American hospitals crawling towards Electronic Medical Records (EMR) and Computerized Physician Order Entry (CPOE)
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- Kristina Jordan
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1 Welcome! American hospitals crawling towards Electronic Medical Records (EMR) and Computerized Physician Order Entry (CPOE) Still <10% of US Hospitals Must reconcile different information systems to exchange data accurately and efficiently Benefits of complete patient data records can be huge Speakers to address benefits at various levels of healthcare administration
2 UCSD Medical Center: Database Driven Decisions Robert Schoenhaus, Pharm.D. Pharmacoeconomics Specialist MUE Coordinator
3 Objectives Describe limitations of data decision support at a single academic medical center Demonstrate value of coordinated data to drive appropriate patient care through informed decision making Review case examples of UCSD medication use evaluations that incorporated patient outcomes taken from several databases
4 UCSD Pharmacy Data Collection Siemens Pharmacy Pt Demographics Drug/dose Pharmacy notes UHC Clinical Resource Management Benchmarking outcomes Pt diagnosis and Procedure codes The Whole UCSD Pharmacy picture TSI (mainframe) Financial cost/charge by cost center Itemized down to the unit Coding data Medical Chart Everything else Clinical rationale intangibles
5 Data Capture
6 A Single Center Experience with Recombinant Factor VIIa in Orthotopic Liver Transplantation Robert Schoenhaus Pharm.D, Linda Awdishu BScPhm, MAS; Sam Martinez Pharm.D, Marquis Hart MD, Thomas Lane MD; UC San Diego Medical Center
7 Introduction Options for treatment of blood loss during liver transplantation: Packed red blood cells Platelets Fresh frozen plasma Cryoprecipitate Vitamin K Factor VIIa?
8 Estimated Number of Patients Treated With Recombinant Human Coagulation Factor VIIa by Year O'Connell, K. A. et al. JAMA 20;295: Copyright restrictions may apply.
9 Number of Reported Deaths Among Patients Administered Human Coagulation Factor VIIa With a Thromboembolic Event by Year O'Connell, K. A. et al. JAMA 20;295:
10 Comparison of Published Literature Parameter Lodge et al (N = 82) (Control versus treatment) De Gasperi et al (N = 12) (Control versus treatment) Planinsic et al (N = 183) (Control versus treatment) Estimated Blood Loss (ml) NR 3,500 vs. 1,800 NR Packed Red Cells (units) 8.2 vs. 7 7 vs vs. 13 Fresh Frozen Plasma (units) 11 vs vs vs 15.5 Platelets 141 ml vs 81.8 ml 2.6 units vs 1.5 units 4 units vs 9 units No significant differences
11
12 Study Objectives Investigate use of factor VIIa in orthotopic liver transplant patients Determine if factor VIIa reduces blood product requirements and operating room time in orthotopic liver transplant (OLT) patients Alter UCSDMC guidelines if needed
13 Study Design Retrospective, single center study Inclusion: Patients receiving an OLT Exclusion: Patients less than 18 years of age Retransplantation Multi-organ transplants ECMO patients Data collected from patients admitted between January 2003-November 20 Analyzed 119 patients
14 Model for End Stage Liver Disease (MELD) Numerical scale from 6 (less ill) to 40 (more ill) that determines the severity of illness for a patient with end stage liver disease based on the following variables INR Bilirubin Creatinine
15 Methods Data collected Estimated blood loss (EBL) during transplantation Blood product administered (in the OR and at 24 hrs) Operating room time (warm ischemia time, cold ischemia time) CBC, chemistries, coagulation studies from the 24h preceding OLT through 24h after OLT
16 Methods Cost Analysis: Total cost of care is assessed based on: Accommodations cost Pharmacy cost Laboratory cost Blood cost Radiology cost Operating room cost (billed by minute) Transplant (organ) cost
17 Data Capture (FVIIa)
18 Statistics Primary Outcome Log transformation for blood products (non-normal distribution) T-test for two independent samples Secondary Outcomes Length of stay Mann Whitney Test for two samples Total Costs Mann Whitney Test for two samples
19 Baseline Characteristics Male Median Age (years) Median Weight (kg) Median pre-op MELD Median pre-op INR Control Group (N=51) 68% 51 (25-67) 83 (43-122) 16.9 (6-35) 1.5 ( ) Factor VIIa Group (N=68) 63% 52 (25-68) 80 (49-145) 15.9 (6-40) 1.4 ( ) No significant differences
20 Primary Outcomes Variable Control (units) Factor 7a (units) P Value Mean PRBC 13.4 ± ± 19.5 Mean logprbc Mean FFP 15.6 ± ± 13.4 Mean Log FFP Mean PLT 6.6 ± 10 4 ± 3.5 Mean LogPLT No significant differences
21 Secondary Outcomes Variable Control Factor 7a P value Median LOS 10 days (1-55) 12 days (0-298) 0.46 Median Blood Costs $5,954 ($517-42,254) $6,154 ($563-55,742) 0.79 Median Surgical Costs $6,821 ($ ,756) $6,667 ($541-27,509) 0.85 Median Total Costs $57,279 ($33, ,673) $55,811 ($32, ,735) 0.89 No significant differences
22 Results Thrombosis events 2 thrombosis events in factor 7a group 1 thrombosis event in control group Factor 7a Dose Median dose 1.7 mg ( )
23 Conclusions The use of factor VIIa appears to not have a significant effect on the amount of red blood cells used The results are consistent with the currently available literature that the use of factor VIIa does not provide a benefit in reduction of blood product usage No difference between blood product cost, surgical costs or total cost of care
24 Factor VIIa Utilization; UCSD Liver Transplant Service $30,000 $25,000 $20,000 $15,000 $10,000 $5,000 $0 Aug- 05 Sep- 05 Oct- 05 Nov- 05 Dec- 05 Jan- Feb- Mar- Apr- May- Jun- Jul- Aug- Sep- Oct- Nov- Dec- Jan- 07 Feb- 07 Mar- 07
25 The Use and Outcomes of Antifibrinolytic Therapy in Cardiothoracic Surgery Patients at 20 US Academic Medical Centers Robert Schoenhaus PharmD, Jim Lane PharmD; UC San Diego Medical Center Karl Matuszewski PharmD, Mary Ellen Bonk PharmD, Michael J. Oinonen PharmD, MPH; University HealthSystem Consortium
26 Background Impaired hemostasis and blood loss is of concern in patients undergoing cardiac surgery Antifibrinolytics (Aprotinin, Aminocaproic Acid and Tranexamic Acid) Safety questioned Mangano DT, et al. The Risk Associated with Aprotinin in Cardiac Surgery. NEJM. 20;354(4): (increased risk of adverse renal, cardiovascular, and cerebrovascular events) September 27, 20, Bayer Pharmaceuticals told FDA that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes Our objective was to examine these findings using a larger, more recent dataset from a database of academic medical centers across the US
27 Methods Data Source University HealthSystem Consortium s Clinical Resource Manager Database Quarterly data feeds of administrative data from 50+ academic medical centers Inclusion Criteria Patients discharged between October 2002 and September 2005 within UHC s Cardiothoracic Surgery (CTS) product line [Diagnostic Related Groups of cardiac surgery in nature (i.e., CABG, Valve, etc)] Exclusion Patients receiving multiple AF agents All tranexamic acid pts (only 17 pts from 4 total hospitals) Three Groups Aminocaproic Acid (AA) n = 9,751 pts Aprotinin (AP) n = 6,855 No AF agent/control n = 46,123 pts
28 Methods, Cont Elements Collected Demographics (i.e. age, gender, race, etc) Comorbidities (Flagged by Comorbidity Software Version 3.1, Agency for HealthCare Research and Quality) Hypertension Diabetes ( , , not in DRG 294, 295) Diabetes w/cc ( , 775.1, not in DRG 294, 295) Peripheral Vascular Disease Ace inhibitor utilization Outcomes In-hospital mortality Hemodialysis (procedure code 39.95) Acute renal failure (diagnosis code 584.x) Blood Transfusions (procedure code 99.0X) Post-op Stroke (UHC complication profiler, post-op CVA secondary diagnosis without a nervous system DRG assignment)
29 Initial Screen for Differences Logistic regression with control for influential variables: Demographics Age Sex Race Comorbidities ACEI use Diabetes Diabetes_cc HTN PVD Renal failure
30 Patient Count All CTS patients Aprotinin (N = 6,855) Aminocaproic acid (N = 9,751) Control (N = 46,123) CABG only Aprotinin (N = 3,6) Aminocap (N = 7,4) Control (N = 6,879)
31 Results Blood Transfusions Acute Renal Failure Hemodialysis Post-OP Stroke Mortality
32 Efficacy Blood Transfusions P value Odds Ratio 95% Confidence Limits All CTS Pts Aprotinin vs. Aminocap P = CABG only Aprotinin vs. Aminocap P =
33 Acute Renal Failure Secondary ICD-9 Diagnosis = 584.X P value Odds Ratio 95% Confidence Limits All CTS Pts Aminocap vs. Control P < All CTS Pts Aprotinin vs. Control P < All CTS Pts Aprotinin vs. Aminocap P < CABG only Aminocap vs. Control P < CABG only Aprotinin vs. Control P < CABG only Aprotinin vs. Aminocap P <
34 Hemodialysis Secondary ICD-9 procedure = P value Odds Ratio 95% Confidence Limits All CTS Pts Aminocap vs. Control P < All CTS Pts Aprotinin vs. Control P < All CTS Pts Aprotinin vs. Aminocap P < CABG only Aminocap vs. Control P < CABG only Aprotinin vs. Control P < CABG only Aprotinin vs. Aminocap P <
35 Mortality (In Hospital) P value Odds Ratio 95% Confidence Limits All CTS Pts Aminocap vs. Control P < All CTS Pts Aprotinin vs. Control P < All CTS Pts Aprotinin vs. Aminocap P < CABG only Aminocap vs. Control P < CABG only Aprotinin vs. Control P < CABG only Aprotinin vs. Aminocap P <
36 Post-Op Stroke P value Odds Ratio 95% Confidence Limits All CTS Pts Aminocaproic Acid vs. control P < All CTS Pts Aprotinin vs. control P < All CTS Pts Aprotinin vs. Aminocap P = CABG only Aminocaproic vs. control P = CABG only Aprotinin vs. control P < CABG only Aprotinin vs. AA P =
37 Conclusions Aprotinin appeared to have superiority for reducing blood transfusions in CABG population, but was strongly correlated with negative outcomes: ARF, hemodialysis, and mortality Similar to Bayer findings (exc. CHF)
38 Aprotinin Dollars Spent (UCSD) $0 $5,000 $10,000 $15,000 $20,000 $25,000 $30,000 $35,000 Jul- 05 Aug- 05 Sep- 05 Oct- 05 Nov- 05 Dec- 05 Jan- Feb- Mar- Apr- May- Jun- Jul- Aug- Sep- Oct- Nov- Dec- Jan- 07 Feb- 07 Mar- 07
39 Questions?
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