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Morton Plant Hospitalists
VTE Prevention Quality Improvement Strategies VTE: venous thromboembolism-DVT/PE Jordan Messler, MD, SFHM Morton Plant Hospitalists Medical Director
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Pulmonary Embolism (PE)
Goldhaber SZ. N Engl J Med. 1998;339(2):
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Objectives Understand the epidemiology of VTE and the impact of VTE prevention Identify quality improvement strategies to improve VTE prevention at the local level Understand some of the latest updates in VTE prevention guidelines
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VTE prevention basics Quality Improvement strategies ACCP 2012 guidelines Other VTE prophylaxis pearls
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VTE: A Major Source of Mortality and Morbidity
350,000 to 650,000 with VTE per year 100,000 to > 200,000 deaths per year Most are hospital related VTE is primary cause of fatality in half- More than HIV, MVAs, Breast CA combined Equals 1 jumbo jet crash / day 10% of hospital deaths May be the #1 preventable cause Huge costs and morbidity (recurrence, post- thrombotic syndrome, chronic PAH) 1 in 10 of the > 2 million Americans developing DVT goes on to die from pulmonary embolism (PE). These 200,000 patient deaths represent more annual deaths than those from breast cancer, AIDS, and traffic accidents combined. Many of these VTE deaths contribute to hospital mortality. Pulmonary embolism is the most common preventable cause of death in the hospital; an estimated 10% of inpatient deaths are secondary to PE. Not only do patients with VTE suffer a 30% cumulative risk for recurrence, they are also at risk for the potentially disabling post-thrombotic syndrome. Incidence of PE in the US about 1 case per 1000 persons per year PE accounts for K hospitalizations per year Surgeon General’s Call to Action to Prevent DVT and PE DHHS
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Half of these are preventable
A 500 bed hospital can expect 250 hospital acquired DVT/PE per year. Half of these are preventable Going from 50 to 90% VTE prophylaxis over the course of a year will avoid 68 DVTs, 29 PEs, & 5 Deaths
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VTE Consequences Leg swelling, discomfort (DVT)
Dyspnea, chest pain, hemoptysis, hypoxemia (PE) Extended hospital LOS Fatal PE (RV failure) ≥3 months of anticoagulant treatment Post thrombotic syndrome Chronic thromboembolic pulmonary HTN (~4%) Pengo et al. N Engl J Med. 2004;350:
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Most hospitalized patients have at least one risk factor for VTE
Risk Factors for VTE Stasis Age > 40 Anesthesia Immobility Heart Failure Stroke Paralysis Spinal cord injury Polycythemia Severe COPD Obesity Varicose Veins Hypercoagulability Cancer Inflammatory Bowel Medications Nephrotic Syndrome Sepsis Smoking Pregnancy Thrombophilia Endothelial Damage Surgery Prior VTE Central lines Trauma Virchow Triad stating: "The detachment of larger or smaller fragments from the end of the softening thrombus which are carried along by the current of blood and driven into remote vessels. This gives rise to the very frequent process on which I have bestowed the name of Embolia". Most hospitalized patients have at least one risk factor for VTE Anderson FA Jr. & Wheeler HB. Clin Chest Med 1995;16:235. Bick RL & Kaplan H. Med Clin North Am 1998;82:409.
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The VTE Population: Who gets clots?
1000 100 Recently hospitalized Cases per 10,000 person-years 10 1 Hospitalized patients Community residents Heit JA et al. Mayo Clin Proc. 2001; 76:
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Many Surgical Patients At-Risk
2003 Nationwide Inpatient Sample Adult surgical patients, LOS ≥2 days 7.8 million surgical discharges 44% low risk 15% moderate risk 24% high risk 17% very high risk 4.4 million at risk for VTE Anderson et al. Am J Hematol. 2007;82:
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Effective, Safe, and Cost-Effective
Pharmacologic prophylaxis substantially reduces the risk for VTE Bleeding complications are rare HIT: a serious but relatively rare complication of heparin therapy 2.37% with prolonged UFH in ill perioperative patients 0.06% with LMWH Monitoring for HIT is warranted Cost-effectiveness of VTE prophylaxis well documented HIT = heparin-induced thrombocytopenia LMWH = low molecular weight heparin UFH = unfractionated heparin Geerts WH et al. Chest. 2008; 133(6 suppl):381S-453S. Shojania KG et al. Making health care safer. Martel N et al. Blood. 2005; 106:
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VTE Prophylaxis: Medical Patients Anticoagulants vs. Placebo Trials
Patients with VTE (%) Enoxaparin n=1102 Dalteparin n=3706 Fondaparinux n=849 RRR=63% p=0.0002 RRR=44% p=0.0015 RRR=49.5% p=0.0029 5 14.9 10.5 5.5 2.8 5.6 4 8 12 16 MEDENOX PREVENT ARTEMIS Placebo LMWH Samama MM et al. N Engl J Med. 1999; 341: Leizorovicz A et al. Circulation. 2004; 110:874-9. Cohen AT et al. BMJ. 2006; 332:325-9. 14
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VTE Prophylaxis Meta-Analysis
9 studies 19,958 medical patients Anticoagulant prophylaxis vs no treatment Results 57% reduction in RR for symptomatic PE 62% reduction in RR for fatal PE 53% reduction in DVT No significant increase in major bleeding Dentali F, et al. Ann Intern Med. 2007;146:
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Registries Highlight the Underuse of VTE Prophylaxis in Hospitalized Patients
IMPROVE1 CURVE2 ENDORSE3 90% at risk Recent investigations like (ENDORSE) [12] offer a perspective of VTE prevention performance from around the world. This cross sectional survey encompassed 358 medical centers from 32 countries. Only 58.5% of surgical patients and 39.5% of medical patients were on prophylaxis consistent with ACCP [7] guidelines, and the United States performance was only marginally better than the world mean, with less than 50% of medical patients receiving guideline recommended prophylaxis. 60% any VTE prophylaxis 23% any VTE prophylaxis (16% appropriate) 40% appropriate VTE prophylaxis Only a minority of hospitalized medical patients receive appropriate VTE prophylaxis 1.Tapson VF et al. Chest. 2007; 132: 2. Kahn SR et al. Thromb Res. 2007; 119: 3. Cohen AT et al. Lancet. 2008; 371:
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Adherence to Guidelines
Premier Database: 429 Hospitals, 2005 and 2006 Appropriate prophylaxis: type, dose, daily, duration according to 7th ACCP-2004 Prophylaxis Medical N=201,224 Surgical N=188,800 Any(>1 dose) 66% 78% Appropriate 13% 16% Amin-JHM 2009;4:E15
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CT Pulmonary Angiography
Goldhaber SZ. N Engl J Med. 1998;339(2): Kearon SF. CMAJ. 2003;168:
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Why don’t we do better? Competing Priorities
National Policies / Incentives / Initiatives / Accreditation not all in place Lack of awareness of guidelines, battling guidelines Underestimation of clot risk, overestimation of bleeding risk Validated and practical risk assessment models needed Measurement Issues Translating complicated guidelines into everyday practice is difficult Medical training failures (QI and systems re-design) Failure to use a good QI framework Multiple reasons have been invoked to explain this persistent under-utilization, in spite of good faith efforts in medical centers to improve performance, and ever increasing external pressures. These include a lack of physician familiarity or agreement with guidelines, underestimation of VTE risk, concern over risk of bleeding, and the perception that the guidelines are resource intensive or difficult to implement in a practical fashion [16]. While many VTE risk assessment models are available in the literature [17-21], the absence until just recently of prospectively validated models, and issues regarding ease of use have hampered widespread integration of VTE risk assessments into order sets and inpatient practice. 16. Kakkar AK, Davidson BL, Haas SK. Compliance with recommended prophylaxis for venous thromboembolism: improving the use and rate of uptake of clinical practice guidelines. J Thromb Haemost. 2004;2:221–27. 17. Anderson F, Spencer F. Risk factors for venous thromboembolism. Circulation. 2003;107:I-9–I-16. 18. Caprini J, Arcelus J, Reyna J. Effective risk stratification of surgical and nonsurgical patients for venous thromboembolic disease. Semin Hematol. 2001;38(2)Suppl 5:12–19. 19. Gensini GF, Prisco D, Falciani M, Comeglio M, Colella A. Identification of candidates for prevention of venous thromboembolism. Semin Thromb Hemost. 1997;23(1):55–67. 20. Haas S. Venous thromboembolic risk and its prevention in hospitalized medical patients. Semin Thromb Hemost. 2002;28(6);577–583. 21. Motykie G, Zebala L, Caprini J, et al. A guide to venous thromboembolism risk factor assessment. J Thromb Thrombolysis. 2000;9:253–262.
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My First Algorithm for Process Improvement
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VTE Prevention Guides www.ahrq.gov/qual/vtguide
Maynard G, Stein J. Agency for Healthcare Research and Quality. August
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Quality Improvement is… Focus on processes of care
Reduced variation by shifting entire practice A change in the design of care Quality Improvement is NOT… Forcing people to work harder / faster / safer Traditional quality assurance or peer review Creating order sets or protocols without monitoring use or effect …not just the outliers …shifting entire practice toward better care by process change …potential for radical change through changing the design of care …Yelling at people to work harder / faster / safer
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VTE Prophylaxis A Multidisciplinary Approach
TEAM AIM STATEMENT: Goals Measurement Analyze Process STANDARDIZE based on best evidence Identification and Mitigation Details from prior talk 24 Maynard G, Stein J. Agency for Healthcare Research and Quality. August 2008. 24
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Hierarchy of Reliability Most hospitals at Level 1 or 2
Predicted Prophylaxis RATE 1 No Protocol- “state of nature” 40% 2 Decision Support Exists Doesn’t link to order writing OR Prompts within orders but no decision support 50% 3 Protocol Well Integrated 65-85% 4 Protocol Enhanced 90% 5 Oversights identified and addressed in real time 95+% Maynard G, Stein J. Agency for Healthcare Research and Quality. August 2008.
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The Multidisciplinary Team: The Engine of Quality Improvement
Backbone of quality improvement (QI) efforts Impact the interventions developed AND their implementation Synergistic Productive capacity = more than the sum of all individual team members taken together
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Metrics are Essential for VTE Prevention Efforts
Key component of institutional support Use consistent metrics over time Report results regularly to med staff/ admin
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Different Types of Metrics in VTE Prevention Efforts
Structure Dedicated quality improvement team? Standardized order sets, protocols? Electronic Health Record? CPOE? Process % with VTE risk assessment documented % with prophylaxis or contraindication within 24 hrs % using standardized order set % receiving pharmacologic prophylaxis, mechanical prophylaxis % adherence to mechanical prophylaxis
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Different Types of Metrics in VTE Prevention Efforts
Outcomes # of patients with Hospital-Acquired VTE (HA VTE) Rate of HA VTE per 1000 days or 1000 discharges % of HA VTE that were potentially preventable Balancing Measures Bleeding incidence Heparin-induced Thrombocytopenia incidence Cost (Savings) Maynard G, Stein J. Agency for Healthcare Research and Quality. August 2008.
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Detailed audits based on your protocol Less detailed audits
VTE Prophylaxis Audits Assessing Prevalence of Adequate VTE Prophylaxis Order set use Detailed audits based on your protocol Less detailed audits (Red / Yellow / Green strategy) 30 30
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VTE prophylaxis can be complicated!
Patient admitted to hospital MD orders appropriate VTE prophylaxis at admission Nurse ensures VTE prophylaxis administered Change in patient’s VTE risk level, contraindications, or site/unit of care Patient discharged Pharmacy dispenses and delivers drug MD performs VTE risk assessment MD links patient’s VTE risk level to menu of appropriate VTE prophylaxis options Support staff ambulates patient 3X/day Central Supply delivers sequential compression devices or graduated compression stockings Analyze Care Delivery: Delivering Appropriate VTE Prophylaxis 35% of failures 30% of failures 15% of failures 20% of failures Mean Baseline Performance: 50% (% of patients on appropriate VTE prophylaxis in the hospital) Integrate the slide like this VTE prophylaxis can be complicated! 31 Maynard G, Stein J. Agency for Healthcare Research and Quality. August URL in ref list.
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Is your VTE order set in competition?
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VTE Protocol Key Principles
Keep protocol simple to access and use Don’t interrupt the workflow Design reliability into the new process Monitor use of your protocol Allow for variation from the protocol based on patient characteristics (rather than providers) - improve protocol based on feedback and justifiable variation Fail faster (pilot small scale w/ongoing feedback & refinement before wider implementation)
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Too Little Guidance Prompt ≠ Protocol
DVT PROPHYLAXIS ORDERS Anti thromboembolism Stockings Sequential Compression Devices UFH 5000 units SubQ q 12 hours UFH 5000 units SubQ q 8 hours LMWH (Enoxaparin) 40 mg SubQ q day LMWH (Enoxaparin) 30 mg SubQ q 12 hours No Prophylaxis, Ambulate
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Low risk Moderate risk High risk VTE Prophylaxis: 3 Patient Groups
Geerts WH et al. Chest. 2008; 133(6 suppl):381S-453S.
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Simplifying Thromboprophylaxis
Patient Group Prophylaxis Duration Medical LMWH or UFH Discharge General surgical Orthopedics LMWH Rivaroxaban plus mech 25 days 15 days Trauma / SCI LMWH plus mech Rehab discharge ICU discharge High bleeding risk Mechanical until risk diminishes, then LMWH
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Validated Risk Scoring Systems
University of California San Diego Retrospective analysis Three-tier risk assessment model (RAM) Predicts Risk Validated in actual use Maynard GA et al. J Hosp Med. 2010; 5:10-8.
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UCSD VTE Protocol Validated
Easy to use, on direct observation – a few seconds Inter-observer agreement – 150 patients, 5 observers- Kappa 0.8 and 0.9 Predictive of VTE Implementation = high levels of VTE prophylaxis From 50% to sustained 98% adequate prophylaxis Rates determined by over 2,900 random sample audits Safe – no discernible increase in HIT or bleeding Effective – 40% reduction in HA VTE 86% reduction in risk of preventable VTE J Hosp Med 2010 Jan:5(1):10-18.
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J Hosp Med 2010 Jan:5(1):10-18. N = 2,944 mean 82 audits / month
Baseline Consensus building Order Set Implementation & Adjustment Real time ID & intervention J Hosp Med 2010 Jan:5(1):10-18. N = 2, mean 82 audits / month Real time ID & intervention Order Set Implementation & Adjustment UCSD experience with thousands of randomly sampled inpatient: High bar for ‘adequate prophylaxis’ Note real time ID / intervention Consensus building Baseline 32
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Oversights identified and addressed in real time 95+%
Level 5 Oversights identified and addressed in real time 95+% Note that originally Medicine had more preventable VTE than surgery, now surgery has more than medicine, as medicine services are now >90% compliant w/ recommendations. 34
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High Reliability Principles
Standardize VTE and anticoagulation risk assessment into the process of admission and transfers “Opt out” of default choices (not opt in) Prompts for VTE risk assessment at point-of-care Scheduled reassessments Redundant responsibility and prompts
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Strategies to Improve Prophylaxis Rates
BASIC INTERVENTIONS In-services Newsletters Quality improvement presentations Review JHM Quality Improvement language STEIN Stickers 43 Dobesh PP et al. J Manag Care Pharm. 2005; 11:
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Optimize Strategies for Effective VTE Prevention
Alert Systems Electronic alerts (E-alerts) Human alerts Computerized decision support Raising situational awareness Audit and feedback Measure-vention a multifaceted approach Variety of techniques SHM collaborative Audit/feedback. For true breakthrough levels of improvement, teams need to use education, standardized order sets, and a method to monitor prophylaxis rates, and act on those that are not on prophylaxis. Kakkar AK, Davidson BL, Haas SK. Compliance with recommended prophylaxis for venous thromboembolism: improving the use and rate of uptake of clinical practice guidelines. J Thromb Haemost. 2004;2:221–27. Maynard G, Morris T, Jenkins I, Stone S, Lee J, Renvall M, Fink E, Schoenhaus R. Optimizing Prevention of Hospital-Acquired Venous Thromboembolism: Prospective Validation of a VTE Risk Assessment Model. Sep, J Hosp Med early view 23. Maynard G, Stein J. Preventing Hospital-Acquired Venous Thromboembolism - A Guide for Effective Quality Improvement. Society of Hospital Medicine website, VTE Quality Improvement Resource Room. Available at: ResourceRoomRedesign/RR_VTE/VTE_Home.cfm. Last accessed July 14, 2009. 24. Maynard G, Stein J. Preventing Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality Improvement, version 3.3. Society of Hospital Medicine supplement, The Hospitalist August 2008, Vol 12 (8) 1-40. 25. Maynard G, Stein J. Preventing Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality Improvement. Prepared by the Society of Hospital Medicine. AHRQ Publication No Rockville, MD: 32. Cohn SL, Adekile A, Mahabir V. Improved use of thromboprophylaxis for deep vein thrombosis following an educational intervention. J Hosp Med. 2006;1:331–338. 33. Stein J, Chernetsky Tejedor S, Shabbir H, O'Malley E. Situational Awareness Improves Prevalence of VTE Prophylaxis on Multiple Nursing Units. J Hosp Med. 2008: Vol 3(S1): 41. 34. Schunemann HJ, Cook D, Grimshaw J, et al. Antithrombotic and thrombolytic therapy: from evidence to application: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126:688S–696S 35. Tooher R, Middleton P, Pham C, et al. A systematic review of strategies to improve prophylaxis for venous thromboembolism in hospitals. Ann Surg 2005; 241:397–415. 36. Oxman AD, Thomson MA, Davis DA, Haynes RB. No magic bullets: a systematic review of 102 trials of interventions to improve professional practice. CMAJ 1995; 153:1423–1431. 37. Levi D, Kupfter Y, Seneviratne C, Tessler S. Computerized order entry sets and intensive education improve the rate of prophylaxis for deep vein thrombophlebitis. Chest 1998;114S:280S. 38. Dobesh PP, Stacy ZA. Effect of a clinical pharmacy education program on improvement in the quantity and quality of venous thromboembolism prophylaxis for medically ill patients. J Manag Care Pharm. 2005;11:755–762. 39. Timmons S, O’Callaghan C, O’Connor M, et al. Audit guided action can improve the compliance with thromboembolic prophylaxis prescribing to hospitalized, acutely ill older adults. J Thromb Haemost 2005; 3:2112–2113 40. Mosen D, Elliott CG, Egger MJ, et al. The effect of a computerized reminder system on the prevention of postoperative venous thromboembolism. Chest 2004; 125:1635– 1641 41. Kucher N, Koo S, Quiroz R, et al. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med 2005; 352:969–977. 42. Durieux P, Nizard R, Ravaud P, Mounier N, Lepage E. A clinical decision support system for prevention of venous thromboembolism. JAMA 2000;283: 43. Dexter PR, Perkins S, Overhage JM, Maharry K, Kohler RB, McDonald CJ. A computerized reminder system to increase the use of preventive care for hospitalized patients. N Engl J Med. 2001; 345: 44
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Courtesy of Lori Porter and Joel McAlduff, Good Samaritan Banner, Phoenix, AZ Automated metrics for each ward can spur direct action. Results can be rolled up for the entire institution. Note that they refined the metrics to incorporate those with elevated INR values.
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MEASURE-VENTION Daily measurement drives concurrent intervention Identify patients not receiving VTE prophylaxis in real time Ongoing assessment, creates data, reports data Use for real-time intervention
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Map to Reach Level 5 Situational Awareness and Measure-vention
Identify patients not receiving anticoagulation Empower nurses to place SCDs on these patients as standing order (if no contraindications) Contact MD when patients are not receiving anticoagulant with no obvious contraindication Template note, ‘text’ page, etc. Administration to support these interventions with clear message that physicians should not “shoot the messenger” SCDs = sequential compression devices
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Map to Reach Level 5 95+ % Prophylaxis
Use Medication Administration Record (MAR) or automated reports to classify all patients in one of three zones: GREEN ZONE receiving anticoagulation YELLOW ZONE receiving mechanical prophylaxis only RED ZONE receiving no prophylaxis Act to move patients at risk for VTE out of the RED!
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Digging Deeper on “Yellow” Patients
Is patient low risk? Ambulating Independently with 0-1 VTE Risk Factors Expected LOS <48 hours Minor Surgery with NO VTE Risk Factors If yes, prophylaxis adequate, if no….. Obvious contraindication to pharmacologic prophylaxis? Active hemorrhage now or within last 3 days Post operative bleeding concerns Platelet count < 50,000 Units INR > 1.8 Known bleeding disorder, post op bleeding high risk Hgb < 8.0 g/dL Concern over CNS bleeding (brain or spinal cord surgery in last week, recent intracranial hemorrhage, proximity in time to epidural insertion or removal, for example) Hypertensive urgency / emergency Comfort care only patient If yes, mechanical prophylaxis alone adequate, if no, prophylaxis inadequate
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Mechanical Prophylaxis Compliance
Setting: 722-bed acute care hospital Method: Prospective observational trial of mechanical VTE prevention compliance Interventions: 1. Consecutive patients (n=150) were observed twice daily Mon – Fri to ensure that sequential compression device (SCD) and venous foot pump (VFP) were used properly 2. Compliance Rate=compliant evaluations/total evaluations p=<0.001 Piazza G et al. Circulation. 2009; 119:
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Hierarchy of Reliability Most hospitals at Level 1 or 2
Predicted Prophylaxis RATE 1 No Protocol- “state of nature” 40% 2 Decision Support Exists Doesn’t link to order writing OR Prompts within orders but no decision support 50% 3 Protocol Well Integrated 65-85% 4 Protocol Enhanced 90% 5 Oversights identified and addressed in real time 95+% Standard order set Standardize process Alerts, identification and mitigation Maynard G, Stein J. Agency for Healthcare Research and Quality. August 2008.
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VTE Prevention Collaboratives Using UCSD Model Over 250 Hospitals
Society of Hospital Medicine (SHM) AHRQ and Quality Improvement Organizations Institute for Healthcare Improvement (IHI) Expedition British Columbia Hospital Medicine American Society of Healthsystems Pharmacists (ASHP) Awards to UCSD, Emory, UNM, Washington DC VA, Blessing (Quincy IL) and British Columbia based on these strategies (all members of mentored implementation) Effective across variety of settings Paper and Computerized / Electronic Small and large institutions Academic and community
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2 Common Questions and Biased Answers
Q. What is the best VTE risk assessment model? Simple, text based model with only 2-3 layers of VTE Risk Q. Who should do the VTE risk assessment? Doctors (via admit transfer order sets), with back up risk assessment by front line nurses or pharmacists, focusing on those without prophylaxis. The best protocols provide decision support at the point of care, and yet are user friendly and efficient to use, and preserve the ability to customize care for special patient situations or circumstances [23 – 26]. Who administers the protocol? Conceivably, anyone in the medical center (eg a nurse or pharmacist) could administer the risk assessment model and present the results to the physician for action. However, our collective experience suggests that the VTE prevention protocol is most effective when embedded in commonly used admission, transfer, and perioperative order sets. Across VTE collaboratives, the physician consistently appears to be in the best position to understand all components of VTE risk, along with the possible contraindications to pharmacologic prophylaxis. Furthermore, an immediate connection in time and space of the VTE risk assessment to the ordering process makes for a more reliable and direct route for ordering adequate prophylaxis. How should I design the risk assessment into the order set? We recommend integrating a simple text based model with no more than 3 levels of VTE risk. More details to follow Maynard G, Stein J. Preventing Hospital-Acquired Venous Thromboembolism - A Guide for Effective Quality Improvement. Society of Hospital Medicine website, VTE Quality Improvement Resource Room. Available at: ResourceRoomRedesign/RR_VTE/VTE_Home.cfm. Last accessed July 14, 2009. Maynard G, Stein J. Preventing Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality Improvement, version 3.3. Society of Hospital Medicine supplement, The Hospitalist August 2008, Vol 12 (8) 1-40. Maynard G, Stein J. Preventing Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality Improvement. Prepared by the Society of Hospital Medicine. AHRQ Publication No Rockville, MD: Agency for Healthcare Research and Quality. September 2008, Available at: Last accessed July 14, 2009.
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Key Points - Recommendations
VTE Risk Assessment embedded in order sets Simple risk stratification schema, based on VTE-risk groups (2-3 levels of risk should do it) Customization for some services is desirable. Simple measures for adequate VTE prophylaxis More detail on selected patients Follow Outcomes Work on adherence to ordered prophylaxis Use measure-vention to accelerate improvement Share information / comparing notes helps Maynard G, Stein J. Designing and Implementing Effective VTE Prevention Protocols: Lessons from Collaboratives. J Thromb Thrombolysis Feb:29(2): 74
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The Joint Commission VTE-1 Venous Thromboembolism Prophylaxis
VTE-2 Intensive Care Unit Venous Thromboembolism Prophylaxis VTE-3 Venous Thromboembolism Patients with Anticoagulation Overlap Therapy VTE-4 Venous Thromboembolism Patients Receiving Unfractionated Heparin with Dosages/Platelet Count Monitoring by Protocol VTE-5 Venous Thromboembolism Discharge Instructions VTE-6 Incidence of Potentially-Preventable Venous Thromboembolism
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The Joint Commission on VTE
Risk Assessment/ Prophylaxis 1. Documentation of VTE risk assessment/prophylaxis within 24 hr of hospital admission 2. Documentation of VTE risk assessment/prophylaxis within 24 hr after admission to or transfer to ICU Treatment Outcomes 6. Incidence of potentially-preventable venous thromboembolism The Joint Commission Measures. Not yet publicly reportable. Optional choice. May become new core measures. Around risk/treatment/management. These reflect all cases. Where as SCIP is surgical patients The Joint Commission. Venous thromboembolism (VTE) core measure set. 53
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Latest guidelines
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What’s New in the ACCP Guidelines
Decrease in 1A recommendations Orthopedic prophylaxis Mechanical Prophylaxis VTE prophylaxis in hospitalized medical patients Risk Assessment Models, endorsement and extrapolation
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Decrease in 1A recommendations
Hirsh J, Guyatt G, Lewis SZ. Chest Jun;133(6): PMID: Guyatt GH. Chest Feb;141(2 Suppl):48S-52S. PMID:
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Decrease in 1A recommendations
Weak recommendations replacing strong recommendations WHY? More critical look at the evidence, “symptomatic DVT vs asymptomatic” recognition of variability in values and preferences. the endorsement of > 80% of panelists to make a strong recommendation required. the exclusion of conflicted experts Guyatt GH. Chest Feb;141(2 Suppl):48S-52S. PMID:
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“Relying on the perspective of unconflicted methodologists, rigorously applying the GRADE approach, and excluding those with financial and intellectual conflict of interests from bottom-line decisions regarding the quality of evidence and strength of recommendations led to re-evaluations of previously existing evidence” Page 50S
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What’s New in the ACCP Guidelines
Decrease in 1A recommendations Orthopedic prophylaxis Mechanical Prophylaxis VTE prophylaxis in hospitalized medical patients Risk Assessment Models, endorsement and extrapolation
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2012 ACCP Guideline 2.1.1 pts undergoing THA or TKA
We recommend use of one of the following for days rather than no anti-thrombotic prophylaxis: LMWH, fondaprinux, apixaban, dabigatran, rivaroxaban, LDUH, VKA, ASA(all grade 1b), or an intermittent IPCD(Grade 1c) THA/TKA=Total Hip or Knee Arthroplasty IPCD=intermittent pneumatic compression device LDUH=low dose unfractionated heparin VKA=Vitamin K Antagonist-warfarin LMWH=low molecular weight heparin
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2012 ACCP Guideline In patients undergoing THA or TKA, irrespective of the concomitant use of an IPCD or length of treatment, we suggest the use of LMWH in preference to the other agents we have recommended as alternatives: fondaparinux, apixaban, dabigatran, rivaroxaban, LDUH (all Grade 2B) , adjusted-dose VKA, or aspirin (all Grade 2C) Allow ASA as a choice (split decision) Allows IPC as stand alone option (with caveats)
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ASA? 2008 ACCP: recommend against LDUH, ASA as sole method, with others getting 1a recommendation, for THR/TKR 2007 AAOS: PE prevention Standard risk for PE and major bleeding pts should receive ASA, LMWH, fondaparinux, warfarin. With concurrent mechanical 2011 AAOS: more general “we suggest the use of pharmacological agents and/or compressive device for the prevention of VTE in pts with elective THR/TKR”
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ASA There is evidence ASA works, recommend better than nothing. Suggest LMWH in preference to others Don’t use ASA for high risk pts
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What’s New in the ACCP Guidelines
Decrease in 1A recommendations Orthopedic prophylaxis Mechanical Prophylaxis VTE prophylaxis in hospitalized medical patients Risk Assessment Models, endorsement and extrapolation
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ACCP endorses a specific SCD type as stand alone
Joe Cummings, PhD, manager UHC Technology Assessment Group
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What’s New in the ACCP Guidelines
Decrease in 1A recommendations Orthopedic prophylaxis Mechanical Prophylaxis VTE prophylaxis in hospitalized medical patients Risk Assessment Models, endorsement and extrapolation
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Medical prophylaxis 2012 ACCP 2008 ACCP
2.3. For acutely ill hospitalized medical patients at increased risk of thrombosis, we recommend anticoagulant thromboprophylaxis with LMWH, UFH or fondaparinux (Grade 1B) 2.4. For acutely ill hospitalized medical patients at low risk of thrombosis, we recommend against the use of pharmacologic prophylaxis or mechanical prophylaxis (Grade 1B) . For acutely ill medical patients admitted to hospital with congestive heart failure or severe respiratory disease, or who are confined to bed and have one or more additional risk factors, including active cancer, previous VTE, sepsis, acute neurologic disease, or inflammatory bowel disease, we recommend thromboprophylaxis with LMWH (Grade 1A), LDUH (Grade 1A), or fondaparinux (Grade 1A)
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What’s New in the ACCP Guidelines
Decrease in 1A recommendations Orthopedic prophylaxis Mechanical Prophylaxis VTE prophylaxis in hospitalized medical patients Risk Assessment Models, endorsement and extrapolation
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Patients Undergoing General, GI, Urologic, Gynecologic, Bariatric, Vascular, Plastic, or Reconstructive Surgery For general and abdominal-pelvic surgery patients at moderate risk for VTE (~ 3.0%; Rogers score, > 10; Caprini score, 3-4) who are not at high risk for major bleeding complications, we suggest LMWH (Grade 2B), LDUH (Grade 2B), or mechanical prophylaxis, preferably with IPC (Grade 2C), over no prophylaxis. Remarks: Three of the seven authors favored a strong (Grade 1B) recommendation in favor of LMWH or LDUH over no prophylaxis in this group.
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Rogers and Caprini Models in Surgical Patients
Endorsed by ACCP Acknowledged that Rogers method is not practical Caprini model said to be fairly easy to use Collaborative improvement experience indicates otherwise!!!! No mention of “3 bucket model” Caprini model validation study ----only 10% at level very low, low risk that do not require AC
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% of Surgical Patients in Each Risk Category
Bahl et al Ann Surg 2009 % of Surgical Patients in Each Risk Category Low Risk % Moderate Risk % High Risk % Highest Risk %
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New Guidelines: Comments / Insights / Implications
Controversial guidelines notable for lack of practical guidance Seemingly, one set of biased assumptions has been replaced by another, skewed in opposite direction Recommended risk models cumbersome Recommended risk models relatively untested in terms of inter-observer agreement and efficacy Dozens in collaboratives have replicated UCSD results….fewer VTE, no increase in bleeding Valid points: Some inpatients not at significant risk, attention to possible over anticoagulation is warranted. Carve outs? CABG patients reasonable Ortho-----depends on your local culture
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Other pearls Recent ACP guidelines Extended prophylaxis New agents
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ACP guideline Risk assessment needed for medical patients(thromboembolism and bleeding risk) Pharmacologic prophylaxis with heparin or related drug for VTE in medical (stroke) patients Avoid universal prophylaxis policies
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Extended Prophylaxis Cancer surgery: 4 weeks 2008 ACCP 2007 AAOS
THR: 10 days to 35 days 2007 AAOS ASA up to 6 weeks LMWH: 7-12 days Warfarin 2-6 weeks 2011 AAOS Unable to make recommendations 2012 ACCP 10-14 days orthopedic, hip fracture, THR/TKR Up to 35 days Fonadparinux study 6-8 days vs days: check for asympto Sympto 0.3% vs 2.7%, bleedingn similar
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Patients Undergoing General, GI, Urologic, Gynecologic, Bariatric, Vascular, Plastic, or Reconstructive Surgery For high-VTE-risk patients undergoing abdominal or pelvic surgery for cancer who are not otherwise at high risk for major bleeding complications, we recommend extended-duration pharmacologic prophylaxis (4 weeks) with LMWH over limited-duration prophylaxis (Grade 1B). Remarks: Patients who place a high value on minimizing out-of-pocket health-care costs might prefer limited-duration over extended-duration prophylaxis in settings where the cost of extended-duration prophylaxis is borne by the patient.
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Patients Undergoing Major Orthopedic Surgery: Total Hip Arthroplasty (THA), Total Knee Arthroplasty (TKA), Hip Fracture Surgery (HFS) In patients undergoing hip fracture surgery (HFS), we recommend use of one of the following rather than no antithrombotic prophylaxis for a minimum of 10 to 14 days: LMWH, fondaparinux, LDUH, adjusted-dose VKA, aspirin (all Grade 1B), or an IPCD (Grade 1C). Remarks: We recommend the use of only portable, battery-powered devices capable of recording and reporting proper wear time on a daily basis for inpatients and outpatients. Efforts should be made to achieve 18 h of daily compliance. One panel member believed strongly that aspirin alone should not be included as an option.
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Patients Undergoing Major Orthopedic Surgery: Total Hip Arthroplasty (THA), Total Knee Arthroplasty (TKA), Hip Fracture Surgery (HFS) For patients undergoing major orthopedic surgery, we suggest extending thromboprophylaxis in the outpatient period for up to 35 days from the day of surgery rather than for only 10 to 14 days (Grade 2B).
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NEWER AGENTS
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Oral agents Study Record 1 Record 3 RE-NOVATE RE-MODEL ADVANCE 1 Agent
Rivaroxaban 10mg Daily Dabigatran 150mg or 220mg daily Apixaban 2.5mg BID initation After surgery length 31-39 d 10-14 d 28-35 d 6-10 d 10-14d comparison Enoxaparin 40 Enox 30 BID Enox 40 N 4541 2531 3494 2101 3195 Procedure THR TKR Oral agent VTE 1.1% 9.6% 6%, 8.6% 36.4%, 40.5% 9% Comparison 3.7% 18.9% 6.7% 37.7% 8.8% Dabigatran: DTI RE MOBILIZE study inferior dabigatran to enox. However given 6-12 hours after surgeyr. Re MODEL given 1-4 hours Ricaroxaban: IN US for prevention of VTE. Bind Xa, as does apixaban
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Bottom line VTE prevention: safe/effective/cost effective
Do Risk assessment/Bleeding assessment Quality Improvement team, using deliberate QI strategy High reliability strategies: “measure-vention” Avoid “mechanical only” in pts at risk and have no CI to pharmacological
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Thanks!
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