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Dale Bratzler, DO, MPH Michael Gulseth, PharmD, BCPS Dan Ford Hayley Burgess, PharmD, BCPP Charles Denham, MD

Preventing Venous Thromboembolism and Improving the Safety of Anticoagulation Therapy. Dale Bratzler, DO, MPH Michael Gulseth, PharmD, BCPS Dan Ford Hayley Burgess, PharmD, BCPP Charles Denham, MD. March 5, 2008. NQF Safe Practices for Better Healthcare: A Consensus Report.

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Dale Bratzler, DO, MPH Michael Gulseth, PharmD, BCPS Dan Ford Hayley Burgess, PharmD, BCPP Charles Denham, MD

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  1. Preventing Venous Thromboembolism and Improving the Safety of Anticoagulation Therapy Dale Bratzler, DO, MPH Michael Gulseth, PharmD, BCPS Dan Ford Hayley Burgess, PharmD, BCPP Charles Denham, MD March 5, 2008

  2. NQF Safe Practices for Better Healthcare: A Consensus Report • 30 Safe Practices Criteria for Inclusion • Specificity • Benefit • Evidence of Effectiveness • Generalization • Readiness

  3. NQF Safe Practices Maintenance Committee Safe Practice Update Process • SWOT analysis of each practice • Comprehensive literature search • Expert technical advisory support from more than 250 experts • Participation by The Joint Commission, CMS, and AHRQ • Input from hospitals and facility involved in 100,000 and 5M Lives Campaign • “Feedback from the Field” - Hospitals that reported publicly through The Leapfrog Group and TMIT National Research Test Bed

  4. Harmonization – The Quality Choir

  5. Culture Consent & Disclosure Consent & Disclosure Workforce Information Management & Continuity of Care Medication Management Healthcare-Assoc. Infections Condition- & Site-Specific Practices Culture SP 1 2007 NQF Report

  6. Culture 2007 NQF Report • CHAPTER 2: Creating and Sustaining a Culture of Patient Safety • Leadership Structures & Systems • Culture Measurement, Feedback, and Interventions • Teamwork Training and Team Interventions • Identification and Mitigation of Risks and Hazards Team Training & Team Interv. ID Mitigation Risk & Hazards Structures & Systems Culture Meas., F.B., & Interv. CHAPTER 1: Background • Summary, and Set of Safe Practices Consent & Disclosure Consent & Disclosure • CHAPTER 3: Informed Consent & Disclosure • Informed Consent • Life-Sustaining Treatment • Disclosure Disclosure Informed Consent Life-Sustaining Treatment Workforce CHAPTERS 2-8 : Practices By Subject • CHAPTER 4: Workforce • Nursing Workforce • Direct Caregivers • ICU Care Nursing Workforce Direct Caregivers ICU Care • CHAPTER 5: Information Management & Continuity of Care • Critical Care Information • Order Read-back • Labeling Studies • Discharge Systems • Safe Adoption of Integrated Clinical Systems including CPOE • Abbreviations Information Management & Continuity of Care Critical Care Info. Order Read-back Labeling Studies Discharge System CPOE Abbreviations Medication Management • CHAPTER 6: Medication Management • Medication Reconciliation • Pharmacist Role • Standardized Medication Labeling & Packaging • High-Alert Medications • Unit-Dose Medications Med. Recon. Pharmacist Central Role High-Alert Meds. Std. Med. Labeling & Pkg. Unit-Dose Medications • CHAPTER 7: Healthcare-Associated Infections • Prevention of Aspiration and Ventilator-Associated Pneumonia • Central Venous Catheter-Related Blood Stream Infection Prevention • Surgical Site Infection Prevention • Hand Hygiene • Influenza Prevention Healthcare-Associated Infections Asp. + VAP Prevention Hand Hygiene Influenza Prevention Central V. Cath. BSI Prevention Sx-Site Inf. Prevention • CHAPTER 8: Condition- & Site-Specific Practices • Evidence-Based Referrals • Wrong-Site, Wrong-Procedure, Wrong-Person Surgery Prevention • Perioperative Myocardial Infarct/Ischemia Prevention • Pressure Ulcer Prevention • DVT/VTE Prevention • Anticoagulation Therapy • Contrast Media-Induced Renal Failure Prevention Condition- & Site-Specific Practices Evidence- Based Ref. Anticoag. Therapy DVT/VTE Prevention Press. Ulcer Prevention Wrong-site Sx Prevention Periop. MI Prevention Contrast Media Use

  7. New Safe Practice Considerations • Methicillin-resistant Staph aureus (MRSA) • Urinary Tract Infections (UTI) • Handover/Hand-off • Second Patient • Organ Donorship

  8. Preventing Venous Thromboembolism and Improving the Safety of Anticoagulation Therapy Objectives: • Describe the impact of Venous Thromboembolism (Safe Practice 28) complications as it relates to the nation's healthcare patient population. • Prepare for pay for performance requirements and review national measures. • Describe the requirements for the Joint Commission National Patient Safety Goal 3E and Anticoagulation Therapy (Safe Practice 29). • Discuss strategy and stepwise process for planning, design, and implementation of an inpatient anticoagulant service.

  9. Safe Practice 28: Reduce the occurrence of venous thromboembolism Safe Practice • Evaluate each patient upon admission, and regularly thereafter, for the risk of developing VTE/DVT. Utilize clinically appropriate, evidence-based methods of thromboprophylaxis. Additional Specifications • Document the VTE risk assessment and prevention plan in the patient’s record. • Explicit organizational policies and procedures should be in place for the prevention of VTE. Applicable Clinical Care Settings • Short and long-term acute care hospitals, long-term care facilities, and nursing homes.

  10. Safe Practice 29:Ensure that long-term antithrombotic (anticoagulation) therapy is effective and safe Safe Practice Every patient on long-term oral anticoagulants should be monitored by a qualified health professional using a careful strategy to ensure an appropriate intensity of supervision. Additional Specifications • Explicit organizational policies and procedures should be in place regarding antithrombotic services that include at least documentation of: • indication for long-term anticoagulation; • target INR range; • duration of long-term anticoagulation and/or a review date; • a longitudinal record of INR values and warfarin doses; and • timing of the next INR appointment. Applicable Clinical Care Settings • This practice is applicable in all care settings

  11. Prevention and Treatment of Venous ThromboembolismDevelopment of National Performance Measures Dale W. Bratzler, DO, MPH QIOSC Medical Director Oklahoma Foundation for Medical Quality Dale W. Bratzler, DO, MPH QIOSC Medical Director

  12. Prevention of Venous Thromboembolism • Recent estimates show that • more than 900,000 Americans suffer VTE each year • about 400,000 of these being DVT • About 500,000 being manifest as PE • In about 300,000 cases, PE proves fatal; it is the third most common cause of hospital-related deaths in the United States. Is pulmonary embolism the most common cause of death in the US? Heit JA, Cohen AT, Anderson FA on behalf of the VTE Impact Assessment Group. [Abstract] American Society of Hematology Annual Meeting, 2005.

  13. Prevention of Venous ThromboembolismIntroduction • VTE Remains a major health problem • In addition to the risk of sudden death • 30% of survivors develop recurrent VTE within 10 years • 28% of survivors develop venous stasis syndrome within 20 years • Incidence increases with age Goldhaber SZ. N Engl J Med. 1998;339:93-104. Silverstein MD, et al. Arch Intern Med. 1998;158:585-593. Heit JA, et al. Thromb Haemost. 2001;86:452-463. Heit JA. Clin Geriatr Med. 2001;17:71-92. Heit JA, et al. Mayo Clin Proc. 2001;76:1102-1110.

  14. Prevention of Venous Thromboembolism • The majority (93%) of estimated VTE-related deaths in the US were due to sudden, fatal PE (34%) or followed undiagnosed VTE (59%) For many patients, the first symptom of VTE is sudden death! How many of those patients with sudden death in the hospital or after discharge attributed to an acute coronary event actually died of acute pulmonary embolism? Heit JA, Cohen AT, Anderson FA on behalf of the VTE Impact Assessment Group. [Abstract] American Society of Hematology Annual Meeting, 2005.

  15. National Body Position Statements • Leapfrog1: • PE is “the most common preventable cause of hospital death in the United States” • Agency for Healthcare Research and Quality (AHRQ)2: • Thromboprophylaxis is the number 1 patient safety practice • American Public Health Association (APHA)3: • “The disconnect between evidence and execution as it relates to DVT prevention amounts to a public health crisis.” • The Leapfrog Group Hospital Quality and Safety Survey. Available at: www.leapfrog.medstat.com/pdf/Final/doc • Shojania KG, et al. Making Healthcare Safer: A Critical Analysis of Patient Safety Practices. AHRQ, 2001. Available at: www.ahrq.gov/clinic/ptsafety/ • White Paper. Deep-vein thrombosis: Advancing awareness to protect patient lives. 2003. Available at: www.alpha.org/ppp/DVT_White_Paper.pdf

  16. Medical “Injuries” During Hospitalization • Postoperative DVT or PE: • 2nd commonestmedical “injury”overall • 2nd commonest cause ofexcess length of stay • 3rd commonest cause ofexcess mortality • 3rd commonest cause ofexcess charges Zhan et a. JAMA 2003;290:1868

  17. Annual cost to treat VTE • $11,000 per DVT episode per patient • $17,000 per PE episode per patient • Recurrence increases hospitalization costs by 20% • Complications of anticoagulation • Time lost from work • Quality of life: venous stasis and pulmonary HTN

  18. Consequences of Surgical Complications • Dimick and colleagues demonstrated increased costs of care: • infectious complications was $1,398 • cardiovascular complications $7,789 • respiratory complications $52,466 • thromboembolic complications $18,310 Dimick JB, et al. J Am Coll Surg 2004;199:531-7.

  19. Group 1 disorders Protein C deficiency (2.5-6%) Protein S deficiency (1.3-5%) Antithrombin deficiency (0.5-7.5%) Group 2 disorders Factor V leiden (6%) Prothrombin (G20210A) (5-10%) Elevated VIII, IX, XI Hyperhomocysteinemia Arteriosclerosis Inherited risk factors for DVT

  20. Acquired Risk Factors Being in the hospital is the greatest risk factor for VTE!

  21. Risk Factors for VTE • Previous venous thromboembolism • Increased age • Surgery • Trauma - major, local leg • Immobilization - ? bedrest, stroke, paralysis • Malignancy & its Rx (CTX, RTX, hormonal) • Heart or respiratory failure • Estrogen use, pregnancy, postpartum • Central venous lines • Thrombophilic abnormalities Most hospitalized patients have at least one additional risk factor for VTE Therefore, most patients in the hospital need VTE prophylaxis!

  22. VTE is a Disease of Hospitalized and Recently Hospitalized Patients 1000 VTE 100X more common in hospitalized patients! 100 Recently hospitalized Cases per 10,000 person-years 10 1 Hospitalized patients Community residents Heit JA. Mayo Clin Proc. 2001;76:1102

  23. Risk of DVT in Hospitalized Patients No prophylaxis + routine objective screening for DVT Patient group DVT incidence Medical patients 10 - 20 % Major gyne/urol/gen surgery 15 - 40 % Neurosurgery 15 - 40 % Stroke 20 - 50 % Hip/knee surgery 40 - 60 % Major trauma 40 - 80 % Spinal cord injury 60 - 80 % Critical care patients 15 - 80 %

  24. Prevention of Venous Thromboembolism • Despite the well known risk of VTE and the publication of evidence-based guidelines for prevention, multiple medical record audits have demonstrated underuse of prophylaxis Anderson FA Jr, et al. Ann Intern Med. 1991;115:591-595. Anderson FA Jr, et al. J Thromb Thrombolysis. 1998; 5 (1 Suppl):7S-11S. Bratzler DW, et al. Arch Intern Med. 1998;158:1909-1912. Stratton MA, et al. Arch Intern Med. 2000;160:334-340.

  25. Thromboprophylaxis Use in Practice1992-2002 Prophylaxis Patient Group Studies Patients Use (any) Orthopedic surgery 4 20,216 90 % (57-98) General surgery 7 2,473 73 % (38-98) Critical care 14 3,654 69 % (33-100) Gynecology 1 456 66 % Medical patients 5 1,010 23 % (14-62) How many patients with COPD, CVA, heart failure, pneumonia, etc do you have in your hospital that are not on DVT prophylaxis?

  26. Prevention of Venous Thromboembolism W. Geerts, chair G. Pineo J. Heit D. Bergqvist M. Lassen C. Colwell J. Ray Seventh ACCP Consensus Conference on Antithrombotic Therapy Chest 2004;126:338S-400S

  27. Prevention of Venous ThromboembolismLow-, moderate-, or high-risk • Benefit: risk uncertain- local practice or individual prophyl. • Laparoscopic surgery • Vascular surgery • Cardiac surgery • Elective spine surgery • Arthroscopic surgery • Burns • Isolated lower • extremity fracture • Benefit: risk favors • routine prophylaxis • Major orthopedic surgery • (THR, TKR, HFS) • Major trauma • Spinal cord injury • Major general, gyne, • urologic surgery • Major neurosurgery • Medical patients with • additional risk factors • Most ICU patients • Benefit: risk favors no prophylaxis • Surgical patients: • - brief duration • - fully mobile • - no additional RFs • Medical patients: • - fully mobile • - no additional RFs • Long distance travel Focus of New Measures How many of these patients do we actually admit to the hospital anymore?

  28. Prophylaxis Modalities • Mechanical • Graduated compression stockings (GCS) (e.g., “white hose”) • Sequential compression devices • Venous foot pumps (currently recommended only for orthopedic surgery in patients with bleeding risk) In most studies, less effective than pharmacologic prophylaxis and patient compliance rates are generally low. Rates of compliance with mechanical forms of prophylaxis in many studies is less than 50% - has become a new target of malpractice litigation.

  29. Pharmacologic Prophylaxis • Low-dose unfractionated heparin (LDUH) • Low-molecular weight heparin (LMWH) • Fondaparinux • Warfarin

  30. Development of National Performance Measures to Prevent and Treat VTE

  31. Why the need for performance measures? • Despite widespread publication and dissemination of guidelines, practices have not changed at an acceptable pace • There are still far too many needless deaths from VTE in the US • Reasonably good evidence that using performance measures for accountability can accelerate the rate of change

  32. 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.”

  33. Venous ThromboembolismCharacteristics of Preferred Practices General Protocol selection by multidisciplinary teams System for ongoing QI Provision for RA/stratification, prophylaxis, diagnosis, treatment QI activity for all phases of care Provider education

  34. Venous ThromboembolismCharacteristics of Preferred Practices(cont.) Risk Assessment/Stratification RA on all patients using evidence-based policy Documentation in patient record that done Prophylaxis Based on assessment & risk/benefit, efficacy/safety Based on formal RA, consistent with accepted, evidence-based guidelines

  35. Venous ThromboembolismCharacteristics of Preferred Practices(cont.) Diagnosis Objective testing to justify continued initial therapy Treatment and Monitoring Ensure safe anticoagulation, consider setting Incorporate Safe Practice 29 Patient education; consider setting and reading levels Guideline-directed therapy Address care setting transitions in therapy

  36. Surgical Care Improvement ProjectFirst Two VTE Measures Endorsed by NQF • Prevention of venous thromboembolism • Proportion who have recommended VTE prophylaxis ordered • Proportion who receive appropriate form of VTE prophylaxis (based on ACCP Consensus Recommendations) within 24 hours before or after surgery Limited to surgical patients – NQF endorsed, required reporting to Medicare for Annual Payment Update, and will be posted to Hospital Compare soon. These measures are NQF-endorsed

  37. Surgical Care Improvement ProjectHospital Voluntary Self-Reporting, Qtr. 2, 2007 Benchmark rates were calculated for all HQA reporting hospitals in the US based on discharges using the Achievable Benchmarks of CareTM methodology (http://main.uab.edu/show.asp?durki=14527).

  38. Ongoing Gaps in PerformanceHospital Voluntary Self-Reporting, Qtr. 2, 2007 Benchmark rates were calculated for all HQA reporting hospitals in the US based on discharges using the Achievable Benchmarks of CareTM methodology (http://main.uab.edu/show.asp?durki=14527).

  39. 7 Refined Measures Recommended for Endorsement by Steering Committee Risk Assessment/Prophylaxis domain Prophylaxis w/in 24 hours of admission or surgery, OR a documented risk assessment showing that the patient does not need prophylaxis Prophylaxis/documentation w/in 24 hours after ICU admission or surgery Discards any “requirement” for a documented risk assessment – allows programs of default prophylaxis.

  40. 7 Refined Measures Recommended for Endorsement by Steering Committee • Treatment and Monitoring domain • IVC filter appropriate indication • Documented acute VTE with a contraindication to anticoagulation; or chronic thromboembolic pulmonary hypertension • Measure recommended for quality improvement only • Patients w/overlap of anticoagulation therapy • At least five calendar days of overlap and discharge with INR > 2.0, or discharge on overlap therapy • Patient receiving UFH with dosage/platelet count monitoring by protocol/nomogram • Nomogram/protocol incorporates routine platelet count monitoring+

  41. 7 Refined Measures Recommended(cont.) Treatment/Monitoring Domain (cont.) Discharge instructions consistent with Joint Commission safety goals (Follow-up Monitoring, Compliance Issues, Dietary Restrictions, Potential for Adverse Drug Reactions/Interactions) Outcome Incidence of potentially-preventable VTE – proportion of patients with hospital-acquired VTE who had NOT received VTE prophylaxis prior to the event Incorporate the new “present on admission” codes

  42. Strategies to Improve VTE Prophylaxis • Hospital policy of risk assessment for all admitted patients?? • Most will have risk factors for VTE and should receive prophylaxis • Preprinted protocols for surgical patients • Electronic reminders (Kucher – NEJM 2005;352:969) • Default prophylaxis (opt out)

  43. 1 point each • age 41-60 • minor surgery planned • major surgery past month • varicose veins • inflamm bowel disease • current leg swelling • obesity (BMI > 25) • acute MI • CHF past month • sepsis past month • serious lung disease past month • COPD • medical patient at bedrest • other_____________________ • 3 points each • age > 70 • previous DVT, PE • family H/O VTE • factor V Leiden • prothrombin 20210A • elevated homocysteine • lupus anticoagulant • elevated ACA • HIT • other thrombophilia • 5 points each • hip / knee arthroplasty • hip/pelvis/leg fracture (< 1 month) • stroke (< 1 month) • multiple trauma (< 1 month) • acute spinal cord injury (< 1 mo) • 2 points each • age 60-74 • arthroscopic surgery • malignancy (current or previous) • major surgery (> 45 min) • laparoscopic surgery (> 45 min) • confined to bed (> 72 hrs) • plaster cast (< 1 month) • central venous access • Women only (1 point each) • BCP or HRT • pregnancy / postpartum (< 1 mo) • H/O unexplained stillbirth, > 3 • spontaneous abortions, premature • birth with toxemia, IUGR Caprini – Dis Mon 2005;51:70

  44. No individual risk assessment protocol has ever been validated in a clinical trial. While it seems intuitive that more points equates to greater risk of VTE, that has never been proven in a study, and we certainly have no idea if you need more prophylaxis for more points!

  45. Should VTE prophylaxis be the default for all hospitalized patients?

  46. Summary • VTE is very common, often unrecognized, and a common cause of hospital morbidity and death • The vast majority of hospitalized patients are at risk for VTE • New national performance measures will focus on evidence-based prevention and treatment of VTE If your organization is serious about Patient Safety, you have to address VTE prevention and treatment!

  47. PATIENT ADVOCATE Dan Ford Vice President Furst Group

  48. NQF Safe Practice 29 and NPSG 3E: How to Accomplish in the Hospital Michael P. Gulseth, Pharm. D., BCPS

  49. Objectives • Compare and contrast NQF safe practice #29 to NPSG 3E • Describe strategies to accomplish this in the hospital • Identify key articles supporting inpatient anticoagulation services

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