Appendix A: Talking Points to Attract Administration Support for Venous Thromboembolism Prevention Programs Hospitalized patients are at high risk for venous thromboembolism (VTE). Pulmonary embolism (PE) and deep vein thrombosis (DVT), collectively known as venous thromboembolism (VTE), represent a major public health problem, affecting 350,000-600,000 Americans annually.1 VTE is primarily a problem of hospitalized and recently hospitalized patients2,3 In a large registry trial capturing more than 5,451 patients at 183 sites over a 6-month period, 50% (2,726) developed their VTE during hospitalization.4 Most hospitalized patients have at least one risk factor for VTE.5 In the absence of prophylaxis, the great majority of inpatient surgical patients have a risk of VTE of at least 3%, with many have a much higher risk.6,7 The high incidence of postoperative VTE and the availability of effective methods of prevention mandate that thromboprophylaxis should be considered in every patient.6 Many medical patients are also at high risk. Medical patients with common risk factors had a VTE risk of 11% in a recent cohort study.8 Medical patients probably account for more than half of all hospital-acquired VTE events. Hospitalized medical patients developed PE more frequently than their surgical counterparts, including most fatal PE. 3,4,9,10 In the DVT FREE Registry study, half the inpatients who suffered from VTE were nonsurgical and had no surgical procedures in the preceding 3 months.4 Venous thromboembolism leads to substantial inpatient costs, morbidity, and mortality. Up to 200,000 patient deaths per year are related to VTE. This is more deaths than those from breast cancer, AIDS, and traffic accidents combined.1 Many of these VTE deaths contribute to hospital mortality. PE is among the most common preventable cause of death in the hospital. 11-13 Symptomatic DVT and PE are associated with high (10-15%) fatality rates and extended hospital stays.1 VTE requires therapeutic anticoagulation for a minimum of three months, which entails inconvenience, cost, and a risk of major / fatal bleeding.14-16 More than 20% of patients with hospital-associated VTE will suffer a recurrent event once anticoagulation has been discontinued, with all the mortality and morbidity that entails.17 30-50% of DVT patients develop painful post-thrombotic syndrome.18 4% of PE patients develop chronic thromboembolic pulmonary hyptertension.19 Patients and their families relay powerful personal stories related to loss of function, difficulty with anticoagulant therapy, fiscal burden, and fear of recurrence. Each HA- DVT represents an incremental cost of $7,700 to $10,800, while each PE represents $9,500 to $16,600 in additional cost. Acute VTE in cancer patients bears an even higher cost, estimated at over $20,000 per episode.20 Acute and longer term costs are estimated at 5-20 billion dollars per year in the US alone.21 The Centers for Medicare & Medicaid Services no longer reimburses for the incremental costs of VTE related to some major orthopedic surgeries, and is considering expanding that list. 22 Effective, safe, and cost effective measures to prevent hospital-acquired VTE exist. Pharmacologic prophylaxis reduces the incidence of asymptomatic and symptomatic DVT and PE by 30 to 65 percent.5,23 The chief concern of prophylaxis is bleeding, but bleeding risk secondary to pharmacologic prophylaxis is a rare event, based on abundant data from meta-analyses and placebo-controlled randomized controlled trials.5,23,24 Overwhelming evidence reveals that pharmacologic VTE prophylaxis for at risk patients not only prevents adverse patient outcomes, it is also cost effective.5,23 The gap between current practice and optimal practice is very large. The high prevalence of hospital-acquired VTE is largely due to the underutilization of simple, cost effective prophylactic measures. Of the 2,726 patients who had their DVT diagnosed while hospitalized in the DVT FREE Registry, only 1,147 (42 percent) received prophylaxis within the 30 days before diagnosis.4,25 A recent cross-sectional study of almost 70,000 patients in 358 hospitals found that appropriate prophylaxis was administered in only 58.5% of surgical and 39.5% of medical inpatients at risk for VTE.26 Several prominent organizations acknowledge the magnitude of this “implementation gap.” o The AHRQ report, “Making Healthcare Safer,” cited the provision of appropriate VTE prophylaxis as the paramount effective strategy to improve patient safety,23 and a 2013 update continues to list improved prophylaxis for VTE as a top ten patient safety strategy to act on now.27 o The American Public Health Association states “Physicians and other healthcare providers must be aware of risk factors and risk stratification. Moreover, they must take more aggressive action in screening patients for risk factors and in prescribing preventive interventions.” o The U.S. Surgeon General produced a call to action document for VTE prevention in 2008, in recognition of VTE as a potentially preventable condition that poses a public health problem.1 The current reality in American hospitals is thus arrestingly substandard, especially considering what could be accomplished with simple, safe, and effective prophylaxis for the at-risk inpatient. Incorporate local data if you have it, regarding prevalence of adequate VTE prophylaxis, number of different order sets, and anecdotes. VTE Prevention is increasingly incorporated into public reporting, guidelines, regulatory agency, and national quality initiative priorities. VTE Prevention is a legal and strategic imperative. The National Quality Forum and The Joint Commission have measures regarding VTE Prevention, and the VTE measures recently became mandated core measures in the inpatient setting.28,29 VTE Prevention is one of the focus areas of Partnerships for Patients, a major effort to foster accelerated improvement from the Center for Medicare and Medicaid Services.30 The Surgical Care Improvement Project has widely used measures for VTE Prevention.31 Hospital-associated VTE are now open to public reporting. The public has an expectation that you will keep them safe, but at the same time, there is a growing perception that they are not safe.32 Having a VTE prophylaxis protocol in place and insuring that it is followed reduces hospital and governing board liability exposure, while serving improved patient safety. 32 Reliably preventing VTE in the hospital is inherently complex. More education alone won’t get the job done. VTE risk and bleeding risks vary within patient populations. The risk of VTE and the risk of bleeding may change for individual patients several times as they progress through their hospital stay. Medication changes, weight, age, renal function, and recent or impending invasive interventions may all influence decisions about the best VTE prevention options. Transitions across care providers and locations lead to multiple opportunities for breakdown in the delivery of optimal VTE prophylaxis. Thoughtful, evidence-based protocols, multidisciplinary system changes, and comprehensive educational efforts are required to achieve optimal VTE prophylaxis in the complex hospital setting.33,34 Essential elements are needed for effective and safe prevention of VTE in the hospital. Educational and awareness efforts alone have proven inadequate in increasing appropriate use of VTE prophylaxis. Similarly, order sets and critical pathways not supported by a healthy quality improvement framework are unlikely to succeed. Process redesign and continuous attention must include essential elements: 1) Standardization of VTE risk assessment embedded in well-designed order sets, with each level of VTE risk tightly linked to institutionally endorsed prophylaxis options. 2) The VTE prevention order sets must be used to be effective, and should be positioned in such a way that they “touch” virtually all patients at critical junctures, such as admission to the hospital, admission or transfer to the critical care unit, changes in level of care, and peri-operatively. 3) Ongoing monitoring and measurement, coupled with real time intervention, to insure that patients on inadequate prophylaxis are identified early, and actions are taken to correct oversights and errors proactively.33,34 A roadmap is in place. Extensive guidance is available from the literature and consensus conferences. AHRQ has produced a comprehensive guide to effective implementation of VTE prevention programs, using a proven performance improvement framework, firsthand experience, and the collective wisdom from hundreds of institutions addressing VTE prevention. The guide includes practical information on: o Organizing and managing a multidisciplinary steering committee, reporting into the medical center administration. o Practical methods to assess institutional performance in VTE prophylaxis and identifying and tracking patients with hospital-acquired VTE. o Constructing an institutional VTE risk assessment model, and integrating it into workflow and order sets. o Methods to bolster chances of success by integration of high-reliability design features and attention to effective implementation techniques Summary -- Push for Support Hospital-acquired VTE is an important issue. Effective, safe, and evidence-based measures to prevent hospital-acquired VTE are currently underutilized at many medical centers, resulting in needless mortality and morbidity. Personnel who are ready to aggressively address this issue are needed to reduce the prevalence of hospital-acquired VTE. A number of guides are available to help them achieve their goals. Administrative support for an empowered multidisciplinary steering committee is needed. Institutional prioritization and the will to standardize and improve systems in the face of substantial cultural and complex barriers is an absolute necessity to achieve breakthrough levels of improvement. Improved data collection and reporting, incremental monitoring, creation of metrics, and improved documentation are necessary. Depending on how advanced or ambitious the effort, it may be important for the team to lay out a business plan, including specific aim, timeline, personnel, full-time equivalent support, and other required resources. References: 1. U.S. Department of Health and Human Services. Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. 2008. Available at: http://www.surgeongeneral.gov/topics/deepvein/. Last accessed January 29, 2013. 2. Heit JA, Melton LJ, Lohse CM, et al. Incidence of venous thromboembolism in hospitalized patients vs.community residents. Mayo Clin Proc. 2001;76:1102-10. 3. Heit JA , Silverstein MD , Mohr DN , Petterson TM , O’Fallon WM , Melton LJ III . Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000; 160(6):809-815. 4. Goldhaber SZ, Tapson VF. A prospective registry of 5,451 patients with ultrasound-confirmed deep vein thrombosis. Am J Cardiol 2004;93:259-62. 5. 6. Geerts WH, Bergqvist D, Pineo GF et al. Prevention of Venous Thromboembolism. Chest June 2008 133:6 suppl 381S-453S; doi:10.1378/chest.08-0656 Gould MK, Garcia DA, Wren SM et al. Prevention of VTE in Nonorthopedic Surgical Patients. Chest February 2012 141:2 suppl e227S-e277S; doi:10.1378/chest.11-2297 7. Bahl V, Hsou MH, Henke PK, Wakefield TW, Campbell DA, Caprini JA. A Validation of a Retrospective Venous Thromboembolism Risk Scoring Method. Ann Surg 2010;251(2):344-50. 8. Barbar S, Noventa F, Rossetto V, et al.(2010) A risk assessment model for the identification of hospitalized medical patients at risk for venous thromboembolism: the Padua Prediction Score. J Thromb Haemost 8(11):2450–2457. 9. Goldhaber SZ , Dunn K , MacDougall RC. New onset of venous thromboembolism among hospitalized patients at Brigham and Women’s Hospital is caused more often by prophylaxis failure than by withholding treatment. Chest 2000;118(6):1680-1684. 10. Piazza G, Seddighzadeh A, Goldhaber SZ. Double Trouble for 2,609 hospitalized medical patients who developed deep vein thrombosis: prophylaxis omitted more often and pulmonary embolism more frequent. Chest 2007; 132(2):554-561. 11. Heit JA, O’Fallon WM, Petterson TM, Lohse CM, Silverstein MD, Mohr DN, et al., Relative impact of risk factors for deep vein thrombosis and pulmonary embolism. Arch Intern Med 2002; 162:1245-1248. 12. Tapson VF, Hyers TM, Waldo AL, Ballard DJ, Becker RC, Caprini JA, et al., Antithrombotic therapy practices in US hospitals in an era of practice guidelines. Arch Intern Med 2005; 165:1458-1464. 13. Clagett GP, Anderson FA Jr, Heit J, Levine MN, Wheeler HB, Prevention of venous thromboembolism. Chest 1995; 108:312S-334S. 14. EINSTEIN Investigators, Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; Dec 23;363(26):2499-510. 15. EINSTEIN-PE Investigators, Buller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; Apr 5;366(14):128797. 16. Levi M, Hovingh GK, Cannegieter SC, Vermeulen M, Buller HR, Rosendaal FR. Bleeding in patients receiving vitamin K antagonists who would have been excluded from trials on which the indication for anticoagulation was based. Blood 2008; May 1;111(9):4471-6. 17. Prandoni P, Noventa F, Ghirarduzzi A, Pengo V, Bernardi E, Pesavento R, et al. The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients. Haematologica 2007; Feb;92(2):199-205. 18. Kahn SR. How I treat postthrombotic syndrome. Blood 2009; Nov 19;114(21):4624-31. 19. Pengo V, Lensing AW, Prins MH, Marchiori A, Davidson BL, Tiozzo F, et al. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med 2004; May 27;350(22):2257-64. 20. Dobesh PP. Economic burden of venous thromboembolism in hospitalized patients. Pharmacotherapy 2009;29(8):943-53. 21. Mahan CE, Borrego ME, Woersching AL, Federici R, Downey R, Tiongson J, et al. Venous thromboembolism: Annualised United States models for total, hospital-acquired and preventable costs utilising long-term attack rates. Thromb Haemost 2012; Jul 25;108(2):291-302. 22. Centers from Medicare & Medicaid Services, Center for Medicare and Medicaid Innovation. Partnership for Patients. Accessed December 10, 2012. http://www.innovations.cms.gov/initiatives/Partnership-forPatients/index.html. 23. Shojania KG, McDonald KM, Wachter RM, Owens DK. Closing The Quality Gap: A Critical Analysis of Quality Improvement Strategies, Volume 1—Series Overview and Methodology. Technical Review 9 (Contract No. 290-02-0017 to the Stanford University–University of California, San Francisco, Evidence-based Practices Center). AHRQ Publication No. 04-0051-1. Rockville, MD: Agency for Healthcare Research and Quality. August 2004. Accessed February 1, 2012: www.ahrq.gov/clinic/tp/qgap1tp.htm 24. Dentali F, Douketis JD, Gianni M, Lim W, Crowther MA. Meta-analysis: anticoagulant prophylaxis to prevent symptomatic venous thromboembolism in hospitalized medical patients. Ann Intern Med 2007; Feb 20;146(4):278-88. 25. Goldhaber SZ, Tapson VF, DVT FREE Steering Committee. A prospective registry of 5,451 patients with ultrasound-confirmed deep vein thrombosis. Am J Cardiol 2004; 93:259-262. 26. Cohen AT, Tapson VF, Bergmann JF, et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): A multinational cross-sectional study. Lancet. 2008;371(9610):387-94. 27. Shekelle PG, Pronvost PJ, Wachter RM, McDonald KM, Schoelles K, Dy SM et al. The Top Patient Safety Strategies That Can Be Encouraged for Adoption Now. Ann Int Med. 2013;158:365-8. 28. National Quality Forum. National Voluntary Consensus Standards for Prevention and Care of Venous Thromboembolism: Policy, Preferred Practices, and Initial Performance Measures. Available at http://www.qualityforum.org/Publications/2006/12/National_Voluntary_Consensus_Standards_for_Prevention_ and_Care_of_Venous_Thromboembolism__Policy,_Preferred_Practices,_and_Initial_Performance_Measures.a spx. Accessed June 14, 2012. 29. The Joint Commission. Performance Measurement Initiatives. Available at http://www.jointcommission.org/PerformanceMeasurement/PerformanceMeasurement. Accessed June 14, 2012. 30. Medicare Quality Improvement Committee. SCIP Project Information. Available from AHRQ National Quality Measures Clearinghouse: http://www.qualitymeasures.ahrq.gov/content.aspx?id=35538&search=scip Accessed March 2013. 31. Centers from Medicare & Medicaid Services, Center for Medicare and Medicaid Innovation. Partnership for Patients. Accessed December 10, 2012. http://www.innovations.cms.gov/initiatives/Partnership-forPatients/index.html. 32. Health Services Advisory Group. Venous Thromboembolism Guide for Executive Leadership. Translating VTE Guidelines Into Practice. Accessed March 2013: http://www.hsag.com/services/special/VTE.aspx 33. 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. J Hosp Med 2010 Jan:5(1):10-18. 34. Maynard G, Stein J. Designing and Implementing Effective VTE Prevention Protocols: Lessons from Collaboratives. J Thromb Thrombolysis 2010 Feb:29(2):159-166.