Venous Thromboembolism (VTE) Prevention in the Hospital

1
Venous Thromboembolism (VTE) Prevention in the
Hospital

• Greg Maynard MD, MSc
• Clinical Professor of Medicine and Chief,
• Division of Hospital Medicine
• University of California, San Diego

2
VTE A Major Source of Mortality and Morbidity

• 350,000 to 650,000 with VTE per year
• 100,000 to gt 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)

Surgeon Generals Call to Action to Prevent DVT
and PE 2008 DHHS
3
Risk Factors for VTE

• Endothelial Damage
• Surgery
• Prior VTE
• Central lines
• Trauma

• Stasis
• Age gt 40
• Immobility
• CHF
• Stroke
• Paralysis
• Spinal Cord injury
• Hyperviscosity
• Polycythemia
• Severe COPD
• Anesthesia
• Obesity
• Varicose Veins

• Hypercoagulability
• Cancer
• High estrogen states
• Inflammatory Bowel
• Nephrotic Syndrome
• Sepsis
• Smoking
• Pregnancy
• Thrombophilia

Anderson FA Jr. Wheeler HB. Clin Chest Med
199516235.
4
Risk Factors for VTE

• Endothelial Damage
• Surgery
• Prior VTE
• Central lines
• Trauma

• Stasis
• Age gt 40
• Immobility
• CHF
• Stroke
• Paralysis
• Spinal Cord injury
• Hyperviscosity
• Polycythemia
• Severe COPD
• Anesthesia
• Obesity
• Varicose Veins

• Hypercoagulability
• Cancer
• High estrogen states
• Inflammatory Bowel
• Nephrotic Syndrome
• Sepsis
• Smoking
• Pregnancy
• Thrombophilia

Most hospitalized patients have at least one risk
factor for VTE
Anderson FA Jr. Wheeler HB. Clin Chest Med
199516235. Bick RL Kaplan H. Med Clin North
Am 199882409.
5
Failure to Do Simple Things Well

• Wash Hands
• 60 Reliable
• Patients Understand Meds / Problems
• 40 Reliable
• Central Lines Placed w/ Proper Technique
• 60 Reliable
• Basal Insulin for Inpt Uncontrolled DM
• 40 Reliable
• VTE Prophylaxis
• 50 Reliable

6
Registry DataHighlight the Underuse of
Thromboprophylaxis
Goldhaber SZ, Tapson VF. Am J Cardiol
200493259-62. Monreal M, et al. J Thromb
Haemost 200421892-8. Tapson V, et al. Blood
200410411. Abstract 1762.
7
Endorse Results

• Out of 70,000 patients in 358 hospitals,
  appropriate prophylaxis was administered in
• 58.5 of surgical patients
• 39.5 of medical patients

Cohen, Tapson, Bergmann, et al. Venous
thromboembolism risk and prophylaxis in the acute
hospital care setting (ENDORSE study) a
multinational cross-sectional study. Lancet 2008
371 38794.
8
The Stick is coming.

• NQF endorses measures already
• Public reporting and TJC measures coming soon
• Prophylaxis in place within 24 hours of admit or
  risk assessment / contraindication justifying
  its absence
• Same for critical care unit admit / transfers
• Track preventable VTE
• CMS DVT or PE with knee or hip replacement
  reimbursed as though complication had not
  occurred.

9
Why dont we do better?

• Lack of awareness or buy in of guidelines
• Underestimation of clot risk, overestimation of
  bleeding risk
• Lack of validated risk assessment model
• Translating complicated guidelines into everyday
  practice is difficult

10
E-Alerts Can Increase Prophylaxis

• 2506 hospitalized patients
• VTE risk score 4
• Randomized to intervention or control

Intervention Treatment Received Treatment Received
Intervention Mechanical, Pharmacologic,
E-Alert 10 23.6
Control 1.5 13
P-value 0.001 0.001
Kucher N, et al. N Engl J Med. 2005352969-977.
11
E-Alerts Decrease VTE
100
98
Intervention
96
Freedom from DVT/ PE
94
41 P 0.001
Control
92
90
0
30
60
90
Time (days)
Number at risk
Intervention
1255
977
900
853
Control
1251
976
893
839
Kucher N, et al. N Engl J Med. 2005352969-977.
12
Effectiveness can wane over time
P lt 0.05

Lecumberri R, et al. Thromb Haemost.
2008100699-704.
13
Human Alerts Increase Prophylaxis

• 2493 hospitalized patients
• VTE risk score 4
• Randomized to intervention or control

Intervention Treatment Received Treatment Received
Intervention Mechanical, Pharmacologic,
Hu-Alert 21 28
Control 8 14
95 CI 10.6-16.0 10.5-16.8
Piazza G, et al. Circulation. 20091192196-2201.
14
Human Alerts Decrease VTE
Freedom from DVT/ PE
P 0.31
Time After Initial Enrollment (days)
Piazza G, et al. Circulation. 20091192196-2201.
15
Bottom Line - Alerts

• A Useful Strategy
• E Alerts and Human Alerts can work
• Not a panacea
• Alert fatigue can be a problem
• Need a multifaceted approach

16
Medical Admission Order Sets Can Improve DVT
Prophylaxis

• Baseline- Only 11 of inpatients on any VTE
  prophylaxis
• Intervention
• A simple prompt for UFH or Mechanical Prophylaxis
  placed into voluntary admission order sets.
• Post intervention
• 44 on any prophylaxis
• 26 pharmacologic prophylaxis

O'Connor C, Adhikari N, DeCaire K, Friedrich Jan.
Medical Admission Order Sets to Improve Deep Vein
Thrombosis Prophylaxis Rates and Other Outcomes.
J Hosp Med 2009
17
but not enough by themselves, and design of the
order set matters

• Best practice prophylaxis not defined
• Prompt ? Protocol
• No protocol No guidance at the point of care
• in order set, heparin, mechanical devices, and no
  prophylaxis presented as equal choices
• Implementation / Reliability
• At 15 months, only about half of inpatient
  admissions utilized standardized order set.
• Other methods needed to enhance performance!

18
Education alone is not sufficient

• .but it is essential to optimize other
  strategies that are effective
• Standardized order sets
• Computerized decision support
• E-alerts
• Human alerts
• Raising situational awareness
• Audit and feedback

19
UCSD experience
N 2,944 mean 82 audits / month
Real time ID intervention
Order Set Implementation Adjustment
Consensus building
Baseline
19
20
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

21
21
22
Hospital Acquired VTE by Year
2008
2005
2006
2007
Patients at Risk
9,720
9,923
11,207
80
Cases w/ any VTE
131
138
92
Risk for HA VTE
1 in 76
1 in 73
1 in 122
Unadjusted RR
1.0
1.03
0.61
(95 CI)
(0.81-1.31)
(0.47- 0.79)
12
Cases with PE
21
22
15
Risk for PE
1 in 463
1 in 451
1 in 747
Unadjusted RR
1.0
1.02
0.62
Dr. Maynard, the CIs are different here and in
the proof. Which are correct?
(95 CI)
(0.54-1.86)
(0.32-1.20)
68
Cases with DVT (and no PE)
110
116
77
Risk for DVT
1 in 88
1 in 85
1 in 146
Unadjusted RR
1.0
1.03
0.61
(95 CI)
(0.80-1.33)
(0.45-0.81)
6
Cases w/ Preventable VTE
44
21
7
Risk for Preventable VTE
1 in 221
1 in 473
1 in 1,601
Unadjusted RR
1.0
0.47
0.14
(95 CI)
(0.28-0.79)
(0.06-0.31)
p lt 0.01 p lt 0.001
Maynard GA, et al. J Hosp Med. 2009
23
VTE Prevention Guides Modeling a Multifaceted
Approach
http//www.hospitalmedicine.org/ResourceRoomRedesi
gn/RR_VTE/VTE_Home.cfm
http//ahrq.hhs.gov/qual/vtguide/
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VTE QI Resource Room www.hospitalmedicine.org
25
Collaborative Efforts

• SHM VTE Prevention Collaborative I - 25 sites
• SHM / VA Pilot Group - 6 sites
• SHM / Cerner Pilot Group 6 sites
• AHRQ / QIO (NY, IL, IA) - 60 sites
• IHI Expedition for VTE Prevention 60 sites
• Effective across wide variety of settings
• Paper and Computerized / Electronic
• Small and large institutions
• Academic and community

26
Basic Ingredients for Success

• Institutional support, will to standardize the
  process
• Designated multidisciplinary team with physician
  leadership
• Specific goals and metrics
• VTE Protocol guidance built into order sets
• Education / consensus
• Alerts / feedback to clinicians in real time

27
Enlist Key Groups / Leaders

• Section Heads
• Hospitalists
• (most groups receive some direct support from the
  hospital)
• Other high volume providers
• Find some more physician champions

28
Educational Detailing - PR

• Quote ACCP 8 Guidelines
• Dont use aspirin alone for DVT prophylaxis
• Mechanical prophylaxis is not first line
  prophylaxis in the absence of contraindications
  to pharmacologic prophylaxis

Geerts WH et al. Chest. 2008133(6
Suppl)381S-453S
29
Use the powerful anecdote and data

• Look for VTE case that could have been prevented
• Personalize the story
• Enlist a patient / family to help you tell the
  story
• Get data on VTE in your medical center
• (it occurs more often than the doctors think it
  does)

30
Q and A

• 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.

31
Hierarchy of Reliability
Predicted Prophylaxis rate
Level

• No protocol (State of Nature)
• Decision support exists but not linked to order
  writing, or prompts within orders but no decision
  support
• Protocol well-integrated
• (into orders at point-of-care)
• Protocol enhanced
• (by other QI / high reliability strategies)
• Oversights identified and addressed in real time

1
40
50
2
3
65-85
4
90
95
5
Protocol standardized decision support,
nested within an order set, i.e. what/when
32
The Essential First Intervention
VTE Protocol

• 1) a standardized VTE risk assessment, linked to
• 2) a menu of appropriate prophylaxis options,
  plus
• 3) a list of contraindications to pharmacologic
  VTE prophylaxis
• Challenges
• Make it easy to use (automatic)
• Make sure it captures almost all patients
• Trade-off between guidance and ease of use /
  efficiency

32
33
Map to Reach Level 3Implementing an Effective
VTE Prevention Protocol

• Examine existing admit, transfer, periop order
  sets with reference to VTE prophylaxis.
• Design a protocol-driven DVT prophylaxis order
  set (w/ integrated risk assessment model RAM)
• Vette / Pilot PDSA
• Educate / consensus building
• Place new standardized DVT order set module
  into all pertinent admit, transfer, periop order
  sets.
• Monitor, tweak - PDSA

34
Is your order set in a competition?
34
35
Too Little GuidancePrompt ? 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

36
No Math!Critiques of VTE Risk Assessment Model
using point scoring techniques

• Point based systems -
• low inter-observer agreement in real use
• users stop adding up points
• too large to be modular (collects dust)
• point scoring is arbitrary
• never validated

37
Low Medium High
Example from UCSD Keep it Simple A 3 bucket
model
Ambulatory with no other risk factors. Same day or minor surgery CHF COPD / Pneumonia Most Medical Patients Most Gen Surg Patients Everybody Else Elective LE arthroplasty Hip/pelvic fx Acute SCI w/ paresis Multiple major trauma Abd / pelvic CA surgery
Early ambulation UFH 5000 units q 8 h (5000 units q 12 h if gt 75 or weight lt50 kg) LMWH Enox 40 mg q day Other LMWH CONSIDER add IPC Enox 30 mg q 12 h or Enox 40 q day or Other LMWH or Fondaparinux 2.5 mg q day or Warfarin INR 2-3 AND MUST HAVE IPC
37
IPC needed if contraindication to AC exists
38
Paper Version 3 Bucket RAM DVT Prophylaxis
Order Set Module
See separate paper version demonstrating 3
bucket model
39
Integrate order set as a module

• Make order set even more portable
• Incorporate module into current heavily used
  order sets
• Or
• Strip out VTE orders from popular order sets and
  refer to the standardized orders
• Clip orders to all admit / transfer orders

40
Most Common Mistakes in VTE Prevention Orders

• Point based risk assessment model
• Improper Balance of guidance / ease of use
• Too little guidance - prompt ? protocol
• Too much guidance- collects dust, too long
• Failure to revise old order sets
• Too many categories of risk
• Allowing non-pharm prophy too much
• Failure to pilot, revise, monitor
• Linkage between risk level and prophy choices are
  separated in time or space

41
Hierarchy of Reliability
Predicted Prophylaxis rate
Level

• No protocol (State of Nature)
• Decision support exists but not linked to order
  writing, or prompts within orders but no decision
  support
• Protocol well-integrated
• (into orders at point-of-care)
• Protocol enhanced
• (by other QI / high reliability strategies)
• Oversights identified and addressed in real time

1
40
50
2
3
65-85
4
90
95
5
Protocol standardized decision support,
nested within an order set, i.e. what/when
42
Daily measurement drives concurrent
intervention (i.e. same as Level 5 in
Hierarchy of Reliability)
Measure-vention

• Identify patients not receiving VTE prophylaxis
  in real time
• Suitable for ongoing assessment, reporting to
  governing body
• Archive-able data (!)
• Can be used for real time intervention
• Actionable data (!)

42
43
Map to Reach Level 595 prophylaxis

• Use MAR or Automated Reports to Classify all
  patients on the Unit as being in one of three
  zones
• GREEN ZONE - on anticoagulation
• YELLOW ZONE - on mechanical prophylaxis only
• RED ZONE on no prophylaxis
• Act to move patients out of the RED!

44
Situational Awareness and Measure-vention
Getting to Level 5

• Identify patients on no anticoagulation
• Empower nurses to place SCDs in patients on no
  prophylaxis as standing order (if no
  contraindications)
• Contact MD if no anticoagulant in place and no
  obvious contraindication
• Templated note, text page, etc
• Need Administration to back up these
  interventions and make it clear that docs can not
  shoot the messenger

45
Effect of Situational Awareness on Prevalence of
VTE Prophylaxis by Nursing Unit Hospital A,
1st Nursing Unit Baseline
Post-Intervention UCL 93 104 Mean
73 99 (p lt 0.01) LCL 53
93 Hospital A, 2nd Nursing Unit
Baseline Post-Intervention UCL
90 102 Mean 68 87 (p lt 0.01) LCL
46 72 Hospital B, 1st
Nursing Unit Baseline
Post-Intervention UCL 89 108 Mean
71 98 (p lt 0.01) LCL 53
88
Intervention
Hospital Days
Intervention
Intervention
_______________________ UCL Upper Control Limit
LCL Lower Control Limit
45
46
Most Common Mistakes in Measurement of DVT
Prophylaxis

• Not doing it at all
• Not doing it concurrently
• Failure to make measured poor performance
  actionable

47
Key Points - Recommendations

• QI building blocks should be used
• Multifaceted approach is needed
• VTE protocols embedded in order sets
• Simple risk stratification schema, based on
  VTE-risk groups (3 levels of risk should do it)
• Institution-wide if possible (a few carve outs
  ok)
• Local modification is OK
• Details in gray areas not that important
• Use measure-vention to accelerate improvement

47
48

• Maynard G, Morris T, Jenkins I, Stone S, Lee J,
  Renvall M, Fink E, Schoenhaus R (2009) Optimizing
  prevention of hospital acquired venous
  thromboembolism prospective validation of a VTE
  risk assessment model. J Hosp Med 4(7).
  doi10.1002/jhm.562
• 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. 08-0075.
  Rockville, MD Agency for Healthcare Research and
  Quality. August 2008, last accessed September 15,
  2008 at http//www.ahrq.gov/qual/vtguide/.
• 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. Designing and Implementing
  Effective VTE Prevention Protocols Lessons from
  Collaboratives. J Thromb Thrombolysis DOI
  10.1007/s11239-009-0405-4 published online Nov
  10, 2009