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

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 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

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.

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;167:1451-2. 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

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.

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.

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 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.

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 2.0-3.0) Elective total knee replacement Venous foot pumps (VFP)

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 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 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

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]

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 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

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 Hospital computer system identified patient VTE risk factors RCT: no physician alert vs physician alert 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 * NNT = 30 Kucher – NEJM 2005;352:969

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 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. http://www.hospitalmedicine.org. Accessed September 2009.

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]

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 // *National sample of 19,497 Medicare patients undergoing surgery in US hospitals during the first quarter of 2005. (Bratzler, unpublished data

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.

Hospital-acquired Conditions 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

dbratzler@ofmq.com