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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. Tania Vila, PharmD Drug Information Specialty Resident Duke University Hospital. Co-Investigators:

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Tania vila pharmd drug information specialty resident duke university hospital

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


Background adverse event detection methods
Background: Adverse Event Detection Methods Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

  • 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

    • Voluntary Reporting

    • Computerized Monitoring

    • 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.


Background adverse event detection methods1
Background: Adverse Event Detection Methods Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

  • Voluntary Reporting

    • Qualitative data informs and guides safety and quality (sentinel events, near misses)

    • First-hand account of event from reporters

    • Anonymous & accessible to all hospital employees (available online)

    • Under-reporting


Computerized Monitoring Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

Automated surveillance for possible ADEs based on logic-based rules followed by chart review

Scans demographic, laboratory, pharmacy system, and other clinical databases

Quantitative data allows for trending

Standardized scoring system for severity and causality (Naranjo Scale)

Only high risk medication rules are evaluated

Background: Adverse Event Detection Methods

Killbridge P, Classen. Surveillance for adverse drug events: history, methods and current issues. VHA’s 2002 Research series;3:1-44.


Example of computerized monitoring ade s rules
Example of Computerized Monitoring (ADE-S) Rules Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

  • Antidotes or combinations of medications and laboratory values

    • Naloxone IV

    • Dextrose 50% IV AND low blood glucose (<50 mg/dL)

    • 2 consecutive aPTT values > 100 OR one >150 seconds in patient receiving heparin


Background: Adverse Event Detection Methods Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

  • IHI Global Trigger Tool™

  • New methodology

  • Trigger-based manual chart review

    • Review team minimum of 3 people

    • 20 charts per month recommended

    • 20 minutes/chart

  • 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; 2007.


Purpose primary objective
Purpose: Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching HospitalPrimary Objective

  • 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:

      • Adverse events/1,000 patient days


Purpose secondary objectives
Purpose: Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching HospitalSecondary Objectives

  • 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


Design
Design Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

  • Retrospective chart review of patients admitted between January 1, 2007 and June 30, 2007

  • Inclusion Criteria

    • ≥18 years

    • Patients admitted to urology or orthopedics

    • Chart must be closed and complete

  • Approved by the Duke University Institutional Review Board


Methods ihi global trigger tool
Methods: IHI Global Trigger Tool™ Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

  • 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

    • Phase I: IHI standardized practice charts with key

    • Phase II: IHI trigger tool with Duke-specific charts

  • Data Collection: Nurse and pharmacist reviewed each chart; MD reviewed discordant cases


Ihi chart review process
IHI Chart Review Process Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

  • 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

    • Event severity was scored according to an internal scale and a nationally validated scale


Methods severity scores
Methods: Severity Scores Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

  • Severity Index, (internal scale; 0 through 6)

    • Only 3 through 6 represent patient harm


Methods severity scores1
Methods: Severity Scores Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

  • National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), (A through I)

    • Only E through I represent patient harm


Patient population definitions
Patient Population Definitions Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

  • 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


Results demographics of adverse event population
Results: Demographics of Adverse Event Population Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

*unique admissions to orthopedics or urology with an adverse event identified

†LOS = Length of stay


Results adverse event detection methods
Results: Adverse Event Detection Methods Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

59 events

57

19 events

IHI Trigger Tool

289 positive triggers

IHI Trigger Tool

Computerized

Monitoring

222 rules fired

Computerized Monitoring

1

16

1

2

Voluntary

Reporting

85 reports

Voluntary Reporting

Random sample

of 120 unique

admissions

10

1294 unique

admissions

13 events


Results adverse event frequencies
Results: Adverse Event Frequencies Trigger Tool Compared to Current Adverse Event Monitoring Systems at a Large Teaching Hospital

IHI Global Trigger Tool

Computerized Monitoring

Voluntary Reporting

High risk medication related adverse events/1000 patients

Adverse events/1000 patients

Primary

endpoint

136

4

3

4

2

23


Results ihi global trigger tool adverse event by category
Results: IHI Global Trigger Tool™ Adverse Event by Category

Fall, 1.7%

Miscellaneous†, 5.1%

Narcotics/Benzodiazepines, 11.9%

Care Module

(47.5%)

Medication

Module

(30.6%)

Surgical

Module

(22%)

Hospital-associated infection, 13.6%

Chest pain, 3.4%

Thrombosis/ Anticoagulation, 5.1%

Adverse drug reaction, 13.6%

Surgical complications, 22%

59 adverse events detected

Transfusion/blood loss anemia, 23.7%

†Miscellaneous includes chemo-induced neutropenia (n = 1), hyponatremia/delirium (n = 2)


Results computerized monitoring adverse event by category
Results: Computerized Monitoring Adverse Event by Category Category

Compared to IHI…

11.9% captured

by IHI

Narcotics/ Benzodiazepines, 26.3%

19 adverse events detected

Anticoagulants, 52.6%

Hypoglycemia, 21.1%

5.1% captured

by IHI

0% captured

by IHI


Results voluntary reporting adverse events by category
Results: Voluntary Reporting Adverse Events by Category Category

Cathartics/Laxatives, 7.7%

Electrolyte Replacement Therapy (potassium), 7.7%

Compared to IHI…

More high risk

medication

adverse events

No hypoglycemia

events

Anesthetics, 7.7%

Narcotics/ Benzodiazepines, 38.5%

Anticoagulants, 15.4%

13 adverse events detected

Antibiotics, 23.1%


Results adverse event severity
Results: Adverse Event Severity Category

Internal Severity Index

Nationally validated

NCC MERP

84.7%

79%

66%

Percentage (%)

67%

34%

21%

33%

15.3%

<3 = did not reach patient; 3 = temporary harm, required corrective therapy OR resulted in labs/vitals outside desirable range; 4 = required aggressive treatment, prolonged LOS > 2 days OR resulted in initial hospitalization


Future enhancements
Future Enhancements Category

  • Expand computerized monitoring

    • 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

    • Example “oversedation” search versus IV naloxone rule


Limitations
Limitations Category

  • Retrospective chart review

  • Not generalizable to other services

  • Causality and preventability not assessed on IHI Global Trigger Tool™

  • Physician reviewer was an orthopedic surgeon which may introduce bias


Limitations1
Limitations Category

  • Subjective judgment of adverse events (e.g. anemia due to blood loss from surgery)

  • 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

    • IHI Trigger Tool™ used a random sample rather than all admissions to orthopedics and urology


Conclusions
Conclusions Category

IHI Trigger Tool™ identifies the greatest number of events overall

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

All 3 adverse event detection methods are complementary


Acknowledgements
Acknowledgements Category

  • Department of Pharmacy

  • Residency Research Committee

  • Computerized Patient Safety Initiatives, Duke Health Technology Solutions

    • Julie Eckstrand, Pharm.D.

    • Monica Horvath, Ph.D.

    • Andrea Long, Pharm.D.

    • Julie Whitehurst, Pharm.D.


Questions
Questions Category


Ade s system

Pharmacy Category

Clinical Rules Engine

Laboratory

Demographic Data

ADE-S System

Immediate

Intervention

required?

Health-system clinical pharmacists

List of Triggers (daily)

Computerized Patient Safety Initiative (CPSI) pharmacists

Score and

document

ADE causality,

severity, and

narrative

Investigate trigger

(e.g. chart review)

Kappa

pharmacist

No

Yes

Kappa

pharmacist

Intervene and document intervention


Do Not Know Category

Adverse Drug Reaction Probability Scale

Yes

No

≥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;30:239-245.


Sample size calculation
Sample Size Calculation Category

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


Ihi surgical trigger tool
IHI Surgical Trigger Tool Category™

Surgical Trigger Tool™ contains 28 triggers

Surgical triggers have corresponding code on global trigger tool (not limited to surgical module)

193 surgical triggers vs. 289 global triggers (67% correspondence)


Results ihi triggers by frequency
Results: IHI Triggers by Frequency Category

  • 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

op-time >6 h

3.1%

Abrupt med stop

3.5%

Fall 2.8%

X-ray intra-op

5.6%

Other triggers

20%

Transfusion

10.1%

Benadryl use

6.9%

Abrupt drop in Hct of 25%

13.9%

Oversedation/ hypotension

7.6%

Anti-emetic use

18.4%

Readmission

8%

289 triggers


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