Lung Day University of Washington. June 17, Translating Data Into Practice in the MICU. Richard K. Albert, M.D.
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1 Lung Day 2011 University of Washington June 17, 2011 Translating Data Into Practice in the MICU Richard K. Albert, M.D. Chief of Medicine Denver Health Professor of Medicine University of Colorado Adjunct Professor of Engineering and Computer Science University of Denver
2 Objectives Denver Health Answer two questions: When should data mandate a change in practice? How can practice be changed?
3 Background van den Berghe I (NEJM 2001): 1548 patients ICU mortality: 8% vs 4.6% (43% ) Response Wide-spread change in practice Included in many guidelines Added to bundles Compliance with bundles assessed
4 Background Denver Health MICU Intense lobbying to adopt tight control Did not change MICU practice Why? - Results seemed too good - 62% of patients with cardiac surgery - High mortality in control group of patients with cardiac surgery pts (5%) - All patients received parenteral or enteral nutrition from day 2 Was I harming patients?
5 Background NICE-SUGAR (NEJM 2009): 6104 patients ICU mortality: - Conventional control : 24.9% - Tight control: 27.5% (10% ) Response: Wide-spread return to previous practice Personal relief Question: When should new data change practice? What is the role of guidelines?
6 Grading the Evidence (2 nd ACCP Conference on Antithrombotic Rx) Level I II III IV V Definition RCTs with low false positive (α) error and low false negative (β) error (high power) RCTs with high false positive (α) error and/or high false negative (β) error (low power) Non-randomized trials with contemporaneous controls Non-randomized trials, historical controls or patients treated at a different institution Case series Sackett, 1989
7 Grading the Recommendations (2 nd ACCP Conference on Antithrombotic Rx) Level A B C Definition 1 (preferably > 1) Level I trial 1 Level II trial Level III, IV or V evidence Should Level A data mandate a change in practice? 1 or > 1 Level I trial? Tight glucose story suggests > 1 What should be done after 1 Level I RCT? Is there any use for Level B/C data?
8 Meta-Analysis Biased against meta-analyses Garbage in-garbage out Differences in inclusion/exclusion criteria Examine each RCT - Good study (Level I) or not - If good, accept conclusion - If not, don t - How can statistical averaging of bad studies result in a valid recommendation? Reservations about my bias - Some EBM groups rank meta-analyses the same as RCTs
9 Meta-Analysis Different conclusions: Heliox for Rx of asthma in ED Anti-TNF Rx for rheumatoid arthritis Meat-analysis, Schmeta-analysis
10 Guidelines Proposed by IOM 1990 inappropriate health care variation Assist patient decisions Assist physician decisions
11 Levels of Recommendation (Guyatt, 1995) Defined (and complicated) interpretation of guidelines Level of recommendation depends on: Strength of evidence Relationship between - Magnitude of the Rx effect - Precision of the estimate - Threshold of Rx effect - Consistency of effect Requires numerous studies of each question
12 GRADE System Quality of evidence RCT (A) Downgraded RCT, upgraded observational study (B) Well-done observational studies (C) Case series or expert opinion (D) Strength of recommendation Strong (I) Weak (II)
13 GRADE System Factors that the strength of evidence Inconsistent results Indirect evidence Imprecision of results Reporting bias Factors that the strength of evidence Large effect magnitute (> 2) without confounders Very large effect magnitude (> 5) Dose-response
14 GRADE System Strength of recommendation Quality of evidence Relative importance of outcomes Magnitude of relative risk Absolute magnitude of effect Precision of estimates of effect Costs
15 Surviving Sepsis Guideline Evidence N % Recommendation (Level I) A 7 8 B C D 9 11 Suggestion (Level II) A 0 0 B 6 7 C 9 11 D 8 10 Total Dellinger, 2008
16 Surviving Sepsis Guidelines 1A recommendations For: - Weaning protocols - DVT prophylaxis - Stress ulcer prophylaxis for sepsis and GI bleeds Against: - Low-dose dopamine for renal protection - Steroids (> 300 mg hydrocortisone) for shock - rhapc for patients with APACHE II < 20 - Routine use of PA catheters Dellinger, 2008
17 Surviving Sepsis Guidelines Intervention Low V T ventilation Abx in first hour after cultures Goal-directed resuscitation Dobutamine for low CI Minimum PEEP ACTH stim testing rhapc Steroids for shock Prone positioning Recommendation 1B 1B 1C 1C 1C 2B 2B-2C 2C 2C Dellinger, 2004
18 Low V T Ventilation Should it be Level B? 1 Level I RCT Study N V T (ml/kg) PEEP (cmh2o) Mortality (%) Con Exp Con Exp Con Exp Amato < * Stewart Brochard Brower ARDSNet *
19 Level A Recommendations Guideline Recommendations Total Level A % No RCTs % Surviving Sepsis I Surviving Sepsis II ACC/AHA Was a new guideline needed?
20 My Proposals Level A evidence 2 Level I RCTs with consistent results 1 Level I RCT if multicenter (?) Guidelines Forget nuances of grading the evidence Focus on Level A evidence only - Anything < Level A: moderate-to-high risk result is false (+) or false (-) Experts should do more trials, not parse and reparse existing data
21 How Can Practice Be Changed? It can be very hard or very easy
22 DKA Protocol Denver Health Background Hospitalist (Sara Bull, now Endocrinologist) Study idea: DKA protocol to ICU LOS What was our LOS for DKA? 30% below UHC benchmark - 91 vs 130 hrs Bad idea? Persistent interest
23 DKA Guidelines Denver Health Many available Phosphate replacement protocol (1983) Insulin nomogram (CCM 2001) Am J Med (2002) ADA (2003) Up-to-Date Studies show little or no effectiveness None are comprehensive None are mandatory
24 Phase 2 (MICU) Denver Health Insulin Dosing (IV #2) Glucose (mg/dl) * Endocrine Consult Insulin Infusion Rate (U/hr) < 65 D/C insulin, give D50 25 ml, blood glucose in 30 mi Rate 50%, blood glucose in 1 hr No 2 U/hr if blood glucose is falling U IV + 1 U/hr No U IV + 1 U/hr 3 U IV + 2 U/hr 4 U IV + 3 U/hr U IV + 1 U/hr 8 U IV + 2 U/hr 8 U IV + 3 U/hr U IV + 1 U/hr 10 U IV + 3 U/hr 10 U IV + 4 U/hr* U IV + 2 U/hr 12 U IV + 4 U/hr 12 U IV + 6 U/hr* > 400 Call MD for New Orders*
25 D5W rate (ml/hr) Phase 2 (MICU) Glucose (mg/ml) D5W rate (ml/hr) < If hemodynamics are stable, may change to D5/½NS and cap IV # > 400 0
26 Patient Population Denver Health Variable Pre-Protocol (N = 130) Post-Protocol (N = 111) Gender (% male) Age (yrs) 40 ± ± 13 Anion gap (mmol/l) 28 ± 6 28 ± 6 Blood glucose (mg/dl) 565 ± ± 245 Blood ketones (0-3) 2.6 ± ± 0.7 Heart rate (beats/min) 107 ± ± 19 MAP (mmhg) 102 ± ± 17
27 Effect of DKA Protocol on ICU LOS % P = Hours ± ± 18 Pre-Protocol Post-Protocol
28 Effect of DKA Protocol on Hospital LOS % P = Hours ± ± 41 Pre-Protocol Post-Protocol
29 Effect of DKA Protocol on Time to AG Clearance* % P < Hours ± ± 5 Pre-Protocol Post-Protocol * = First report
30 Effect of DKA Protocol on Time to Ketone Clearance % P = Hours ± ± 36 Pre-Protocol Post-Protocol
31 Effect of DKA Protocol on Recurrence of AG Percent % P < % 3% Pre-Protocol Post-Protocol
32 Effect of DKA Protocol on Hypoglycemic Episodes Patients with hypoglycemia (%) / with 1 8 with 2 Pre-Protocol 16%, P = NS All asymptomatic 23/ with 1 3 with 2 1 with 3 Post-Protocol
33 Very Easy Residents and nurses initially reluctant Rapidly accepted after observing improvements Photocopied for use at other hospitals
34 Very Easy Denver Health Nurses phone calls and pages Teamwork Constant approach = fewer chances for error Physicians phone calls and pages orders LOS (fewer patients)
35 Provider Autonomy Learning by trial-and-error? Patient safety Cost Learn a single system that everyone uses - Easier to pick-up variations
36 Very Hard 30 o bed head elevation Surreptitious data collection WAP-VAP Patented device Comparative public charting Handwashing Reasons? More work Trying to correct uncommon problems
37 Journal Club Denver Health The Checklist Manifesto Atul Gewande, M.D.
38 MICU Checklist (v 3.3) Daily questions Can any medications be discontinued? Can central venous catheter be removed? Can any peripheral IVs be removed? Can any lab tests be ordered less frequently? If a Foley is in placed, is it still needed? Is DVT prophylaxis appropriate? Is nutritional support appropriate? What is the daily volume status goal? Has PCP been notified on day of discharge?
39 Checklists Denver Health Time Period MICU Pts (N) Lab Tests Ordered (N) Lab Tests Ordered/ Pt (N) Pre , Post ,916 44
40 Checklists Denver Health Who should run the checklist? That s not my problem is possibly the worst thing people can think Tenerife tragedy > The 2 nd officer never believed he had the permission, let alone the duty, to halt the captain instead the captain was allowed to plow ahead and kill them all Nurses Facilitates teamwork Facilitates communication
41 Checklists Denver Health Sully Sullenberger, US Air Two pilots with 150 yrs of experience I want to correct the record right now. This was a crew effort. The outcome was the result of teamwork and adherence to procedure You make creamed corn a few hundred times and you believe you have it, but that s when things begin to slip
42 Checklists Denver Health Teamwork The job is not performing isolated tasks but helping the group get the best results Everyone has to be integrally involved The biggest cause of serious error is a failure to communicate
43 My Proposals Changing practice Focus on implementing Level A recommendations - Systems of care (not MD-dependent) - Monitoring and comparing data Pick your battles (Level I evidence) Teamwork and communication
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