Drivers of Quality through the ACS Trauma Center Verification Program: Structure, Process, or Commitment?

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Drivers of Quality through the ACS Trauma Center Verification Program: Structure, Process, or Commitment? Avery B. Nathens MD PhD, Medical Director, Trauma Quality Programs

None Disclosures

Objectives Conceptual framework of structure, process, and outcome as measures of quality Structure and process as the foundation of the trauma center verification process Review evidence for structure-process-outcome relationships Structure and process in trauma: the commitment-outcome relationship

How do the standards lead to better outcomes?

AVEDIS DONABEDIAN Professor, Public health, University of Michigan

Structure Staff, physical resources, policies Quality assessment Donabedian framework Process Was medicine properly practiced? Outcome

WHAT EVIDENCE DO WE HAVE SUPPORTING THE VERIFICATION PROCESS?

Westchester Medical Center DiRusso, J Trauma, 2001 Compared pre-verification to post verification (verified in 1999) Preparation included Two trauma/critical care surgeons Designation of a trauma team 1 FTE Trauma Program Manager, trauma nurse practitioners, trauma case managers, two social workers Expansion of QI and educational activities Benefits: Lower mortality, shorter LOS, cost savings ~$4000 per patient

West Virginia University Hospital Ehrlich, J Trauma, 2002 More expedient evaluation, better documentation of vital signs, more prompt CT scans Shorter ICU LOS, fewer ICU bouncebacks Fewer re-intubations, delayed laparotomies, more patients admitted to trauma service PI committee evolved from a few general surgeons to a 27- member multidisciplinary group Research activity went from 0 to 60 IRB-approved trauma research projects

Stanford University Medical Center Maggio, J Trauma, 2009 Unsuccessful site visit led to Hire of new trauma director, new trauma surgeons, nurse coordinator, ortho trauma surgeon, registry staff Correction of deficiencies in trauma QI program New Trauma Executive Committee; new accountability structure Closed ICU with dedicated surgical intensivists with new ventilator and central line bundles New trauma protocols for care in the trauma bay Benefits: Significantly lower mortality, better surgeon response times, trend toward shorter ICU LOS, greater revenue (volumes)/contribution margin

NSCOT National Study of Cost and Outcomes in Trauma Care Prospective cohort study 18 level I trauma centers and 51 large nondesignated centers in 15 urban regions Extensive data collection to allow for risk adjustment Follow-up x 1 year

National Evaluation of the Effect of Trauma Center Care on Mortality Mortality (%) N Engl J Med, 2006 14 12 N=15,000 patients 10 8 6 4 NTC TC 2 0 In hospital 30 d 90 d 365 d Time from injury 25% lower risk of death at one year in trauma centers

NSCOT Is trauma center care associated with better functional outcomes among survivors? SF-36, functional capacity, return to work Modest benefit (SF-36 scores) only among those with severe lower extremity trauma (J Bone Joint Surgery, 2008) Are trauma centers cost effective? One year costs: $80,232 in trauma centers vs $58, 320 in nontrauma centers $36,319 per life year gained or $790,931 per life saved 50-100k per life year gained is considered acceptable

WHAT STRUCTURES/PROCESSES MIGHT ACCOUNT FOR THE BETTER OUTCOMES IN TRAUMA CENTERS?

Structure: In-house trauma surgeons Six studies no differences in outcome Helling, J Trauma, 2003 (OH less time to OR) Arbabi, Arch Surg, 2003, (Surgical critical care fellowship associated with lower risk of death) Fulda, J Trauma, 2002 (Response times 4 vs 14 min) Kheterpal, J Trauma, 1999 (IH less time to OR for penetrating) Luchette, J Trauma, 1997 (IH quicker to OR during regular work hours) Demarest, J Trauma, 1999 (OH - responded more quickly than IH)

Process measure time to OR Adjusted RR of death Brain Injury+Mass Effect Time to OR (hrs) Penetrating Truncal Injury+Shock Trauma centre 0.61 (0.43-0.86) 3.3 1.0 Non-verified center Reference 3.6 0.79 Haas, JACS, 2008

Structure of ICU care and Outcome Intensivist-model ICU Distinct ICU service (led by an intensivist) or were comanaged with an intensivist (a physician boardcertified in critical care) Level 1 trauma centres: 80% intensivist model Non-verified centers: ~10% intensivist model Nathens, Ann Surg, 2006

Trauma mortality as a function of ICU model 22% reduction in risk of death in closed ICU s Effects varied Greatest effect if ICU director was a surgeon Elderly patients derived the greatest benefit

Adherence to SCIP measures and SSI Process-outcome relationships Evaluated relationship between SCIP measures and rates of surgical site infection across 400 hospitals SCIP measures analyzed individually and as a composite S-INF Core (composite of all three core SCIP measures) S-INF: at least two of any SCIP measures Stulberg, JAMA, 2010

SCIP measures and SSI Antibiotics w/in 1 hr of incision Appropriate antibiotics Antibiotics stopped w/in 24 hrs Cardiac surg with normal postop glucose Appropriate hair removal Periop normothermia in CR patients All 3 original SIP measures in a single visit All patients with at least 2 SCIP measures in a single visit

Hearld, Medical Care Research & Review, 2008 Structure-Process-Outcome Relationships Structure- Outcome (n=208) Structure- Process (n=53) Process- Outcome (n=56) Positive 72 (34%) 32 (60%) 36 (64%) Negative 42 (20%) 7 (13%) 5 (9%) Nonsignificant 94 (45%) 14 (26%) 15 (26%)

Donabedian Framework Structure Process Inferences about relationship were limited Outcome

Donabedian on Outcomes, 1966 Outcome Recovery, restoration of function, and of survival Pros Valid, highly valued, concrete & amenable to precise measurement Limitations Only valid if modifiable (or desired) Outcomes must be used with discrimination Donabedian, Milbank Quarterly, 1966

Donabedian, Milbank Quarterly, 1966 Donabedian on Process, 1966 Process is justifiable as a measure of quality Less interested in whether care can achieve results Interested in whether good medical care has been applied Estimates of quality are less stable than outcomes More relevant to the question: was medicine properly practiced?

Donabedian on Structure, 1966 Structure provides the administrative and related needs that support/direct the provision of care Adequacy of facilities/equipment; qualifications of medical staff and their organization; the administrative structure; fiscal organization Assumes that given the proper setting good medical care will follow Pros Concrete and accessible information Cons Relationship between structure and process or structure on outcome not well established Donabedian, Milbank Quarterly, 1966

Donabedian over time Berwick, Millbank Quarterly, 2016 As told by an oral historian in 1998 he indicated that he had no solutions... but everywhere in my work is the admonition, implicit and explicit, [that] this is a good way of thinking about these problems

Donabedian over time Berwick, Millbank Quarterly, 2016 Three years later, he said that systems... are enabling mechanisms only. It is the ethical dimension of individuals that is essential to a system s success.

Donabedian over time Berwick, Millbank Quarterly, 2016 Became worried about the industrial model of QI and in an interview just before his death said The secret of quality is love. You have to love your patient, you have to love your profession, you have to love your God.

Glickman, Int J Qual Health Care, 2007 Contemporary view on Quality Organizational theory People (management and employees) and organizational arrangements are key determinants of performance and quality Juran management commitment is pertinent to every successful quality revolution, no exceptions are known Essential structural elements function as primary catalysts for process change Leadership, human capital, information management systems, and group dynamics (culture, incentive systems)

Organizational attributes ( Structure ) Physical characteristics Management Executive leadership Board responsibilities Culture Organizational design Information management Incentives Necessary, but not sufficient Enablers Process Diagnosis Treatment Outcomes Morbidity Mortality

Aggregate measures of quality Individual item performance rates do not necessarily point toward high quality hospitals E.g. a single SCIP measure; a single criterion for trauma center verification When taken in aggregate, improved performance on global all or none composite measures is associated with improved outcomes E.g. composite SCIP measures

Aggregate measures of quality Aggregate measures better indicators of high quality care All or none measures raise the bar E.g. meeting 4/4 quality practices is a much more difficult task than adherence on 1 measure Requires extraordinary commitment

How do the standards lead to better outcomes?

265 individual measures

The aggregate measure of quality in trauma Meeting structural and process measures reflect organizational & professional commitment to trauma care Commitment is the enabler that allows process change and optimal outcomes

BUT SOMETIMES INDIVIDUAL MEASURES ARE NECESSARY TO RAISE THE BAR

Trauma center care & the elderly The unspoken NSCOT data Trauma center Non-trauma center Mortality reduction Overall 7.6% 9.5% 20% Age<55 5.9% 9.0% 34% Age>55 12.3% 13.1% 6% (NS) Mackenzie, New Engl J Med, 2006

TQIP Benchmarking report

The routine involvement of appropriate medical specialists to evaluate and manage the elderly patient s comorbid conditions is desirable. Moreover, a well coordinated, multidisciplinary approach that acknowledges the unique challenges associated with the elderly is encouraged

Summary Demonstrating a relationship between all standards and a positive outcome will not be possible Many standards are evidence based yet many others together reflect institutional and/or professional commitment to the care of the injured patient

Conclusion It is the commitment that enables quality improvement, organizational change and highly effective care