and patient engagement: learning from the venous ... · and patient engagement: learning from the...

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

Thromboembolism ExampleElliott R. Haut, MD, PhD, FACS

Vice Chair of Quality and Safety,Associate Professor of Surgery & ACCM &

Emergency Medicine & Health Policy / Management

10/10/17 Center for Health Services and Outcomes Research (CHSOR) Seminar

@elliotthaut

• Deep Vein Thrombosis (DVT) • Pulmonary Embolism (PE)

What is Venous Thromboembolism (VTE) ?

What Causes Venous Thromboembolism (VTE)?

Hypercoaguability

Rudolf Virchow (1821-1902)

Why focus on VTE?

• VTE is common– 350,000 to 600,000

Americans suffer DVT and/or PE each year

http://www.surgeongeneral.gov/topics/deepvein/calltoaction/call-to-action-on-dvt-2008.pdf


Why focus on VTE?

• VTE is Deadly– >100,000 deaths per year

• More deaths than combined from– Breast Cancer– Motor Vehicle Collisions– AIDS



Johns Hopkins DVT Symposium 2009

Risk Factors for VTE

• Age• Cancer• Chemotherapy• Previous DVT/PE• Trauma• Major surgery• Hospitalization• Thrombophilia• Pregnancy

• Hormone therapy• Family history of VTE• Recent Stroke• Cardiac disease• Respiratory disease• Infection• Immobility > 3 days• Varicose veins• Obesity

Why focus on VTE?

• Increases cost– Increased per patient, per event cost

estimates vary• $11,930 (Spyropoulos)• $15,941 (Lefebvre)

– Annual direct costs > $250 million annually for venous stasis/ulcer alone

• $7-10 billion total yearly cost the USSpyropoulos 2002, Lefebvre 2012, Ashrani 2009, Heit 2001, Grosse 2016

Why focus on VTE?

• VTE is (mostly) preventable

VTE Should NOT be Considered a “Never Event”

• Not ALL events are preventable

• VTE occurs even in patients receiving best practice prophylaxis

• 8 RCTs of VTE Prophylaxis in Joint Replacement Surgery (4 TKA, 4 THR)– 0.3%-2.5% Symptomatic VTE

Streiff & Haut, JAMA 2009

Evidence BasedVTE Prophylaxis Guidelines

• American College of Chest Physicians (ACCP)

• Eastern Association for the Surgery of Trauma (EAST)

• American Academy of Orthopedic Surgeons (AAOS)

• American College of Obstetricians and Gynecologists (ACOG)

• American College of Physicians (ACP)

DVT Prophylaxis is Vastly Underutilized!

• 68,183 patients• 358 hospitals in 32 countries• Prophylaxis

• 58.5 % compliance - surgical patients• 39.5 % compliance - medical patientsCohen, Lancet 2008

DVT: Advancing Awareness to Protect Patient Lives

American Public Health Association (APHA)White Paper 2003

Agency for Healthcare Research and Quality (AHRQ)

www.ahrq.gov

http://www.ahrq.gov/research/findings/evidence-based-reports/services/quality/ptsafetysum.pdf

• “Strategies to increase appropriate prophylaxis for VTE” included on list of top 10 “Strongly Encouraged Patient Safety Practices”

http://www.ahrq.gov/research/findings/evidence-based-reports/patientsftyupdate/ptsafetyIIchap28.pdf

Surveillance Bias and Public Reporting of VTE

@elliotthaut

How did I get interested in VTE?

• Adult Trauma Performance Improvement• Paraphrased letter we received• Dear Johns Hopkins Adult Trauma• You have the highest DVT rate of all

Trauma Centers in Maryland• Why?• Sincerely, Maryland Institute for

Emergency Medical Services Systems (MIEMSS)

A New Research Idea is Born

• Johns Hopkins screens aggressively• What do other trauma centers do?• Does this impact reported DVT rates?

Conflict Regarding Duplex Screening for asymptomatic DVT

• Conflicting data on efficacy and cost-effectiveness of duplex screening of asymptomatic trauma patients

• Pro: Identify DVT early allowing treatment before fatal PE

• Con: Large expense, not cost effective, harm from anticoagulation

Should we Screen High-Risk Trauma Patients for DVT?

Conflicting Guidelines

vs.

Rogers, J Trauma 2002Gould, CHEST 2012

Eastern Association for the Surgery of Trauma (EAST) Guideline

• “Serial duplex ultrasound imaging of high-risk asymptomatic trauma patients to screen for DVT may be cost-effective and decrease the incidence of PE.”

http://www.EAST.org/resources/treatment-guidelinesRogers, J Trauma 2002

American College of Chest Physicians (ACCP) Guidelines

• “For major trauma patients, we suggest that periodic surveillance with venous compression ultrasonographyshould not be performed (Grade 2C).”

Gould, CHEST 2012

0

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Before (1995-1997) After (1999-2005) DVT

/PE

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Before Vs. After Periods

Duplex DVT PE

Single Center (JHH)- Duplex & DVT ratesBefore v. After Screening Guideline

82

0.721

* **7

p<0.0001p=0.0024Haut, J Trauma 2007

Multi-Center (NTDB)- Hospital LevelDuplex & DVT rates

• Trauma centers with higher rates of duplex ultrasound report higher DVT rates to the National Trauma Data Bank

Pierce, J Trauma 2008

The More We Look, The More We Find

Pierce, Haut, et al. J Trauma 2008

7-fold higher DVT rate at hospitals in top quartile of duplex ultrasounds

Pierce, J Trauma 2008

Hospital Screening Status is an Independent Risk Factor for DVT Reporting

Haut, J Trauma 2009

Variability in Trauma Surgeons Opinions of DVT Screening

• AAST/EAST member survey• 317 individual trauma surgeons

Haut, J Trauma 2011

A Classic Example ofSurveillance Bias

• Providers who screen more aggressively by performing more duplex ultrasounds may identify more cases of DVT and appear to provide worse quality of care than those providers who order fewer tests

Haut & Pronovost, JAMA 2011

Implications

Variability in DVT

Screening

Variability in DVT Rates

Reported

Biased DVT

Rates


“We’ll just use the test results anyway because it’s the only data we have”

http://dilbert.com/strips/comic/2010-11-07

Defining Preventable HarmThe VTE Example

• We suggested that “performance measures could link a process of care with adverse outcomes when defining incidences of preventable harm”


Preventable Harm =VTE + No Prophylaxis

We Talked

• Centers for Medicare & Medicaid Services listened

We Talked

• Financial incentives for the “meaningful use” of certified EHR technology to improve patient care

“Meaningful Use” Quality Reporting Criteria Related to VTE

•“Meaningful Use” of Electronic Health Record (EHR) Technology

–VTE1 Prophylaxis within 24 hours of arrival–VTE2 ICU VTE Prophylaxis –VTE3 Anticoagulation Overlap Therapy –VTE4 Platelet Monitoring on UFH–VTE5 VTE Discharge Instructions–VTE6 Incidence of Potentially Preventable VTE

https://www.cms.gov/EHRIncentivePrograms/30_Meaningful_Use.asp

“Meaningful Use” Definition of Potentially Preventable VTE

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

Surveillance Bias in VTE Reporting in Surgery

Bilimoria, JAMA 2013


• 2,786 hospitals• 954,526 Medicare patients >=65 years• 11 major operations

– AAA, CABG, craniotomy, colectomy, cystectomy, esophagectomy, gastric bypass, lung resection, pancreatic resection, proctectomy, total knee arthroplasty


Public Reporting for VTE is a Moving Target

• What is the optimal approach to public reporting of VTE??

Bilimoria KY. JAMA 2015 x2 commentaries

No Association Between Hospital-Reported Perioperative VTE Prophylaxis and Outcome Ratesin Publicly Reported Data

JohnBull,JAMA-Surg 2014

• 3040 hospitals• Median prophylaxis

performance = 94.5% • The median risk-

adjusted VTE rate was 4.13 per 1000 surgical discharges

Process

Hospitalsreporting 100% perfect

VTE prophylaxis performance(n = 141)

Hospitalsin the bottom quintile

of prophylaxis performance(n = 618)

JohnBull, JAMA-Surg 2014

Nearly identical median VTE outcome rates(4.18 vs. 4.17; P = .98)

vs.

No Association Between Hospital-Reported Perioperative VTE Prophylaxis and Outcome Ratesin Publicly Reported Data

Public Reporting for VTE is a Moving Target

• In 2017, VTE-1 and VTE-2 are electronic clinical quality measures (eCQM) available for selection by hospitals to meet hospital accreditation program requirements for eCQMs.

• VTE-6 is the lone remaining measure required for chart abstracted measures.

The American College of SurgeonsInspiring Quality Tour: Lessons Learned

http://www.facs.org/quality/lessons-learned.pdf

Can a Systems Approach Improve VTE Prevention and Outcomes

@elliotthaut

What approaches can improve VTE prophylaxis ?

• “Passive dissemination of guidelines is unlikely to improve VTE prophylaxis practice.”

• “A number of active strategies used together, which incorporate some method for reminding clinicians to assess patients for DVT risk and assisting the selection of appropriate prophylaxis, are likely to result in the achievement of optimal outcomes.”

Tooher, A Systematic Review of Strategies to Improve Prophylaxisfor Venous Thromboembolism in Hospitals. Ann Surg 2005.

Improving VTE Prophylaxisat The Johns Hopkins Hospital

Streiff, BMJ 2012

Streiff, BMJ 2012

Improving VTE Prophylaxis at

The Johns

Hopkins Hospital

Paper Order Sets

Improving VTE Prophylaxisat The Johns Hopkins Hospital

• Mandatory VTE risk stratification tool into the computerized provider order entry (CPOE) system

• Advanced computerized clinical decision support (CDS)

Streiff, BMJ 2012

Parent order set

Different Order Sets have Different VTE Modules. Use is Mandatory in POE workflow.

General Surgery VTE ProphylaxisAny CONTRAINDICATIONS to

pharmacologic prophylaxis? High risk of bleeding Active bleeding

Systemic anticoagulation INR ≥ 1.5 or aPTT ratio ≥ 1.3 Platelet count < 50,000

Yes

TEDs/SCDsUse mechanical prophylaxis

until contraindication no longerpresent. Review patient status daily

Any Minor VTE risk factors? Acute Infection/Sepsis

Bed rest Central venous catheter

Estrogens/Selective estrogen receptor modulators (e.g., Tamoxifen)Inflammatory bowel disease

Moderate Risk VTE Orders

Heparin 5000 units sc q12h(Give first dose 2 hrs. pre-op

and then beginning 12-24 hours post-op)

With option to ADD TEDs/SCDs

Very high risk VTE orders Heparin 5000 units sc q8h(Give first dose 2 hrs. pre-op


PlusTEDS/SCDs

Yes

No

Very high risk VTE ordersHeparin 5000 units sc q8h

(Give first dose 2 hrs. pre-op and thenbeginning 12-24 hours post-op)

PlusTEDS/SCD

Enoxaparin 40mg sc qDay(First dose 2 hours pre-op and then

12-24 hours post-op)(Remove epidural catheter at nadir (20-22 hrs.) of anticoagulant effect and wait at least 2 hours

after catheter removal to redose)Plus

TEDS/SCDs

No

Yes

Creatinine clearance < 30 ml/min or

unstable renal function (potential for CrCl to

Decline below 30ml/min during therapy)

Any Major VTE risk factors? Previous VTECancer

Thrombophilia Prolonged procedure (> 2 hrs.)NYHA Class III/IV Heart FailureRespiratory failure requiring mechanical ventilation

Acute Stroke with paresis (< 3 mos.) Pregnancy/post-partum (up to 6 weeks)

No

Age > 60?

Yes

Age ≥40?

No

High risk VTE orders

Heparin 5000 units sc q8h(Give first dose 2 hrs. pre-op


With Option to add TEDS/SCD

No

Yes

No

Yes

Any CONTRAINDICATIONS topharmacologic prophylaxis? High risk of bleeding Active bleeding


No

TEDs/SCDsUse mechanical prophylaxis

until contraindication no longerpresent. Review patient status daily

YesAny CONTRAINDICATIONS to

pharmacologic prophylaxis? High risk of bleeding Active bleeding


Yes

No

Mandatory choice from each section for risk factors and contraindications

Benefits of the Computerized VTE Prevention System

• Puts VTE prevention into the work flow• Enables rapid, accurate risk stratification

and risk-appropriate VTE prophylaxis• Applies evidence directly to clinical care• Allows for performance monitoring/reporting

Streiff, BMJ 2012

Keys to Success

• Multidisciplinary team– Physicians, Nurses, Pharmacists, Informatics

• Leadership buy-in• Collaborate with service teams• Educate front-line providers• Measure baseline performance• Conduct ongoing performance evaluations

Streiff, BMJ 2012

Does Improving Prophylaxis Change Outcomes?

•YES

•2 examples–Johns Hopkins Trauma Surgery–Johns Hopkins Internal Medicine

Does Improving Prophylaxis Change Outcomes? The JHH Trauma Example

Haut, Arch Surg 2012


• Single Center (Johns Hopkins Hospital)• Pre/Post Intervention Study• 1-year PRE vs. 3-years POST• Retrospective data collection• IRB approved


• Significantincrease in VTE prophylaxis

• Significant drop in preventable harm from VTE• 1.0% vs. 0.17%

(p=0.04)


62.2%

84.4%


Does Improving Prophylaxis Change Outcomes? The JHH Medicine Example

Zeidan, Am J Hematology 2013


• Retrospective Review (PRE v. POST)• Patients : 1,000 PRE v. 942 POST• Patients prescribed Optimal Prophylaxis

– 65.6% v. 90.1% (p<0.0001)• Patients prescribed NO prophylaxis

– 23.6% v. 4.4% (p<0.0001)



ZERO Preventable VTE –A Realistic Goal

VTE Prophylaxis-Computerized Decision Support

66www.natfonline.org

www.AHRQ.gov 2015

Improving VTE Prophylaxis Administration with Targeted Performance Feedback

@elliotthaut

The Role of Health Informatics

• Harness the power of analytics• Bringing performance data to individual

providers and units• Can competition drive improvements?

Trauma Attending & Resident Prophylaxis

Lau, JAMA-Surg 2015

42 residents at 100%

7 residents at 0%

87.7%Sept

93.3%October

96.3%November

Lau, Ann Surg 2016

Surgery Resident Feedback Improves VTE Prophylaxis

Quality Improvement can Lead to Fundable Research

• 5-year R01 grant• AHRQ• “Individualized

Performance Feedback on Venous Thromboembolism Prevention Practice”

Missed Doses of VTE Prophylaxis

@elliotthaut

A Big Assumption

• As physicians, we assume that medication orders we place are consistently delivered

• But is that truly the case?• Does prescription = administration?

Steps to Optimal Pharmacologic VTE Prophylaxis

Provider Prescription

Nurse Administration

Patient Acceptance

Do Missed VTE Prophylaxis Doses Matter?

• Methods• Retrospective analysis• 202 trauma and general surgery patients ordered

enoxaparin• Results

• Overall incidence of DVT = 15.8%• 58.9% of patients missed >=1 dose• DVT compared missed vs. no missed doses

• 23.5% vs. 4.8% (p < 0.01)

Louis, JAMA Surgery 2014

Haut, JAMA Surgery 2015

Do Missed VTE Prophylaxis Doses Matter?

• 92 VTE patients

• 39% missed >=1 dose of prophylaxis

Missed Doses of VTE Prophylaxis Medications at Johns Hopkins

• December 1, 2007 to June 30, 2008– >100,000 doses– 12% of doses not administered

• Patient refusal most frequent (~60%) documented reason

Shermock, PlosOne 2013

Shermock, PlosOne 2013

Missed Doses are Clustered Within Floors

What’s the Real Story Behind Missed Doses?

• “Hidden Barriers to Delivery of Pharmacologic Venous Thromboembolism Prophylaxis”

• Mixed methods study (quantitative/qualitative)– Quantitative Nursing survey– Qualitative observations of nurse/patient

interaction– Focus groups with nurses

Elder, Journal of Patient Safety epub 2014

What’s the Real Story Behind Missed Doses? - Quantitative

• “I have the clinical knowledge and experience to determine if it is necessary to administer DVT/PE prophylaxis injections to patients.”– AGREE 87%/79% medicine/surgery

• “Nurses use their clinical decision-making skills to determine when to omit unnecessary doses of prescribed DVT/PE prophylaxis injections for each individual patient”– AGREE 80%/50% medicine/surgery


Is VTE Prophylaxis Optional?

• “I push harder for my patients to accept heparin [prophylaxis] if they have, like, sickle cell disease, as opposed to say pneumonia or something where they are just here for [IV] antibiotics.”

• “Sometimes, if it is the middle of the night and [LDUH] is the only medication I have to give a patient, I won’t wake them up just to give VTE prophylaxis.”


The Ambulation Myth

• “We make the clinical decision all the time as to whether a patient needs VTE prophylaxis every day, based on how much the patient is ambulating.”

• “Hey Ms. R, it’s time for your heparin dose, but as long as I see you up, high-fiving me in the hallways, we can hold off for now.”


Our PCORI Project

• Preventing Venous Thromboembolism: Empowering Patients and Enabling Patient-Centered Care via Health Information Technology

http://www.pcori.org/research-in-action/improving-patient-nurse-communication-prevent-life-threatening-complication

Our PCORI Objectives

• 1) Enable patients to make informed decisions about their preventive care by improving the quality of patient-nurse communication about the harms of VTE and benefits of VTE prophylaxis

• 2) Empower patients to take an active role in their VTE preventive care

• 3) Identify and facilitate active engagement of patients who are not administered doses of VTE prophylaxis using a real-time escalating alert


Our PCORICollaborators / Key Stakeholders

Patient and Family Advisory Council


PCORI Website “Research in Action”

http://on.wsj.com/1M18Aqu

http://on.wsj.com/1M18Aqu

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

@elliotthaut

Lau, PLoS ONE 2017

Methods

• Partnered with Central Nursing Education to build two educational programs in the MyLearning platform

• Static : Linear static education to cover point-by-point general concepts

Lau, PLoS ONE 2017

Static PowerPoint Slides With Voice Over

Lau, PLoS ONE 2017

Methods

• Partnered with Central Nursing Education to build two educational programs in the MyLearning platform

• Static: Linear static education to cover point-by-point general concepts

• Dynamic: Learner-centric interactive scenario-based dynamic education

Lau, PLoS ONE 2017

Learner centric scenario based

Methods

• Cluster Randomized Trial– 10 surgery floors– 11 medicine floors– All nurses on a specific floor were assigned either

Static or Dynamic Education• Administered satisfaction survey to compare

perceptions of education delivery after completions

• Primary Outcome - Dose Administration

Lau, PLoS ONE 2017

Nurse Education TrialPrimary Outcome- Dose Administration

• Overall, non-administration improved significantly following education

• 12.4% vs. 11.1% (p=0.002)

• Conditional OR 0.87, 95% CI (0.80-0.95)

Lau, PLoS ONE 2017

Nurse Education Trial

89.0%

82.0%

67.8%

58.8%

78.8%

94.0%*

88.8%*

78.1%*80.9%*

90.3%*

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

This course directlyapplies to my

practice

This course will helpme to communicate

better about theimportance of VTE to

my patients

I enjoyed thislearning intervention

I found this courseengaging

This course providedthe right level ofinformation and

resources

Static

Dynamic

Lau, PLoS ONE 2017

Kirkpatrick’s Learning Evaluation Theory

← They like it

← Module completion

← VTE events

← Missed doses

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

@elliotthaut

Modified Delphi Method

• Iterative process involving surveys, feedback and revisions

• Engaged patients and family members• Recruited via email and/or social media

(websites, Facebook, Twitter) through respective organizations

• > 400 respondents

Popoola, PLoS ONE 2016

What Do Patients Want?

Popoola, PLoS ONE 2016

What Do Patients Want?

Patient VTEEducation Bundle

@elliotthaut

What Do Patients Want?Paper Form (2-pages)

They spoke, we listened

• www.hopkinsmedicine.org/armstrong/bloodclots

http://www.hopkinsmedicine.org/armstrong/bloodclots

Easy to Find in Hopkins Policies Online (HPO)

• Top of the list when searching– “VTE”– “DVT”– “PE”– “Blood Clots”

Multiple Languages &Large Font

• Patients wanted- 10 minute video- Physicians, nurses and patients talking

• Screened for JHH PFAC- Changes based on group feedback

They spoke, we listened

What Do Patients Want?Video

http://bit.ly/bloodclots


http://bit.ly/bloodclotsVideo


Easy to Find in Public DomainOur VTE Prevention Website

• www.hopkinsmedicine.org/armstrong/bloodclots

http://www.hopkinsmedicine.org/armstrong/bloodclots

• Real time alert of dose non-administration from POE system via pager/email

• Patient education bundle– Targeted education– Direct one-on-one discussion with nurse– Supported by paper handout and/or video

• Prospective Cohort Study– April 2015 thru December 2015 (8 months)

What Do Patients Want?Patient Education Intervention Project

Acknowledgements

Changing Practice is a Team Effort

@elliotthaut

CDC Healthcare-Associated VTE Prevention Challenge Champions

Research Collaborators

• Johns Hopkins VTE Collaborative• Streiff, Hobson, Kraus, Lau, Shermock,

Shaffer, Shihab, Carolan, Zeidan, Popoola, Aboyage, Owodunni, Florecki, Welsh

• Armstrong Institute• Pronovost, Berenholtz, Demski, Holzmueller,

Michtalik

Collaborators from Surgery

• Division of Acute Care Surgery• Efron, Haider, Stevens, Chi, Rushing, Velopulos,

Cornwell, Schneider, Jones, Sakran, Mankayan

• Other Surgical Divisions/Departments• Colorectal, Surg Onc, Vascular, Pediatrics,

Transplant, Urology, Ortho, Neurosurgery

• Other Surgical Faculty• Gearhart, Wick, Efron, Safar, Lidor, Pawlik, Weiss,

Wolfgang, Freischlag, Black, Abdullah, Stewart, Colombani, Segev

Streiff, J Hosp Med 2016

VTE and Trainee Mentoring

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

Trainees

• Surgery Residents• Weiss, Hayanga, VanArendonk, Howley,

Kodadek, Arnaoutakis, Poruk, Beaulieu, Ellison• Trauma/Acute Care Surgery Fellows

• Garcia, Velopulos, Koenig, Kieninger, Leeper, Feinman, Yanagawa, Dultz, Kent

• Medical Students• Dat, Boelig, JohnBull, Farrow, Ray-Mazumder

• Pharmacy Residents• Elder, Newman, Wong, Piechowski

Bloomberg JHSPH Trainees / Collaborators

• JHSPH students• Pierce, Kardooni, Kraenzlin, Rosenberg,

Aboagye, Shrestha, Lucas, Nastasi, etc.• JHSPH faculty

• MacKenzie, Yenokyan, Sugar, Diener-West• Evidence Based Practice Center

• Segal, Singh, Brotman, Kebede

@elliotthaut (Twitter)[email protected] (email)

• Hopkins VTE Website (with paper forms)– http://www.Hopkinsmedicine.org/Armstrong/bloodclots

• Patient Education Video– http://bit.ly/bloodclots

• PCORI Research in Action– http://www.pcori.org/research-in-action/improving-

patient-nurse-communication-prevent-life-threatening-complication

mailto:[email protected]

http://www.hopkinsmedicine.org/Armstrong/bloodclots


and patient engagement: learning from the venous ... · and patient engagement: learning from the...

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