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

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imp

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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