
Level 2 Learning MCQs, Skills
Level 3 Behaviour Patient care
Level 4 Results Clinical Outcome
Kirkpatrick, D. (1998). Evaluating Training
Programs The four levels. San Francisco,
Berrett-Kochler Publishers.
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SaFE Study
Pre-training Assessment
Training Intervention
Post-training Assessments 3 weeks, 6 months and
12 months
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Knowledge Summary

• Significant increase in knowledge following
  training
• 93 increased MCQ score
• Knowledge at 6 12 months was significantly
  higher than pre-training
• None of the training interventions appeared to be
  superior

Crofts, J., D. Ellis, et al. (2007). "Change in
knowledge of midwives and obstetricians following
obstetric emergency training a randomised
controlled trial of local hospital, simulation
centre and teamwork training." BJOG An
International Journal of Obstetrics and
Gynaecology 114(12) 1534-1541.
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Eclampsia

• 140 staff randomised to training on
  patient-actor or whole body simulator
• Following training
• completion of basic tasks (87 to 100)
• administration of MgSO4 (61 to 92)
• medication given 2 minutes earlier
• No differences in training style except improved
  communication with actress

Ellis et al. (2008). "Hospital, Simulation
Center, and Teamwork Training for Eclampsia
Management A Randomized Controlled Trial."
Obstet Gynecol 111(3) 723-731.
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Shoulder Dystocia
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Simulation of SD
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SaFE SD skills
Action achieved achieved
Action Pre-training Post-training Significance
All basic manouevres 81.4 94.7 P0.002
Achieved delivery 42.9 83.3 Plt0.001
Good communication 56.8 82.6 Plt0.001
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High v Low fidelity mannequin
Action PROMPT Low Significance
Achieved delivery 94 72 P0.002
Delivery time 135 s 161 s P0.004
Mean peak force 102 N 112 N P0.242
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Shoulder dystocia simulation

• 140 staff randomised
• Training is required
• Pre-training 43 successful shoulder dystocia
• Simulation improves performance
• Post-training 83 successful shoulder dystocia
• PROMPT mannequin
• Improved delivery rate (72 vs 94)
• Shorter delivery time (161s vs 135s)

Crofts, Bartlett, et al. (2006). Obstet Gynecol
108(6) 1477-85.. Crofts, Fox, et al. (2008).
Obstet Gynecol 112(4) 906-12.
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Not all training equal

• Two UK cities
• Similar demographic
• Shoulder dystocia training started in 2000
• City 1 70 decrease in OBPI
• City 2 100 increase in OBPI
• Draycott et al. Obstet Gynecol 2008 112 14-20
• MacKenzie et al. Obstet Gynecol 2007 110
  1059-1068

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Differences in training

• Effective
• 98 staff
• Multi-professional
• PROMPT model
• Simple algorithm

• Ineffective
• 60 staff
• Separate
• Low fidelity model
• Mnemonic

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Labour Delivery CRM trial

• 15 hospitals (6 military, 9 civilian)
• 28,536 deliveries
• 4 month intervention
• 4 hour didactic training (CRM)
• Team structure implementation
• Primary outcome reduction in overall frequency
  of adverse outcomes

Nielsen PE, Goldman MB, Mann S, Shapiro DE,
Marcus RG, Pratt SD, et al. Effects of teamwork
training on adverse outcomes and process of care
in labor and delivery a randomized controlled
trial. Obstet Gynecol. 2007 Jan109(1)48-55.
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Adverse Outcome Index
Adverse Event Score
Maternal death 750
Intrapartum / neonatal death gt 2500g 400
Uterine rupture 100
Maternal admission to ITU 65
Birth trauma 60
Return to theatre or delivery suite 40
Admission to NICU gt2500g for gt24 hours 35
Apgar lt7 at 5 minutes 25
Blood transfusion 20
3rd or 4th perineal tear 5
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Labour Delivery CRM trial

• No difference in adverse outcomes (both groups
  improved)
• Problems
• CRM does not work / as implemented ?
• Short implementation period
• Wrong measures ?
• Hawthorne effect ?
• Underpowered ?

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Nine years of progress

• What works
• Where
• Why
• What next?

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Common Effective Themes

• Simulation of emergencies
• High fidelity training tools
• Situated Local training
• Nearly 100 staff
• Multi-professional
• Insurance based financial incentives

Siassakos, Crofts, et al. (2009). "The active
components of effective training in obstetric
emergencies." Bjog 116(8) 1028-32.
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Does Simulation work ?

• Yes
• Increasing retrospective data suggesting
  improvements in neonatal outcome after the
  introduction of simulation training

(Some, but not all)
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Can we do better ?

• Yes
• Increasing retrospective data suggesting
  improvements in neonatal outcome after the
  introduction of simulation training

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Nine year vision

• Effective evidenced based training to reduce
  preventable harm
• All staff
• All mothers babies
• Improved training materials
• Commit to more, and better research for the
  future
• Prospective
• Hard clinical outcomes

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The Future

• Whole body mannequins
• Sepsis
• Maternal collapse
• Virtual reality
• Instrumental delivery

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The Future

• Accessible training
• Simple training aids

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Simulation training is required

• 1000 women die every day due to pregnancy and
  childbirth complications that could have been
  prevented
• Almost all of them (99) live and die in
  developing countries
• World Health Organisation

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Thank you

• jo.crofts_at_bristol.ac.uk