Viewpoint 2:
A scientific approach to link effective care
measurement with tangible improvement
Professor Mike Grocott
Professor of Anaesthesia and Critical Care Medicine.
Chair, National Emergency Laparotomy Audit
Director of the NIAA Health Services Research Centre,
Health Services Research Centre RCoA
Declaration of interests
• I am a co-investigator on the EPOCH study
Linking audit to quality improvement?
• Definitions
• Healthcare problem = emergency laparotomy
• HQIP Audit = NELA
• Adding value through linked research projects
• Conclusions
Definitions and context
• Clinical audit
• ”…a quality improvement process that seeks to
improve patient care and outcomes through
systematic review of care against explicit criteria
and the implementation of change.”
NICE 2002
Definitions and context
• Emergency Laparotomy
• An abdominal surgical procedure performed at
short notice to treat life-threatening intraabdominal conditions e.g. obstruction or
perforation of the bowel
Definitions and context
• ELN = Emergency Laparotomy Network
• NELA = National Emergency Laparotomy Audit
• EPOCH = Enhanced Perioperative Care for HighRisk Patients (clinical trial)
Emergency Laparotomy: 1998-2012
• High incidence of adverse outcome
• Poor supervision
• Low critical care usage
• High cost
Cook BJA 1998
Ford BJA 2007
Shapter Anaesthesia 2012
Emergency Laparotomy: 1998-2012
2000-2009
n = 367,796
Symons BJS 2013
Emergency Laparotomy Network (ELN)
Emergency Laparotomy Network (ELN)
Saunders BJA 2012
ELN results: data collection
• 37 Hospitals returned data
• 2 hospitals excluded (< 50% case ascertainment)
• 35 hospitals
•
•
•
•
> 90% case ascertainment
1853 patients
1941 emergency laparotomies
46 (range 8-184) procedures per hospital
Saunders BJA 2012
ELN results: outcomes
Saunders BJA 2012
ELN results: outcomes
Saunders BJA 2012
ELN results: outcomes
ASA - Physical Status
Classification
1
Number
Mortality (%)
113
0
2
565
4.1
3
643
13.4
4
332
33.6
5
42
69.2
ASA = American Society of Anesthesiologists
Saunders BJA 2012
ELN results: outcomes
Saunders BJA 2012
ELN results: process measures
•
•
•
•
Consultant Surgeon present (41-100%)
Consultant Anaesthetist present (25-100%)
Level 3 care (10-88%)
Goal-directed fluid therapy (0-63%)
• Consultant presence decreases out of hours
Saunders BJA 2012
NELA: overview
• 2012-13
Organisational audit
• 2013-2015
Individual patient audit
• Wide range of stakeholders (CRG)
• Web-based data entry (and feedback)
NELA: organisational audit
• December 2012-13
• 190/191 eligible hospitals
• Report published May 2014
NELA: organisational audit
• Consultant availability variable
• 1/5 no dedicated theatre
• 2/3 no interventional radiology
• 2/3 no endoscopy
• Pathways and audit variable
NELA: patient audit
• 191/191 entering patient-level data
• First 6 months results reflect ELN data
Case Completion Rates
16000
14000
12000
10000
8000
6000
4000
2000
0
1
Cases Entered
target (60% total)
1592
2
3
4
5
6
7
8
9
1136
2633
4652
6302
8171
10283
12522
14314
3184
4776
6368
7960
9552
11144
12736
14328
NELA: quality improvement
• Organisational audit
• Model action plan
• Sharing best practice
• Patient audit
• Local availability of data
• Software added value e.g. run charts
How does audit achieve QI?
How does audit achieve QI?
• Effect of data collection “Hawthorne effect”
• Audit driving QI
Ivers Cochrane DSR 2012
How does audit achieve QI?
• Effect of data collection “Hawthorne effect”
• Audit driving QI
• Research studies
• Observational studies
• Platform for interventional studies
Ivers Cochrane DSR 2012
Audit and QI
• Observational vs. interventional studies
• Confounding
• Bias
Anglemyer Cochrane DSR 2014
EPOCH
Enhanced Peri-Operative Care
for High-risk patients
Chief Investigator: Prof Rupert Pearse
QI Lead: Prof Carol Peden
EPOCH background: emergency laparotomy
• Emergency Laparotomy Network & HES data
• ≈ 30,000 cases per year (England and Wales)
• Overall 25% mortality at 90 days
• Variation in 30-day mortality (4 to 31%)
• Variation in delivered care (vs. standards)
EPOCH background: enhanced recovery
Mean length
of stay
Day of
surgery
admission
Enhanced Recovery Partnership DoH 2012
EPOCH: objectives
• Can a quality improvement project to
implement a care pathway improve 90-day
survival for emergency laparotomy?
• Integrated ethnographic evaluation
• Cost-effectiveness of project
• Long-term impact on mortality (via HQIP-NELA)
EPOCH: trial design
• Stepped wedge randomised cluster trial
• Data capture via HQIP-NELA web portal
• Intervention (vs. usual care):
• Integrated Care Pathway
• Based on RCS-DoH Recommendations
• Package of training and support
RCTs and Cluster RCTs
• RCT = randomised controlled trial
• Minimisation of confounding (randomisation)
• Minimisation of bias (blinding)
• A priori analysis plan addressing single question
• RCT: unit of randomisation = patient
• Cluster RCT: unit of randomisation = cluster
Parallel Group Cluster RCT
INTERVENTION
RANDOMISE
CONTROL
Brown BMC Med Res Meth 2006
Stepped Wedge Cluster RCT
Brown BMC Med Res Meth 2006
EPOCH: trial timelines
• December 2013
• Start-up
• March 2014
• Trial starts
• April 2014
• First cluster ‘activated’
• August 2015
• Final cluster activated
• Mid - Sept 2015
• Final patient recruited
EPOCH: patients
• Aged ≥40 years undergoing non-elective open
abdominal surgery in acute NHS hospitals
• Exclusions: Gynaecological and trauma
laparotomy, Repeat laparotomy,
Appendicectomy
EPOCH: integrated care pathway
• Visits by QI experts
• Local champions
• Local & cluster level multidisciplinary meetings
• Web resources
• Local review of local data
EPOCH: integrated care pathway
• Visits by QI experts
• Local champions
• Local & cluster level multidisciplinary meetings
• Web resources
Comparator = usual care
• Local review of local data
EPOCH: outcome measures
• Primary: 90 day mortality
• Secondary:
•
•
•
•
Hospital stay
Hospital re-admission
180 day mortality
Cost effectiveness
EPOCH: sample size
• 98 NHS hospitals in 15 regional clusters
• 27,540 patients
• 90% power: 25 to 22% mortality reduction
• Fixed 85 week intervention period
• Potential to recruit every eligible patient
NELA-EPOCH: learning points
• Risk of confusion over aims of distinct projects
• Risk of internal conflicts of interest/roles
• Risk of brand confusion and disengagement
• EPOCH will distort the results of NELA
• NELA will distort the results of EPOCH
NELA-EPOCH: learning points
• QI agenda gives the audit more “meaning”
• EPOCH evaluates QI that NELA may role out
• Parallel publicity promotes the shared agenda
• Collaborative team working helps both projects
• Importance of clearly defined roles
Would we do it again?
• Yes
• Yes
• Yes
• Better wait for the results!
Linking audit to quality improvement?
• Audit alone can improve quality
• Audit plus focussed QI offers greater improvement
• National audits offer an economical and efficient
platform for clinical trials
• Research informs standards and guidelines
• The combination may increase the rate of quality
improvement derived from national audits
Linking audit to quality improvement?
Any questions…?