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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, post-
  thrombotic syndrome, chronic PAH)
     Surgeon General’s Call to Action to Prevent DVT and PE 2008 DHHS
            Risk Factors for VTE

Stasis           Hypercoagulability                       Endothelial
Age > 40         Cancer                                   Damage
Immobility       High estrogen states                     Surgery
CHF              Inflammatory Bowel                       Prior VTE
                                                          Central lines
Stroke           Nephrotic Syndrome
                                                          Trauma
Paralysis        Sepsis
Spinal Cord      Smoking
   injury        Pregnancy
Hyperviscosity   Thrombophilia
Polycythemia
Severe COPD
Anesthesia
Obesity
Varicose Veins
                           Anderson FA Jr. & Wheeler HB. Clin Chest Med 1995;16:235.
            Risk Factors for VTE

Stasis           Hypercoagulability                            Endothelial
Age > 40         Cancer                                        Damage
Immobility       High estrogen states                          Surgery
CHF              Inflammatory Bowel                            Prior VTE
                                                               Central lines
Stroke           Nephrotic Syndrome
                                                               Trauma
Paralysis        Sepsis
Spinal Cord      Smoking
   injury        Pregnancy
Hyperviscosity   Thrombophilia
Polycythemia
Severe COPD
Anesthesia
Obesity
Varicose Veins         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
     –     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
                                    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


                                                      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. 2005;352:969-977.
                                  E-Alerts Decrease VTE
                 % Freedom from DVT/ PE   100


                                          98


                                          96                                     Intervention

                                          94
                                                                                                      41%
                                          92                                         Control        P = 0.001

                                          90

                                                0      30                   60                 90

        Number at risk                                      Time (days)

       Intervention                             1255   977                900            853

       Control                                  1251   976                893            839


Kucher N, et al. N Engl J Med. 2005;352:969-977.
             Effectiveness can wane over time
       VTE Incidence/1000 Patients



                                     4.5
                                       4                        *P < 0.05
                                     3.5                                      2005 (pre-
                                       3                                      intervention)
                                     2.5                                      2006
                                       2
                                     1.5                    *                 2007
                                       1
                                     0.5
                                       0
                                           Overall   Medical       Surgical
                                                     Patients      Patients


Lecumberri R, et al. Thromb Haemost. 2008;100:699-704.
                       Human Alerts Increase
                           Prophylaxis
               • 2493 hospitalized patients
               • VTE risk score ≥ 4
               • Randomized to intervention or control

                                                           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. 2009;119:2196-2201.
           Human Alerts Decrease VTE
                  % Freedom from DVT/ PE




                                                                      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 ≠ 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
                   Percent of Randomly Sampled Inpatients with
                            Adequate VTE Prophylaxis
UCSD experience                            N = 2,944              mean 82 audits / month
100%

  90%

  80%                                                                                                      Real time ID &
                                                                                                           intervention
  70%                                                            Order Set Implementation
                                                                 & Adjustment
  60%

  50%
                                     Consensus
  40%                                building
             Baseline
  30%

  20%
         5




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                    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             Oversights identified and addressed in real time                                95+%
           14

                12

                10                                                                                             Medicine
# of Patients




                 8                                                                                             Surgery
                                                                                                               Ortho
                 6
                                                                                                               Other
                 4                                                                                             Total

                 2

                 0
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                                                              Quarter                                                  21
                               Hospital Acquired VTE by Year
                                   2005           2006                                                           2007         2008
               Patients at Risk         9,720                                                      9,923         11,207

           Cases w/ any VTE             131                                                          138            92        80




                                                   Dr. Maynard, the CIs are different here and
             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)

               Cases with PE              21                                                          22            15        12




                                                   in the proof. Which are correct?
                  Risk for PE          1 in 463                                                    1 in 451      1 in 747
               Unadjusted RR              1.0                                                        1.02          0.62
                     (95% CI)                                                                    (0.54-1.86)   (0.32-1.20)

  Cases with DVT (and no PE)            110                                                          116            77        68
                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)

    Cases w/ Preventable VTE              44                                                          21             7         6
     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 < 0.01 *p < 0.001
Maynard GA, et al. J Hosp Med. 2009;
          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
  Level                                                                    rate
   1    No protocol* (“State of Nature”)                                  40%

    2       Decision support exists but not linked to                     50%
                order writing, or prompts within orders
                but no decision support
    3       Protocol well-integrated                                      65-85%
                (into orders at point-of-care)
     4      Protocol enhanced                                             90%
                 (by other QI / high reliability strategies)
    5       Oversights identified and addressed in                        95+%
                real time
* 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 ≠ 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
                  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      CHF                          Elective LE arthroplasty
with no other   COPD / Pneumonia             Hip/pelvic fx
risk factors.   Most Medical Patients        Acute SCI w/ paresis
Same day or
minor surgery   Most Gen Surg Patients       Multiple major trauma
                Everybody Else               Abd / pelvic CA surgery

Early           UFH 5000 units q 8 h         Enox 30 mg q 12 h or
ambulation      (5000 units q 12 h if > 75   Enox 40 q day     or
                or weight <50 kg)            Other LMWH       or

                LMWH                         Fondaparinux 2.5 mg q day
                  Enox 40 mg q day           or
                  Other LMWH                 Warfarin INR 2-3
                                             AND MUST HAVE
                CONSIDER add IPC
                                             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
  Level                                                                    rate
   1    No protocol* (“State of Nature”)                                  40%

    2       Decision support exists but not linked to                     50%
                order writing, or prompts within orders
                but no decision support
    3       Protocol well-integrated                                      65-85%
                (into orders at point-of-care)
     4      Protocol enhanced                                             90%
                 (by other QI / high reliability strategies)
    5       Oversights identified and addressed in                        95+%
                real time
* 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”
                                            100%
                                                                                                                                                                  Effect of Situational Awareness on
                                             90%
                                                                                                                                                                  Prevalence of VTE Prophylaxis by
                                                                                                                                                                              Nursing Unit
            Prevalence of VTE Prophylaxis


                                             80%
                                             70%
                                             60%                                                                                                              Hospital A, 1st Nursing Unit
                                             50%
                                                                          Intervention                                                                              Baseline   Post-Intervention
                                             40%
                                                                                                                                                           UCL:      93%         104%
                                             30%
                                             20%                                                                                                           Mean:      73%         99% (p < 0.01)
                                             10%                                                                                                           LCL:       53%         93%
                                              0%
                                                   1   6   11   16   21   26   31   36   41   46   51   56   61   66   71   76   81   86   Hospital Days

                                            100%
                                            90%
                                                                                                                                                              Hospital A, 2nd Nursing Unit
Prevalence of VTE Prophylaxis




                                            80%
                                            70%
                                                                                                                                                                    Baseline   Post-Intervention
                                            60%                                                                                                            UCL:       90%        102%
                                            50%                                                                                                            Mean:       68%        87% (p < 0.01)
                                            40%
                                            30%
                                                                                     Intervention                                                          LCL:        46%        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


                                            100%
                                                                                                                                                              Hospital B, 1st Nursing Unit
                                            90%
  Prevalence of VTE Prophylaxis




                                            80%
                                                                                                                                                                    Baseline   Post-Intervention
                                            70%                                                                                                            UCL:       89%        108%
                                            60%                                                                                                            Mean:       71%        98% (p < 0.01)
                                            50%
                                                                                                                                                           LCL:        53%        88%
                                            40%
                                                                                                                                 Intervention
                                            30%
                                            20%
                                            10%
                                                                                                                                                           _______________________
                                             0%                                                                                                            UCL = Upper Control Limit        45
                                                   1   6   11   16   21   26   31   36   41   46   51   56   61   66   71   76   81   86   91   96 101
                                                                                                                                                           LCL = Lower Control Limit
   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 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
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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