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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
VTE: A Major Source of
Mortality and Morbidity
•
•
•
•
350,000 to 650,000 with VTE per year
100,000 to > 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, postthrombotic syndrome, chronic PAH)
Surgeon General’s Call to Action to Prevent DVT and PE 2008 DHHS
Risk Factors for VTE
Stasis
Hypercoagulability
Age > 40
Immobility
CHF
Stroke
Paralysis
Spinal Cord
injury
Hyperviscosity
Polycythemia
Severe COPD
Anesthesia
Obesity
Varicose Veins
Cancer
High estrogen states
Inflammatory Bowel
Nephrotic Syndrome
Sepsis
Smoking
Pregnancy
Thrombophilia
Endothelial
Damage
Surgery
Prior VTE
Central lines
Trauma
Anderson FA Jr. & Wheeler HB. Clin Chest Med 1995;16:235.
Risk Factors for VTE
Stasis
Hypercoagulability
Age > 40
Immobility
CHF
Stroke
Paralysis
Spinal Cord
injury
Hyperviscosity
Polycythemia
Severe COPD
Anesthesia
Obesity
Varicose Veins
Cancer
High estrogen states
Inflammatory Bowel
Nephrotic Syndrome
Sepsis
Smoking
Pregnancy
Thrombophilia
Endothelial
Damage
Surgery
Prior VTE
Central lines
Trauma
Anderson FA Jr. & Wheeler HB. Clin Chest Med 1995;16:235.
Bick RL & Kaplan H. Med Clin North Am 1998;82:409.
Failure to Do Simple Things Well
•
Wash Hands
–
•
Patients Understand Meds / Problems
–
•
40% Reliable
Central Lines Placed w/ Proper Technique
–
•
60% Reliable
Basal Insulin for Inpt Uncontrolled DM
–
•
60% Reliable
40% Reliable
VTE Prophylaxis
–
50% Reliable
Registry Data
Highlight the Underuse of Thromboprophylaxis
DVT-FREE
RIETE
IMPROVE
BAD NEWS!
Only a minority of hospitalized
patients receive thromboprophylaxis
Goldhaber SZ, Tapson VF. Am J Cardiol 2004;93:259-62.
Monreal M, et al. J Thromb Haemost 2004;2:1892-8.
Tapson V, et al. Blood 2004;104:11. Abstract #1762.
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: 387–94.
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 it’s 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.
Why don’t 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
E-Alerts Can Increase
Prophylaxis
• 2506 hospitalized patients
• VTE risk score ≥ 4
• Randomized to intervention or control
Intervention
Treatment Received
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. 2005;352:969-977.
E-Alerts Decrease VTE
% Freedom from DVT/ PE
100
98
Intervention
96
94
92
41%
P = 0.001
Control
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. 2005;352:969-977.
VTE Incidence/1000 Patients
Effectiveness can wane over time
4.5
4
3.5
3
2.5
2
1.5
1
0.5
0
*P < 0.05
2005 (preintervention)
2006
2007
*
Overall
Medical
Patients
Lecumberri R, et al. Thromb Haemost. 2008;100:699-704.
Surgical
Patients
Human Alerts Increase
Prophylaxis
• 2493 hospitalized patients
• VTE risk score ≥ 4
• Randomized to intervention or control
Intervention
Treatment Received
Mechanical, %
Pharmacologic, %
Hu-Alert
21
28
Control
8
14
95% CI
10.6-16.0
10.5-16.8
Piazza G, et al. Circulation. 2009;119:2196-2201.
% Freedom from DVT/ PE
Human Alerts Decrease VTE
P = 0.31
Time After Initial Enrollment (days)
Piazza G, et al. Circulation. 2009;119:2196-2201.
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
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
…but not enough by themselves, and design
of the order set matters
• Best practice prophylaxis not defined
Prompt в‰ 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!
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
P e rc e n t o f R a n d o m ly S a m p le d In p a tie n ts w ith
A d e q u a te V T E P ro p h y la x is
UCSD experience
N = 2,944
mean 82 audits / month
100%
90%
80%
Real time ID &
intervention
Order Set Implementation
& Adjustment
70%
60%
50%
Consensus
building
40%
Baseline
30%
7
Q
4
'0
7
Q
3
'0
7
Q
2
'0
7
Q
1
'0
6
Q
4
'0
6
'0
3
Q
Q
2
'0
6
06
Q
1'
5
Q
4
'0
5
'0
3
Q
2
Q
Q
1
'0
'0
5
5
20%
19
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
UCSD - Decrease in Patients with Preventable HA
VTE
Level 5
14
Oversights identified and addressed in real time
95+%
10
Medicine
8
Surgery
Ortho
6
Other
4
Total
2
Quarter
'0
7
Q
1
'0
6
Q
4
'0
6
Q
3
'0
6
2
Q
1'
06
Q
'0
5
Q
4
'0
5
3
Q
2
Q
1
'0
5
'0
5
0
Q
# of Patients
12
21
Hospital Acquired VTE by Year
2005
2006
2007
2008
9,720
9,923
11,207
Cases w/ any VTE
Risk for HA VTE
Unadjusted RR
(95% CI)
131
1 in 76
1.0
138
1 in 73
1.03
(0.81-1.31)
92
1 in 122
0.61#
(0.47- 0.79)
Cases with PE
Risk for PE
Unadjusted RR
(95% CI)
21
1 in 463
1.0
22
1 in 451
1.02
(0.54-1.86)
15
1 in 747
0.62
(0.32-1.20)
116
1 in 85
1.03
(0.80-1.33)
77
1 in 146
0.61*
(0.45-0.81)
68
21
1 in 473
0.47#
(0.28-0.79)
7
1 in 1,601
0.14*
(0.06-0.31)
6
Cases with DVT (and no PE)
Risk for DVT
Unadjusted RR
(95% CI)
110
1 in 88
1.0
Cases w/ Preventable VTE
Risk for Preventable VTE
Unadjusted RR
(95% CI)
44
1 in 221
1.0
Dr. Maynard, the CIs are different here and
in the proof. Which are correct?
Patients at Risk
# p < 0.01 *p < 0.001
Maynard GA, et al. J Hosp Med. 2009;
80
12
VTE Prevention Guides Modeling a
Multifaceted Approach
http://www.hospitalmedicine.org/ResourceRoomRedesign/RR_VTE/VTE_Home.cfm
http://ahrq.hhs.gov/qual/vtguide/
VTE QI Resource Room
www.hospitalmedicine.org
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
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
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
Educational Detailing - PR
Quote ACCP 8 Guidelines
Don’t 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. 2008;133(6 Suppl):381S-453S
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)
Q and A
Q. What is the best VTE risk assessment model?
A. Simple, text based model with only 2-3 layers of
VTE Risk
Q. Who should do the VTE risk assessment?
A. Doctors (via admit transfer order sets), with back
up risk assessment by front line nurses or
pharmacists, focusing on those without
prophylaxis.
Hierarchy of Reliability
Predicted
Prophylaxis
rate
Level
1
No protocol* (“State of Nature”)
40%
2
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
50%
3
4
5
65-85%
90%
95+%
* Protocol = standardized decision support, nested within an order set, i.e. what/when
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 /32
efficiency
Map to Reach Level 3
Implementing 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
Is your order set in a competition?
34
Too Little Guidance
Prompt в‰ Protocol
DVT PROPHYLAXIS ORDERS
пЃ± Anti thromboembolism Stockings
пЃ±
пЃ±
пЃ±
пЃ±
пЃ±
пЃ±
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
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
Example from UCSD
Keep it Simple – A “3 bucket” model
Low
Medium
High
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
Enox 30 mg q 12 h or
Enox 40 q day
or
Other LMWH
or
(5000 units q 12 h if > 75
or weight <50 kg)
LMWH
Enox 40 mg q day
Other LMWH
CONSIDER add IPC
Fondaparinux 2.5 mg q day
or
Warfarin INR 2-3
AND MUST HAVE
IPC
37
IPC needed if contraindication to AC exists
Paper Version – “3 Bucket” RAM
DVT Prophylaxis Order Set Module
See separate paper version demonstrating 3 bucket model
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
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
Hierarchy of Reliability
Predicted
Prophylaxis
rate
Level
1
No protocol* (“State of Nature”)
40%
2
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
50%
3
4
5
65-85%
90%
95+%
* Protocol = standardized decision support, nested within an order set, i.e. what/when
Measure-vention
Daily measurement drives concurrent intervention
(i.e. same as Level 5 in Hierarchy of Reliability)
Identify patients not receiving VTE prophylaxis in
real time
1) Suitable for ongoing assessment, reporting to
governing body
Archive-able data (!)
2) Can be used for real time intervention
Actionable data (!)
42
Map to Reach Level 5
95+ % 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!
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”
Effect of Situational Awareness on
Prevalence of VTE Prophylaxis by
Nursing Unit
Prevalence of VTE Prophylaxis
100%
90%
80%
70%
Hospital A, 1st Nursing Unit
60%
50%
Intervention
40%
UCL:
30%
Baseline
93%
20%
Mean:
73%
10%
LCL:
53%
Post-Intervention
104%
99% (p < 0.01)
93%
0%
1
6
11
16
21
26
31
36
41
46
51
56
61
66
71
76
81
86
Hospital Days
Prevalence of VTE Prophylaxis
100%
Hospital A, 2nd Nursing Unit
90%
80%
70%
Baseline
90%
60%
UCL:
50%
Mean:
68%
LCL:
46%
40%
Intervention
30%
Post-Intervention
102%
87% (p < 0.01)
72%
20%
10%
0%
1
6
11
16
21
26
31
36
41
46
51
56
61
66
71
76
81
86
91
96 101
Hospital B, 1st Nursing Unit
Prevalence of VTE Prophylaxis
100%
90%
80%
Baseline
89%
70%
UCL:
60%
Mean:
71%
LCL:
53%
50%
40%
Post-Intervention
108%
98% (p < 0.01)
88%
Intervention
30%
20%
10%
0%
1
6
11
16
21
26
31
36
41
46
51
56
61
66
71
76
81
86
91
96 101
_______________________
UCL = Upper Control Limit
LCL = Lower Control Limit
45
Most Common Mistakes in
Measurement of DVT Prophylaxis
• Not doing it at all
• Not doing it concurrently
• Failure to make measured poor
performance actionable
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 VTErisk 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
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). doi:10.1002/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
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