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Safer Surgical Services : Are system and culture interventions synergistic?. Peter McCulloch, University of Oxford, England. Conflict of Interest. Paid to give talks: No Paid for my advice: No Paid for me to attend Conferences: NIHR Funded my research: NIHR ( PGfAR Programme)
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Safer Surgical Services: Are system and cultureinterventions synergistic? Peter McCulloch, University of Oxford, England
Conflict of Interest • Paid to give talks: No • Paid for my advice: No • Paid for me to attend Conferences: NIHR • Funded my research: • NIHR (PGfARProgramme) • BUPA Foundation • Health Foundation
Waves of Safety Research • Is there a problem? • IoM report • How big is it? • Vincent et al, Gawande, • What causes it? • Lingard, Sevdalis, Catchpole • What works to fix it? • Why does it work?
What do safety interventions do? • Improving Systems • Industrial QI engagement and PDCA approaches • SOP/Checklist approaches • IT based solutions • Enhancing Culture • CRM teamwork training • Supportive policies • McCulloch, P. and Catchpole K. A three-dimensional model of error and safety in surgical health care microsystems. Rationale, development and initial testing. BMC Surg, 2011. 11: p. 23-7.
S3 Hypothesis • Fixing CULTURE and SYSTEM provides SYNERGISTIC benefits to team performance
Testing the Hypothesis • Multiple comparisons required • Hugely variable environment/context • Available process measures subjective • Outcome measures very distal/insensitive • Signal/Noise ratio therefore problematic
Programme Design • Suite of identical CONTROLLED prospective studies • Standardised, validated process and outcome measures used throughout. • Planned meta-analysis to allow evaluation of over-arching questions
Study Design • Pre-intervention data collection 3-6/12 • Intervention Period 3-6/12 • Post-intervention data collection 3-6/12 • Control group in SAME TRUST, doing work of SIMILAR NATURE • Observation and Intervention separation • No blinding (Alas..) • Observer pairs watch whole procedure
Measures • Non-technical skills Oxford NOTECHS II • Technical performance Glitch rate • Safety Culture WHO checklist adherence LOS • Clinical Outcome 30 day complications 90 day readmissions • PROMs EQ5D Measure of improvement: comparison of Before: After ratio for Active vs Control group
Interventions • “Lean” Approach (System) • 1 day course plus coaching support during intervention period • Emphasised staff engagement and freedom to set agenda • Used 5S, process mapping, PDCA cycles, poka yoke etc • Standardisation Approach (System) • 1 day course on standards and principles plus coaching support • Emphasised staff engagement and freedom to set agenda • Aimed to standardise and visualise work process • Crew Resource Management training (Culture) • Based on previous study • 1 day course plus 6 weeks coaching • Partner with Atrainability
Studies and Settings • CRM alone: Kettering DGH (Ortho/Vascular) • SOP alone: Nuffield Orthopaedic Centre (Hip/Knee teams) • Lean alone: UHCW Trust (Trauma/Ortho) • CRM & SOP: UHCW Trust (Hip/Knee teams) • CRM & Lean: NOC (Plastics/Hip & Knee)
Results • Orthopaedic, Trauma, Plastic and Vascular surgery observed • 5 Hospital sites in 3 Trusts • 453 operations observed • >2,000 hours observer time in theatre • 5,124 patient clinical outcomes analysed
Change in Oxford NOTECHS II[Change in Active – Change in Control] * P = 0.002 * p=0.058 * p=0.047
Change in Glitch Count * p<0.001
Change in WHO compliance% Relative Improvement * P<0.001 * P<0.001 * P=0.032
Conclusions & Reflections • Single intervention modalities do what you would expect – but weakly • Dual intervention increased both BREADTH and STRENGTH of response CULTURE Motivation Understanding of aims Focus Buy-in SYSTEM Understanding of systems Confidence Ability to Make change
Importance of Study Design • Control groups essential • Valid standard measures important • Lack of blinding a weakness • Challenges: • Hawthorne effects • Contamination • It CAN be done!
Barriers & Future Research • Compartments • LACK: • TIME for IMPROVEMENT • KNOWLEDGE • SUPPORT • MOTIVATION • Nurses & PAMS • Junior Doctors • Senior Doctors • Middle Management RESEARCH IMPLICATIONS • How to Upscale? • Measuring Resistance • Trialling Implementation plans • Step-Wedge trial OR?
Radical Change? • Strengthen line management • Clarify Accountability • Abolish professional silos
Thank You Captain Trevor Dale Dr Karen Barker Prof Renee Lyons Prof Damian Griffin Surgical Staff at: Oxford University Hospitals University Hospitals Coventry & Warwick Kettering District General Hospital • Dr Steve New • Dr Ken Catchpole • Dr Lauren Morgan • Sharon Pickering • Mohammed Hadi • Eleanor Robertson • Laura Blakely