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BC Patient Safety & Quality Council
“Meeting Your Goals for Preventing Venous Thromboembolism”
Vancouver – March 17, 2011
Reviewing the Evidence & Setting the Business
CaseBill Geerts, MD, FRCPC
Thromboembolism Specialist, Sunnybrook HSC
Professor of Medicine, University of Toronto
National Lead, VTE Prevention, Safer Healthcare Now!
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Objectives: Why are we here?
VTE prevention in 2011:
What is the rationale?
What are the recommended options?
How well do we do?
How can we do even better?
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52 yo high school math teacher, previously well
Jan 31 - admitted with generalized seizure
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52 yo high school math teacher, previously well
Jan 31 - admitted with generalized seizure
Feb 5 - craniotomy for resection of meningioma
Day 1 postop Day 8 postop
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52 yo high school math teacher, previously well
Jan 31 - admitted with generalized seizure
Feb 5 - craniotomy for resection of meningioma
Feb 7 - discharged home
Feb 13 - to ER with acute shortness of breath,
heart pounding, feeling faint
O/E: P = 125 BP = 90/50
RR = 22 SaO2 = 85%
JVP = 10 cm >SA (Rt heart failure)
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Young, healthy woman
Curative surgery
Near-fatal PE
Readmitted
Traumatized by the experience
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Young, healthy woman
Curative surgery
Near-fatal PE
Readmitted
Traumatized by the experience
No thromboprophylaxis
given at any time!
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Feb 13 Feb 14
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1. VTE is common in hospital patients
2. VTE is bad (acutely and long-term)
3. VTE is preventable (safely and inexpensively)
4. Preventing VTE is standard of care for almost all hospital patients in 2011
Rationale for Thromboprophylaxis
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Risk Factors for VTE
Surgery
Trauma - major, local leg
Acute medical illness
Immobilization - bedrest, stroke, paralysis
Cancer and its treatment - CTX, RTX, hormonal
Previous DVT or PE
Increased age
Estrogen use (BCP, HRT), pregnancy, postpartum
Central venous lines
Blood clotting disorders - thrombophilia
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Risk Factors for VTE
Surgery
Trauma - major, local leg
Acute medical illness
Immobilization - bedrest, stroke, paralysis
Cancer and its treatment - CTX, RTX, hormonal
Previous DVT or PE
Increased age
Estrogen use (BCP, HRT), pregnancy, postpartum
Central venous lines
Blood clotting disorders - thrombophilia
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Symptomatic VTE after Surgery
California Patient Discharge Database (N = 1,653,275)
VTE during surgical admission or within 3 mos
Benign disease
THR 2.4 %
Craniot/excision 2.3 %
TKR 1.7 %
CABG 1.1 %
Colectomy 1.1 %
Hysterectomy 0.3 %
Malignant disease
Craniot/excision 3.6 %
Colectomy 1.7 %
Pneumonectomy 1.6 %
Rad prostatect 1.5 %
Hysterectomy 1.2 %
Mastectomy 0.4 %
White - Thromb Haemost 2003;90:446
For major surgery, symptomatic VTE in 1-4% of patients
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We all need to be aware that . . .
60% of all VTE is hospital-
acquired
Pulmonary embolism is the
commonest preventable cause
of hospital death
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Consequences of Unprevented VTE
$
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VTE after General Surgery
Mukherjee – J Gastrointest Surg 2008:12:2015
375,748 surgical patients in the National Inpatient
Sample (20% of all hospitals in 37 states) 2001-5
No VTE
(n=272,975)
VTE
(n=5,773)
P
Hospital mortality 3.8% 13.4% <0.001
LOS 9.0 days 22.4 days <0.001
Hospital charges $48,763 $129,179 <0.001
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Impact of Postop VTE (Vancouver)
All Pts VTE Adj
Hosp costs $2,100 $6,500 106%
Median LOS 3 d 8 d 103%
Khan – J Gen Intern Med 2006;21:177
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We also need to be aware that . . .
More than 400 randomized studies
prove that VTE CAN be prevented
safely and inexpensively
Guidelines have recommended routine
prophylaxis use for 25 years
Thromboprophylaxis is the number 1
ranked patient safety strategy in
hospitalized patients
Making Health Care Safer: A Critical Analysis of Patient Safety
Practices - Shojania (2001) - www.ahrq.gov/clinic/ptsafety/
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Low Dose Heparin Reduced DVT in 46
RCTs of Surgical Patients (n=15,598)
%
25
20
15
10
5
0
22 %
9 %
Risk
Reduction
59 %
DVT
Control
Low dose heparin
Collins – NEJM 1988;318:1162
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Low Dose Heparin also Reduced Fatal PE
%
25
20
15
10
5
0
22 %
9 %
Risk
Reduction
59 %
0.8 % 0.3 %
Risk
Reduction
63%
DVT Fatal PE
Control
Low dose heparin
Collins – NEJM 1988;318:1162
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How can VTE be prevented in hospitals?
1. Getting patients up and walking as
early as possible helps . . .
but this is not enough for most
patients.
2. Giving patients low doses of an
anticoagulant every day is required.
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1. Graduated compression stockings (TEDs™, elastic
stockings)
2. Pneumatic compression devices (IPC, SCDs™, leg
squeezers)
3. Foot pumps
If used properly, these methods work in some
patient groups, but
They generally don’t work as well as
anticoagulants,
and
They require a big effort to work at all.
Mechanical Methods of Prophylaxis
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1. Use in patients who can’t have
anticoagulant
2. Ensure they fit properly
3. Start ASAP (preop or on admission)
4. Have on ~24 hours/day – only remove
- for leg washing
- when patient actually walking (for SCDs)
5. Legal obligation to ensure compliance
Using Mechanical Thromboprophylaxis
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1. Low dose heparin / minidose heparin
2. Low molecular weight heparindalteparin (Fragmin®)
enoxaparin (Lovenox®)
tinzaparin (Innohep®)
3. Fondaparinux (Arixtra®)
4. Warfarin (Coumadin®)
5. Oral Factor IIa inhibitors, Xa inhibitorsdabigatran (Pradax®)
rivaroxaban (Xarelto®)
Pharmacologic (anticoagulant) Methods of Prophylaxis
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Does Warfarin still have a role as Thromboprophylaxis in 2011?
No:
There are more effective, safer, and
much easier to use alternatives that are
not more costly and are more patient-
friendly
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White - Arch Intern Med (1998)
TKR
~1 month
THR
~3 months
Some Patients Need Post-Discharge Thromboprophylaxis
DischargeN=43,645
Readmissions to Hospital for VTE
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Extended Thromboprophylaxis Reduces DVT after THR
Meta-analysis:
9 THR studies
N=3,999
Eikelboom - Lancet 2001;358:9
19.6%
9.6%
Risk reduction
51%
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Extended Thromboprophylaxis Reduces DVT and Symptomatic VTE
Meta-analysis:
9 THR studies
N=3,999
Eikelboom - Lancet 2001;358:9
19.6%
9.6%
1.3%3.3%
Risk reduction
51%
Risk reduction
61%
No post-discharge
major bleeding
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2011 Thromboprophylaxis Options
Patient Group Options Duration
Acute medical
illness
LMWH
low dose heparin
Discharge
Surgery:
general, gyne,
urol, thorac
LMWH
low dose heparin
Discharge
Major
orthopedics (THR, TKR, HFS)
rivaroxaban, dabigatran
LMWH
fondaparinux
14-28 days
High bleeding
risk
mechanical Until
anticoagulant
can start
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2006 Routine Use of Recommended Prophylaxis in 195 Canadian Hospitals
100%
75%
50%
25%
086%94% 30% 32% 11%36% 33%
Appropriate
use
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Prophylaxis Use in Medical Patients
1,894 medical patients in 29 hospitals in 6 provinces
Khan – Thromb Res 2007;119:145
90%
Prophylaxis Prophylaxis Recommended
indicated given prophylaxis
23% 15%
100%
75%
50%
25%
0
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TOPPS: Baseline Prophylaxis Use
100%
80%
60%
40%
20%
0Hip Major general Medical Combined
fracture surgery patients (n=341) (n=416) (n=418) (n=1,175)
79.2%
43.3%
31.1%
49.4%
Quality improvement initiative in 8 Toronto area hospitals
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Strategies to Improve Thromboprophylaxis Success
I. National/provincial
II. Local
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Strategies to Improve Thromboprophylaxis Success
Surgical Safety Checklist
Accreditation Canada VTE ROP
Safer Healthcare Now!
UK thromboprophylaxis mandate
BC Clinical Care Management
I. National/provincial
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Surgical Checklist Safe Surgery Saves Lives
VTE Prophylaxis:
“The Checklist Coordinator should ensure that the OR team
has instituted an appropriate plan for the intra-operative
and/or post-operative prevention of VTE, consistent with
hospital policy.”
www.safesurgerysaveslives.ca
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Mandatory reporting of
checklist use as of July, 2010
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ACCREDITATION CANADA VTE Prophylaxis ROP
Hospital accreditation requirement
started January, 2011
www.accreditation.ca
The hospital “identifies medical and surgical clients at risk of venous thromboembolism (DVT and PE) and provides appropriate thromboprophylaxis.”
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ACCREDITATION CANADA
2011 VTE Prophylaxis ROP
1. The hospital has an organization-wide, written
thromboprophylaxis policy or guideline.
2. Identifies patients at risk for VTE and provides
appropriate, evidence-based VTE prophylaxis.
3. Establishes measures for appropriate
thromboprophylaxis use, audits its implementation,
and uses this for quality improvement.
4. Identifies major orthopedic surgery patients who require
post-discharge prophylaxis and provides it.
5. Educates health professionals and patients about VTE
and its prevention.www.accreditation.ca
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Prevention of VTE
Overall Objective: to improve hospital
safety across Canada by increasing
adherence to evidence-based guidelines
on the use of thromboprophylaxis
www.saferhealthcarenow.ca
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VTE Prevention in the UK
VTE accounts for up to 25,000
preventable deaths in the UK/year
Fatal PE is more common than deaths
from breast cancer, AIDS and traffic
accidents combined
PE deaths are 25 times more common
than deaths from MRSA
VTE prevention calculated to be cost-
saving
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NICE VTE Guideline Costing Report 2010
Annual Cost of Guideline Implementation in England
Additional costs of
implementation*
£ 3,554,000
Saving* £ 4,441,000
Overall net saving* £ 887,000
*assuming 100% of patients at risk receive
recommended thrombopoprophylaxis
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Thrombosis Prevention in the UK
2005 Government decision to “fix” VTE prevention
nationally
2007 National guidelines for surgical prophylaxis
2008 National VTE risk assessment tool
2009 National VTE prevention guidelines revised to
include all hospital patients [NICE]
2010 National educational strategy for VTE [e-VTE]
Mentor centers of VTE excellence [Exemplar]
2010 Mandatory monthly reporting of VTE risk
assessment and prophylaxis for every admission
Root cause analysis for every hosp-acquired VTE
2010 Financial incentives for delivering VTE Prevention
(0.3% of transfer payments)
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Recommended for all
patients on admission to
hospital
AND reassessed every 48-
72 hours
STEP ONE
Review TE risk factors and tick
each one present
Any tick should prompt
prophylaxis
STEP TWO
Review bleeding risk factors
Any tick: Is anticoagulant
appropriate?
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Strategies to Improve Thromboprophylaxis Success
1. Follow the ACCP guidelines
2. Have a written hospital policy on prophylaxis
3. Keep it simple and standardize it
4. Use order sets, computer order entry
5. Make a prophylaxis decision mandatory
6. Involve everyone – MD, RN, pharm, patients
7. Audit and feedback
II. Local
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The Specific Prophylaxis Matters!
Amin – Thromb Res 2010;125:513
Outcome Non-ACCP
prophylaxis
(n=15,865)
ACCP
prophylaxis*
(n=5,136)
p
Hospital-acquired VTE 1.9% 1.4% 0.04
Hospital-acquired PE 0.9% 0.5% 0.01
Major bleeding 0.4% 0.1% 0.002
Anticoagulant costs/pat $308 $577 0.01
Total costs/patient $23,823 $17,386 <0.001
21,001 patients who received thromboprophylaxis
*According to 7th ACCP
>
>
>
>
<
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Which Hospital Patients Should Receive Thromboprophylaxis?
Medical patients – acutely ill, bedrest,
stroke, CHF, acute resp illness, infection
Major general surgical, major
gynecologic, major urology, bariatrics,
cardiovascular, neurosurgery
Orthopedics, trauma
ICU
i.e. most patients in hospital
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“Patients without risk factors
for VTE are called
outpatients.”
G. Maynard (2010)
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Simplifying DVT Prophylaxis: 2 Patient Groups
Low risk = no prophylaxis
e.g. vaginal delivery, most psych, pacemaker insertion
At risk = routine
evidence-based prophylaxis
~10%
~90%
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What Thromboprophylaxis Options Do We Have to Choose From?
i.e. only 2 or 3 options
Anticoagulant Options:
LDH – BID or TID
LMWH – dalteparin,
enoxaparin, tinzaparin, etc
Rivaroxaban, dabigatran
Choose 1 (or possibly 2):
________________
________________
Mechanical Options:
GC stockings
Pneum compr devices
Choose 1:
________________
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Too Little Guidance
Select one or more option(s):
Anti-embolism stockings
Sequential compression devices
UFH 5000 units SC Q12h
UFH 5000 units SC Q8h
LMWH (enoxaparin) 40 mg SC QD
LMWH (enoxaparin) 30 mg SC Q12h
UFH 5000 units SC Q12h + SCDs
Warfarin target INR 1.5-2.5
No Prophylaxis, Ambulate
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Simplifying Thromboprophylaxis( 2011)
Patient group Prophylaxis Duration
Medical LMWH Discharge
General surgical, etc LMWH Discharge
Orthopedics LMWH Discharge +10d
rivaroxaban 15 d
Trauma/SCI LMWH Rehab d/c
ICU LMWH Discharge
High bleeding risk TEDS until risk LMWH
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Embed Prophylaxis into Order Sets
YYYY/MM/DD Yes No DVT ProphylaxisSignature
of nurse
Choose one option below:
enoxaparin 40 mg SC once daily
enoxaparin 30 mg SC once daily if creat
clearance <30 mL/min or weight <40 kg
For high bleeding risk patients only, apply
properly measured, bilateral, below-knee
support stockings – reassess daily for
conversion to enoxaparin
No prophylaxis – state reason _________
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Sunnybrook Monthly Thromboprophylaxis Audit Results
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Appropriate Prophylaxis* Use in General IM Patients at Sunnybrook
9%
2003 2007 2008 2009
21%
100%
75%
50%
25%
0
60%
96%*based on direct chart audit
Quality improvement in action!
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Appropriate Prophylaxis* Use in General IM Patients at Sunnybrook
9%
2003 2007 2008 2009 2010
21%
100%
75%
50%
25%
0
60%
96%*based on direct chart audit
We opened the champagne too soon!
72%
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Sunnybrook Thromboprophylaxis Target
100% appropriate
prophylaxis for all
patients at risk
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TOPPS: Baseline, T1 and T2
100%
80%
60%
40%
20%
0
Hip Major general Medical Combined fracture surgery patients
90%
65%71%
75%
Quality improvement initiative in 8 Toronto area hospitals
79%
43%
31%
49%
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What were the Interventions in TOPPS?
100%
80%
60%
40%
20%
0
Combined
61%
1. Senior leadership support
2. Emphasis on order sets
3. Involvement of Pharmacy
4. Support: sharing of
policies, guidelines, tools
5. Audit and feedback
6. “Handholding”
75%
49%
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Maynard – J Hosp Med 2010;5:10
Appropriate Thromboprophylaxis
54% 67% 80% 90% 98%
Randomly sampled patients
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Multi-component VTE Prevention QI
Maynard – J Hosp Med 2010;5:10
risk assessment tool linked to recommended prophylaxis options
active monitoring, feedback and interventions to improve adherence
2005 2007 P
Patients at risk 9,720 11,207
Patient-days at risk 59,000 62,505
Appropriate prophylaxis 58% 98% <0.001
Hospital-acquired VTE 131 92 <0.001
Preventable hospital-
acquired VTE
44 7 <0.001
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Patient Safety Initiatives
May be difficult
May not succeed
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Patient Safety Initiatives: low hanging fruit
VTE
Prevention
Congratulations B.C. for your leadership!
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Venous Thromboembolism (VTE) = DVT + PE
Pulmonary
Embolism (PE)
Deep Vein
Thrombosis (DVT)
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Even 29 y.o. elite athletes can get PE!
13-time Grand Slam singles champion
July, 2010 stepped on broken glass 2 surgeries to repair tendon
Attended Oscars few days later: PE
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Risk of DVT in Hospitalized Patients
Patient group DVT prevalence, %
Medical patients 10 - 20
General surgery, bariatric 15 - 40
Major gyne / urol surgery 15 - 40
Neurosurgery 15 - 40
Stroke 20 - 50
Hip, knee arthroplasty, hip fracture 40 - 60
Major trauma 40 - 80
Spinal cord injury 60 - 80
No prophylaxis + routine screening for DVT
Moderate
risk
High
risk
8th ACCP Guidelines on Antithrombotic Therapy – Chest 2008;133:381S
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VTE after General Surgery
Mukherjee – J Gastrointest Surg 2008:12:2015
National Inpatient Sample (20% of all hospitals
in 37 states) 2001-5
Procedure No. In hosp VTE
Bariatric 76,630 0.4%
Colorectal 250,847 1.8% *
Hepatectomy 6,346 1.8% *
Splenectomy 16,032 2.4% *
Gastrectomy 9,938 2.6% *
Pancreatectomy 6,553 2.9% *
Esophagectomy 2,211 3.7% *
*P<0.001 vs bariatric
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Postoperative DVT and PE
2nd commonest medical complication overall
2nd commonest cause of excess LOS
3rd commonest cause of excess mortality
3rd commonest cause of excess charges
Zhan - JAMA 2003;290:1868
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Procedure-related:
Cancer > benign
Open > laparoscopic
GA > regional anesthesia (if no prophylaxis)
Duration of procedure
VTE Risk Factors in General Surgery
Patient-related: Age
Previous VTE
Obesity
Reduced mobility
Infection
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8th ACCP Guidelines on Antithrombotic Therapy
Prevention of Venous
Thromboembolism
W. Geerts
D. Bergqvist
G. Pineo
J. Heit
C.M. Samama
M. Lassen
C. Colwell
1986, 1989, 1992, 1995, 1998, 2001, 2004, 2008
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Thromboembolism Risk Groups
8th ACCP Guidelines on the Prevention of VTE
General surgery
Vascular surgery
Gynecologic surgery
Urologic surgery
Thoracic surgery
Bariatric surgery
Laparoscopic surgery
Coronary bypass surgery
Hip arthroplasty
Knee arthroplasty
Knee arthroscopy
Hip fracture surgery
Spine surgery
Lower extremity injuries
Neurosurgery
Major trauma
Spinal cord injuries
Burn patients
Medical patients
Cancer patients
Central venous catheters
Critical care patients
Long distance travel
Geerts – Chest 2008;133:381S
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Compression Stockings for DVT Prevention
Sachdeva – Cochrane Database Syst Rev 2010
Outcomes Comparison Trials
(pts)
Event rates RRR
(95% CI)
NNT
Control GCS
DVT No
prophylaxis
8
(1279)
26% 12% 54%
(42-63)
8
Other
prophylaxis
10
(1248)
16% 4% 72%
(59-81)
9
PE No
prophylaxis
1
(95)
2% 0% 67%
(-682-99)
NS
Other
prophylaxis
3
(254)
9% 3% 63%
(-7-87)
NS
18 RCTs (1,463 patients) – stroke excluded
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Knee- vs Thigh-Length Stockings
Similar venous blood flow velocity
Compression above calf may have no added
physiologic effect
4 small randomized trials show no difference
Advantages of calf length:
1) Less leg size variability
2) Greater ease of measurement, apply
3) Nursing preference
4) Greater patient comfort
5) Reduced soiling, infection concerns
6) Cheaper
greater compliance
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IPC vs GCS: A Systematic Review
Direct comparisons between IPC and GCS
Only 10 studies 1970-2008
None used venography and only 1 used Doppler US
Stockings: calf-length 2, thigh length 1, unspecified 7
IPC: calf 4, thigh 2, unspecified 4
Funding: device producers 5, uncertain 5
Statistical significance in only 2
Largest trial (65% of all patients) showed no difference
Too heterogeneous to combine
Cannot conclude that one method is superior
Morris & Woodcock – Ann Surg 2010;251:393
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Compression Stockings for DVT PreventionLimitations
Sachdeva – Cochrane Database Syst Rev 2010
? relevant studies – old (14/18 1970s-80s); ½ GS, no medical; ½ of
combo trials used prophylaxis no longer used (dextran 70, aspirin)
Several best studies excluded – stroke excluded
Poor methodology: unclear randomization (10), pseudorandomization
(2), unclear allocation concealment (12), none clinician blinded
6 trials used one leg vs the other
In 5/18 trials, length of stocking NR
Variable duration of use: mobilization, discharge, 7 days
FgLS outcome in 15/18 = inaccurate, biased and no longer used
Complications of stockings not reported in 2/3
10 studies funded by industry
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Mechanical Thromboprophylaxis
NICE VTE Guideline Development Group, 2010:156
“There is a lack of strong evidence
available to suggest one method of
mechanical prophylaxis is better than
any other, or to suggest thigh length
of stockings or intermittent pneumatic
compression devices are better than
knee length.”
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Adherence with IPC
Twice daily direct observation of patients with IPC
Stewart – Am Surg 2006;72:921
Patient location % correct usage
observations
Surgical ward 131/213 (62%)
Medical ward 73/152 (48%)
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Adherence with IPC and Stockings
137 patients prescribed graduated compression
stockings (GCS) or intermittent pneumatic
compression devices (IPC)
Single observation
Brady – Crit Care Nurs Quart 2007;30:255
Method Using Wearing
correctly
GCS 63% 26%
IPC 29% 19%
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Hospital-wide Thromboprophylaxis Audit – Jan 26, 2010
Thromboprophylaxis indicated
N=362
Anticoagulant prophylaxis
contra-indicated N=31 (8.6%)
Mechanical prophylaxis
NOT ORDERED
18 (58%)
Ordered but NOT
ON patient 7 (23%)
Ordered, on patient, WRONG
SIZE 3 (10%)
ORDERED, on patient, correct size 3 (10%)
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Thromboprophylaxis Shown to Reduce Mortality after Hip Fracture 50 years ago!!
Controls Phenindione*
n=150 n=150
Symptomatic DVT 29 % >> 3 %#
Symptomatic PE 5 % >> 0
Total deaths 28 % >> 17 %
Sevitt & Gallagher – Lancet 1959:2:981
NNT
4
20
9
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RR (95% CI)
0.90 (0.79–1.02)
0.71 (0.51–0.99)
Asymptomatic DVT (n = 17,995)
Clinical VTE (n = 13,776)
Major bleeding (n = 18,555)
Death (n = 41,387 )
0.89 (0.75–1.05)
1.04 (0.89–1.20)
LMWH better UFH better
10.50 2 3
0.88 (0.64–1.20)Clinical PE (n = 46,646)
LDH vs LMWH in General Surgery: A meta-analysis
Mismetti - Br J Surg 2001;88:913RR = relative risk; CI = confidence interval
51 studies, 48,600 patients
p = 0.01
p = 0.41
p = 0.049
p = 0.16
p = 0.63
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End point LDH (n=872)
Enox (n=877)
p
VTE day 14 18% 10% 0.0001
Prox DVT 10% 5% 0.0003
Sympt VTE 7 (1%) 2 (<1%) 0.096
Bleeding - any
Sympt ICB
Death day 14
8%
6 (1%)
5%
8%
4 (1%)
6%
0.90
0.55
0.58
Sherman - Lancet 2007;369:1347
Patients with acute ischemic stroke + unable to walk
Open-label RCT: heparin 5,000 U bid vs enoxaparin 40 mg qd
Routine venography adjudicated by blinded central committee
VTE Prevention in Stroke (PREVAIL)
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Should LMWH Replace LDH as Routine Thromboprophylaxis?
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LDH vs LMWH
Factor LDH LMWH
efficacy +++ +++
safety +++ +++
dosing 2-3 x/day once daily
HIT potential low very low
cost $ $ - $$
applicable in all
patients at risk no yes *
=
=
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Thromboprophylaxis Summary in 2011
Patient Group Options Duration
Acute medical
illness
LMWH
low dose heparin
Discharge
Surgery:
general, gyne,
urol
LMWH
low dose heparin
Discharge
Major
orthopedics
rivaroxaban,dabigatran
LMWH
fondaparinux
14-28 days
High bleeding
risk
mechanical Until
anticoagulant
can start
Not low dose
heparin
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Should LMWH Replace LDH as Routine Thromboprophylaxis?
Yes:
If the cost difference between
LMWH and LDH is not too great
and for patients at high risk of HIT (CVS)
Why: Simplifies thromboprophylaxis and
makes it consistent for most patients
May reduce HIT
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What is the Evidence?
General Surgery
~150 RCTs
LDH ~ LMWH ~ fondaparinux
DVT risk reduction: 60-75%
Prevents fatal PE
For cancer patients, dose is important
e.g. LDH TID
Small increase in wound hematoma
No increase in major bleeding
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What is the Evidence?
Laparoscopic Surgery
Reported VTE rates are low (<open
surgery)
BUT, indications/complexity expanding
Only 3 RCTs (each with limitations)
Ageno – J Thromb Haemost 2007;5:503
Nguyen – Arch Surg 2007;246:1021
Geerts – Chest 2008;133:381S
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What is the Evidence?
Laparoscopic Surgery
Thromboprophylaxis Options:
1) None
2) Mechanical alone
3) LMWH or LDH in all
4) Individualize (“high” risk only)
High risk patients
High risk procedures
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What is the Evidence?
Bariatric Surgery
Risk of symptomatic VTE:
Open surgery 1-2%
Laparoscopic <1%
Only 1 RCT (n=60, with limitations)
Despite the paucity of high quality
evidence, it is sensible to provide
routine thromboprophylaxis
Moderate NOT
high risk
Geerts – Chest 2008;133:381S
Agarwal – Surg Obes Relat Dis 2010;6:213
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LMWH Effect is Weight-Related
Frederiksen – Br J Surg 2003;90:547
19 patients given enoxaparin 40 mg
Serial anti-Xa testing
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Anti-Xa Levels and Enoxaparin Laparoscopic GBP or banding (~130 kg, BMI ~48)
AXa 3-5 hours after 1st and 3rd dose
0.5
0.4
0.3
0.2
0.1
0
Rowan – Obes Surg 2008;18:162
Simone – Surg Endosc 2008;22:2292
40 mg BID
enoxaparin
60 mg BID
Target AXa =
0.18-0.44 U/mL
An
ti-X
a level
1st dose
3rd dose
30 mg BID
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What is the Evidence?
Bariatric Surgery
Thromboprophylaxis Options:
1) Weight-adjusted LMWH
2) Weight-adjusted LMWH + IPC
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Weight- or BMI-Based Dosing
BMI enoxaparin
40-50 40 mg BID
51-60 60 mg BID
61-85 80 mg BID
Enoxaparin 0.4 mg/kg BID
Dalteparin 40 U/kg BID
Enoxaparin 1 mg/BMI BID
Dalteparin 100 U/BMI BID
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Complications after Non-cancer and Cancer Surgery
Haas – Thromb Haemost 2005;94:814
Non-cancer Cancer
Outcome N=16,954) (N=6,124) RR P
Fatal PE* 0.09 % 0.33 % 3.7 0.0001
Death 0.7 % 3.1 % 4.5 0.0001
Abn bleeding 0.04 % 0.29% 7.3 0.0001
Double-blind RCT of LDH TID vs certoparin QD
* autopsy-proven
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Major trauma patients are the
HIGHEST RISK group
for thrombosis
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Risk Factors for VTE in Trauma
Spinal cord injuries
Lower extremity/pelvic fractures
Severe head injury
Surgical procedure
Central venous catheter
Major venous injury
Age
Failure to use or delayed prophylaxis
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High Bleeding Risk?
frank intracranial bleed
incomplete SCI
active major bleeding
Mechanical
Prophylaxis(SCDs, TEDs)
Anticoagulant
Prophylaxis
(LMWH)
High bleeding
risk
resolves
NoYes
Thromboprophylaxis in Trauma
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National and
Provincial Data
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Canadian Anticoagulant Survey
Sent to all Canadian hospitals in 2006
– 195 hospitals responded
Represent 39,890 hospital beds
Three key areas:
1. DVT prophylaxis
2. Use of heparin
3. Management of patients on anticoagulants
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Canadian Anticoagulant Survey
Perceived Barriers to Optimal Thromboprophylaxis:
Physicians prescribe individually 75 %
No time to implement program yet 30 %
Physicians cannot agree 27 %
Bleeding concerns 17 %
Cost concerns 12 %
Prophylaxis is not important 0.5%
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Thromboprophylaxis after THR, 2003-2007
Canadian Joint Registry (CIHI) 2009
LMWH
Warfarin
SCDs
Overall, more than 99% of THR patients received prophylaxis
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Ontario Hospital Survey - 2009
Patient
group
Never Rarely Sometimes Most of
the time
Always
Major
general
surgery
2% 2% 20% 43% 33%
Hip
fracture
surgery
7% 2% 9% 15% 47%
THA
TKA
7% 4% 6% 10% 50%
Do all surgeons routinely prescribe VTE prophylaxis to patients?
105 responses
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The Great Canadian VTE Audit Day(May 14, 2009)
Major
General
Surgery
Hip
Fracture
Surgery
Hospitals reporting 52 48
Patients 551 276
Appropriate
thromboprophylaxis
438 (80%) 261 (95%)
P<0.0001
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The “Great Canadian” VTE Audit Day
20
18
16
14
12
10
8
6
4
2
0
No. of
hospitals
100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0
Appropriate prophylaxis given
Major General Surgery(52 hospitals - May 14, 2009)
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Regional and Local
Data
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Toronto Regional Thromboprophylaxis
Patient Safety Initiative (TOPPS)
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Objective:To increase the use of appropriate thromboprophylaxis for patients hospitalized for:
hip fracture surgery
major general surgery
acute medical illness
7 community hospitals + 1 HSC
TOronto thromboProphylaxis Patient Safety initiative (TOPPS)
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Formal agreement to participate
Meet with key stakeholders
Collect baseline data + feedback
Collect phase 1 data + feedback
Collect phase 2 data + feedback
Interventions to optimize adherence in 1 group
Interventions to optimize adherence in 2 groups
TOronto regional thromboProphylaxis Patient Safety initiative (TOPPS)
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Reasons For Non-adherence (baseline)
Patient Group
HFS Gen
Surgery
Gen
Medicine
% cases nonadherent (total cases) 21% (341) 57% (416) 69% (418)
Reason for Non-adherence*
No prophylaxis given 9 130 242
No pre-op prophylaxis when indicated 9 18 NA
Prophylaxis started >24 h after
admission/OR†
13 7 24
Not recommended drug/therapy 2 4 7
Inappropriate dose 6 67 0
Inappropriate duration of prophylaxis‡ 34 14 20
*Cases could be deemed non-adherent for more than one reason.†If a delay of >24hours in hip fracture surgery or general surgery.‡ Prophylaxis administered until discharge for general medicine and general surgery; at least 10 days for hip fracture surgery.
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Sunnybrook HSC
1 day audits
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Audit it: Sunnybrook 1-Day Thromboprophylaxis Audits
Every acute care patient
Except: psychiatry, obstetrics
Data analyzed by:- unit- service- program- department
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Unit type No. Excl.* Eligible Ordered
Surgical 259 70 189 164 (87%)
Medical 192 64 128 99 (77%)
Major ICU 39 6 33 32 (97%)
All 490 140 350 295 (84%)
*receiving therapeutic anticoagulation or prophylaxis not indicated
2009 Hospital-Wide One-Day Thromboprophylaxis Audit
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Unit type No. Excl.* Prophylaxis
Indicated Ordered
Surgical 245 56 189 171 (89%)
Medical 200 61 139 100 (72%)
Major ICU 41 7 34 33 (97%)
All 486 124 362 300 (83%)
*receiving therapeutic anticoagulation or prophylaxis not indicated
2010 Hospital-Wide 1-Day Thromboprophylaxis Audit
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Unit
Total no.
patients
No. pts
excluded
Prophylaxis
indicated
Appropriate
thromboprophylaxis
2009 2010 2009 2010 2009 2010 2009 2010
All surgical
units
260 245 74 56 186 189 159 (85%) 171 (89%)
All medical
units
186 200 69 61 117 139 96 (82%) 100 (72%)
All major
ICUs
40 41 6 7 34 34 32 (94%) 33 (97%)
Combined 486 486 149 124 337 362 287 (85%) 304 (84%)
Appropriate Prophylaxis by Unit Groups
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Unit type No. Excl.* Prophylaxis
Indicated Ordered
Surgical 185 31 154 132 (86%)
Medical 169 43 126 100 (79%)
Major ICU 78 16 62 49 (79%)
All 432 90 342 281 (82%)
*receiving therapeutic anticoagulation or prophylaxis not indicated
2011 Hospital-Wide 1-Day Thromboprophylaxis Audit
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How can we do better?
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Prevention of VTE
www.saferhealthcarenow.ca
Mission for 2011:
The “go-to” resource for VTE
prevention in Canada oriented to the
Accreditation Canada VTE ROP.
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Selby et al – ISTH 2009;OC-MO-051 and OC-TU-020
3,497 THR/TKR patients
ALL of whom received thromboprophylaxis
non-ACCP ACCP proph p(n=2,102) (n=1,395)
DVT <90 days 3.8% >> 2.0% 0.003
PE <90 days 1.2% >>> 0.1% 0.001
VTE cost/patient $ 252 > $ 213
Adherence with prophylaxis guidelines was associated
with REDUCED VTE AND REDUCED COSTS.
The Specific Prophylaxis Matters!
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1.2 VTE Prophylaxis Policy
1.2.1 We recommend that every general
hospital develop a formal, active
strategy that addresses the
prevention of VTE [Grade 1A].
8th ACCP Guidelines on Antithrombotic Therapy
Geerts – Chest 2008;133:381S
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Guidelines for Medical Thromboprophylaxis
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“it is critically important that every patient
admitted to hospital is assessed for risk and
receives prophylaxis appropriate for their
risk.”
www.nhmrc.gov.au/nics (2008)
Stop the Clot: Integrating VTE
prevention guideline recommendations
into routine hospital care (Australia)
“ensure that a hospital-wide policy exists or
is developed to ensure that risk assessment is
applied to all admitted patients.”
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Incorporate strategies that work well together
1. Keep it Simple- patient selection
- prophylaxis options
2. Build it into routine care- hospital policy
- order sets – default or opt out
3. Audit and feedback
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Default (“opt out”) Prophylaxis
Everyone gets routine, evidence-based prophylaxis
Everyone at risk gets anticoagulant
prophylaxis
Unless thrombosis
risk too low
Unless bleeding
risk too high
Obsessive
mechanical
prophylaxisDaily reassessment
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Thromboprophylaxis: the 3 steps
Step 1: Is thromboprophylaxis NOT
INDICATED?
Step 2: Is anticoagulant thromboprophylaxis
CONTRAINDICATED?
Step 3: Order appropriate prophylaxis
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Thromboprophylaxis: the 3 steps
Step 1: Is thromboprophylaxis NOT INDICATED?
Patient fully mobile
Brief length of stay
No routine prophylaxis
Reassess daily
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Thromboprophylaxis: the 3 steps
Step 1: Is thromboprophylaxis NOT INDICATED?
Step 2: Is anticoagulant thromboprophylaxis
CONTRAINDICATED?
Patient fully mobile
Brief length of stay
No routine prophylaxis
Reassess daily
Active bleeding
High bleeding risk
TED stockings
Reassess daily
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Thromboprophylaxis: the 3 steps
Step 1: Is thromboprophylaxis NOT INDICATED?
Step 2: Is anticoagulant thromboprophylaxis
CONTRAINDICATED?
Step 3: Order appropriate prophylaxis
Patient fully mobile
Brief length of stay
No routine prophylaxis
Reassess daily
Active bleeding
High bleeding risk
TED stockings
Reassess daily
For almost all patients, the recommended prophylaxis is:
LMWH SC once daily
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Exclusion-Based VTE Risk Assessment
497 medical patients
All patients receive prophylaxis unless it’s clearly not indicated
or contraindicated100%
80%
60%
40%
0
Baseline 12 mos 28 mos 36 mos
RAM
Formal
education
Ap
pro
pri
ate
Th
rom
bo
pro
ph
yla
xis
49%48%
70% 76%
Bagot – Q J Med 2010:103:597
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What have we learned?
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Improving Thromboprophylaxis
What does NOT work?
Education
Grand rounds
Decision support tools e.g. reminders
Hospital policy
Local champion
Producing order sets
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Improving Thromboprophylaxis
What DOES work?
Institutional commitment + written hospital policy
PLUS KISS “KEEP IT SIMPLE smartie”
PLUS local champion/leader
PLUS some education of MDs, RNs, Pharms
PLUS mandatory use of order sets
PLUS empower everyone to be involved – docs,
nurses, pharmacists (“It’s what we do here.”)
PLUS audit and feedback
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TOPPS: Effect of the Intervention
100%
80%
60%
40%
20%
0
Hip Major general Medical Combined fracture surgery patients
79% 86%
43% 67% 31% 64% 49% 71%
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Markham Stouffville Data
100%
80%
60%
40%
20%
0
Hip Major general Medical fracture surgery patients
95%100%100%
15%
73%
60%
34%
80%
93%
Baseline audit
End of Phase 1
End of Phase 2
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Build it into
practice
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OSOS DVT Prophylaxis Module
Pharmacological Prophylaxis
If Creatinine less than 150 mol/L: Enoxaparin 40 mg Subcutaneous once daily
If Creatinine is 150 mol/L or greater: Enoxaparin 30 mg Subcutaneous once daily
OR
Mechanical Prophylaxis (Consider only if high bleeding risk)
GCS: Bilateral Graduated Compression (Antiembolic) Stockings
IPC: Bilateral Intermittent Pneumatic Compression (Sequential Compression Device)
with stockinettes
- If GCS or IPC ordered: use continuously on both legs except during bathing, walking
and TID skin care
- If only Mechanical Prophylaxis ordered reassess daily for change to Pharmacological
Prophylaxis
No DVT Prophylaxis Reason:
□ Patient on therapeutic anticoagulation
Other: ______________________________________
- Reassess DVT Prophylaxis daily if not ordered
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Involve everyone
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Emphasize
importance to
everyone
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Empower the
patient….
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What can YOU do to prevent blood clots? In General
1. Stay as active as possible
2. Don’t smoke or stop smoking if you do
3. Maintain a normal body weight
4. Be knowledgeable about blood clots
and educate your family and friends.
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Tying it all together…
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Multi-faceted VTE QI Initiative
Maynard – J Hosp Med 2010;5:
Support of administration
Consensus building with physician leaders
Multidisciplinary QI team
Simple risk assessment with preferred prophylaxis
Education - rounds
Mandatory use of standardized VTE prophylaxis modules in all admission/transfer order sets, CPOE
Random daily patient audits for adequate prophylaxis (~80/mo)
Real-time feedback to physicians and nurses if their patient had inadequate prophylaxis
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Hierarchy of Reliability
Level Activities Predicted
prophylaxis
rate
1 No protocol (“state of nature”) 40%
2 Decision support exists but is not linked
to order writing e.g. have a policy or
prompts but no decision support
50%
3 Protocol well-integrated into order sets
at point-of-care
65-85%
4 Protocol enhanced by other QI / high
reliability strategies
90%
5 Oversights identified and addressed
daily in real time (“measure-vention”)
95+%
Maynard - 2010
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What can YOU do to prevent blood clots in your patients?
1. Assess every patient for risk of VTE (surgery,
cancer, previous VTE, immobility, trauma,
medical illness, etc).
2. Ensure that every at-risk patient is receiving
prophylaxis.
3. Mobilize patients as much as possible.
4. Initiate or support efforts to implement and
standardize thromboprophylaxis – order sets.
5. Report suspected DVT or PE to staff.
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What can YOU do to reduce the burden of VTE?
1. Assess each of your in-patients for risk of VTE
and ensure they receive optimal prophylaxis.
2. Assess VTE risk and order prophylaxis for
patients you see in consult.
3. Initiate, lead or support efforts to develop and
implement a hospital-wide prophylaxis policy
based on the routine use of order sets.
4. Aim for 100% appropriate prophylaxis for
patients at risk.
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Reduces VTE morbidity
Saves money
Is standard of care for
most hospital patients
Thromboprophylaxis . . .
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Making the Hospital a Safer Place for Patients: Better
Prevention and Treatment of Blood Clots