Outcome-based research in Obstetric simulation

Dr Jo Crofts

Academic Clinical Lecturer in Obstetrics

University of Bristol, UK

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

Childbirth is dangerous

1000 women die every day due to pregnancy and childbirth complications

that ‘could have been prevented’

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. 1997CEMD – Why Mothers Die. 1998

CEMACH – Saving Mothers Lives 2007

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

Training

• Simulated emergencies should be organised to improve management of rare obstetric emergencies

CESDI – 4th Annual Report 1997CEMD – Why Mothers Die 1998

NHSLA. CNST Maternity Standards 2000CEMACH – Saving Mothers Lives 2007

Kings Fund: Safer Births everybody’s business. 2008

• Include teamwork training To Err is Human: building a safer health system. 2000

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

Outcome based research

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.

The SaFE Study

Simulation and Fire drill

Evaluation

Training Intervention

Post-training Assessments3 weeks, 6 months and 12 months

Pre-training Assessment

SaFE Study

Local HospitalNo team training

One day

Simulation CentreNo team training

One day

Local HospitalTeam training

Two days

Simulation CentreTeam training

Two days

MCQClinical Scenarios

MCQClinical Scenarios

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.

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.

Shoulder Dystocia

Simulation of SD

SaFE: SD skills

Action

% achieved

Pre-training Post-training Significance

All basic manouevres 81.4 94.7 P=0.002

Achieved delivery 42.9 83.3 P<0.001

Good communication 56.8 82.6 P<0.001

High v Low fidelity mannequin

Action PROMPT Low Significance

Achieved delivery 94% 72% P=0.002

Delivery time 135 s 161 s P=0.004

Mean peak force 102 N 112 N P=0.242

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.

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

Differences in training

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

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

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 Jan;109(1):48-55.

Adverse Outcome Index

Adverse Event Score

Maternal death 750

Intrapartum / neonatal death > 2500g 400

Uterine rupture 100

Maternal admission to ITU 65

Birth trauma 60

Return to theatre or delivery suite 40

Admission to NICU >2500g for >24 hours 35

Apgar <7 at 5 minutes 25

Blood transfusion 20

3rd or 4th perineal tear 5

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 ?

Nine years of progress

• What works

• Where

• Why

• What next……?

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.

Does Simulation work ?

YesIncreasing retrospective data suggesting

improvements in neonatal outcome after the introduction of simulation

training

(Some, but not all)

Can we do better ?

YesIncreasing retrospective data suggesting

improvements in neonatal outcome after the introduction of simulation

training

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

The Future

• Whole body mannequins• Sepsis• Maternal collapse

• Virtual reality• Instrumental delivery

The Future

• Accessible training

• Simple training aids

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

Thank you

• jo.crofts@bristol.ac.uk