Welcome to PCORI · PDF fileRomana Hasnain-Wynia, PhD, MS ... total loss of any part of the...

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Welcome to PCORI Please be seated by 8:50 AM ET. The webinar will start at 9:00 AM ET.

Transcript of Welcome to PCORI · PDF fileRomana Hasnain-Wynia, PhD, MS ... total loss of any part of the...

Page 1: Welcome to PCORI · PDF fileRomana Hasnain-Wynia, PhD, MS ... total loss of any part of the lower limb and can range from minor (i.e., an amputation performed below the ankle) to major

Welcome to PCORI

Please be seated by 8:50 AM ET.

The webinar will start at 9:00 AM ET.

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Information for Workgroup Participants

Restrooms are located outside near the elevators. Key fobs

are available at our front desk.

As webinar participants will join us online and by telephone,

please state your name and title before speaking.

Please stand your name tent up to let the moderator know

that you are interested in speaking.

To use the push-to-talk microphones, please press the

button on the lower right-hand side and speak into the

microphone when red circle lights up around microphone.

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Clinical Interventions to

Reduce Lower-Extremity

Amputation Disparities Workgroup

November 4, 2013

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Welcome and Introductions

Romana Hasnain-Wynia, PhD, MS

Program Director

Addressing Disparities Program, PCORI

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David G. Armstrong, DPM, MD, PhD

Director, Southern Arizona Limb Salvage Alliance

(SALSA)

Professor of Surgery, University of Arizona College

of Medicine

Introductions: Moderator and Chair

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Harry Glauber, MD

Endocrinologist, Kaiser Permanente Northwest

America’s Health Insurance Plans (AHIP)

Representative

Introductions: Workgroup Participants

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Michael Herndon, DO

Senior Medical Director, Oklahoma Medicaid

Medical Directors Network

Introductions: Workgroup Participants

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Carolyn Jenkins, DrPH, APRN, LD, RD, FAAN

Ann Darlington Edwards Endowed Chair and

Professor, Medical University of South Carolina,

College of Nursing

Introductions: Workgroup Participants

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Lawrence Lavery, DPM, MPH

Professor, UT Southwestern Medical Center

Co-Director, Plastic Surgery Research Division

Introductions: Workgroup Participants

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Joseph W. LeMaster, MD, MPH

Primary Care Physician and Associate Professor,

The University of Kansas School of Medicine

Introductions: Workgroup Participants

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Gayle E. Reiber, PhD, MPH

Senior VA Career Scientist

Professor, Department of Health Services and

Epidemiology, University of Washington

Introductions: Workgroup Participants

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Reva Mariah S. ShieldChief

AIS Chair, Pawnee Nation College

Patient Representative

Introductions: Workgroup Participants

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Charlie Steele

Board of Directors, The Amputee Coalition

Introductions: Workgroup Participants

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Carl D. Stevens, MD, MPH

Health Sciences Clinical Professor, David Geffen

School of Medicine at UCLA

Introductions: Workgroup Participants

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Workgroup Agenda

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Time Agenda Item

9:00 AM Welcome and Introductions

9:15 AM Introduction to PCORI and Workgroup

9:30 AM Setting the Stage

9:50 AM Perspectives on Priority Topics: Patients, Stakeholders, and Researchers

10:30 AM Break

10:40 AM Perspectives on Priority Topics: Patients, Stakeholders, and Researchers

(Continued)

11:45 AM Lunch

12:30 PM Recap of Priority Topics in Lower-Extremity Amputations

12:45 PM Discussion and Consensus around Key Research Gaps

2:15 PM Break

2:25 PM Identification and Refinement of Comparative Effectiveness Research Questions

3:55 PM Next Steps and Wrap-Up

4:00 PM Adjourn

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Introduction to PCORI

and Workgroup

Romana Hasnain-Wynia, PhD, MS

Program Director

Addressing Disparities Program

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Overview

Background on PCORI

Addressing Disparities Program Mission and Goals

PCORI’s Process for Identifying Research Topics

and Gaps

Identification of Current Workgroup Topic

Managing Conflict of Interest

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About PCORI

An independent non-profit research organization

authorized by Congress as part of the 2010 Patient

Protection and Affordable Care Act (ACA).

Committed to continuously seeking input from

patients and a broad range of stakeholders to

guide its work.

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PCORI’s Mission and Vision

Mission

The Patient-Centered Outcomes Research Institute (PCORI) helps people make informed healthcare decisions, and improves healthcare delivery and outcomes, by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community.

Vision

Patients and the public have the information they need to make decisions that reflect their desired health outcomes.

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PCORI Criteria for Knowledge Gaps and

Research Questions

Knowledge Gaps and Research questions should:

Be patient-centered: Is the proposed knowledge gap of specific interest to patients, their caregivers, and clinicians?

Assess current options: What current guidance is available on the topic and is there ongoing research? How does this help determine whether further research is valuable?

Have potential to improve care and patient-centered outcomes: Would new knowledge generated by research be likely to have an impact in practice?

Provide knowledge that is durable: Would new knowledge on this topic remain current for several years, or would it be rendered obsolete quickly by subsequent studies?

Compare among options: Which of two or more options leads to better outcomes for particular groups of patients?

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Questions External to PCORI’s Mandate

Cost-effectiveness: PCORI will not answer questions related to cost-

effectiveness, costs of treatments or interventions. However, PCORI will

consider the measurement of factors that may differentially affect

patients’ adherence to the alternatives, such as out-of-pocket costs.

Medical billing: PCORI will not address questions about individual

insurance coverage or about coverage decisions from third-party

payers.

Disease processes and causes: PCORI will not consider questions

that pertain to risk factors, origin, and mechanisms of diseases or

questions related to bench science.

Lacking comparative nature or foundation: PCORI will not consider

questions that lack any comparative aspect.

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Addressing Disparities Program Mission

Statement

Program’s Mission Statement

To reduce disparities in healthcare outcomes and

advance equity in health and health care

Program’s Guiding Principle

To support comparative effectiveness research that will

identify best options for eliminating disparities

PCORI’s

Vision, Mission, Strategic Plan

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• Identify high-priority research questions relevant to reducing and eliminating disparities in healthcare outcomes

Identify Research Questions

• Fund comparative effectiveness research with the highest potential to reduce and eliminate healthcare disparities

Fund Research

• Disseminate and facilitate the adoption of promising/best practices to reduce and eliminate healthcare disparities

Disseminate Promising/Best

Practices

Addressing Disparities: Program Goals

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PCORI’s Process for Identifying

Research Topics and Gaps

Topics/Questions

proposed for

further

consideration

Topics come from

multiple sources

Gap

confirmation

Priority

topics/

questions

(Multi-stakeholder

Advisory Panels

and Workgroups)

(PCORI staff in

collaboration with

AHRQ and others)

1:1 interactions

with

stakeholders

Guidelines

development,

evidence

syntheses

Website, staff,

Advisory Panel

suggestions

Board topics

Workgroups,

roundtables

• Eliminating

non-

comparative

questions

• Aggregating

similar

questions

• Assessing

research gaps

• Preparing topic

briefs

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Identification of Workgroup Topic on Clinical

Interventions to Reduce Disparities in Lower-

Extremity Amputations

PCORI’s Addressing Disparities Advisory Panel prioritized

12 topics in April 2013.

One of the top five topics was reducing lower-extremity

amputations (LEA) in populations that experience

disparities.

Next step is to better understand the research gaps.

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How PCORI Gathers Input

The researchers, patients, and stakeholders who’ve been invited to this

workgroup give input during the workgroup.

The broad community of researchers, patients, and other stakeholders can give

input via our website.

Webinar participants can provide input via the webinar “chat” feature.

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PCORI seeks input on topics to determine specific research gaps on

comparative effectiveness research questions.

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How PCORI Manages the Potential for

Conflict of Interest

Participants in this workgroup will be eligible to apply for funding if PCORI decides to produce a funding announcement.

The Chair(s) of the workgroup will be eligible to apply for funding should they not participate in any subsequent discussions with PCORI following the workgroup.

Input received during the workgroup deliberations are broadcast via webinar, and the webinar is then archived and available to other researchers, patients, or stakeholders on the website.

PCORI does not have subsequent discussions with the participants after this workgroup.

Participants have been explicitly instructed and are expected to address a set of questions we’ve asked – not to tell us about their research.

There should be no “influence advantage” to being a workgroup member, or any knowledge advantage by participating in the workgroup.

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Setting the Stage

David G. Armstrong, DPM, MD, PhD

Director, Southern Arizona Limb

Salvage Alliance (SALSA)

Professor of Surgery, University of Arizona College of Medicine

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Setting the Stage

Lower-Extremity Amputation Overview

Lower-Extremity Amputation Burden and

Disparities

Workgroup Objectives

Collaborative Workgroup Discussion

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Lower-Extremity Amputation: Definition

Lower-extremity amputation (LEA) refers to the

total loss of any part of the lower limb and can

range from minor (i.e., an amputation performed

below the ankle) to major (i.e., an amputation

performed above the ankle).

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Claire M. Buckley, Fauzi Ali, Graham Roberts, Patricia M. Kearney, Ivan J. Perry,

and Colin P. Bradley, 'Timing of Access to Secondary Healthcare Services for

Diabetes Management and Lower Extremity Amputation in People with Diabetes:

A Protocol of a Case-Control Study', BMJ Open, 3 (2013), e003871-e71.

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Risk Factors for LEA

Diabetes is the leading cause of non-traumatic LEA

in the United States

29.1 million Americans (9.3%) have diabetes, with

an additional 86 million Americans estimated to

have prediabetes

Diabetes is the 7th leading cause of death in the

United States

31

Division of Diabetes Translation National Center for Chronic Disease Prevention

and Health Promotion, 'National Diabetes Statistics Report, 2014'

<http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-

web.pdf>

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Risk Factors for LEA (cont’d)

32

7.60%

9%

12.80% 13.20%

15.90%

non-HispanicWhites

Asian Americnas Hispanics non-Hispanicblacks

AmericanIndians/Alaska

Natives

Diabetes Prevalence

Division of Diabetes Translation National Center for Chronic Disease Prevention

and Health Promotion, 'National Diabetes Statistics Report, 2014'

<http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-

web.pdf>

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Foot Ulcers and LEA

Diabetic patients carry a 25% risk of developing a foot ulcer

within their lifetime.2

Foot ulcers are the leading cause of amputations in diabetics,

preceding over 85% of these surgeries.3

Inadequate diabetes control, smoking, neuropathy, prolonged

hyperglycemia, and peripheral artery disease are risk factors

that predispose diabetic patients to the development of foot

ulcers.1

If a diabetic foot ulcer is left untreated, a patient may have to

undergo amputation.

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1. Claire M. Buckley, Fauzi Ali, Graham Roberts, Patricia M. Kearney, Ivan J. Perry, and Colin P.

Bradley, 'Timing of Access to Secondary Healthcare Services for Diabetes Management and Lower

Extremity Amputation in People with Diabetes: A Protocol of a Case-Control Study', BMJ Open, 3

(2013), e003871-e71.

2. David J. Margolis, Ole Hoffstad, Jeffrey Nafash, Charles E. Leonard, Cristin P. Freeman, Sean

Hennessy, and Douglas J. Wiebe, 'Location, Location, Location: Geographic Clustering of Lower-

Extremity Amputation among Medicare Beneficiaries with Diabetes', Diabetes Care, 34 (2011), 2363-

67.

3. David G. Armstrong, Vikram A. Kanda, Lawrence A. Lavery, William

Marston, Joseph L. Mills, Sr., and Andrew J. M. Boulton, 'Mind the Gap:

Disparity between Research Funding and Costs of Care for Diabetic Foot

Ulcers', Diabetes Care, 36 (2013), 1815-17.

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Foot Ulcers and LEA (cont’d)

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Effects of LEA

In 2010, diabetic complications resulted in over

73,000 non-traumatic LEAs, accounting for 60% of

surgeries of this type.

42% percent of patients with LEA require having

their opposite limb amputated within the

subsequent one to three years.

Within five years of the first LEA surgery, the

mortality rate for patients ranges from 39% to 80%.

35

Emily A. Cook, Jeremy J. Cook, Magdala Peixoto Labre, Howard Givens, and

James J. Diresta, 'The Amputation Prevention Initiative', Journal Of The American

Podiatric Medical Association, 104 (2014), 1-10.

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LEA Disparities

As of 2009, African Americans experienced an

amputation rate almost 50% greater than that of

non-Hispanic whites.1

Medicare data from 2008 show that American

Indian/Alaska Natives had an incidence rate double

that of non-Hispanic whites.2

Disparities also exist in regard to the severity and

level of amputation.1

36

1. Kristin M. Lefebvre, and Lawrence A. Lavery, 'Disparities in Amputations in

Minorities', Clinical Orthopaedics & Related Research, 469 (2011), 1941-50.

2. D. J. Margolis, D. S. Malay, O. J. Hoffstad, C. E. Leonard, T. MaCurdy, K. L. de

Nava, Y. Tan, T. Molina, and K. L. Siegel, 'Incidence of Diabetic Foot Ulcer and

Lower Extremity Amputation among Medicare Beneficiaries, 2006 to 2008: Data

Points #2', in Data Points Publication Series (Rockville MD: 2011).

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LEA Disparities (cont’d)

37

Carl D. Stevens, David L. Schriger, Brian Raffetto, Anna C. Davis, David

Zingmond, and Dylan H. Roby, 'Geographic Clustering of Diabetic Lower-

Extremity Amputations in Low-Income Regions of California', Health Affairs, 33

(2014), 1383-90.

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LEA Disparities (cont’d)

Contributing factors to LEA disparities:

Impaired access to multicomponent, interdisciplinary

care (e.g., podiatrists, vascular surgeons, dietitians,

educators)1

At-risk patients are often treated at safety-net hospitals,

which may be inadequately equipped to provide the high-

quality care needed by these individuals.2

Greater reliance might be placed on amputation

procedures, as opposed to less invasive, limb-sparing

treatment options.2

38

1. Emily A. Cook, Jeremy J. Cook, Magdala Peixoto Labre, Howard Givens, and James J. Diresta, 'The

Amputation Prevention Initiative', Journal Of The American Podiatric Medical Association, 104 (2014), 1-

10.

2. Carl D. Stevens, David L. Schriger, Brian Raffetto, Anna C. Davis, David Zingmond, and Dylan H.

Roby, 'Geographic Clustering of Diabetic Lower-Extremity Amputations in Low-Income Regions of

California', Health Affairs, 33 (2014), 1383-90.

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Strategies for Prevention of LEA

39

Emily A. Cook, Jeremy J. Cook, Magdala Peixoto Labre, Howard Givens, and

James J. Diresta, 'The Amputation Prevention Initiative', Journal of The American

Podiatric Medical Association, 104 (2014), 1-10.

Pre

ve

ntio

n S

tra

tegie

s

Increased use of screening examinations by physicians and daily self-examinations by patients

Referral of at-risk patients to a specialist

Smoking cessation

Maintenance of glycemic control

Management of hypertension, renal disease, and peripheral arterial disease

Clinician and patient education

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Strategies for Prevention of LEA (cont’d)

Beyond prevention, a number of interventions exist

to spare a patient’s limb.

Revascularization procedures restore and

increase circulation and blood flow to the affected

limb.

Angioplasty, the insertion of a stent to open the blocked

artery.

Lower-extremity bypass, where an alternate passage

for blood flow is created to bypass the blockage.

40

R. J. Hinchliffe, G. Andros, J. Apelqvist, K. Bakker, S. Friederichs, J. Lammer, M.

Lepantalo, J. L. Mills, J. Reekers, C. P. Shearman, G. Valk, R. E. Zierler, and N. C.

Schaper, 'A Systematic Review of the Effectiveness of Revascularization of the Ulcerated

Foot in Patients with Diabetes and Peripheral Arterial Disease', Diabetes/Metabolism

Research And Reviews, 28 Suppl 1 (2012), 179-217.

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Strategies to Reduce LEA

Multicomponent, multidisciplinary interventions that

follow standardized guidelines show the most

promise for reduction in the rate of LEAs

However, there are no agreed-upon guidelines for the

treatment of diabetic foot ulcers or for determining when

an LEA is necessary

Programs for increasing patient knowledge and

engaging patients in preventive self-management

have also shown promise.

41Kristin M. Lefebvre, and Lawrence A. Lavery, 'Disparities in Amputations in

Minorities', Clinical Orthopaedics & Related Research, 469 (2011), 1941-50.

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Addressing Disparities in LEA

The US Department of Health and Human Services

“Healthy People 2020” report specifically calls for

the reduction in the rate of LEA in persons

diagnosed with diabetes.

There are few studies focusing on reducing

disparities among those at risk for LEA.

42

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LEA Workgroup Goal

Identify high-priority comparative effectiveness

research questions on interventions that, if

addressed, could reduce disparities in LEA among

racial and ethnic minorities and low-income

populations.

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Examples of Comparative Effectiveness

Research Questions

Compare the effectiveness of interventions to help eliminate healthcare system barriers that may disproportionately affect outcomes for racial and ethnic minorities and low-income populations at risk for LEA

Compare the effectiveness of treatments with significant potential to improve health care and quality of life for racial and ethnic minorities and low-income populations at risk for LEA

Compare the effectiveness of strategies to improve screening, increase access to quality care, and reduce risk factors for racial and ethnic minorities and low-income populations at risk for LEA

44

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Workgroup Objectives

Obtain a diversity of perspectives and input on

important patient-centered research gaps and

topics in LEA;

Identify high-impact CER questions that will result

in findings that are likely to endure and that are not

currently studied;

Seek consensus on identified LEA research gaps

and specific comparative effectiveness research

questions that address those gaps.

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Collaborative Workgroup Discussion

Focus: Provide targeted input on priority topics.

Honor Timelines: Provide brief and concise presentations and comments.

Level the Playing Field: Use language that is familiar to all (e.g., explain any acronyms before using them)

Participate: Encourage exchange of ideas among diverse perspectives that are present today: Patients

Clinicians

Researchers

Other Stakeholders

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Perspectives on Priority Topics:

Patients, Stakeholders, and

Researchers

47

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48

Presenter:

Carolyn Jenkins, DrPH, APRN, LD, RD, FAAN

Ann Darlington Edwards Endowed Chair and

Professor, Medical University of South Carolina,

College of Nursing

Perspectives on Priority Topics

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Perspectives on Priority Topics

Potential Topics/Questions to Explore to Reduce

Disparities in LEA:

Compare the effectiveness of strategies to improve

screening, increase access to quality care, and

prevent/reduce risk factors for racial and ethnic

minorities and low-income populations at risk for LEA.

49

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Perspectives on Priority Topics

Potential Topics/Questions to Explore to Reduce Disparities in LEA: Compare the effectiveness of interventions to help

eliminate healthcare system barriers that may disproportionately affect outcomes for racial and ethnic minorities and low-income populations at risk for LEA.

Examples:

• Accountable Care Organization vs. Fee for Service vs. Expanded Medicaid

• Transportation vs. No Transportation

• Rapid Access vs. Traditional Appointment

• Integrated vs. Non-Integrated Healthcare Systems

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Perspectives on Priority Topics

Potential Topics/Questions to Explore to Reduce Disparities in LEA: Compare the effectiveness of different systems

approaches to reducing diabetes-related foot ulcers and amputation in high-risk racial and ethnic minorities and low-income populations at risk for LEA.

Examples:

• Patient-centered medical home management (with training in quality diabetes care and foot care) vs. specialty care management (to be defined).

• Comprehensive clinical care system (LEAP) vs. comprehensive community care system vs. integrated community and clinical care systems (REACH)

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Perspectives on Priority Topics

Potential Topics/Questions to Explore to Reduce

Disparities in LEA:

Compare the effectiveness of different

approaches/delivery of self-management

training/education for prevention and early

identification/treatment of foot lesions in racial and ethnic

minorities and low-income populations at risk for LEA.

Examples:

• Traditional Classroom DSME vs. Group Visits

• In-person Educator(s) vs. Tele-Health

• Synchronous vs. Asynchronous Technology

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Presenter:

Charlie Steele

Board of Directors, The Amputee Coalition

Perspectives on Priority Topics

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Perspectives on Priority Topics

Potential Topics/Questions to Explore Significant Racial Disparities

• 42% of all amputations are performed on minority populations

CARE Disparity • Lack of coordinated TEAM approach and poor outcomes –

especially in large urban areas

Secondary Limb Loss Disparity• Significant disparity with minorities losing the other leg; again,

lack of team approach

Acute Rehab vs. Nursing Home• Recent study showed that treatment in in-patient rehab facilities

(INF) provided better long-term outcomes than in skilled nursing facilities (SNF)

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Presenter:

Gayle E. Reiber, PhD, MPH

Senior VA Career Scientist

Professor, Department of Health Services and

Epidemiology, University of Washington

Perspectives on Priority Topics

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Perspectives on Priority Topics

To what extent can patient coaches assigned to patients at very high risk of limb loss (high psychiatric comorbidity, prior ulcer, current ulcer, amputation) decrease the risk of lower-limb ulcers/amputations?

To what extent can electronic medical record templates improve ulcer outcomes? (Simple care templates would monitor delivery of evidence-based components of care, healing progress, and facilitate dual care communication and coordination)

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Presenter:

Carl D. Stevens, MD, MPH

Health Sciences Clinical Professor, David Geffen

School of Medicine at UCLA

Perspectives on Priority Topics

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Perspectives on Priority Topics

Income-related amputation rate disparities: the

view from Los Angeles

CER target areas and study questions

“Supply-side” factors: access and quality of care

“Demand-side” factors: patient and household

education, self-efficacy and “activation”

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Perspectives on Priority Topics

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Stevens CD, Schriger DL, Raffetto B, Davis AC, Zingmond D,

Roby DH. Geographic clustering of diabetic lower-extremity

amputations in low-income regions of California. Health Aff

(Millwood). 2014 Aug;33(8):1383-90

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Perspectives on Priority Topics

Income-related disparities in diabetic LEA rates:

possible CER target areas

“Supply-side” factors

Access barriers• Safety-net providers by neighborhood: Patient-Centered Medical

Home (PCMH) up and running?

• Long wait times for ED visit vs. available PCP appointments?

• Primary care “gate-keeping” when urgent specialty care needed?

Quality of care in the “safety net”• Standardized secondary prevention protocols including foot care

• Access to expert, limb-sparing wound care for foot ulcers

“Demand-side” factors Patient activation, education, self-efficacy

Immediate care-seeking plan of action for foot concerns

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Perspectives on Priority Topics

Income-related disparities in diabetic LEA rates:

possible CER study questions

“Supply-side” study questions: PCP vs. dedicated foot care (podiatry/orthopedic)

Clinical pathways in safety-net EDs and clinics (standardized initial management and referral protocols)

Team-based primary and secondary prevention of ulcers

Identification of providers with low severity-adjusted amputation rates from public and Managed Care Organization (MCO) data sets

“Demand-side” study questions: Comparison of patient education/“activation” strategies

Intensive disease management/adherence after first ulcer or distal amputation

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BREAK

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• Visit us at www.pcori.org

• Submit comments via Chat

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Presenter:

Joseph W. LeMaster, MD, MPH

Primary Care Physician and Associate Professor,

The University of Kansas School of Medicine

Perspectives on Priority Topics

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Perspectives on Priority Topics

Endovascular procedural disparity reduction

Reducing disparities in access to limb-sparing vascular procedures (PubMed lit-review): Amputation risk higher for:

• Non-white race/ethnicity: Hispanics and Hispanics have greater rates and critical ischemia (Morrissey 2007; Amaranto 2009; Rowe 2010; Hughes 2014)

• Medically underserved counties (by 29%) (McGinigle 2014)

• Low income: Income < 100% poverty 16X greater risk, more advanced presentation, older age, less statin use (Durham 2010)

Endovascular/limb-sparing procedures increasing, but some groups less likely to receive

• Women: fewer procedures (Egorova 2010)

• Non-white race/ethnicity: Blacks have less limb-related admissions, revascularization, wound debridement, or toe amputation (Holman 2011)

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Perspectives on Priority Topics

Endovascular procedural disparity reduction

Randomized studies or outcome studies demonstrating interventions to reduce risk in most at-risk disparity groups are lacking

Large databases previously used for analysis:

National Inpatient Sample

Inpatient Medicare data

State-based Medicaid (not easily compatible across states)

These analyses will be subject to limitations in recorded data (e.g., patient self-report of race/ethnicity is a fairly recent addition to many hospital-based databases)

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Perspectives on Priority Topics

Endovascular procedural disparity reduction:

possible strategy

Hospital-Practice networks documenting procedures PCORI Clinical Data Research Networks: ongoing discharge

data stream

System, hospital, or practice surveys exploring patient, provider, and systemic policies and/or programs to eliminate healthcare disparities and increase access to care for groups at high risk

Studies could link these data streams to identify system-, clinic-, or provider-based best practices associated with improved outcomes for groups experiencing disparities (identifying candidate disparity-reducing interventions for CER)

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Presenter:

Harry Glauber, MD

Endocrinologist, Kaiser Permanente Northwest

America’s Health Insurance Plans (AHIP)

Representative

Perspectives on Priority Topics

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Perspectives on Priority Topics

Potential Topics/Questions to Explore

What are the primary drivers of differences in LEA rates

in different ethnic groups?

• Inherent biologic variability in pathophysiology of DM and its

complications

• Differences in self-care (medication adherence, diet/exercise

adherence, clinic visits, foot self-care, footwear quality, etc.)

• Differences in health system management of DM minority

patients (treatment goals, testing rates, choice of medications,

use of referrals, etc.)

• Differences in access to primary and specialty care (variance in

insurance coverage, convenient availability of care)

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Perspectives on Priority Topics

Compare different strategies to improve frequency

of foot exams at routine primary care visits, and to

assess impact on ulcer rates, and ultimately

amputation rates

Clinician education

Patient education (comparing culture-/language-specific

print, online, one-on-one vs. group, lay-provided vs.

professional)

Electronic Medical Record (EMR) prompts or other real-

time clinical decision support

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Perspectives on Priority Topics

For patients with sensory loss or peripheral

vascular disease (PVD), what is the effect of

referral to a “high-risk foot” case management

program on participation, self-care measures, and

diabetic foot ulcer (DFU)/amputation rates in

different ethnic groups?

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Presenter:

Reva Mariah S. ShieldChief

AIS Chair, Pawnee Nation College

Patient Representative

Perspectives on Priority Topics

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Perspectives on Priority Topics

Potential Topics/Questions to Explore

..How to communicate pertinent medical information to

Tribal Nations’ members in a manner that “speaks” to

them?

• Asking patients to participate rather than telling them what you,

as medical staff, want/expect.

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Michael Herndon, DO

Senior Medical Director, Oklahoma Medicaid

Medical Directors Network

Perspectives on Priority Topics

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Perspectives on Priority Topics

Potential Topics/Questions to Explore

Do practices that utilize team-based care

and standing orders have a lower

incidence of lower-extremity amputation

compared to traditional healthcare delivery

models?

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Perspectives on Priority Topics

Is the current delivery system, which is

designed to reimburse providers based upon

encounter, a barrier to diabetic patients and

those at risk of LEA receiving adequate

education regarding their disease and risk of

morbidities including LEA?

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Perspectives on Priority Topics

If practice redesign strategies are taught and

implemented within a practice setting,

including: Team-based care

Utilization of standing orders to ensure standards of care

are being delivered

Appropriate educational materials given to the patient

Would patients at high-risk for LEA have fewer LEA

procedures?

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Lawrence Lavery, DPM, MPH

Professor, UT Southwestern Medical Center

Co-Director, Plastic Surgery Research Division

Perspectives on Priority Topics

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Perspectives on Priority Topics

Prevention vs. TreatmentMultiple factors that contribute to ulcer prevention

When evaluated individually…. inconsistent outcomes

Education: patients, family, physicians, staff Quality, content, frequency

Education: global and foot specific

Therapeutic shoes and insoles: quality, replacement

Regular foot care: consistent monitoring

Innovation: self-monitoring, iphone monitoring & trending

CER: systems of care, continuity, quality,

High risk population: dialysis, amputees, history of ulcer

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Perspectives on Priority Topics

Treatment: ulcers, infections, PADPeripheral vascular disease: endovascular vs.

bypass

Ulcer treatments: standards are low, inconsistent

Infection treatments: by convention not evidence

Antibiotics are over used: reistence, AE

iIl-defined starting and stopping parameters

Collaborative teams vs. stand alone

Long-term care because recurrence & risk are high

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LUNCH

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• Submit comments via Chat

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Recap of Priority Topics in

Lower-Extremity Amputations

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Discussion and Consensus

around Key Research Gaps

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PCORI Criteria for Comparative

Effectiveness Research Questions

Questions should:

Be patient-centered: Is the proposed knowledge gap of specific interest to patients, their caregivers, and clinicians?

Assess current options: What current guidance is available on the topic and is there ongoing research? How does this help determine whether further research is valuable?

Have potential to improve care and patient-centered outcomes: Would new knowledge generated by research be likely to have an impact in practice?

Provide knowledge that is durable: Would new knowledge on this topic remain current for several years, or would it be rendered obsolete quickly by subsequent studies?

Compare among care options: Which of two or more approaches leads to better outcomes for particular groups of patients?

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BREAK

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• Submit comments via Chat

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Identification and Refinement of

Comparative Effectiveness Research

Questions

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PCORI Criteria for Comparative

Effectiveness Research Questions

Questions should:

Be patient-centered: Is the proposed knowledge gap of specific interest to patients, their caregivers, and clinicians?

Assess current options: What current guidance is available on the topic and is there ongoing research? How does this help determine whether further research is valuable?

Have potential to improve care and patient-centered outcomes: Would new knowledge generated by research be likely to have an impact in practice?

Provide knowledge that is durable: Would new knowledge on this topic remain current for several years, or would it be rendered obsolete quickly by subsequent studies?

Compare among care options: Which of two or more approaches leads to better outcomes for particular groups of patients?

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Next Steps and Wrap-Up

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Thank You for Your

Participation

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