duke cardiovascular certs · 2020. 6. 4. · duke cv certs aims the specific aims of our past...
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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
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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
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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.
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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:
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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.
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Duke CERTs – Data Sources
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“Be a yardstick of quality.
Some people aren't used to
an environment where
excellence is expected.”
Implementation Innovation