1. Prevention of Venous Thromboembolism Surgical Care Improvement Project
Dale W. Bratzler, DO, MPH
President and CEO
Oklahoma Foundation for Medical Quality
Dale W. Bratzler, DO, MPH
QIOSC Medical Director

2. Why is there a need to measure the quality of hospital care?
The passive strategy of guideline publication and dissemination does not effectively change clinical practice
The time lag between publication of evidence and incorporation into care at the bedside is very long
Variations in care and delivery of care that is not consistent with evidence-based recommendations is well documented
Bratzler DW. Development of national performance measures on the prevention and treatment of venous thromboembolism. J Thromb Thrombolysis (in press)

3. Prevention of Venous Thromboembolism (VTE) – an example
The American College of Chest Physicians published their first consensus conference on antithrombotic therapy in 1986
In 2008 published their 8th edition of the evidence-based guideline
Despite all of these published editions…..
VTE - the most common preventable cause of hospital death
- 2/3 of all cases occur in recently hospitalized patients
- up to 3/4 of all cases of PE death are a result of hospitalization

4. Prevention of Venous Thromboembolism – an example
Multiple studies that have included hospital medical record audits show consistent underuse of VTE prophylaxis
Up to 2/3 of patients with hospital-acquired VTE did not receive prophylaxis
Audits of patients receiving treatment for confirmed VTE show non-compliance with guideline-recommended treatment
Bratzler DW. Development of national performance measures on the prevention and treatment of venous thromboembolism. J Thromb Thrombolysis (in press)

5. “The best estimates indicate that 350,000 to 600,000 Americans each year suffer from DVT and PE, and that at least 100,000 deaths may be directly or indirectly related to these diseases. This is far too many, since many of these deaths can be avoided. Because the disease disproportionately affects older Americans, we can expect more suffering and more deaths in the future as our population ages–unless we do something about it.”

6. Risk Factors for DVT or PE Nested Case-Control Study (n=625 case-control pairs)
Surgery
Trauma
Inpatient
Malignancy with chemotherapy
Malignancy without chemotherapy
Central venous catheter or pacemaker
Neurologic disease
Superficial vein thrombosis
Varicose veins/age 45 yr
Varicose veins/age 60 yr
Varicose veins/age 70 yr
CHF, VTE incidental on autopsy
CHF, antemortem VTE/causal for death
Liver disease 5 10 15 20 25 50
Odds ratio

7. Risk Factors for VTE Surgery Trauma Immobility, paresis Malignancy
Most hospitalized patients have at least one additional risk factor for VTE
Surgery
Trauma
Immobility, paresis
Malignancy
Cancer therapy
hormonal therapy, chemotherapy or radiotherapy
Previous VTE
Increasing age
Pregnancy and post-partum period
Estrogen-containing oral contraception or HRT or SERM
Acute medical illness
Heart failure
Respiratory failure
Inflammatory bowel disease
Nephrotic syndrome
Myeloproliferative disorders
Obesity
Smoking
Varicose veins
Central venous catheterization
Inherited or acquired thrombophilia
Travel
So how do we begin assessing patients for the risk of VTE?
This leads me to risk factors. It is rather apparent, that we need to be assessing patients for risk factors in order to ensure that we provide effective prophylaxis and improve our quality of patient care.
The risk factors for VTE are fairly well-known and documented.
As your can see from this slide, I have highlighted the need to especially consider the risks of developing VTE in patients with a prior history of VTE, suffer from heart failure, or respiratory failure. We have already established the significance of risk factors in this presentation.
Geerts W et al. Chest. 2004;126:338S-400S.

8. VTE Facts
Almost half of the outpatients with VTE had been recently hospitalized
Less than half of the recently hospitalized patients had received VTE prophylaxis during their hospitalizations
About half had a length of stay (LOS) of < 4 days
Days After Discharge
0-29
30-59
60-90 70 60 50 40
Outpatients With VTE, % 30 20 10
Medical
Hospitalization
Only
Hospitalization
with Surgery
Goldhaber S. Arch Intern Med. 2007;167:
Spencer FA et al. Arch Intern Med. 2007;167(14):

9. Categories of Risk for Venous Thromboembolism in Patients
Low risk:
Minor surgery in mobile patients
Moderate risk:
Most medically ill, general, open gyn or urologic surgery patients
High risk:
Cancer surgery, hip or knee arthroplasty, hip fracture surgery, major trauma or spinal cord injury
Geerts W et al. Chest. 2008;133:381S-453S.

10. Mechanical Methods of VTE Prevention
Graduated Compression Stockings (GCS)
Intermittent Pneumatic Compression Devices (IPCs)
Venous Foot Pump (VFP)

11. Pharmacologic Options for VTE Prevention
Unfractionated Heparin (UFH)
Low-Molecular Weight Heparins (LMWHs)
Pentasaccharide (Fondaparinux)
Warfarin

12. 5,000 IU SC 2 hours preoperatively and 8 hours thereafter for 7 days.
Prophylaxis Against Fatal Post-Operative PE With LDUH: A Multicenter, Prospective, Randomized Trial
Study population: 4,121 patients age > 40 y undergoing a variety of elective major surgical procedures
P < 0.005
0.9
0.77
0.8
0.7
0.6
0.5
Patients with PE (%)
0.4
0.3
0.2
0.097
0.1
Control (N = 2,076)
UFH* (N = 2,045)
5,000 IU SC 2 hours preoperatively and 8 hours thereafter for 7 days.
Kakkar VV et al. Lancet. 1975;2:45-51.

13. Mechanical Thromboprophylaxis
For particularly high-risk surgery patients with multiple risk factors, pharmacologic method should be combined with mechanical method (GCS, IPC) (1C)
Use mechanical methods for patients with high bleeding risk (1A), when bleeding risk decreases substitute or add pharmacological thromboprophylaxis (1C)
Geerts WH et al. Chest. 2008;133(6 Suppl):381S-453S.

14. Problems with Mechanical Prophylaxis
Non-compliance
~ 50% of med-surg floors
~80% in intensive care units
Most common reasons for non-compliance
~80% of the time, not on the patient
~20% of the time, on the patient but not turned on

15. VTE Prophylaxis Grade 1 Recommendations
Surgery*
Recommended Prophylaxis
General surgery
Low-dose unfractionated heparin (LDUH)
Low molecular weight heparin (LMWH)
Fondaparinux (effective 10/01/07)
LDUH or LMWH combined with IPC or GCS
General surgery with a reason for not administering pharmacologic prophylaxis documented
Graduated Compression stockings (GCS)
Intermittent pneumatic compression (IPC)
Gynecologic surgery
Factor Xa inhibitor
Intermittent pneumatic compression devices (IPC)
LDUH, LMWH, or factor Xa inhibitor combined with IPC or GCS
*Limited to those patients who have an anesthesia duration of at least 60 minutes, and a hospital stay of at least three calendar days (two nights in the hospital).
*Open surgical procedure > 30 minutes requiring in-hospital stay > 24 hours postoperative.

16. VTE Prophylaxis Grade 1 Recommendations
Surgery
Recommended Prophylaxis
Urologic surgery
Low-dose unfractionated heparin (LDUH) 5000 units bid or tid
Low molecular weight heparin (LMWH)
Factor Xa inhibitor (fondaparinux)
Intermittent pneumatic compression devices (IPC)
Graduated compression stockings (GCS)
LDUH, LMWH, or factor Xa inhibitor combined with IPC or GCS
Elective total hip replacement
Adjusted-dose warfarin (INR target 2.5, range )
Elective total knee replacement
Venous foot pumps (VFP)

17. VTE Prophylaxis Grade 1 Recommendations
Surgery
Recommended Prophylaxis
Hip fracture surgery
Low molecular weight heparin (LMWH)
Factor Xa inhibitor
Adjusted-dose warfarin (INR target 2.5, range )
Low-dose unfractionated heparin (LDUH)
Hip fracture surgery (HFS) or elective total hip replacement with a reason for not administering pharmacologic prophylaxis documented
Graduated Compression stockings (GCS) (HFS only)
Intermittent pneumatic compression (IPC)
Venous foot pumps (VFP)
Intracranial neurosurgery
IPC with or without GCS
Postoperative Low molecular weight heparin (LMWH)
LDUH or LMWH combined with IPC or GCS
*Open surgical procedure > 30 minutes requiring in-hospital stay > 24 hours postoperative.

18. Performance Measurement Does Not Happen without Controversy

19. Hip or Knee Arthroplasty
Summary American Academy of Orthopedic Surgeons (AAOS) Clinical Guideline on Prevention of Symptomatic Pulmonary Embolism in Patients Undergoing Total Hip or Knee Arthroplasty
Standard risk PE, Standard risk Bleeding*
aspirin
LMWH
synthetic pentasaccharides
warfarin
Level III, Grade B recommendation
Standard risk PE, Elevated risk Bleeding
none
Level III, Grade C recommendation
Elevated risk PE, Standard risk Bleeding
Elevated risk PE, Elevated risk Bleeding
SCIP VTE 1 Performance Measure
Hip or Knee Arthroplasty
No Bleeding Risk Documented
Documented Bleeding Risk
Hip or knee arthroplasty:
Knee arthroplasty only:
intermittent pneumatic compression devices
venous foot pump
Mechanical Prophylaxis
[any other modality (including aspirin or warfarin) can be added]

20. What else does the AAOS guideline say?
They do NOT recommend the use of aspirin alone
They recommend the use of mechanical prophylaxis started in the operating room or immediately postoperatively in all patients – continued to discharge
They recommend pharmacologic prophylaxis with LMWH, factor Xa inhibitor, or warfarin in high risk patients
previous history of cancer, thromboembolism, hypercoagulable states such as polycythemia, spinal cord injury patients, multi-trauma patients, and genetic predisposition

21. VTE Prophylaxis Other issues Timing of prophylaxis
Neuraxial anesthesia
Renal insufficiency
Duration of prophylaxis

23. Venous Thromboembolism Statement of Organization Policy
“Every healthcare facility shall have a written policy appropriate for its scope, that is evidence-based and that drives continuous quality improvement related to VTE risk assessment, prophylaxis, diagnosis, and treatment.” 23

24. Measure specifications available at: www.qualitynet.org

25. Electronic Submission of Performance Measures
In the recently published final IPPS rule for fiscal year 2010, CMS has announced that through an interagency agreement with the Office of the National Coordinator for Healthcare Information Technology, they are developing interoperable standards for electronic medical record submission of the newly-endorsed VTE measures. Vendors of electronic medical record systems would be able to code their systems with the new specifications by the end of 2009.
Centers for Medicare & Medicaid Services. Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Fiscal Year 2010 Rates; and Changes to the Long-Term Care Hospital Prospective Payment System and Rate Years 2010 and 2009 Rates. Available at: Accessed 10 August 2009.

26. Improving Use of VTE Prophylaxis

27. Strategies to Improve VTE Prophylaxis
Hospital policy of risk assessment or routine prophylaxis for all admitted patients
Most will have risk factors for VTE and should receive prophylaxis
Preprinted protocols for surgical patients

28. Electronic Alerts to Prevent VTE among Hospitalized Patients
Hospital computer system identified patient VTE risk factors
RCT: no physician alert vs physician alert
Control Alert
group group P
No , ,255
Any prophylaxis % % <0.001
VTE at 90 days % * 4.9 %
Major bleeding % % NS
* NNT = 30
Kucher – NEJM 2005;352:969

29. Improving Compliance with Treatment Protocols
Use of standardized protocols, nomograms, algorithms, or preprinted orders
Address overlap (either 5 days in hospital or discharge on overlap)
When used, UFH should be managed by nomogram/protocol, and the protocol should ensure routine platelet count monitoring

30. Essential Elements for Improvement
Institutional support
A multidisciplinary team or steering committee
Reliable data collection and performance tracking
Specific goals or aims
A proven QI framework
Protocols
Essential elements to reach breakthrough levels of improvement in care include:
Institutional support and prioritization for the initiative, expressed in terms of a meaningful investment in time, equipment, personnel, and informatics, and a sharing of institutional improvement experience and resources to support any project needs
A multidisciplinary team or steering committee focused on reaching VTE prophylaxis targets and reporting to key medical staff committees
Reliable data collection and performance tracking
Specific goals, or aims, which are ambitious, time-defined, and measurable
A proven QI framework to coordinate steps towards breakthrough improvement
Protocols that standardize VTE risk assessment and prophylaxis
Institutional infrastructure, policies, practices, or educational programs promoting the use of the protocol. The protocol that standardizes VTE risk assessment is so fundamental that is must not merely exist. It must be embedded in patient care. High reliability design should be used to enhance effective implementation.
SHM Resource Room. Accessed September 2009.

31. Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]
Risk
Assessment
Prophylaxis
Low
Ambulatory patient without VTE risk factors; observation patient with expected LOS 2 days; same day surgery or minor surgery
Early ambulation
Moderate
All other patients (not in low-risk or high-risk category); most medical/surgical patients; respiratory insufficiency, heart failure, acute infectious, or inflammatory disease
UFH 5000 units SC q 8 hours; OR LMWH q day; OR UFH 5000 units SC q 12 hours (if weight < 50 kg or age > 75 years); AND suggest adding IPC
High
Lower extremity arthroplasty; hip, pelvic, or severe lower extremity fractures; acute SCI with paresis; multiple major trauma; abdominal or pelvic surgery for cancer
LMWH (UFH if ESRD); OR fondaparinux 2.5 mg SC daily; OR warfarin, INR 2-3; AND IPC (unless not feasible)
Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]

32. Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]

33. Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]

34. Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]

35. Attention to Transitions of Care
Ensure adequate training of the patient
Education on medications, diet, follow up appointments, lab monitoring, dietary precautions, and adverse reactions or drug-drug interactions
Education for family
Referral to anticoagulation clinic
Hospital abstractors must find explicit documentation of this training/education in the chart

36. Does public reporting accelerate quality improvement?

37. Changes in National Performance Baseline to Q1, 2009//
*National sample of 19,497 Medicare patients undergoing surgery in US hospitals during the first quarter of (Bratzler, unpublished data

38. Hospital-acquired Conditions Background of the “Never Events”
Deficit Reduction Act (DRA) of 2005 requires the Secretary of HHS to identify conditions that are:
High cost or high volume (or both); and
Result in the assignment of a case to a DRG that has a higher payment when present as a secondary diagnosis; and
Could reasonably have been prevented through the application of evidence-based guidelines.

39. Hospital-acquired Conditions
Deep vein thrombosis/pulmonary embolism following
Total knee replacement
Hip replacement

40. Conclusions VTE remains a substantial health problem in the US
VTE prophylaxis remains underutilized
National performance measures will address both prophylaxis and treatment of VTE across broad hospital populations