prevention of venous thromboembolism surgical care improvement project dale w. bratzler, do, mph...
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Prevention of Venous Thromboembolism
Surgical Care Improvement Project
Dale W. Bratzler, DO, MPH
QIOSC Medical Director
Dale W. Bratzler, DO, MPH
President and CEO
Oklahoma Foundation for Medical Quality
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. 2009 (in press)
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
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. 2009 (in press)
“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.”
Risk Factors for DVT or PENested 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
00 55 1010 1515 2020 2525 5050Odds ratioOdds ratio
Most hospitalized patients have at least one additional risk factor for VTE
Risk Factors 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
Geerts W et al. Chest. 2004;126:338S-400S.
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
Medical Hospitalization
Only
Hospitalization with Surgery
Ou
tpat
ien
ts W
ith
VT
E,
% 70
60
50
40
30
20
10
0
Days After Discharge
0-29 30-59 60-90
Goldhaber S. Arch Intern Med. 2007;167:1451-2.Spencer FA et al. Arch Intern Med. 2007;167(14):1471-5.
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.
Mechanical Methods of VTE Prevention
• Graduated Compression Stockings (GCS)
• Intermittent Pneumatic Compression Devices (IPCs)
• Venous Foot Pump (VFP)
Pharmacologic Options for VTE Prevention
• Unfractionated Heparin (UFH)
• Low-Molecular Weight Heparins (LMWHs)
• Pentasaccharide (Fondaparinux)
• Warfarin
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
• 5,000 IU SC 2 hours preoperatively and 8 hours thereafter for 7 days.
Pat
ien
ts w
ith
PE
(%
)
Kakkar VV et al. Lancet. 1975;2:45-51.
0.77
0.097
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
Control (N = 2,076) UFH* (N = 2,045)
Mechanical Thromboprophylaxis
Geerts WH et al. Chest. 2008;133(6 Suppl):381S-453S.
• 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)
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
VTE ProphylaxisGrade 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 Low-dose unfractionated heparin (LDUH)
Low molecular weight heparin (LMWH)
Factor Xa inhibitor
Intermittent pneumatic compression devices (IPC)
LDUH, LMWH, or factor Xa inhibitor combined with IPC or GCS
*Open surgical procedure > 30 minutes requiring in-hospital stay > 24 hours postoperative.
*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).
VTE ProphylaxisGrade 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
Low molecular weight heparin (LMWH)
Factor Xa inhibitor (fondaparinux)
Adjusted-dose warfarin (INR target 2.5, range 2.0-3.0)
Elective total knee replacement
Low molecular weight heparin (LMWH)
Factor Xa inhibitor (fondaparinux)
Adjusted-dose warfarin (INR target 2.5, range 2.0-3.0)
Intermittent pneumatic compression devices (IPC)
Venous foot pumps (VFP)
VTE ProphylaxisGrade 1 Recommendations
Surgery Recommended Prophylaxis
Hip fracture surgery Low molecular weight heparin (LMWH)
Factor Xa inhibitor
Adjusted-dose warfarin (INR target 2.5, range 2.0-3.0)
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
Low-dose unfractionated heparin (LDUH)
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.
Performance Measurement Does Not Happen without Controversy
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 warfarinLevel III, Grade B recommendation
Standard risk PE, Elevated risk Bleeding aspirin warfarin noneLevel III, Grade C recommendation
Elevated risk PE, Standard risk Bleeding LMWH synthetic pentasaccharides warfarinLevel III, Grade B recommendation
Elevated risk PE, Elevated risk Bleeding aspirin warfarin noneLevel III, Grade C recommendation
SCIP VTE 1 Performance MeasureHip or Knee Arthroplasty
No Bleeding Risk Documented Documented Bleeding Risk
Hip or knee arthroplasty: LMWH synthetic pentasaccharides warfarin
Knee arthroplasty only: intermittent pneumatic compression devices venous foot pump
Mechanical Prophylaxis[any other modality (including aspirin or warfarin) can be added]
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
VTE Prophylaxis
• Other issues– Timing of prophylaxis– Neuraxial anesthesia– Renal insufficiency– Duration of prophylaxis
Venous ThromboembolismStatement 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.”
Measure specifications available at: www.qualitynet.org
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: http://www.federalregister.gov/OFRUpload/OFRData/2009-18663_PI.pdf. Accessed 10 August 2009.
Improving Use of VTE Prophylaxis
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
Electronic Alerts to Prevent VTE among Hospitalized Patients
Control Alert group group P
No. 1,251 1,255
Any prophylaxis 15 % 34 % <0.001
VTE at 90 days 8.2 % * 4.9 % 0.001
Major bleeding 1.5 % 1.5 % NS
Kucher – NEJM 2005;352:969
• Hospital computer system identified patient VTE risk factors
• RCT: no physician alert vs physician alert
* NNT = 30
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
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
SHM Resource Room. http://www.hospitalmedicine.org. Accessed September 2009.
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]
Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]
Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]
Maynard GA, et al. J Hosp Med 2009 Sep 14. [Epub ahead of print]
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
Does public reporting accelerate quality improvement?
Changes in National Performance Baseline to Q1, 2009
92.6 91.6 92.8
90.3 89.1 90.3
71.9
91.8
69.7
89.3
0
20
40
60
80
100
Q1,2005*
Q2 2006 Q3 2006 Q4 2006 Q1 2007 Q2 2007 Q3 2007 Q4 2007 Q1 2008 Q2 2008 Q3 2008 Q4 2008 Q1 2009
Pe
rce
nt
Recommended VTE prophylaxis VTE prophylaxis received
//
*National sample of 19,497 Medicare patients undergoing surgery in US hospitals during the first quarter of 2005. (Bratzler, unpublished data
Hospital-acquired ConditionsBackground 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.
Hospital-acquired Conditions
10. Deep vein thrombosis/pulmonary embolism following– Total knee replacement– Hip replacement
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