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Impact of the Institute for Healthcare Improvement Global Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital.

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Presentation on theme: "Impact of the Institute for Healthcare Improvement Global Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital."— Presentation transcript:

1 Impact of the Institute for Healthcare Improvement Global Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital Tania Vila, PharmD Drug Information Specialty Resident Duke University Hospital Co-Investigators: Heidi Cozart, R.Ph.; Lynn Eschenbacher, PharmD, MBA; Diana Brown, RN; William Richardson, MD

2 Background: Adverse Event Detection Methods 44,000 to 98,000 deaths per year occur in U.S. hospitals as a result of errors 44,000 to 98,000 deaths per year occur in U.S. hospitals as a result of errors Three-pronged approach to adverse event monitoring Three-pronged approach to adverse event monitoring Voluntary Reporting Voluntary Reporting Computerized Monitoring Computerized Monitoring Global Trigger Tool – New methodology Global Trigger Tool – New methodology Kohn LT, Corrigan JM, Donaldson MS, editors. To err is human: building a safer health system. Washington, DC: National Academy Press; 2000.

3 Background: Adverse Event Detection Methods Voluntary Reporting Voluntary Reporting Qualitative data informs and guides safety and quality (sentinel events, near misses) Qualitative data informs and guides safety and quality (sentinel events, near misses) First-hand account of event from reporters First-hand account of event from reporters Anonymous & accessible to all hospital employees (available online) Anonymous & accessible to all hospital employees (available online) Under-reporting Under-reporting

4 Computerized Monitoring Computerized Monitoring Automated surveillance for possible ADEs based on logic-based rules followed by chart review Automated surveillance for possible ADEs based on logic-based rules followed by chart review Scans demographic, laboratory, pharmacy system, and other clinical databases Scans demographic, laboratory, pharmacy system, and other clinical databases Quantitative data allows for trending Quantitative data allows for trending Standardized scoring system for severity and causality (Naranjo Scale) Standardized scoring system for severity and causality (Naranjo Scale) Only high risk medication rules are evaluated Only high risk medication rules are evaluated Killbridge P, Classen. Surveillance for adverse drug events: history, methods and current issues. VHA’s 2002 Research series;3:1-44. Background: Adverse Event Detection Methods

5 Example of Computerized Monitoring (ADE-S) Rules Antidotes or combinations of medications and laboratory values Antidotes or combinations of medications and laboratory values Naloxone IV Naloxone IV Dextrose 50% IV AND low blood glucose (<50 mg/dL) Dextrose 50% IV AND low blood glucose (<50 mg/dL) 2 consecutive aPTT values > 100 OR one >150 seconds in patient receiving heparin 2 consecutive aPTT values > 100 OR one >150 seconds in patient receiving heparin

6 IHI Global Trigger Tool ™ IHI Global Trigger Tool ™ New methodology New methodology Trigger-based manual chart review Trigger-based manual chart review Review team minimum of 3 people Review team minimum of 3 people 20 charts per month recommended 20 charts per month recommended 20 minutes/chart 20 minutes/chart Less resource intensive Less resource intensive Griffin FA, Resar RK. IHI Global Trigger Tool for Measuring Adverse Events. IHI Innovation Series white paper. Cambridge, MA: Institute for Healthcare Improvement; Background: Adverse Event Detection Methods

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8 Purpose: Primary Objective To determine the frequency and types of adverse events in urology and orthopedics services as identified by the IHI Global Trigger Tool ™ To determine the frequency and types of adverse events in urology and orthopedics services as identified by the IHI Global Trigger Tool ™ Frequency defined as follows: Frequency defined as follows: Adverse events/1,000 patient days Adverse events/1,000 patient days

9 Purpose: Secondary Objectives To compare the frequency and characteristics of AEs detected by the IHI Global Trigger Tool ™, computerized monitoring, and the voluntary reporting system To compare the frequency and characteristics of AEs detected by the IHI Global Trigger Tool ™, computerized monitoring, and the voluntary reporting system To identify potential quality improvement opportunities and to recommend enhancements to the computerized monitoring system based on results To identify potential quality improvement opportunities and to recommend enhancements to the computerized monitoring system based on results

10 Design Retrospective chart review of patients admitted between January 1, 2007 and June 30, 2007 Retrospective chart review of patients admitted between January 1, 2007 and June 30, 2007 Inclusion Criteria Inclusion Criteria ≥18 years ≥18 years Patients admitted to urology or orthopedics Patients admitted to urology or orthopedics Chart must be closed and complete Chart must be closed and complete Approved by the Duke University Institutional Review Board Approved by the Duke University Institutional Review Board

11 Methods: IHI Global Trigger Tool™ 120 patients admitted to urology and orthopedic services were randomly selected (5/service) in 2 week blocks 120 patients admitted to urology and orthopedic services were randomly selected (5/service) in 2 week blocks Training: Nurse, pharmacist, and physician completed IHI training process Training: Nurse, pharmacist, and physician completed IHI training process Phase I: IHI standardized practice charts with key Phase I: IHI standardized practice charts with key Phase II: IHI trigger tool with Duke-specific charts Phase II: IHI trigger tool with Duke-specific charts Data Collection: Nurse and pharmacist reviewed each chart; MD reviewed discordant cases Data Collection: Nurse and pharmacist reviewed each chart; MD reviewed discordant cases

12 IHI Chart Review Process Data Collection Process Discharge summary Laboratory results Physician orders/MAR Nursing notes/flow sheets and progress notes Documentation All triggers documented whether or not an adverse event occurred All triggers documented whether or not an adverse event occurred Event severity was scored according to an internal scale and a nationally validated scale Event severity was scored according to an internal scale and a nationally validated scale

13 Methods: Severity Scores Severity Index, (internal scale; 0 through 6) Severity Index, (internal scale; 0 through 6) Only 3 through 6 represent patient harm Only 3 through 6 represent patient harm 3 Transient adverse patient effects occurred which required some corrective therapy, increased length of stay (LOS) 1- 2 days or resulted in lab values, vital signs or medication effects outside the desirable parameters 4 Significant adverse patient effects occurred which required aggressive intervention such as code, intubation, transfer to ICU, antidote, interventional drug therapy or increased LOS > 2 days 5 Permanent adverse patient effects occurred such as paralysis, brain damage, disability or loss of limb, organ, or bodily function 6 Patient death

14 Methods: Severity Scores National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), (A through I) National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), (A through I) Only E through I represent patient harm Only E through I represent patient harm E Temporary harm to the patient and required intervention F Temporary harm to the patient and required initial or prolonged hospitalization G Permanent patient harm H Intervention required to sustain life I Patient death

15 Patient Population Definitions IHI Global Trigger Tool™ Random sample of 120 patients from all orthopedics and urology admissions between Jan. 1 to June 30, 2007 Voluntary Reporting and Computerized Monitoring Unique admissions to orthopedics or urology services on the 2 patient care units most likely to care for these patients between Jan. 1 to June 30, 2007

16 Results: Demographics of Adverse Event Population Detection Method (admissions with AE*) IHI (n = 50) Computerized Monitoring (n = 17) Voluntary Reporting (n =11) Mean Age, years ± SD Range Range years, n (%) years, n (%) ≥65 years, n (%) ≥65 years, n (%) 59.9 ± (58%) 21 (42%) 69.5 ± (29%) 12 (71%) 51.2 ± (91%) 1 (9%) Gender Male, n (%) Male, n (%) 31 (62%) 7 (41%) 5 (46%) Admit Service Orthopedics, n (%) Orthopedics, n (%) Urology, n (%) Urology, n (%) 24 (48%) 26 (52%) 9 (53%) 8 (47%) 9 (73%) 3 (27%) Median LOS †, Days Range *unique admissions to orthopedics or urology with an adverse event identified †LOS = Length of stay

17 Results: Adverse Event Detection Methods events 13 events 59 events 1294 unique admissions Random sample of 120 unique admissions IHI Trigger Tool 289 positive triggers Voluntary Reporting VoluntaryReporting 85 reports Computerized Monitoring ComputerizedMonitoring 222 rules fired

18 Results: Adverse Event Frequencies High risk medication related adverse events/1000 patients Adverse events/1000 patients IHI Global Trigger Tool Computerized Monitoring Voluntary Reporting Primary endpoint

19 Results: IHI Global Trigger Tool™ Adverse Event by Category Fall, 1.7% Hospital- associated infection, 13.6% Adverse drug reaction, 13.6% Transfusion/blood loss anemia, 23.7% Surgical complications, 22% Thrombosis/ Anticoagulation, 5.1% Chest pain, 3.4% Narcotics/Benzodiazepines, 11.9% Miscellaneous †, 5.1% †Miscellaneous includes chemo-induced neutropenia (n = 1), hyponatremia/delirium (n = 2) Care Module (47.5%) Medication Module (30.6%) Surgical Module (22%) 59 adverse events detected

20 Results: Computerized Monitoring Adverse Event by Category Anticoagulants, 52.6% Narcotics/ Benzodiazepines, 26.3% Hypoglycemia, 21.1% 19 adverse events detected 5.1% captured by IHI 0% captured by IHI 11.9% captured by IHI Compared to IHI…

21 Results: Voluntary Reporting Adverse Events by Category Narcotics/ Benzodiazepines, 38.5% Anticoagulants, 15.4% Antibiotics, 23.1% Anesthetics, 7.7% Electrolyte Replacement Therapy (potassium), 7.7% Cathartics/Laxatives, 7.7% 13 adverse events detected Compared to IHI… More high risk medication adverse events No hypoglycemia events

22 Results: Adverse Event Severity Nationally validated NCC MERP Internal Severity Index 79% 21% 66% 34% 67% 33% 2 days OR resulted in initial hospitalization Percentage (%) 15.3% 84.7%

23 Future Enhancements Expand computerized monitoring Expand computerized monitoring Discharge notes and nursing notes were valuable in adverse event identification in IHI Discharge notes and nursing notes were valuable in adverse event identification in IHI As technology advances and nursing notes become electronic, free-text scanning may become a valuable implementation As technology advances and nursing notes become electronic, free-text scanning may become a valuable implementation Example “oversedation” search versus IV naloxone rule Example “oversedation” search versus IV naloxone rule

24 Limitations Retrospective chart review Retrospective chart review Not generalizable to other services Not generalizable to other services Causality and preventability not assessed on IHI Global Trigger Tool™ Causality and preventability not assessed on IHI Global Trigger Tool™ Physician reviewer was an orthopedic surgeon which may introduce bias Physician reviewer was an orthopedic surgeon which may introduce bias

25 Limitations Subjective judgment of adverse events (e.g. anemia due to blood loss from surgery) Subjective judgment of adverse events (e.g. anemia due to blood loss from surgery) Not 1:1 comparisons with IHI Not 1:1 comparisons with IHI Computerized monitoring and voluntary reporting data extracted by the units most likely to care for these orthopedics and urology patients Computerized monitoring and voluntary reporting data extracted by the units most likely to care for these orthopedics and urology patients IHI Trigger Tool™ used a random sample rather than all admissions to orthopedics and urology IHI Trigger Tool™ used a random sample rather than all admissions to orthopedics and urology

26 Conclusions IHI Trigger Tool™ identifies the greatest number of events overall IHI Trigger Tool™ identifies the greatest number of events overall Computerized monitoring and voluntary reporting identify greater proportion of medication-related events Computerized monitoring and voluntary reporting identify greater proportion of medication-related events Voluntary systems good at capturing near misses/rare events whereas surveillance (IHI and computerized monitoring) better at capturing harm Voluntary systems good at capturing near misses/rare events whereas surveillance (IHI and computerized monitoring) better at capturing harm All 3 adverse event detection methods are complementary All 3 adverse event detection methods are complementary

27 Acknowledgements Department of Pharmacy Department of Pharmacy Residency Research Committee Residency Research Committee Computerized Patient Safety Initiatives, Duke Health Technology Solutions Computerized Patient Safety Initiatives, Duke Health Technology Solutions Julie Eckstrand, Pharm.D. Julie Eckstrand, Pharm.D. Monica Horvath, Ph.D. Monica Horvath, Ph.D. Andrea Long, Pharm.D. Andrea Long, Pharm.D. Julie Whitehurst, Pharm.D. Julie Whitehurst, Pharm.D.

28 Questions

29 ADE-S System Clinical Rules Engine Laboratory Demographic Data Pharmacy List of Triggers (daily) Health-system clinical pharmacists Computerized Patient Safety Initiative (CPSI) pharmacists Immediate Intervention required? Yes No Investigate trigger (e.g. chart review) Intervene and document intervention Score and document ADE causality, severity, and narrative Kappa pharmacist Kappa pharmacist

30 Are there previous conclusive reports on this reaction?+100 Did the adverse event appear after the drug was administered?+20 Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered? +100 Did the adverse reaction reappear when the drug was re- administered? +20 Are there alternative causes (other than the drug) that could, on their own, have caused the reaction? -20 Did the reaction re-appear when a placebo was given?+10 Was the drug detected in the blood (or other fluids) in concentrations known to be toxic? +100 Was the reaction more severe when the dose was decreased?+100 Did the patient have a similar reaction to the same or similar drugs in any previous exposure? +100 Was the adverse event confirmed by an objective evidence?+100 YesNo Do Not Know Adverse Drug Reaction Probability Scale ≥9 Definite; 8 to 5 Probable; 1 to 4 Possible; ≤0 Doubtful Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:

31 Sample Size Calculation 87% power at 120 charts to detect a 4- fold difference in rates between IHI Trigger Tool™ and ADE-S during a 6 month period 87% power at 120 charts to detect a 4- fold difference in rates between IHI Trigger Tool™ and ADE-S during a 6 month period

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34 IHI Surgical Trigger Tool ™ Surgical Trigger Tool ™ contains 28 triggers Surgical Trigger Tool ™ contains 28 triggers Surgical triggers have corresponding code on global trigger tool (not limited to surgical module) Surgical triggers have corresponding code on global trigger tool (not limited to surgical module) 193 surgical triggers vs. 289 global triggers (67% correspondence) 193 surgical triggers vs. 289 global triggers (67% correspondence)

35 Results: IHI Triggers by Frequency Other triggers 20% Transfusion 10.1% Anti-emetic use 18.4% Abrupt drop in Hct of 25% 13.9% Oversedation/ hypotension 7.6% Benadryl use 6.9% Readmission 8% X-ray intra-op 5.6% op-time >6 h 3.1% Abrupt med stop 3.5% Fall 2.8% Return to surgery Admission to ICU post-op X-ray or doppler studies for emboli Any procedure complication SCr > 2 times baseline Consult requested in PACU C. diff positive culture Romazicon (flumazenil) use Time in ED > 6 h Narcan (naloxone) use 289 triggers


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