Practice, Policy, Public Reporting, and Patient Engagement: Learning from the Venous Thromboembolism Example

Transcription

1 Practice, Policy, Public Reporting, and Patient Engagement: Learning from the Venous Thromboembolism Example Elliott R. Haut, MD, PhD, FACS Vice Chair of Quality and Safety, Associate Professor of Surgery & ACCM & Emergency Medicine & Health Policy / 10/10/17 Center for Health Services and Outcomes Research (CHSOR) Seminar

2 What is Venous Thromboembolism (VTE)? Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE)

3 What Causes Venous Thromboembolism (VTE)? Rudolf Virchow ( ) Hypercoaguability

4 Why focus on VTE? VTE is common 350,000 to 600,000 Americans suffer DVT and/or PE each year eepvein/calltoaction/call-to-action-ondvt-2008.pdf

5 Why focus on VTE? VTE is Deadly >100,000 deaths per year More deaths than combined from Breast Cancer Motor Vehicle Collisions AIDS eepvein/calltoaction/call-to-action-ondvt-2008.pdf

6 Johns Hopkins DVT Symposium 2009

7 Risk Factors for VTE Age Cancer Chemotherapy Previous DVT/PE Trauma Major surgery Hospitalization Thrombophilia Pregnancy Hormone therapy Family history of VTE Recent Stroke Cardiac disease Respiratory disease Infection Immobility > 3 days Varicose veins Obesity

8 Why focus on VTE? Increases cost Increased per patient, per event cost estimates vary $11,930 (Spyropoulos) $15,941 (Lefebvre) Annual direct costs > $250 million annually for venous stasis/ulcer alone $7-10 billion total yearly cost the US Spyropoulos 2002, Lefebvre 2012, Ashrani 2009, Heit 2001, Grosse 2016

9 Why focus on VTE? VTE is (mostly) preventable

10 VTE Should NOT be Considered a Never Event Not ALL events are preventable VTE occurs even in patients receiving best practice prophylaxis 8 RCTs of VTE Prophylaxis in Joint Replacement Surgery (4 TKA, 4 THR) 0.3%-2.5% Symptomatic VTE Streiff & Haut, JAMA 2009

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12 Evidence Based VTE Prophylaxis Guidelines American College of Chest Physicians (ACCP) Eastern Association for the Surgery of Trauma (EAST) American Academy of Orthopedic Surgeons (AAOS) American College of Obstetricians and Gynecologists (ACOG) American College of Physicians (ACP)

13 DVT Prophylaxis is Vastly Underutilized!

14 68,183 patients 358 hospitals in 32 countries Prophylaxis 58.5 % compliance - surgical patients 39.5 % compliance - medical patients Cohen, Lancet 2008

15 DVT: Advancing Awareness to Protect Patient Lives American Public Health Association (APHA) White Paper 2003

16 Agency for Healthcare Research and Quality (AHRQ)

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18 Strategies to increase appropriate prophylaxis for VTE included on list of top 10 Strongly Encouraged Patient Safety Practices evidence-based-reports/patientsftyupdate/ptsafetyiichap28.pdf

19 Surveillance Bias and Public Reporting of

20 How did I get interested in VTE? Adult Trauma Performance Improvement Paraphrased letter we received Dear Johns Hopkins Adult Trauma You have the highest DVT rate of all Trauma Centers in Maryland Why? Sincerely, Maryland Institute for Emergency Medical Services Systems (MIEMSS)

21 A New Research Idea is Born Johns Hopkins screens aggressively What do other trauma centers do? Does this impact reported DVT rates?

22 Conflict Regarding Duplex Screening for asymptomatic DVT Conflicting data on efficacy and costeffectiveness of duplex screening of asymptomatic trauma patients Pro: Identify DVT early allowing treatment before fatal PE Con: Large expense, not cost effective, harm from anticoagulation

23 Should we Screen High-Risk Trauma Patients for DVT? Conflicting Guidelines vs. Rogers, J Trauma 2002 Gould, CHEST 2012

24 Eastern Association for the Surgery of Trauma (EAST) Guideline Serial duplex ultrasound imaging of high-risk asymptomatic trauma patients to screen for DVT may be cost-effective and decrease the incidence of PE. Rogers, J Trauma 2002

25 American College of Chest Physicians (ACCP) Guidelines For major trauma patients, we suggest that periodic surveillance with venous compression ultrasonography should not be performed (Grade 2C). Gould, CHEST 2012

26 Single Center (JHH)- Duplex & DVT rates Before v. After Screening Guideline Duplex Rate per 1000 Trauma Admissions Haut, J Trauma 2007 Before ( ) After ( ) Before Vs. After Periods Duplex DVT PE * ** p< p= DVT/PE Rate per 1000 Trauma Admissions

27 Multi-Center (NTDB)- Hospital Level Duplex & DVT rates Trauma centers with higher rates of duplex ultrasound report higher DVT rates to the National Trauma Data Bank Pierce, J Trauma 2008

28 The More We Look, The More We Find 7-fold higher DVT rate at hospitals in top quartile of duplex ultrasounds Pierce, J Trauma Pierce, 2008 Haut, et al. J Trauma 2008

29 Hospital Screening Status is an Independent Risk Factor for DVT Reporting Haut, J Trauma 2009

30 Variability in Trauma Surgeons Opinions of DVT Screening AAST/EAST member survey 317 individual trauma surgeons Haut, J Trauma 2011

31 A Classic Example of Surveillance Bias Providers who screen more aggressively by performing more duplex ultrasounds may identify more cases of DVT and appear to provide worse quality of care than those providers who order fewer tests Haut & Pronovost, JAMA 2011

32 Implications Variability in DVT Screening Variability in DVT Rates Reported Biased DVT Rates Haut & Pronovost, JAMA 2011

33 We ll just use the test results anyway because it s the only data we have

34 Defining Preventable Harm The VTE Example We suggested that performance measures could link a process of care with adverse outcomes when defining incidences of preventable harm Preventable Harm = VTE + No Prophylaxis Haut & Pronovost, JAMA 2011

35 We Talked Centers for Medicare & Medicaid Services listened

36 We Talked Financial incentives for the meaningful use of certified EHR technology to improve patient care

37 Meaningful Use Quality Reporting Criteria Related to VTE Meaningful Use of Electronic Health Record (EHR) Technology VTE1 Prophylaxis within 24 hours of arrival VTE2 ICU VTE Prophylaxis VTE3 Anticoagulation Overlap Therapy VTE4 Platelet Monitoring on UFH VTE5 VTE Discharge Instructions VTE6 Incidence of Potentially Preventable VTE

38 Meaningful Use Definition of Potentially Preventable VTE VTE-6 Incidence of Potentially Preventable VTE This measure assesses the number of patients diagnosed with confirmed VTE during hospitalization (not present or suspected at admission) who did not receive VTE prophylaxis between hospital admission and the day before the VTE diagnostic testing order date.

39 Surveillance Bias in VTE Reporting in Surgery Bilimoria, JAMA 2013

40 Surveillance Bias in VTE Reporting in Surgery 2,786 hospitals 954,526 Medicare patients >=65 years 11 major operations AAA, CABG, craniotomy, colectomy, cystectomy, esophagectomy, gastric bypass, lung resection, pancreatic resection, proctectomy, total knee arthroplasty Bilimoria, JAMA 2013

41 Surveillance Bias in VTE Reporting in Surgery Bilimoria, JAMA 2013

42 Public Reporting for VTE is a Moving Target What is the optimal approach to public reporting of VTE?? Bilimoria KY. JAMA 2015 x2 commentaries

43 No Association Between Hospital-Reported Perioperative VTE Prophylaxis and Outcome Rates in Publicly Reported Data 3040 hospitals Median prophylaxis performance = 94.5% The median riskadjusted VTE rate was 4.13 per 1000 surgical discharges JohnBull, JAMA-Surg 2014 Process

44 No Association Between Hospital-Reported Perioperative VTE Prophylaxis and Outcome Rates in Publicly Reported Data Hospitals reporting 100% perfect VTE prophylaxis performance (n = 141) vs. Hospitals in the bottom quintile of prophylaxis performance (n = 618) Nearly identical median VTE outcome rates (4.18 vs. 4.17; P =.98) JohnBull, JAMA-Surg 2014

45 Public Reporting for VTE is a Moving Target In 2017, VTE-1 and VTE-2 are electronic clinical quality measures (ecqm) available for selection by hospitals to meet hospital accreditation program requirements for ecqms. VTE-6 is the lone remaining measure required for chart abstracted measures.

46 The American College of Surgeons Inspiring Quality Tour: Lessons Learned

47 The American College of Surgeons Inspiring Quality Tour: Lessons Learned ty/lessons-learned.pdf

48 Can a Systems Approach Improve VTE Prevention and

49 What approaches can improve VTE prophylaxis? Passive dissemination of guidelines is unlikely to improve VTE prophylaxis practice. A number of active strategies used together, which incorporate some method for reminding clinicians to assess patients for DVT risk and assisting the selection of appropriate prophylaxis, are likely to result in the achievement of optimal outcomes. Tooher, A Systematic Review of Strategies to Improve Prophylaxis for Venous Thromboembolism in Hospitals. Ann Surg 2005.

50 Improving VTE Prophylaxis at The Johns Hopkins Hospital Streiff, BMJ 2012

51 Improving VTE Prophylaxis at The Johns Hopkins Hospital Paper Order Sets Streiff, BMJ 2012

52 Improving VTE Prophylaxis at The Johns Hopkins Hospital Mandatory VTE risk stratification tool into the computerized provider order entry (CPOE) system Advanced computerized clinical decision support (CDS) Streiff, BMJ 2012

53 Different Order Sets have Different VTE Modules. Use is Mandatory in POE workflow. Parent order set

54 General Surgery VTE Prophylaxis Any Major VTE risk factors? Previous VTE Cancer Thrombophilia Prolonged procedure (> 2 hrs.) NYHA Class III/IV Heart Failure Respiratory failure requiring mechanical ventilation Acute Stroke with paresis (< 3 mos.) Pregnancy/post-partum (up to 6 weeks) Any Minor VTE risk factors? Acute Infection/Sepsis Bed rest Central venous catheter Estrogens/Selective estrogen receptor modulators (e.g., Tamoxifen) Inflammatory bowel disease No Yes No Any CONTRAINDICATIONS to pharmacologic prophylaxis? High risk of bleeding Active bleeding Systemic anticoagulation INR 1.5 or aptt ratio 1.3 Platelet count < 50,000 TEDs/SCDs Use mechanical prophylaxis until contraindication no longer present. Review patient status daily No Yes Yes Age 40? Any CONTRAINDICATIONS to pharmacologic prophylaxis? High risk of bleeding Active bleeding Systemic anticoagulation INR 1.5 or aptt ratio 1.3 Platelet count < 50,000 TEDs/SCDs Use mechanical prophylaxis until contraindication no longer present. Review patient status daily No Yes Moderate Risk VTE Orders Heparin 5000 units sc q12h (Give first dose 2 hrs. pre-op and then beginning hours post-op) With option to ADD TEDs/SCDs Yes Any CONTRAINDICATIONS to pharmacologic prophylaxis? High risk of bleeding Active bleeding Systemic anticoagulation INR 1.5 or aptt ratio 1.3 Platelet count < 50,000 Yes No No Creatinine clearance < 30 ml/min or unstable renal function (potential for CrCl to Decline below 30ml/min during therapy) Yes Age > 60? No High risk VTE orders Heparin 5000 units sc q8h (Give first dose 2 hrs. pre-op and then beginning hours post-op) With Option to add TEDS/SCD No Yes Very high risk VTE orders Heparin 5000 units sc q8h (Give first dose 2 hrs. pre-op and then beginning hours post-op) Plus TEDS/SCDs Very high risk VTE orders Heparin 5000 units sc q8h (Give first dose 2 hrs. pre-op and then beginning hours post-op) Plus TEDS/SCD Enoxaparin 40mg sc qday (First dose 2 hours pre-op and then hours post-op) (Remove epidural catheter at nadir (20-22 hrs.) of anticoagulant effect and wait at least 2 hours after catheter removal to redose) Plus TEDS/SCDs

55 Mandatory choice from each section for risk factors and contraindications

56 Benefits of the Computerized VTE Prevention System Puts VTE prevention into the work flow Enables rapid, accurate risk stratification and risk-appropriate VTE prophylaxis Applies evidence directly to clinical care Allows for performance monitoring/reporting Streiff, BMJ 2012

57 Keys to Success Multidisciplinary team Physicians, Nurses, Pharmacists, Informatics Leadership buy-in Collaborate with service teams Educate front-line providers Measure baseline performance Conduct ongoing performance evaluations Streiff, BMJ 2012

58 Does Improving Prophylaxis Change Outcomes? YES 2 examples Johns Hopkins Trauma Surgery Johns Hopkins Internal Medicine

59 Does Improving Prophylaxis Change Outcomes? The JHH Trauma Example Haut, Arch Surg 2012

60 Does Improving Prophylaxis Change Outcomes? The JHH Trauma Example Single Center (Johns Hopkins Hospital) Pre/Post Intervention Study 1-year PRE vs. 3-years POST Retrospective data collection IRB approved Haut, Arch Surg 2012

61 Does Improving Prophylaxis Change Outcomes? The JHH Trauma Example 62.2% 84.4% Significant increase in VTE prophylaxis Significant drop in preventable harm from VTE 1.0% vs. 0.17% (p=0.04) Haut, Arch Surg 2012

62 Does Improving Prophylaxis Change Outcomes? The JHH Medicine Example Zeidan, Am J Hematology 2013

63 Does Improving Prophylaxis Change Outcomes? The JHH Medicine Example Retrospective Review (PRE v. POST) Patients : 1,000 PRE v. 942 POST Patients prescribed Optimal Prophylaxis 65.6% v. 90.1% (p<0.0001) Patients prescribed NO prophylaxis 23.6% v. 4.4% (p<0.0001) Zeidan, Am J Hematology 2013

64 Does Improving Prophylaxis Change Outcomes? The JHH Medicine Example Zeidan, Am J Hematology 2013

65 ZERO Preventable VTE A Realistic Goal Zeidan, Am J Hematology 2013

66 VTE Prophylaxis- Computerized Decision Support 66

67 2015

68 Improving VTE Prophylaxis Administration with Targeted Performance

69 The Role of Health Informatics Harness the power of analytics Bringing performance data to individual providers and units Can competition drive improvements?

70 Trauma Attending & Resident Prophylaxis 7 residents at 0% 42 residents at 100% Lau, JAMA-Surg 2015

71 96.3% November 93.3% October 87.7% Sept

72 Surgery Resident Feedback Improves VTE Prophylaxis Lau, Ann Surg 2016

73 Quality Improvement can Lead to Fundable Research 5-year R01 grant AHRQ Individualized Performance Feedback on Venous Thromboembolism Prevention Practice

74 Missed Doses of VTE

75 A Big Assumption As physicians, we assume that medication orders we place are consistently delivered But is that truly the case? Does prescription = administration?

76 Steps to Optimal Pharmacologic VTE Prophylaxis Provider Prescription Nurse Administration Patient Acceptance

77 Do Missed VTE Prophylaxis Doses Matter? Methods Retrospective analysis 202 trauma and general surgery patients ordered enoxaparin Results Overall incidence of DVT = 15.8% 58.9% of patients missed >=1 dose DVT compared missed vs. no missed doses 23.5% vs. 4.8% (p < 0.01) Louis, JAMA Surgery 2014

78 Do Missed VTE Prophylaxis Doses Matter? 92 VTE patients 39% missed >=1 dose of prophylaxis Haut, JAMA Surgery 2015

79 Missed Doses of VTE Prophylaxis Medications at Johns Hopkins December 1, 2007 to June 30, 2008 >100,000 doses 12% of doses not administered Patient refusal most frequent (~60%) documented reason Shermock, PlosOne 2013

80 Missed Doses are Clustered Within Floors Shermock, PlosOne 2013

81 What s the Real Story Behind Missed Doses? Hidden Barriers to Delivery of Pharmacologic Venous Thromboembolism Prophylaxis Mixed methods study (quantitative/qualitative) Quantitative Nursing survey Qualitative observations of nurse/patient interaction Focus groups with nurses Elder, Journal of Patient Safety epub 2014

82 What s the Real Story Behind Missed Doses? - Quantitative I have the clinical knowledge and experience to determine if it is necessary to administer DVT/PE prophylaxis injections to patients. AGREE 87%/79% medicine/surgery Nurses use their clinical decision-making skills to determine when to omit unnecessary doses of prescribed DVT/PE prophylaxis injections for each individual patient AGREE 80%/50% medicine/surgery Elder, Journal of Patient Safety epub 2014

83 Is VTE Prophylaxis Optional? I push harder for my patients to accept heparin [prophylaxis] if they have, like, sickle cell disease, as opposed to say pneumonia or something where they are just here for [IV] antibiotics. Sometimes, if it is the middle of the night and [LDUH] is the only medication I have to give a patient, I won t wake them up just to give VTE prophylaxis. Elder, Journal of Patient Safety epub 2014

84 The Ambulation Myth We make the clinical decision all the time as to whether a patient needs VTE prophylaxis every day, based on how much the patient is ambulating. Hey Ms. R, it s time for your heparin dose, but as long as I see you up, high-fiving me in the hallways, we can hold off for now. Elder, Journal of Patient Safety epub 2014

85 Our PCORI Project Preventing Venous Thromboembolism: Empowering Patients and Enabling Patient- Centered Care via Health Information Technology

86 Our PCORI Objectives 1) Enable patients to make informed decisions about their preventive care by improving the quality of patient-nurse communication about the harms of VTE and benefits of VTE prophylaxis 2) Empower patients to take an active role in their VTE preventive care 3) Identify and facilitate active engagement of patients who are not administered doses of VTE prophylaxis using a real-time escalating alert

87 Our PCORI Collaborators / Key Stakeholders Patient and Family Advisory Council

88 PCORI Website Research in Action

89

90 Does Nurse Education Improve VTE Prophylaxis administration? Results from a Cluster Randomized

91 Lau, PLoS ONE 2017

92 Methods Partnered with Central Nursing Education to build two educational programs in the MyLearning platform Static : Linear static education to cover point-by-point general concepts Lau, PLoS ONE 2017

93 Static PowerPoint Slides With Voice Over Lau, PLoS ONE 2017

94 Methods Partnered with Central Nursing Education to build two educational programs in the MyLearning platform Static: Linear static education to cover point-by-point general concepts Dynamic: Learner-centric interactive scenario-based dynamic education Lau, PLoS ONE 2017

95 Learner centric scenario based

96 Methods Cluster Randomized Trial 10 surgery floors 11 medicine floors All nurses on a specific floor were assigned either Static or Dynamic Education Administered satisfaction survey to compare perceptions of education delivery after completions Primary Outcome - Dose Administration Lau, PLoS ONE 2017

97 Nurse Education Trial Primary Outcome- Dose Administration Overall, non-administration improved significantly following education 12.4% vs. 11.1% (p=0.002) Conditional OR 0.87, 95% CI ( ) Lau, PLoS ONE 2017

98 Nurse Education Trial 100% 90% 80% 89.0% 94.0%* 82.0% 88.8%* 78.1%* 80.9%* 78.8% 90.3%* 70% 67.8% 60% 58.8% 50% 40% 30% Static Dynamic 20% 10% 0% This course directly applies to my practice This course will help I enjoyed this me to communicate learning intervention better about the importance of VTE to my patients I found this course engaging This course provided the right level of information and resources Lau, PLoS ONE 2017

99 Kirkpatrick s Learning Evaluation Theory VTE events Missed doses Module completion They like it

100 What VTE Education Do Patients Really Want? Results from a Delphi

101 Modified Delphi Method Iterative process involving surveys, feedback and revisions Engaged patients and family members Recruited via and/or social media (websites, Facebook, Twitter) through respective organizations > 400 respondents Popoola, PLoS ONE 2016

102 What Do Patients Want? Popoola, PLoS ONE 2016

103 What Do Patients Want?

104 Patient VTE Education

105 What Do Patients Want? Paper Form (2-pages) bloodclots They spoke, we listened

106 Easy to Find in Hopkins Policies Online (HPO) Top of the list when searching VTE DVT PE Blood Clots

107 Multiple Languages & Large Font

108 What Do Patients Want? Video Patients wanted - 10 minute video - Physicians, nurses and patients talking Screened for JHH PFAC - Changes based on group feedback They spoke, we listened

109 Video

110 Easy to Find in Public Domain Our VTE Prevention Website oodclots

111 What Do Patients Want? Patient Education Intervention Project Real time alert of dose non-administration from POE system via pager/ Patient education bundle Targeted education Direct one-on-one discussion with nurse Supported by paper handout and/or video Prospective Cohort Study April 2015 thru December 2015 (8 months)

112 Acknowledgements

113 Changing Practice is a Team

114 CDC Healthcare-Associated VTE Prevention Challenge Champions

115 Research Collaborators Johns Hopkins VTE Collaborative Streiff, Hobson, Kraus, Lau, Shermock, Shaffer, Shihab, Carolan, Zeidan, Popoola, Aboyage, Owodunni, Florecki, Welsh Armstrong Institute Pronovost, Berenholtz, Demski, Holzmueller, Michtalik

116 Collaborators from Surgery Division of Acute Care Surgery Efron, Haider, Stevens, Chi, Rushing, Velopulos, Cornwell, Schneider, Jones, Sakran, Mankayan Other Surgical Divisions/Departments Colorectal, Surg Onc, Vascular, Pediatrics, Transplant, Urology, Ortho, Neurosurgery Other Surgical Faculty Gearhart, Wick, Efron, Safar, Lidor, Pawlik, Weiss, Wolfgang, Freischlag, Black, Abdullah, Stewart, Colombani, Segev

117 Streiff, J Hosp Med 2016

118 VTE and Trainee Mentoring 10 MPH student capstone projects 4 full-time post-doctoral research fellows 6 clinical trauma surgery fellows 3 clinical hematology fellows 1 med student full-time research year 1 surgical resident full-time research year 1 human factors engineer post-doctoral 5 pharmacy residents

119 Trainees Surgery Residents Weiss, Hayanga, VanArendonk, Howley, Kodadek, Arnaoutakis, Poruk, Beaulieu, Ellison Trauma/Acute Care Surgery Fellows Garcia, Velopulos, Koenig, Kieninger, Leeper, Feinman, Yanagawa, Dultz, Kent Medical Students Dat, Boelig, JohnBull, Farrow, Ray-Mazumder Pharmacy Residents Elder, Newman, Wong, Piechowski

120 Bloomberg JHSPH Trainees / Collaborators JHSPH students Pierce, Kardooni, Kraenzlin, Rosenberg, Aboagye, Shrestha, Lucas, Nastasi, etc. JHSPH faculty MacKenzie, Yenokyan, Sugar, Diener-West Evidence Based Practice Center Segal, Singh, Brotman, Kebede

121 @elliotthaut (Twitter) ( ) Hopkins VTE Website (with paper forms) Patient Education Video PCORI Research in Action