PCORI In Practice: Highlighting PCORnet Opportunities for General - - PowerPoint PPT Presentation

PCORI In Practice: Highlighting PCORnet Opportunities for General Internists

September 8, 2015

Welcome and Introductions

We welcome your questions and comments via the chat function on the right side of your screen We welcome your comments via Twitter to @PCORI and #PCORI An archive of this webinar will be posted to http://www.pcori.org/get-involved/pcori-in- practice/ following this event.

Today’s Presenters

Rachael Fleurence, PhD Program Director, CER Methods and Infrastructure, PCORI Leslie Dunne Director of Development and Project Management, SGIM Tara Bishop, MD, MPH PCORnet Researcher, NYC CDRN, General Internist, Weill Cornell Medical Center Alexander Low, MBA PCORnet Researcher, NYC CDRN, Director of Strategy & Development, Center for Healthcare Informatics and Policy, Weill Cornell Medical Center

Agenda

Goals for Today

• Familiarize the general internists community and researchers with PCORI, PCORnet,

and future use of PCORI funded research findings

• Engage the community of SGIM members and general internists more actively in

PCORI’s work and funding

• Encourage the community of general internists to activate their research capacity

for conducting patient-centered comparative effectiveness research

• Explore what other players in the general internists community are doing in the

way of patient and other stakeholder engagement

PCORI in Practice: Highlighting PCORnet Opportunities for General Internists

Society of General Internal Medicine Engaging PCORI Priority Stakeholders through SGIM Jennifer Kraschnewski, PI Leslie Dunne, SGIM Staff

SGIM Overview

• National medical society of 3,000 physicians who

are the primary internal medicine faculty of every medical school and major teaching hospital in the United States.

• Our mission is to lead excellence, change, and

innovation in clinical care, education, and research in general internal medicine to achieve health care delivery that is comprehensive, technologically-advanced and individualized

Engaging PCORI Priority Stakeholders through SGIM

Project Goals:

• To educate SGIM members about PCORI

research and to provide avenues for better engagement in the PCORI research process by clinicians and clinician educators; and to provide PCORI with key perspectives from SGIM members regarding their participation in PCOR.

Project Activities

• Presentations at the 2015 and 2016 SGIM Annual

Meetings and SGIM Regional Meetings

• Keynote by Dr. Joseph Selby
• Sessions on health care systems and practices, patient

engagement in the PCOR process, participation in big data studies and clinical trials done differently

• Assessment of SGIM members about their attitudes and

needs regarding participation in PCOR

• Development of Training Tools on PCOR to share with

SGIM members

• White paper with lessons learned through the grant

process

The Patient-Centered Outcomes Research Institute—Studying What Works for Whom

Rachael Fleurence, PhD

Program Director CER Methods and Infrastructure

Who We Are and What We Do

About Us

• An independent research institute authorized by Congress in 2010 and

governed by a 21-member Board of Governors representing the entire healthcare community

• Funds comparative clinical effectiveness research (CER) that engages patients

and other stakeholders throughout the research process

• Seeks answers to real-world questions about what works best for patients

based on their circumstances and concerns

Why Is Our Work Needed?

• For all the advances it produces,

traditional healthcare research has not answered many questions patients face.

• People want to know which preventive,

diagnostic, or treatment option is best for them.

• Patients and their clinicians need

information they can understand and use.

How is Our Work Different?

• We fund research on which care options work, for

whom, under which circumstances.

• We focus on answering questions most important to

patients and those who care for them.

• We aim to produce evidence that can be easily

applied in real-world settings.

• We engage patients, caregivers, clinicians, insurers,

employers and other stakeholders throughout the research process.

• This makes it more likely we’ll get the research

questions right and that the study results will be useful and taken up in practice.

Our Mission and Strategic Goals

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. Our Strategic Goals: Increase quantity, quality, and timeliness of useful, trustworthy research information available to support health decisions Speed the implementation and use of patient-centered outcomes research evidence Influence research funded by others to be more patient-centered

Who Are Our Stakeholders?

Purchasers Caregivers/Family Members Payers Patients/Consumers Clinicians Training Institutions Policy Makers Hospitals/Health Systems Industry Patient/Caregiver Advocacy Organizations

Our Research Focus

Research that….

• Generates and synthesizes evidence comparing benefits and harms of at

least two different methods to prevent, diagnose, treat, and monitor a clinical condition or improve care delivery

• Measures benefits in real-world populations
• Informs a specific clinical or policy decision
• Describes results in subgroups of people
• Applies appropriate methods and data sources
• Helps consumers, clinicians, purchasers, and

policy makers make informed decisions that will improve care for individuals and populations

Adapted from Initial National Priorities for Comparative Effectiveness Research, Institute of Medicine of the National Academies

We Fund Comparative Clinical Effectiveness Research

Snapshot of Funded Projects

Number of projects: 440 Amount awarded: $1.09 billion Number of states where we are funding research: 40 (plus the District of Columbia)

As of August 18, 2015

Our Growing Research Portfolio

Portfolio Analysis: Primary Condition

Where are funded projects concentrated? Where is the most funding (in millions)?

As of August 18, 2015

The National Patient-Centered Clinical Research Network (PCORnet)

21 Patient-Powered Research Networks

Patients with a single condition form a research network; $16.8 million awarded

Coordinating Center

Provides technical and logistical assistance under the direction of a steering committee and PCORI staff

13 Clinical Data Research Networks

Health system-based networks, such as hospital systems; $76.8 million awarded On July 21, 2015, PCORI’s Board of Governors approved funding for 34 partner networks in Phase II. The awards include funding for seven additional networks to join PCORnet in its second phase, which will begin in fall 2015.

The National Patient-Centered Clinical Research Network (PCORnet)

• Improve the nation’s capacity to conduct clinical research faster, more

efficiently and less expensively, with greater power

• Establish a large, highly representative, national patient-centered clinical

research network with a focus on conducting randomized and

• bservational comparative studies
• Support a learning US healthcare system, which would allow for large-

scale research to be conducted with greater accuracy and efficiency within real-world care-delivery systems

PCORnet’s infrastructure built to:

To leverage rich clinical electronic health data linking EHR data with private and public claims data (incl. CMS) Support both large observational studies and embedded randomized clinical trials Support novel models of participant-led research, integrate patient-preference science, and build robust patient- participation Involve patients, clinicians, and health systems leaders in governance and use of the network

Fall 2015: Coming Into View

• Each CDRN Network will have 1-10 DataMarts
• Total anticipated DataMarts: 75
• Annotated Data Dictionaries received: 62
• Software installation completed: 30
• Nine of 11 CDRNs have transformed data for at least one

million individuals

DataMarts leveraging the CDRNs Electronic Health Data

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CDRNs Disease Cohorts

Organization Common Cohort Rare Cohort ADVANCE Diabetes Co-infection with HIV and hepatitis C virus CAPriCORN Anemia; Asthma Sickle cell disease; Recurrent C. Difficile colitis Great Plains Collaborative Breast Cancer Amyotrophic Lateral Sclerosis (ALS) Louisiana Clinical Data Research Network Diabetes Sickle Cell Disease, Rare Cancers NYC-CDRN Diabetes Cystic fibrosis Mid-South CDRN Coronary Heart Disease (CHD) Sickle Cell Disease (SCD) PEDSNet Inflammatory bowel disease Hypoplastic left heart syndrome PORTAL Colorectal Cancer Severe Congenital Heart Disease pSCANNER Congestive Heart Failure Kawasaki Disease P2ATH Atrial Fibrillation Idiopathic Pulmonary Fibrosis SCIHLS Osteoarthritis Pulmonary arterial hypertension

Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)

Matthew T. Roe, MD, MHS Associate Professor of Medicine, Duke Cardiology Potential Impact

• Demonstrate PCORnet’s capability to

conduct important CER efficiently and economically

• Identify the optimal dose of aspirin for

secondary prevention of heart attacks and stroke in patients with heart disease Engagement

• ADAPTORS patient group involved

throughout the trial, contributing to design, start-up, enrollment, follow-up, analysis, and dissemination Methods

• Individual-randomized pragmatic clinical

trial to compare the effectiveness of two doses of aspirin, using the PCORnet Common Data Model as a key data source An innovative pragmatic clinical trial conducted within the PCORnet infrastructure to determine the optimal daily aspirin dose (325 mg versus 81 mg) for patients with heart

• disease. The trial leverages existing electronic

health records, which link to insurance claims. A web-based patient portal collects patient-reported outcomes and additional patient-encounter data. The trial engages patients, their healthcare providers, and researchers in using the infrastructure that PCORnet has developed and continues to refine.

CER Methods and Infrastructure, awarded April 2015

Thank You

Rachael Fleurence

Program Director, CER Methods and Infrastructure

New York City Clinical Data Research Network: Harnessing the Power of Healthcare Data Across New York City

Tara Bishop, MD, MPH: tlfernan@med.cornell.edu Alex Low: all9050@med.cornell.edu Weill Cornell Medical College

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New York City

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Nyccdrn.org

NYC-CDRN Mission Create an accessible, sustainable, scalable clinical data network to facilitate:

patient-centered research; learning healthcare systems; and a national research network.

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PCORnet Infrastructure

This map depicts the number of PCORI-funded Patient-Powered or Clinical Data Research Networks that have coverage in each state.

Source: “Introducing PCORnet: The National Patient-Centered Clinical Research Network,” http://pcornet.org/resource-center/other-resources/

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PCORnet Features

• First large infrastructure based on EHRs

(not claims data)

• Infrastructure for both large
• bservational studies and randomized

clinical trials

• Involve patients, clinicians and health

system leaders in governance and use of data

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NYC-CDRN Partners

NYU Langone Montefiore NY Genome Center Mount Sinai Columbia BRANY Healthix Bronx RHIO Cornell Tech Rockefeller Clinical Directors Network Weill Cornell NY Presbyterian

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HHC

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NYC-CDRN Goals

• Ensure privacy and security for patients,

clinicians, and health systems

• Build a research infrastructure
• Embed research into healthcare delivery
• Engage NYC’s diverse patients and clinicians
• Develop a high-functioning, sustainable

governance structure

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Data – Current Characteristics

• Clinical data from 6 health systems and 3 community health

centers

• Other data sources in progress
• 4 million unique patients and 40 million encounters
• Retrospective data from 2007
• Some “truncation” at beginning and end
• Quarterly data refreshes
• Restrictions of deidentified dataset
• No real dates (“date-shifting”)
• 3-digit zips
• Ability to collect other data (inc real dates/5-digit zips) via

“distributed query”

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NYC-CDRN Services

• Data queries
• Study specific data marts
• Data quality assurance and monitoring
• Analytic support
• Streamlined research administrative / regulatory

processes

• Support for pragmatic multi-site clinical trials
• Patient and clinician engagement and support
• Support for regulatory reporting (e.g. FDA)
• Dissemination of study results

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PCORI and Research Use Cases

Use Case Prep-to-Research Observational Studies Individually-Randomized Studies Cluster-Randomized Studies Regulated Trials (Industry-Sponsored)

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Potential “Health System” Use Cases

Use Case Avoidable Hospitalizations Quality Improvement and Patient Safety Population Health Management Choosing Wisely

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NYC-CDRN Unique Characteristics

• Centralized structure
• Deep informatics and analytics expertise
• Geographic co-localization in a fragmented health

care market

• Significant academic medical center concentration
• Health system leaders, CTSA leaders and researcher

support

• Safety-net health care providers
• Large, diverse population
• Diverse data sources, including genomic data
• Significant interest and efforts in population health

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NYC-CDRN Review Process

PI submits request via “Research Partnership Form” NYC-CDRN works with PI

• n any items

needing extra clarification or specification

SUBMIT REFINE EVALUATE APPROVE

Research Review and Prioritization Group (RRPG) reviews and scores projects RRPG forwards recommendatio n to Governance Board for final approval

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Funded Projects Using NYC-CDRN

PI Project (Funding Agency) NYC-CDRN Services Jonathan Tobin, PhD (Clinical Directors Network) Patient-Centered CER of Home- based Interventions to Prevent CA-MRSA Infection Recurrence (PCORI)

• Data query (identify

patients with antibiotic- resistant infections)

• Dissemination

Zachary Grinspan, MD (Weill Cornell) Rare Epilepsies in New York: Epidemiology, Natural Language Processing, and Health Services Research Using Physician Notes from Electronic Health Records (CDC)

• Data query (identify

cohorts of patients with epilepsy)

• Dissemination

Michael Rinke, MD, PhD (Montefiore Medical Center) Pediatric Ambulatory HAIs: Incidence Rates, Risk Factors, Outcomes, Costs and Algorithms for Detection (AHRQ)

• Data query (Identify

cohorts of pediatrics patients with 3 types of HAIs)

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Question and Answer Session

Submitting Questions: Submit questions via the chat function in

• n the right of your screen

If we are unable to address your question during this time, please e-mail your question to us at getinvolved@pcori.org An archive of this webinar will be posted to http://www.pcori.org/get-involved/pcori- in-practice/ following this event. Accessing this Webinar:

Have More Questions?

General Inquiries info@pcori.org | (202) 827-7200 Research/Programmatic Questions sciencequestions@pcori.org | (202) 627-1884 Administrative/Financial/Technical Questions pfa@pcori.org Find us Online at: www.pcori.org

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