Duke Cardiovascular CERTs

Concept

Outcomes

Clinical

Trials

Guidelines

Performance

Indicators

Measurement

Provider Led

Quality Improvement

Safe, Effective,

Long-term Use

Purpose of CERTs

2

• Agency for Healthcare Research and Quality (AHRQ)

Centers for Education and Research on Therapeutics

(CERTs) Program.

“To conduct research and provide education that will advance

the optimal use of drugs, medical devices, and biologic

products; with the ultimate vision of improving outcomes”

• Duke first awarded-1999-2002

– Renewed in: 2002-2007

– Renewed in 2007-2011

– Renewed in 2011-2016!!

Duke CV CERTs Aims

The specific aims of our past CERTs:

1. Promote the optimization of CV registries as national

surveillance systems

2. Identify barriers to the translation of evidence for CV

therapeutics into routine practice

- MD use

- Patient longitudinal adherence

3. Rigorously evaluate provider- and patient interventions

designed to improve safe and effective use

4. Widely disseminate effective interventions

5. Train the next generation of CV outcomes researchers

3

4

https://dukecerts.dcri.duke.edu/folder3

Duke Cardiovascular CERTs

CERTs: ACS

Karen P. Alexander, MD

Safety of ACS Care

Excessive Antithrombotic Dosing

12.5

28.7

8.512.5

3733.1

16.5

38.5

64.5

0

10

20

30

40

50

60

70

LMW Heparin UF Heparin GP IIb/IIIa

% E

xcessiv

e D

ose

< 65 yrs 65-75 yrs >75 yrs

Alexander KA, et al. JAMA 2005;294:3108-3116

Safety Matters!

Major Bleeding Risks with Excess Dosing

1.40 (1.12, 1.75)

1.09 (0.99, 1.26)

1.38 (1.12, 1.70)

2.02 (1.51, 2.69)

1.42 (1.16, 1.73)

Both Excessive

LMWH

UF Heparin

GP IIb/IIIa inhibitor

One Excessive Agent

Adjusted* Odds of Major Bleeding

1 2 0

Excess v. Recommended

*Adjusted for age, sex, SBP, CHF, renal insufficiency

Alexander KA, JAMA 2005

Failure to Individualize Care: Weight and Dosing

Unfractionated Heparin Bolus by Weight in Kg

Melloni, Circulation 2007; Am Heart J 2008

Registry SITES

STANDARD QI FEEDBACK Individualized GAP Analysis

Top 3 Quality or Safety Targets

Targeted Data Reports

Educational Modules and QI Tools

EVALUATION

• Composite Metrics of Quality and Safety

• Benchmarks Achieved

• Surveys assessing implementation and usability

Personalized And Targeted QI

Target Metric Distribution

0

5

10

15

20

25

30

35

40

45

50

ASA 24 BB 24 BB dc ASA dc Clop dc ACE dc Statin

dc

Smoke

dc

Rehab

dc

EKG

10min

LDL

inhosp

UFH

dose

LMWH

dose

GP

dose

NST AP

24

NST AT

24

ST

reper

D2N 30 D2B 90 D2B tx

120

# h

osp

ita

ls S

ele

cte

d fo

r Ta

rge

t M

etr

ic

Based on 2006 AHA/ACC MI Performance Measures; 2007 ACC/AHA class 1 NSTEMI recommendations

Personalized Report

Timeline

Q4/08

2009

Q1/09

2010 2011 Data

Analysis RAND

6/09 9/09 11/09 3/10 7/10 1/11

Q2/09 Q3/09 Q4/09 Q1/10 Q2/10 Q3/10 Q4/10 Q1/11

WEBINARS

Discharge Meds,

Reperfusion, Dosing, Reports

PI Consult: Dosing

Circ QCO 2011;4;129-135

Primary Outcome • Composite of all 18 metrics; hospital level performance score (%) (=

all the achievements / all the opportunities*100)

• Adjusted for baseline performance

• Intervention % achievement = 0.0004 higher; P = 0.96

• Delta pre, post; P=0.98

Intervention Control

Implementation Research QI Culture Survey

• 100 of 124 sites responded

• Providers

– 61% open model, 31% closed model

– 26% ≥30 MD, 44% 11-29 MD, 25% ≤10 MD

– 21% one MD group, 28% ≥4 MD groups

• Processes

– Order Entry: 60% computer

– Standing Orders (92% admission, 65% discharge)

– Pharmacy Review (93%)

CERTs: Improving

Longitudinal Stroke Care

and Prevention

Cheryl Bushnell, MD, MHS

DaiWai Olson, PhD RN

Eric Peterson, MD, MPH

Aims of this Project

• To evaluate patient, provider and system factors that affect

use of evidence-based stroke treatments and patient

outcomes

• To develop and test a coaching intervention to improve

education and communication between healthcare providers

and stroke patients and measure impact on longitudinal

medication persistence

• To identify factors associated with shorter door to needle

time for patients with acute ischemic stroke

17

Adherence eValuation After Ischemic

stroke Longitudinal study

AVAIL

AHA

GWTG

BMS-Sanofi

CERTS

AVAIL: Project Overview

• Longitudinal, observational study examining:

– Medication persistence at 3 months and 1 year • Rates

• IF not, why not?

– Patient outcomes at 3 months and 1 year • Clinical events, mortality,

• Functional status (recovery, quality of life, depression

• Re-hospitalizations

AVAIL: Results

Self (N=2,222)

Proxy (N=500)

Proxy (N=572)

Self (N=2,077)

Total Enrolled N=3,001 El

Excluded

Baseline Sample N=2,879

7 Died before D/C

9 No GWTG match

Total completed 3-month

interview N = 2,722

Total completed 12-month

interview N = 2,649

6 Not sure Stroke

< 5%

L.T.F.

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

antiplatelet anti-HTN Lipid Low Diabetes overall

3 month 98.7% 92.6% 85.9% 87.4% 75.6%

12 month 87.2% 87.4% 77.0% 81.6% 65.1%

% p

ersi

sten

t AVAIL: 12 Month Persistence

By Medication Class

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

ASA ASA /

Dipyrid

Clopidogrel Warfarin

3 month 85% 67% 78% 82%

12 month 78% 56% 64% 67%

% p

ersi

sten

t

AVAIL: 12 Month Persistence Antithrombotics

0%

10%

20%

30%

40%

50%

60%

70%

PCP Neurology Cardiology Other None

0 -3 month 65% 40% 16% 8% 6%

3 -12 month 69% 30% 16% 7% 7%

% r

esp

on

din

g “

yes”

AVAIL: Type of Physician Seen

3 vs. 12 month follow-up

Factors Associated with

12 Month Persistence

Variable

Persistent

(n=1620)

Non-persistent

(n=837)

P-value

History of Hypertension 1203(81.2) 584 (77.0) 0.021

History of Dyslipidemia 746 (50.3) 331 (43.7) 0.003

No. of Meds at D/C – median (IQR) 6 (4-9) 7 (4-10) <0.001

Medicaid Insurance 100 (6.9) 67 (9.3) 0.047

Adequate Income to Meet Needs 950 (68.3) 404 (62.3) 0.023

3-month Persistence 1508 (93.1) 374 (44.7) <0.001

Appointment with Neurologist 701 (43.3) 293(35.0) 0.020

# of MDs seen after discharge 106 (5.7) 51 (8.4) 0.0018

Received Inpatient Rehab 217 (13.4) 181 (21.6) <0.0001

Modified Rankin Scale Score >=3 449 (27.7) 315 (37.6) <0.001

Patient-Related Factors

and Persistence Persistent Non-persistent P-value

Understand WHY Meds Taken 1363 (95.6) 617 (92.5) 0.012

Understand Med Side Effects 1167 (81.9) 505 (75.7) 0.002

Overall Satisfaction w/ HCP

Communication (good, vg, excellent)

1237 (93.4)

534 (88.6)

0.0003

Paid caregiver helps track meds 74 (6.5) 88 (14.5) <0.0001

Use reminder tool to track meds 734 (64.6) 337 (55.5) 0.0002

PHQ-8 score (median, IQR) 3 (1-7) 4 (1-8) 0.0015

EQ5-D Quality of Life score,

median (IQR)

0.83 (0.76-1.00) 0.81 (0.71-0.86) 0.0003

Clinical Factors Associated with

12-month Persistence

Variable

Persistent

(n=1663)

Non-

persistent

(n=881)

P-value

Discharge Status* 0.0008

Home 1168 (70.2%) 547 (62.1%)

Rehab 378 (22.7%) 250 (28.4%)

Ambulatory status at d/c*

Non-ambulatory

Ambulate independently

61 (3.7%)

1149 (69.1%)

54 (6.1%)

554 (62.9%)

0.0019

NIHSS score, median (IQR)* 2.0 (1-5) 3.0 (1-7) <0.0001

Length of stay, median (IQR)* 3.0 (2-5) 4.0 (3-6) <0.0001

*Significant at 3 months

* Indicates variable was significant at 3 month preliminary analysis

AVAIL Results: Outcomes Death + rehosp

Adjusted model *

TIA

Not ambulating indep.

Hx: a-fib/flutter

Hx: prior stroke/TIA

Hx: CAD/prior MI

Hx: carotid stenosis

HR

1.19

1.19

1.25

1.37

1.30

1.31

95% C.I.

1.01 – 1.41

1.00 – 1.42

1.04 – 1.51

1.19 – 1.58

1.13 – 1.50

1.01 – 1.70

* Adjusted Cox Model

• Within 12-mos of discharge, nearly 40% of IS/TIA

patients were rehospitalized or died – 50% of these events occur in the first 3-months

• Stroke type, medical history, and medication

persistence factors influence outcomes after stroke/TIA. – Socioeconomic factors trended towards influence

– There was a trend towards an association between

socioeconomic factors and the outcome

• Identifying the factors associated with death or

rehospitalization may help target high risk patients for

interventions and more intensive follow-up care.

AVAIL: Conclusion

Bushnell C, Zimmer L, Schwamm L, Goldstein LB, Clapp-Channing N, Harding T,

Drew L, Zhao X, Peterson ED. The Adherence Evaluation after Ischemic Stroke

Longitudinal registry: Design, Rationale, and baseline characteristics. Amer Heart J

2009 March;157(3);428-435.e2.

Rodriguez D, Cox M, Zimmer L, Olson DM. Goldstein L, Drew L, Peterson ED,

Bushnell CB. (2011). Similar Secondary Stroke Prevention and Medication

Persistence Rates among Rural and Urban Patients. Journal of Rural Health.

(ePRINT). DOI: 10.1111/j.1748-0361.2010.00352.x.

Bushnell CD, Zimmer LO, Pan W, Olson DM, Zhao X, Meteleva T, Schwamm L,

Ovbiagele B, Williams L, LaBresh KA, Peterson ED, for the Adherence Evaluation

After Acute Ischemic Stroke-Longitudinal Investigators. (2010). Persistence with

stroke prevention medications 3 months after hospitalization. Archives of Neurology.

DOI: archneurol.2010.190 [pii]10.1001/archneurol.2010.190.

Bushnell CD, Olson DM, Zhao X, Pan W, Zimmer LO, Alberts MJ, Fagan S, Fonarow

GC, Frankel M, Johnston SC, Kidwell C, LaBresh KA, Ovbiagele B, Schwamm

LH, Peterson ED. Persistence with secondary prevention medications one year after

stroke: Results from AVAIL.

AVAIL: Publication List

Lopes RD, Shah BR, Olson DM, Zhao X, Pan W, Bushnell CD, Peterson ED.

Antithrombotic Therapy Use at Discharge and 1-Year in Patients with Atrial

Fibrillation and Acute Stroke: Results from the AVAIL Registry

El-Husseini NK, Laskowitz DL, Cox M, Olson DM, Pan W, Goldstein LB, Bushnell

CD, Peterson ED. Depression and the use of antidepressants at 3 and 12 months

post hospitalization in stroke and TIA patients in the AVAIL Study.

West A, Cox M, Zimmer L, Fedder W, Weber C, Peterson ED, Bushnell CD, Drew L,

Olson DM. An evaluation of stroke education in AVAIL registry hospitals.

Hawes J, Cox M, Zhao X, Olson DM, Duncan PW, Zorowitz R, Peterson ED,

Bushnell CD. Patterns of rehabilitation service use following acute ischemic stroke

and its association with 12-month rehospitalization: The AVAIL registry.

Olson DM, Bushnell CD, Cox M, Pan W, Zimmer L, Sacco RL, Fonarow GC,

Zorowitz R, LaBresh KA, Schwamm LH, Williams L, Goldstein LA, Peterson ED.

Death and rehospitalization following hospitalization for stroke or transient

ischemic attack: One year findings from AVAIL.

AVAIL: Publication List

Target Stroke

Survey of Strategies for Reducing Door-to-Needle Time

in Acute Ischemic Stroke

• Describe the use of specific strategies reported among

hospitals participating in Target: Stroke prior to

implementation of Target: Stroke initiatives

• Determine the association between each hospital

strategy and door-to-needle time, to determine which

strategies are associated with shorter door-to-needle

time and the magnitude of time difference.

32

Door-To-Needle in Acute Ischemic

Stroke Study: Project Overview

33

Part I

TARGET: Stroke

Prime Survey

Part II

Qualitative Study

“ID Times”

Final Instrument

Measures Concordance of factors

associated with lower DTN times.

Part III

Field Interviews

Part II:

34

Interviews

Structure Components

Define Domains Content Experts

Develop Questions

Pilot Test (20-30 sites)

Instrument Field Testing

TARGET: Stroke Domains

Refine

TARGET: Stroke Free-text responses

GWTG-Stroke Hospitals

TARGET: Stroke Hospitals

Qualitative Study “ID Times”

Target Stroke – Part II

Five Domains

1. Communication & Teamwork

2. Process

3. Organizational Culture

4. Performance monitoring & feedback

5. Overcoming barriers

Olson DM et al. A qualitative assessment of practices associated with shorter door-

to-needle time for thrombolytic therapy in acute ischemic stroke. J Neurosci

Nursing. 2011;43(6): 329-336.

Part III:

36

Field Interviews

300 Surveys

Univariate (adjusted for DTN)

TARGET vs GWTG

ANOVA High vs Low

(top 100 vs bottom 100)

Factor Analysis Prime Survey

Final Instrument Measures Concordance of factors associated

with lower DTN times.

GWTG Hospitals TARGET Stroke – participant

TARGET Stroke – not participant

Duke CERTS - Analysis

Completed by

Telephone

Interview

AVAIL: Acknowledgements

• Cheryl Bushnell MD MHS – Lead investigator

• Eric Peterson, MD, MPH - co-PI

• AVAIL Coordinating Team at DCRI:

– Louise Zimmer, MA, MPH, Project Leader

– Laura Drew, RN, BSN, Project Coordinator

– Wenqin Pan PhD, Statistician

– Xin Zhao MS, Statistician

– Margueritte Cox MS, Statistician

Bob, Judy, Sarah, Charlotte, Cindy, Mindy, Beth, Barbara,

Gavin, Mark, Tara, Leslie, Nancy, Marian, so many others…

CERTs: Efficient and

Equitable Use of ICDs for the

Prevention of Sudden

Cardiac Death Co-PI: Sana M. Al-Khatib, MD, MHS

Co-PI: Gillian D. Sanders, PhD

L. Curtis et al. JAMA 2007;298(13)1517-1524

Hernandez et al. JAMA 2007

Percentage of Respondents Making an

Appropriate Recommendation about an ICD

Al-Khatib et al. Ann Noninvasive Electrocardiol 2011

Regional Variations in Physicians’

Attitudes and Recommendations

Surrounding ICDs

• Independent of variations in physicians' attitudes towards ICDs, physicians in regions of low ICD use are not less likely to recommend ICDs in situations clearly supported by guidelines while those in regions of high ICD use are more likely to recommend ICDs to patients who might have limited benefit.

Matlock DD, Kutner JS, Emsermann C, Al-Khatib SM,

Sanders GD et al. J Card Fail 2011;17:318-324.

Extent of and Reasons for

Underutilization of ICDs

• Of the 542 potentially eligible patients identified, 224

(41%) did not have an ICD

• Female sex (OR=1.90; 95% CI, 1.28 to 2.81) and

increasing age (OR=1.07; 95% CI, 1.04 to 1.11) were

associated with a higher likelihood of not having an ICD

• After detailed chart review, of the 224 patients without an

ICD, 117 (52%) were ineligible for the device and 38

(17%) patients refused the device, resulting in only 69

(13%) patients eligible for an ICD who failed to receive

one

Allen LaPointe et al. Circ Cardiovasc Qual Outcomes 2011

Al-Khatib

An Educational Video to Improve

Racial Disparities in ICD Therapy Via

Innovative Designs (VIVID)

• Video intervention to increase patient knowledge and

decrease decisional conflict

– ? Improve engagement

– ? Reduce racial disparities in ICD use

• Evaluate racial concordance among subjects and video

participants.

– Lower decisional conflict?

– Greater ICD implantation

• So far: 54 patients enrolled at 5 Duke sites + Alamance

Cost Effectiveness of ICD Therapy in

Medicare Patients

Base Case

The Sudden Cardiac Arrest Thought

Leadership Alliance

SCATLA Publications

• Kong MH, Fonarow GC, MD, Peterson ED, Curtis AB,

Hernandez AF, Sanders GD, Thomas KL, Hayes DL, Al-

Khatib SM. Systematic review of the incidence of sudden

cardiac death in the United States. J Am Coll Cardiol

2011;57:794-801.

• Eapen ZJ, Peterson ED, Fonarow GC, MD, Sanders GD,

Yancy CW, Sears SF, Carlson MD, Curtis AB, Hall LL,

Hayes DL, Hernandez AF, Mirro M, Prystowsky E,

Russo AM, Thomas KL, Al-Khatib SM. Quality of care for

sudden cardiac arrest: proposed steps to improve the

translation of evidence into practice. Am Heart J

2011;162:222-231.

ICD/ SCD Acknowledgments

Eric Peterson, MD, MPH

Louise Zimmer, MA, MPH

ACC staff

Physicians who participated in the survey and

the videos

Everyone else who contributed to our projects

Patients

Adrian F. Hernandez, MD, MHS

Associate Professor of Medicine

Lesley H. Curtis, PhD

Associate Professor of Medicine

CERTS- Heart Failure

Outcomes Among Medicare HF Patients 65 and older

Curtis LH et al. Archives of Internal Medicine 2008; Dec

Medical Therapy and Quality of Care

HF with Reduced Ejection Fraction

Unadjusted HR:

0.65 (0.57-0.73)

Adjusted HR:

0.77 (0.68-0.87)

Survival EF ≥ 40%

Unadjusted HR:

0.87 (0.77-0.97)

Adjusted HR:

0.94 (0.84-1.07)

Hernandez AF et al J Am Coll Cardiol. 2009 Jan 13;53(2):184-92.

Device Therapy in Heart Failure

Adjusted Odds for an ICD*

Black female

White female

Black male

0 0.4 0.8 0.2

* Compared with white male

0.6 1.0

0.73

0.62

0.56

Shah, B. et al. J Am Coll Cardiol 2009;53:416-422

Variation in ICD Use

Rates of New or Planned

ICD Therapy for Eligible

HF Patients in GWTG-HF

Adjusted Odds for a CRT

All CRT

White women

vs. white men

New Implant Black

vs.White

0 0.4 0.8 0.2

* Compared with white male

0.6 1.0

0.45

0.51

0.89

New Implant

Others vs.White

Piccini, JP, et al. Circ. 2008;118(9):926-33.

0

5

10

15

20

25

1 7 13 19 25 31 37 43 49 55 61 67 73 79 85 91 97103109115121127133139145151157

NewCRT%

RegistrySite

Variation in CRT Use

Piccini, JP, et al. Circ. 2008;118(9):926-33.

Hospital rates of CRT

Implantation Among Patients

w/LVEF ≤ 35%

Heart Failure and Ventricular Assist Devices

Primary VAD

First procedure w/VAD

Typically (but not always) implantable

Post-Cardiotomy VAD

Any cardiac surgery episode of care or up to 30 days before device implantation

Typically (but not always nonimplantable)

Hernandez AF et al. JAMA 2008;300:2398-406 .

Overall Survival

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

0 365 730 1095 1460

Surv

ival

Post-Cardiotomy Primary

`

1 –year 51.6%

1 –year 30.8%

Hernandez AF et al. JAMA 2008;300:2398-406.

Readmission rates

Primary device group

55.6% 6 month readmission

Mean days in hospital during 2 years f/u = 29.8 (SD, 45.0) days

Postcardiotomy

48.3% 6 month readmission

Mean days in hospital during 2 years f/u 16.7 (SD, 31.6)

Hernandez AF et al. JAMA 2008;300:2398-406.

Quality Improvement Trial

Randomize GWTG-HF Sites

Intervention (N≥ 80) Pushed-quarterly site feedback

data reports

Personalized feedback via

teleconferences

Focused webinars

Comprehensive toolkits

Control (N≥ 80) General QI

PMT on-demand reports

General GWTG webinars

GWTG toolbox project

PRIMARY ENDPOINT: OVERALL QUALITY OF CARE AFTER

12 MONTHS

SECONDARY ENDPOINTS: INDIVUDUAL MEASURES OF

QUALITY OF CARE; LENGTH OF STAY MORTALITY

Preliminary Results of GWTG-HF QI trial Achievement Measures

Baseline

Intervention

(N=73)

Baseline

Control

(N=74)

Absolute

Change

Intervention

Absolute

Change

Control

P-

Value

ACE/ARB 95.1 88.7 2.0 1.6 0.80

Beta-

blocker

95.8 94.7 1.3 0.7 0.54

Discharge

instructions

92.0 91.9 2.3 1.3 0.51

Measure

LV

Function

98.7 97.9 0.6 0.2 0.62

Smoking

Cessation 98.9 97.3 1.3 0.04 0.30

Preliminary Results of GWTG-HF QI trial Quality Measures

Baseline

Intervention

(N=73)

Baseline

Control

(N=74)

Absolute

Change

Intervention

Absolute

Change

Control

P-

Value

Aldosterone

Antagonist 17.6 23.1 -0.05 4.1 0.19

Anticoagulation

A Fib 58.2 66.6 14.73 5.4 0.40

CRT 38.1 18.8 -4.53 17.8 0.32

DVT

Prophylaxis 35.4 46.3 2.17 6.1 0.40

EB Beta

Blockers 42.4 55.3 3.85 7.9 0.36

Hydralazine

Nitrate 6.0 18.3 3.34 3.5 0.97

ICD 21.9 33.1 -4.08 0.8 0.25

Pneumococcal

Vaccination 44.7 51.8 -0.45 7.6 0.12

Heart Failure CERTs Team

Laura Webb

Brad Hammill

Melissa Greiner

Damon Seils

Li Liang

Margueritte Cox

Barbara Lytle

Robb Kociol

Zubin Eapen

Jonathan Piccini

Bimal Shah

Sana Al-Khatib

Sean O’Brien

Duke CERTs Next Generation 2011-2016

We propose 5 Specific Aims to be conducted across 4 CV Disease Areas:

Atrial Fibrillation (AF)

Acute Coronary Syndrome (ACS)

Heart Failure (HF); and

High Blood Pressure (HBP)

1. Create national platforms for studying AF, ACS, HF, and HBP;

2. Apply these platforms to conduct comparative effectiveness and safety studies that address existing and emerging CV therapeutic issues;

3. Evaluate novel implementation patient and provider strategies to more effectively, safely, and efficiently use CV therapeutics;

4. Work with medical society, government, and other partners to disseminate those interventions found to be most effective;

5. Collaborate with others to advance methodology, carry out cross-center research, and train next generation of outcomes researchers.

72

Duke CERTs – Data Sources

73

“Be a yardstick of quality.

Some people aren't used to

an environment where

excellence is expected.”

Implementation Innovation