Talking Points - Patient Safety

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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
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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.
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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.
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