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Pa)ent Safety and Quality of Medical Care: An overview of the effec)veness of Checklists, Outcome
Repor)ng and System Based Conference ini)a)ves
CM Burkle MD, JD, FACLM Associate Professor of Anesthesiology
Mayo Clinic
Quality and Safety Communica)on Modali)es
• “Morbidity & Mortality”/System Based Conferences • Checklists • Public Repor)ng – Mandatory – Voluntary
Donabedian Elements of Quality of Health Care
1. Structure Measures – Evaluate pa)ent resources afforded by a hospital
2. Process Measures – Assess compliance with recommenda)ons
3. Outcome Measures – Quan)fy morbidity, mortality, LOS, costs….
JAMA 1988;260(12):1743-‐8
System Based Morbidity & Mortality Conferences
Morbidity & Mortality Conferences
-‐E.A. Codman (1869 – 1940)
– A`er gradua)ng from Harvard Medical School, Codman joined the surgical staff of Massachusebs General.
– He ins)tuted the first M&M conference, however in 1914 the hospital refused his plan for evalua)ng surgeon competence, and he lost his staff privileges there.
– Eventually established his own hospital (which he called the "End Result Hospital") to pursue the performance measurement and improvement objec)ves he believed in so fervently.
• 1983 – ACGME mandated M&M’s as part of surgery educa)onal programs
• M&M conferences well established in clinical environments.
Morbidity & Mortality Conferences
Tradi)onal Goals -‐
“The M&M conference,…., provid[es] an opportunity to admit personal failures, expose faulty reasoning and promote transparency among colleagues.”
Med Humani1es 2010;36:108-‐111
“Involves a cri)que of the clinical decisions made by individual physicians that led to an adverse event”
Acad Med
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Morbidity & Mortality Conferences
• “Blame is the enemy of safety” Leveson NG, Engineering a safer world: systems thinking applied to safety. Cambridge, MA: MIT Press, 2012
• Dwells on unsuccessful outcomes
Morbidity & Mortality Conferences
Recent changes -‐ – Health care reform efforts:
• Reducing pa)ent harm • Improving value
– ACGME competencies • Pa)ent safety • Quality improvement • Interpersonal collabora)on • Health systems training
Tradi)on M&M Systems Based M&M
System Based Morbidity & Mortality Conferences
Goals -‐ Promotes a “just culture” in which a mul)disciplinary set of healthcare team members engage in a nonjudgmental review of adverse outcomes and work towards a systema)c process means of change.”
• But how effec)ve are these changes in mee)ng the goal of pa)ent safety and quality?
System Based Morbidity & Mortality Conferences
Northwestern Memorial Hospital (899 bed academic medical center in Chicago)
• Pa)ent Safety Morbidity and Mortality Conference – System based thinking approach – Interdisciplinary group seong – Retrospec)ve root cause analysis
• Results – 66% increase in event repor)ng
• No objec)ve quality improvement data reported
Joint Commission Journal on Quality and Pa1ent Safety (2010) Volume 36(1): 3-‐48(46)
System Based Morbidity & Mortality Conferences
Johns Hopkins Department of Pediatrics
• Morbidity and Mortality Interdisciplinary Conference goals: (1) Iden)fy events resul)ng in adverse pa)ent outcomes (2) Develop a forum to address causes for medical errors (3) Modify behavior and judgments by learning from past adverse events (4) Address educa)onal and systema)c flaws that led to adverse outcomes (5) Iden)fy a group to engineer needed changes and quality improvement
Clin Pediatr 2012 Nov;51(11):1079-‐86.
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System Based Morbidity & Mortality Conferences
– No objec)ve quality improvement data reported
Clin Pediatr. 2012 Nov;51(11):1079-‐86.
Pa)ent Mul)disciplinary “Rounds”
Berkshire Medical Center • Mul)disciplinary Mee)ngs
Am J Med Qual. 2014 Sep 10
Pa)ent Mul)disciplinary “Rounds”
Results:
Am J Med Qual. 2014 Sep 10
Berkshire Medical Center
Results
Conference
Berkshire Medical Center
Results
Conference Other Events
Summary: Conferences
• Reports have been largely observa)onal without adequate methodology to firmly determine objec)ve outcomes
• More studies required to determine with any finality the efficacy of these conferences on reaching our ul)mate goal of improved healthcare quality and pa)ent safety
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Checklists
Checklists
• WHO Based Surgical Safety Checklist
– Reduced surgical complica)ons (11.0% to 7.0%)
– Reduced in-‐hospital deaths (1.5% to 0.8%)
– 500,000/yr adverse events may be prevented
N Engl J Med 2009;360:491-‐9.
Checklists
• Immediate impact
– In the UK, a na)onwide checklist program was implemented by the NHS within weeks a`er WHO publica)on
– Almost 6000 hospitals worldwide using or have interest
N Engl J Med 2014; 370:1029-‐1038
Checklists
Follow up findings:
• The effect of mandatory checklist implementa)on is unclear-‐ – Studies of implementa)on have been observa)onal – Limited to a small number of centers – Have not evaluated pa)ent outcomes
N Engl J Med 2014; 370:1029-‐1038
Checklists : Follow-‐up Findings
Berg J. et al. BJS 2014; 101:150-‐158
• Systema)c review and meta-‐analysis-‐ – Inclusion criteria
• English-‐ language • Quan)ta)ve evalua)on • Mul)ple complica)ons • Randomized trials, non-‐
randomized trials, controlled before-‐a`er studies, interrupted )mes series (ITS), repeated measures studies
– Outcomes • Any complica)on • Mortality • SSI • Blood loss • Unplanned return to the OR • Pneumonia
Checklists : Follow-‐up Findings
• Any complica)on
Berg J. et al. BJS 2014; 101:150-‐158
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Checklists : Follow-‐up Findings
• Mortality
Berg J. et al. BJS 2014; 101:150-‐158
Checklists : Follow-‐up Findings
• Surgical-‐site infec)on
Berg J. et al. BJS 2014; 101:150-‐158
Summary: Checklists
• Largely observa)onal, small reports failing to evaluate pa)ent outcomes.
• When evalua)ng those studies with stronger methodology, perhaps some improvement in a limited subset of complica)ons (SSI) and minimal improvement in mortality.
• More studies required to determine with any finality the efficacy of these checklists on reaching our ul)mate goal of improved healthcare quality and pa)ent safety
Public Repor)ng: Mandatory and Voluntary
Mandatory Repor)ng
• Public repor)ng was first ini)ated at the state level – In 1989, New York (NY) State
• Risk-‐adjusted mortality rates for (CABG) surgery reported by hospital and surgeon.
– Other states have followed.
• Na)onal public repor)ng began in the early 2000s. – Medicare Moderniza)on Act of 2003 )ed public repor)ng to payment (reimbursement) • Hospital Quality Alliance (HQA) data allowed American public to access quality data on a centralized website (Hospital Compare).
State Mandatory Repor)ng
• First outcome studies were from the state-‐level CABG repor)ng programs.
– Ini)al results suggested that public repor)ng in NY led to decreases in CABG mortality over )me. • De-‐selec)on of surgeons with high mortality rates • Improvements in processes of care in response to repor)ng
– Subsequent work showed comparable decreases in states without public repor)ng (Shahian et al., Ann Thorac Surg, 2011)
• improvements might not have been the result of public repor)ng alone
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Na)onal Mandatory Repor)ng
• First evalua)ons of the Hospital Compare – Overall performance on process measures improved significantly over the first 2 years of public repor)ng
• More recent studies of Hospital Compare are less convincing – Improvements in mortality secondary to underlying hospital quality not public repor)ng
Na)onal Mandatory Repor)ng
• 2006 study of 962 hospitals
– 180 hospitals in the top quin)le of mortality rates for AMI, fewer than one-‐third (31%) were in the top quin)le of the composite process score.
– Composite process score-‐ Significant rela)onship between the interven)on being applied and quality care being achieved
JAMA 2006 Jul 5;296(1):72-‐8
Na)onal Mandatory Repor)ng
• 2006 study of 962 hospitals
– 30-‐day mortality rates for AMI, HF, and pneumonia improved following introduc)on of Hospital Compare
– Improvement for AMI and pneumonia followed the same trends in mortality prior to the program • Public repor)ng did not lead to a more rapid improvement in mortality rates
Health Aff (Millwood). 2012; 31:585-‐592
Voluntary Repor)ng
• Veterans Administra)on – In 1994, VA was launched to collect and report clinical variables and outcomes across all VA hospitals
• American College of Surgeons – The American College of Surgeons Na)onal Surgical Quality Improvement Program (ACS NSQIP) • Largest measure and repor)ng of surgical outcomes
NSQIP NSQIP
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Voluntary Repor)ng
VA review of over 400,000 pa)ents:
• 1991-‐1997 – 30-‐day mortality fell 9% – Morbidity fell 30% – Surgical pneumonia savings of $9.3 billion annually
BMJ Qual Saf. 2014;23:589-‐599
Voluntary Repor)ng
Montroy J. et al. Plos One 2016, 11(1):1-‐14
• Systema)c review of studies relevant to NSQIP-‐ – Inclusion criteria
• English-‐ language • Before and a`er analysis
of either NSQIP Individual Site reports and/or implementa)on of a quality improvement program
– Outcomes • 30 day morbidity • 30 day mortality
Voluntary Repor)ng
Results: • Mortality-‐ only 1 hospital reported on 30 day mortality
– Did not implement a quality improvement (QI) program – No change a`er joining NSQIP
• Morbidi)es – Overall 30 day morbidity (2 studies: 1 no QIP, 1 with QIP)
• No significant difference a`er joining NSQIP – SSI
• Implementa)on of QI programs significantly decreased rates – Thromboembolic complica)ons
• Implementa)on of QI programs significantly decreased rates Summary: • NSQIP is effec)ve in reducing surgical morbidity. • Improvement in surgical quality appears to be more marked at centers
that implemented a formal quality improvement program directed at the reduc)on of specific morbidi)es.
Montroy J. et al. Plos One 2016, 11(1):1-‐14
Summary
• More methodological sound studies are needed
• What we know (and don’t know) to date-‐ – May improve quality and pa)ent safety metrics: • System based conferences • Checklists • Voluntary repor)ng
– Limited proof of improved quality and pa)ent safety metrics: • Mandatory repor)ng
Thank You!!!!