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Data Collection in the Clinic for Rheumatoid Arthritis: From Meaningful
Use to Meaningful Outcomes
Salahuddin Kazi, MD
UT Southwestern Medical Center
Early Translational
Steps
Clinical Trials
Guidelines
Quality Indicators
Quality Measures
Performance Measures
Outcomes
Clinical questions
Population Based Knowledge
Clinical Trial Based Knowledge
Clo
se t
he
imp
lem
enta
tio
n g
ap
Rheumatoid Arthritis 1.5 million US adults have rheumatoid arthritis (2005 – CDC)
2.9 million ambulatory care visits in the United States among people with rheumatoid arthritis (2007)
Estimated annual direct cost is $20 billion1
Gaps in quality of care are common2
1. Birnbaum H, Pike C, Kaufman R, Marynchenko M, Kidolezi Y, Cifaldi M. Societal cost of rheumatoid arthritis patients in the US. Curr Med Res Opin. 2010 Jan;26(1):77-90
2. MacLean CH, Louie R, Leake B, McCaffrey DF, Paulus HE, Brook RH, Shekelle PG. Quality of care for patients with rheumatoid arthritis. JAMA. 2000 Aug 23-30;284(8):984-92
A BRIEF HISTORY OF RHEUMATOID ARTHRITIS
1985 1985 1989 1993 1997 2001 2005 2009 2012
Updated guidelines for treatment and disease activity measurement 2012
New Classification Criteria for Rheumatoid Arthritis 2010
Physician Quality Reporting System - RA measure set 2009
Guidelines for Rheumatoid Arthritis treatment published 2008
Genome wide scans in Rheumatoid Arthritis 2007
Treat to Target (T2T) emerges 2004
Guidelines for Rheumatoid Arthritis treatment published 2002
Periodontitis associated with Rheumatoid Arthritis 2001
Anti-CCP antibodies detected in Rheumatoid Arthritis 1998
Anti-TNF and the Biologic Revolution 1997
Triple therapy 1996
Concept of Early Rheumatoid Arthritis and Pyramid inversion 1989
ACR Criteria for RA Classification 1987
Combination therapy 1986
Methotrexate therapy 1985
Treat to Target in Rheumatoid Arthritis
2004 – Treat to Target
2009 – PQRS - RA Measure
group
2010 – EULAR Guidelines
2012 – ACR Revised
treatment guidelines
2012 – Disease activity
measures
Current Manage
ment
Treat to Target
1997 – Biologic revolution begins with breakthrough efficacy in rheumatoid arthritis
2004 – the TICORA study shows that similar degrees of efficacy can be achieved with tight control driven by frequent monitoring and treating to a target using non-biologic medications
2005 – BeSt study – early and intensive suppression of disease activity results in earlier clinical improvement and suppression of joint damage – treatment strategy trumps drug selection
TICORA
4.6
3.7 3.4
3.1 2.8 2.7 2.7
4.9
2.7
2.3 2.1
1.8 1.5 1.4
0
1
2
3
4
5
6
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
RoutineIntensive
Dis
eas
e A
ctiv
ity
Sco
re
Months
Treat to Target
http://www.t2t-ra.com
The mission of Treat To Target is to provide clear direction on rheumatoid arthritis treatment target(s) and tight control, apply it in daily practice, and define a clinical state where irreversible joint damage and disability is avoided.
Active RA
Adapt therapy according to
disease activity
MAIN TARGET
Adapt therapy if state is lost
REMISSION SUSTAINEDREMISSION
LOW DISEASE ACTIVITY
SUSTAINED LOW
DISEASE ACTIVITY Adapt therapy if
state is lost
Adapt therapy according to
disease activity
ALTERNATIVE TARGET
Use a composite Measure of
Disease activity Every 1-3 months
Assess disease Disease activity
Every 3-6 months
Physician Quality Reporting System (PQRS)
The Physician Quality Reporting System is a voluntary program that allows physicians and other healthcare professionals to report information to Medicare about the quality of care they provide to people with Medicare who have certain medical conditions.
The 2006 Tax Relief and Health Care Act required the establishment of a physician quality reporting system, including an incentive payment for eligible professionals who satisfactorily report data on quality measures for covered professional services provided to Medicare beneficiaries
PQRS - RA Measures Group - 2009
DMARD use
Functional Assessment
Estimation of Prognosis
Measurement of Disease Activity
TB testing prior to TNF based therapy
Glucocorticoid Management
2012 RA Guidelines
Disease Activity
Features of Poor
Prognosis
Features of Poor
Prognosis
Target Low
Disease Activity or Remission
DMARD Monotherapy
Combination DMARD therapy
DMARD Monotherapy or
MTX + HCQ
Anti-TNF with or without MTX or Combination DMARD therapy
Low High
Without With Without With
Moderate
Disease Activity Measurement
Which rheumatoid arthritis disease
activity measures are valid?
What’s feasible to perform in clinical
settings?
Measure Selection Process
Continuous composite measure for clinical
practice (point-0f-care)
OMERACT* Filter
Truth
Discrimination
Feasibility
*Outcome Measures in Rheumatoid Arthritis Clinical Trials
ACR endorsed RA disease activity measures
Disease Activity
Tool Range Remission Low Moderate High
DAS28-ESR 0-9.4 < 2.6 ≥ 2.6 - < 3.2 ≥ 3.2 - ≤ 5.1 > 5.1
DAS28-CRP 0-9.4 < 2.6 ≥ 2.6 - < 3.2 ≥ 3.2 - ≤ 5.1 > 5.1
CDAI 0-76 ≤ 2.8 > 2.8 - 10.0 > 10.0 - 22.0 > 22.0
SDAI 0-86 ≤ 3.3 > 3.3 - ≤ 11.0 > 11.0 - ≤ 26 > 26
RAPID3 0-10 0 - 1.0 > 1.0 - 2.0 > 2.0 - 4.0 > 4.0 - 10
PAS 0-10 0.00 - 0.25 0.26 - 3.70 3.71 - 7.99 8.00 - 10.00
PAS II 0-10 0.00 - 0.25 0.26 - 3.70 3.71 - 7.99 8.00 - 10.00
Patient
Lab Data
Provider
HAQ + Pain + Patient Global = PAS HAQII + Pain + Patient Global = PAS II MDHAQ + Pain + Patient Global = RAPID 3
CDAI SDAI
DAS 28
Composite Disease Activity Measures in Rheumatoid Arthritis
ESR or CRP
Tender Joints Swollen Joints Provider Global
Summary of Rheumatoid Arthritis Management: 2014
Treat to target is endorsed by the European League against Rheumatism (EULAR) and the American College of Rheumatology (ACR)
The combined assessment of disease activity and prognosis helps guide therapeutic decisions
Remission or low disease activity are the goals of therapy for rheumatoid arthritis
Implementation
Letting it Happen
• Evidence-based guidelines are published
• Practitioners are expected to adopt new guidelines
Helping it Happen
• Professional societies develop toolkits
• Clinical decision support tools are developed within health information systems
• External regulatory agencies develop incentives and/or penalties
Making it Happen
Organizations or practices make a commitment to implementation
The first rule of any technology used in a business
is that automation applied to an efficient operation
will magnify the efficiency. The second is that
automation applied to an inefficient operation will
magnify the inefficiency
– Bill Gates
Process Improvements in Rheumatoid Arthritis Management
• Disease Activity Score Measure the
Target
• Treat-to-Target Manage the
Target
• Population Management
• Benchmarking Master the
Target (improve)
Measure the Target (Disease Activity Score)
Determine the current workflow
Understand competing priorities
Develop a cause-and-effect diagram
Use a Pareto chart to understand the contribution of each cause
Use improvement tools such as a rapid process improvement workshop (RPIW)
Current Workflow
Patient checks in at front desk
Receptionist provides patient a questionnaire
Patient completes questionnaire
Patient is roomed MA/Nurse transcribes
information from questionnaire in to EHR
Provider uses nurse entered data along with joint counts,
global assessment +/- lab result to calculate disease
activity score
Provider adjusts therapy as needed
Patient checks out
System Reliability
Step 1 Step 2 Step 3 Step 4 Step 5
95% 95% 95% 95% 95%
Form Given
Form Completed
Information Collected Scored Act on Result
80% 80% 80% 80% 80%
Overall = 77%
Overall Reliability = 33%
Ishikawa Diagram
Front Desk Factors Lab Factors Physician Factors
Patient Not Given Form
Patient Given Wrong Form
Lab Draw After Visit
Lab Draw Missed
Lab Not Ordered
No Buy-In
No Formal Joint Count
No Global Assessment
Patient Factors Technology Factors Nurse/MA Factors
Did Not Understand Form
Did Not Complete Form
Form Not Legible
No Place in EHR to Record
No Calculator
Information Not Transcribed
Data Entry Errors
120 65 42 21 18 14 11
41.2
63.5
77.9 85.1
91.3 96.1 100
0
20
40
60
80
100
120
140
Pareto Chart for Reasons Disease Activity Not Recorded
Count
Cumulative Percent
Process Improvements in Rheumatoid Arthritis Management
• Disease Activity Score Measure the
Target
• Treat-to-Target Manage the
Target
• Population Management
• Benchmarking Master the
Target (improve)
Manage the Target (treat to low disease activity or remission)
Drive non-essential work away from the rheumatologist
Engage non-MD clinic
staff to drive therapy
Engage patients in
self management
Design rapid treatment escalation
The Nurse as the “RA Metrologist”
• RA questionnaire
Patient
• tender and swollen joint count, global assessment, disease activity score
Trained nurse metrologist
• reviews the information and adjusts therapy as needed
MD
Process Improvements in Rheumatoid Arthritis Management
• Disease Activity Score Measure the
Target
• Treat-to-Target Manage the
Target
• Population Management
• Benchmarking Master the
Target (improve)
Population Management
Improving individual care
Long-term tracking of the individual
patient
Improving population
care
Identify outliers
• High disease activity scores
• Disease activity never measured
The Patient Registry as Tool to Improve Care
Allows population tracking over time
Permits benchmarking across a wide spectrum of patients and healthcare systems
Can be used for quality reporting
Facilitates comparative effectiveness research
Repurposing Data
Data
Information
Knowledge
Wisdom
Quality Reporting Business Reports Best Practice Alerts
Summary Treat to target in rheumatoid arthritis is a useful strategy to achieve the goals of therapy – i.e. remission or low disease activity
Implementation is being increasingly impelled by external drivers
Implementation is complex and is often a clinic microenvironment systems issue
Cannot be solved by “working harder”
The implementation gap can be closed by employing human engineering, systems redesign, patient engagement and by leveraging clinical information systems