THE CHALLENGES OF COMPLIANCE WITH VTE PROPHYLAXIS GUIDELINES. Pr I. ELALAMY Service d Hématologie Biologique HOPITAL TENON ER2 UPMC PARIS

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1 THE CHALLENGES OF COMPLIANCE WITH VTE PROPHYLAXIS GUIDELINES Pr I. ELALAMY Service d Hématologie Biologique HOPITAL TENON ER2 UPMC PARIS

2 VTE Commonest avoidable cause of hospital death Patient safety issue Clear benefit of VTE prophylaxis Important misuse of prophylaxis

3 A real life clinical case An 86-year-old man with a history multiple myeloma and prostate cancer was admitted and treated successfully for infectious diarrhoea. Whilst awaiting hospital discharge, he developed acute breathlessness and collapsed Obvious Under-use of Prophylaxis Severe bilateral PE treated with tenecteplase with a proven benefit of prompt treatment for acute PE Prophylaxis of VTE in this patient was not considered during his hospitalization before the development of PE. Connor A et al, Resuscitation (2006) 68,

4 ENDORSE : A Worldwide Study Epidemiologic International Day for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting 32 countries hospitals A.T Cohen et al Lancet 2008

5 Hospitals by Country Country Hospitals Country Hospitals Country Hospitals Algeria 6 Australia 8 Bangladesh 5 Brazil 12 Bulgaria 11 Colombia 5 Czech Republic 10 Egypt 6 France 18 Germany 16 Greece 10 Hungary 9 India 10 Ireland 3 Kuwait 3 Mexico 11 Pakistan 5 Poland 10 Portugal 9 Romania 11 Russia 10 Saudi Arabia 3 Slovakia 9 Spain 20 Switzerland 10 Thailand 5 Tunisia 5 Turkey 11 UAE 2 UK 19 USA 81 Venezuela 5 A.T Cohen et al Lancet 2008

6 Study Population (N=54,812) Evaluable patients Surgical (N =18,461) 34% Medical (N =21,221) 66% A.T Cohen et al Lancet 2008

7 % of Hospitalized patients at Risk for VTE per Country Mean=59% % Algeria Australia Bangladesh Brazil Bulgaria Colombia Czech Rep Egypt France Germany Greece Hungary India Ireland Kuwait Mexico Pakistan Poland Portugal Romania Russia Saudi Arabia Slovakia Spain Switzerland Thailand Tunisia Turkey UAE UK USA Venezuela A.T Cohen et al Lancet 2008

8 % Use of ACCP recommended Px among Hospitalized patients at Risk for VTE per Country Mean=58% % 10 0 Algeria Australia Bangladesh Brazil Bulgaria Colombia Czech Rep Egypt France Germany Greece Hungary India Ireland Kuwait Mexico Pakistan Poland Portugal Romania Russia Saudi Arabia Slovakia Spain Switzerland Thailand Tunisia Turkey UAE UK USA Venezuela A.T Cohen et al Lancet 2008

9 % of Surgical Patients at risk for VTE per Country Mean=93% Algeria Australia Bangladesh Brazil Bulgaria Colombia Czech Rep Egypt France Germany Greece Hungary India Ireland Kuwait Mexico Pakistan Poland Portugal Romania Russia Saudi Arabia Slovakia Spain Switzerland Thailand Tunisia Turkey UAE UK USA Venezuela 0 A.T Cohen et al Lancet 2008 %

10 % Use of ACCP recommended Px among Surgical patients at Risk for VTE per Country Mean=67% Algeria Australia Bangladesh Brazil Bulgaria Colombia Czech Rep Egypt France Germany Greece Hungary India Ireland Kuwait Mexico Pakistan Poland Portugal Romania Russia Saudi Arabia Slovakia Spain Switzerland Thailand Tunisia Turkey UAE UK USA Venezuela A.T Cohen et al Lancet 2008 %

11 % of Medical Patients at risk for VTE per Country Mean=43% Australia Bangladesh Brazil Bulgaria Colombia Czech Rep Egypt France Germany Greece Hungary India Ireland Kuwait Mexico Pakistan Poland Portugal Romania Russia Saudi Arabia Slovakia Spain Switzerland Thailand Tunisia Turkey UAE UK USA Venezuela A.T Cohen et al Lancet 2008 Algeria %

12 % Use of ACCP recommended Px among Medical patients at Risk for VTE per Country Mean=48% Algeria Australia Bangladesh Brazil Bulgaria Colombia Czech Rep Egypt France Germany Greece Hungary India Ireland Kuwait Mexico Pakistan Poland Portugal Romania Russia Saudi Arabia Slovakia Spain Switzerland Thailand Tunisia Turkey UAE UK USA Venezuela A.T Cohen et al Lancet 2008 %

13 CURRENT USE OF PROPHYLAXIS The ENDORSE study patients in 358 hospitals in 32 countries Surgical patients 45% Medical patients 55% Patients at risk of VTE 64% Patients at risk of VTE 42% VTE prophylaxis 59% VTE prophylaxis 40% Cohen AT et al. Lancet. 2008

14 aher et al J Thromb Thrombolysis 2011 AVAIL ME STUDY

15 VTE PROPHYLAXIS DRIVERS Taher et al J Thromb Thrombolysis 2011

16 Are hospitals delivering appropriate VTE prevention? The venous thromboembolism study to assess the rate of thromboprophylaxis (VTE start) N= pts at discharge from 16 hospitals Amin et al. J Thromb Thrombolysis 2010 More than 25% of hospitalized pts were at risk of VTE 37% received no prophylaxis 50% received inappropriate prophylaxis

17 Potential barriers to the appropriate use of VTE prophylaxis? Strategies to increase the appropriate use of VTE prophylaxis?

18 GAPS EXIST BETWEEN EVIDENCE-BASED GUIDELINES AND RECOMMENDATIONS AND PRACTICE IN THE HOSPITAL SETTING Marked differences between countries could be due to: Physician awareness (surgical > medical) Difficulty with assessing patients level of risk - Misperception about benefit-to-harm ratio of prophylaxis Scepticism about the clinical relevance of the surrogate endpoints used in trials Fear of bleeding Availability of guidelines (information, contextualization) Education factors (risk stratification, local strategy) Reimbursement and compliance National health-care resources.

19 Rates of major bleeding reported in VTE prophylaxis trials in hip and knee arthroplasty are markedly different Hip arthroplasty Dahl O.E. J Thromb Haemost. 2010

20 Rates of major bleeding reported in VTE prophylaxis trials in hip and knee arthroplasty are markedly different Knee arthroplasty Dahl O.E. J Thromb Haemost. 2010

21 Websites with More Information and Recent Updates on the Joint Commission Initiative Michota J Gen Intern Med 2010

22 COMPUTER PROGRAM We developed a computer program linked to the patient database that screened the system daily to identify high-risk patients. We included consecutive high-risk patients on medical and surgical services who were not receiving DVT prophylaxis. Kucher N et al. N Engl J Med 2005

23 DEFINITION: HIGH RISK VTE risk score 4 points: Cancer 3 (ICD codes) Prior VTE 3 (ICD codes) Hypercoagulability 3 (Leiden, ACLA) Major surgery 2 (> 60 minutes) Bed rest 1 ( bed rest order) Advanced age 1 (> 70 years) Obesity 1 (BMI > 29 kg/m 2 ) HRT/OC 1 (order entry) Kucher N et al. N Engl J Med 2005

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25 Increasing the use of prophylaxis and reducing the rate of VTE by using a computerized-alert VTE prophylaxis use, n/n (%) Intervention group 421/1255 (33.5) Control group 182/1251 (14.5) VTE at 90 days, % Kucher N et al. N Engl J Med 2005

26 PRIMARY END POINT %Freedom from DVT/ PE Intervention Control Number at risk Time (days) Intervention Control Kucher N et al. N Engl J Med 2005

27 Improving VTE prophylaxis prescription in medical patients by implementing electronic alert systems Rate of appropriate prophylaxis Cohort studies Before After Lecumberri et al, Kucher et al, Nendaz et al,

28 Electronic alerting systems Limitations Electronic alerting systems: are not always accepted by physicians may cause decreased physician compliance ( alert fatigue ) require sophisticated technology infrastructure and financial resources

29 GAPS EXIST BETWEEN EVIDENCE-BASED GUIDELINES AND RECOMMENDATIONS AND PRACTICE IN THE HOSPITAL SETTING Marked differences between countries could be due to: Physician awareness (surgical > medical) Difficulty with assessing patients level of risk - Misperception about benefit-to-harm ratio of prophylaxis Scepticism about the clinical relevance of the surrogate endpoints used in trials Fear of bleeding Availability of guidelines (information, contextualization) Education factors (risk stratification, local strategy) Reimbursement and compliance National health-care resources.

30 What strategy to change practice? Passive dissemination of guidelines or tools is ineffective as a single intervention Interventions for effective quality improvement Education (champion thrombosis referent...) Reminders Audits with feedback

31 Increasing the use of prophylaxis and reducing the rate of VTE by direct staff communication VTE prophylaxis use, n/n (%) Intervention group 569/1238 (46.0) Control group 259/1255 (20.6) VTE at 90 days, % Piazza G et al. Circulation 2009

32 Achieving dramatic improvement in VTE prophylaxis with a multidisciplinary approach A Quality Improvement project at San Diego Medical Center: Formation of a core multidisciplinary team including physicians, pharmacists and nurses Creation a simple VTE prevention protocol Integration of the protocol into the flow of patient care via standardized order sets Staff education Audits with feedback and concurrent identification of non-adherence Maynard G.A. et al. J Hosp Med 2010

33 Achieving dramatic improvement in VTE prophylaxis : an observationnal study VTE prophylaxis use, % Hospital-acquired VTE, % Preventable VTE, % Maynard G.A. et al. J Hosp Med 2010

34 Gibbs et al Thrombosis J 2011

35 Venous thromboembolism prophylaxis guideline implementation is improved by nurse directed feedback and audit

36 Performance measures for improving the prevention of venous thromboembolism: achievement in clinical practice Practical implementation of VTE protocols at Norton Healthcare Wilson & Merli J Thromb Thrombolysis 2011

37 Implementing guidelines: what are the challenges? To implement a local multicomponent strategy focused on physicians, pharmacists and nurses: require institutional support and financial resources To compare various interventions to assess their effect on appropriate type, dose, and duration of prophylaxis their effect over time their cost-effectiveness their impact on unnecessary prophylaxis for patients not at risk

38 VTE Risk Perception in Acutely Ill Medical Patients Risk Assessment may be difficult Heterogeneity of patients and diseases Some acute medical illnesses are considered in themselves as risk factors for DVT Additional patients-related risk factors Absence of validated tools for risk assessment

39 ultiple trauma (# 1 month) Bahl & Caprini et al, Ann Surg 2010

40 Low VTE-risk : score = 0-1 Moderate-risk : score = 2 Higher risk patients : score = 3-4 Highest risk patients : score 5 Incidence of 30 day symptomatic VTE? => increase in risk level in Low-risk patients 0%, Moderate-risk patients 0.70%, High-risk patients 1%, Highest risk patients 2%. Conclusion : importance of assessing individual patient risk for VTE. Bahl & Caprini et al, Ann Surg 2010

41 GROUP-SPECIFIC RISK ASSESSMENT STRATEGY LIMITATIONS - Inability to account for patient groups heterogeneity - Inability to assess all relevant exposing VTE-risk factors - May contribute to underutilization of VTE prophylaxis in hospitalized patients including those with cardiopulmonary disease, ischemic stroke, and acute infection

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43 Reasons for omitting VTE prophylaxis as stated by alerted physicians in a cohort of 455 at-risk patients Main reasons n (%) Risk of bleeding outweighs benefit of anticoagulant 137 (30.1) Scheduled procedure 56 (12.3) Patients ambulating 45 (9.9) Fiumara K et al. Thromb Haemost 2010

44 Risk factors of bleeding in acutely ill medical patients included in International Medical Prevention Registry on VTE Decousus H et al. Chest 2011

45 Bleeding risk score in acutely ill medical patients Decousus H et al. Chest 2011 Bleeding risk score Points Moderate renal failure, GFR vs 60 ml/min/m 2 1 Male vs female 1 Age, y vs < 40 y 1.5 Current cancer 2 Rheumatic disease 2 Central venous catheter 2 ICU/CCU 2.5 Severe renal failure, GFR < 30 vs 60 ml/min/m Hepatic failure (INR > 1.5) 2.5 Age 85 y vs < 40 y 3.5 Platelet count < 50 x 10 9 cells/l 4 Bleeding during the 3 months prior to admission 4 Active gastroduodenal ulcer 4.5

46 Implications of bleeding risk score for clinical decision making Decousus H et al. Chest 2011

47 Clinicians prefer simple educational tools for implementing practice change Clinicians from different health care professions preferred seminars and pocket cards when learning about and using new clinical recommendations. The high degree of compliance with the practice change resulting from the new recommendations and evidence of knowledge retention suggests that these tools were effective. Those involved in the implementation of new clinical guidelines should consider educational strategies that are simple and easily available. Jefferies & Shah Med Teach 2011

48 Implement an active QI Initiative Every Health Care facility evidence-based written policy (Joint Commission Initiative NQS) Multifaceted Protocols Institution s protocols Adopted or adapted from vidence based consensus guidelines Continuous/Iterative Process On going QI activity/monitoring Audit and Feed Back Periodic assessment of compliance with policies and measures Documentation Risk assessment performed Acting on evidence-based guidelines practice Provider Education All aspects of VTE prevention Staffs meetings RAM stratification Adequate regimens Decision Support Prophylaxis based on formal risk assessment and accepted guidelines Standard forms attached to Admission forms Electronic Support or Pocket cards Posters

49 CONCLUSION - Integrated, Multifaceted, Interdisciplinary approaches : to improve Adherence - Implementation of a working group : to identify barriers to change and the introduction of risk-reminder cards - Educational presentations and pocket guidelines, - Extend appropriate thromboprophylaxis : according to the patients risk - Hospital-based costs associated with VTE prophylaxis

50 BE ACCURATE AND RELEVANT