Rethinking Clinical Research

HCN Educational SessionJune 25, 2014

RESEARCH

A CEO’s Perspective ...To Research or Not to Research

That is the Question?

NO !@%# WAY!!!!

Not Our Mission! Our job is to take care of people NOT study them

NO Time!Already pedaling so fast we can’t keep upCan’t ask providers to do any more

NO Resources!Our $$ need to go to direct servicesDon’t have staff expertise

NO Difference to our patients!

Changing Health Care Environment

Being forced to bend the cost/quality curve Reduce ER visits, lower hospital re-admissions System Integration, ACO, PCMH, CMS Innovation

Value not Volume New payment models Data-driven changes ACA places CHCs front and center

“walking our talk” and let our voice to be heard

Success in this environment requires we innovate and work in new ways!

Benefits of Research Use it to advocate for needs of our patients

Academic “petri dish” researchers can’t and don’t know needs of our patients

Data is an Asset -- we are data-rich Leverage to benefit patients

Influence policy Design evidenced-based best practices and find

“Better ways to do what we do” Generate new opportunities and revenues

SOME LAST THOUGHTS…. Be at the table when questions are asked and

decisions made… If we don’t advocate, Who will … Prefer to “drive the bus” … Don’t want to say “We wish we would of….” Our Moral Obligation

Opportunity to make a difference!Fulfill our Mission!

Let’s not be left behind!

Research at OCHIN

Presented by:Abby SearsChief Executive OfficerOCHIN, Inc.

20th Annual HCN Educational Session

• OCHIN and OCHIN Research: Overview

• OCHIN’s Investment in Research• The Truth Behind Research ROI• Board Level: Contract Changes

& Strong Data Use Policy• Our Mission: Enhanced by

Research

Agenda

• As a nonprofit organization, we are a healthcare innovation organization designed to promote access to quality, affordable healthcare for all.

Who Is OCHIN?

• One of the nation’s largest and most successful Health Information Networks

In 18 states, coast to coast

Touching over 4,500 physicians

• Health Services Research . . . – examines access to health care, cost of care & patient outcomes – identifies effective ways to organize, manage, finance and deliver

high quality care, reduce medical errors & improve patient safety • Epidemiology . . .

– is the study of the factors determining and influencing the frequency and distribution of disease, injury, and other health-related events and their causes in a defined human population

– is the sum of knowledge gained in such a study

OCHIN Engages in Health Research

• OCHIN Research is Unique– Our collaborative is one of only a few organizations in the nation

currently capturing aggregate health care data and statistics of low income and uninsured populations

– One of the nation’s most diverse patient databases of Medicaid-insured and uninsured individuals, a unique resource for researchers

– Centralized expertise and a large group of innovative organizations that enables the development and testing of IT tools

– Provides a “community laboratory” for conducting research at the clinic-level

OCHIN Research: Quick Review

2005: Discussions between OCHIN & Kaiser Permanente NW about data driven research. Kaiser Permanente NW Community Benefit Initiative Fund funds several research projects

2006: First formal meeting of OCHIN Practice-Based Research Network (O-PBRN, Formerly Safety Net West). Mission and purpose statement adopted.

2007: Registered with AHRQ as PBRN; ACQ grant funded; 1 paper published2008: PASS 2 grant funded

2009: PODS grant funded; 2 papers published2010: 7 grants funded; Jen DeVoe hired as Executive Director

2011: 3 grants funded; 9 papers published2012: 6 grants funded; 12 papers published

2013: 6 grants funded; 5 papers published

2014: 5 grants/contracts funded; 5 papers published

History of Research at OCHIN

• 19 active projects as of June 2014• 17 completed projects (since 2005)• More than $21.1 million dollars in total research grant and

contract revenue since 2005• Foci:

– Health Policy– HIT Tools– Practice Transformation– Chronic Disease

OCHIN Research Portfolio

• Our mission has always been to use data to impact policy around patient care and the delivery system reform

• Research is credible and tangible way to deliver a message; provides evidence and data to support

• We thought we could subsidize the running of Epic from the Research indirect money….but this has proven to be a fallacy

OCHIN’s Investment in Research

• Brand new infrastructure required to manage research grants– Grant administration– Proposal coordination– PR and press releases Publication management– Grant accounting– Doubled compliance requirements– Research associates– PIs– Biostatisticians and SAS and SPSS analysts

• Competitive environment for Research funding– Need for Principal Investigators that can win grants– Competing with Academic Health Centers for these resources– AHCs are now guaranteeing parts of their salaries to recruit

The Truth Behind Research ROI

• Started small– 2010: Asked for permission to share data for public health

reporting only• Built trust

– 2005 – 2011: Asked for permission from each member organization for data use and data sharing for each research project

– Included clinicians from member organizations on research project teams

– Created Board subcommittee (Data Stewardship Committee) to oversee data uses covered by the policy

Board Level: Contract Changes & Strong Data Use Policy

• Went back to Board on multiple occasions to gain more support– 2011: Asked for permission for data use and data sharing

for research purposes (up to a limited data set)– 2012: Changed requirements for member approval to

passive approval after set period of time– 2013: Added language that OCHIN may respond directly

to requests for access to PHI on behalf of member organizations provided the member is notified, and the member may explicitly disapprove

Board Level: Contract Changes & Strong Data Use Policy

• Enabling more innovation for clinics• Advancing and strengthening our analytical capabilities• Improving national presence• Supporting clinicians and their growth and interests• Bringing issues and challenges to the forefront publicly • Increasing our need for advocacy

Our Mission: Enhanced by Research

“OCHIN is a nonprofit healthcare innovation center designed to provide knowledge solutions that promote quality, affordable healthcare to all.”

Patient Level RCT

Clinic Level RCT CER HIT Best Practices

D&I Natural Experiment

Patient Level Surveillance

Complex Data-set Linkage

ALL

IMPACCT

STOP CRC

Team Up

Heintzman K

MOHR

MoodHelper

My Preventive Care

FAMILY

CARDIAC

APM Evaluation

PRIME

Low Back Pain Imaging

RCT = Randomized Controlled Trial; CER = Comparative Effectiveness Research; D&I = Dissemination and Implementation

Types of Research Projects

• Patient Centered Outcomes Research Institute (PCORI) Clinical Data Research Network Program– Goal is to improve the nation’s capacity to conduct

comparative effectiveness research (CER) by creating a large, highly representative electronic data infrastructure for conducting clinical outcomes research

– 18 Patient Powered Research Networks funded– 11 Clinical Data Research Networks (CDNRs) funded,

including the OCHIN-led ADVANCE CDRN

OCHIN’s Research Partnership with HCN

ADVANCE Governance Model

• EHR data standardized within collaboration network (CDRN)• A minimum of 1 million patients enrolled • Capable of implementing clinical trials• Individual network’s data in inter-operable format with other

awardee networks and successfully responds to queries• Patients, system, and clinicians involved in governance and

use of network• At least three patient cohorts identified, characterized, and

surveyed

PCORI’s Goals for the CDRNs

ADVANCE: Accelerating Data Value Across a National Community Health Center Network

For more information, visit ochin.org/offerings/research/

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My perspectiveAndrew L Brickman, PhD

?

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Show me the data

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My perspective

What’s a Learning Healthcare System?

Research Influences Practice Practice Influences Research

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It’s all aboutthe data.

Brickman et al. Bradycardia during stimulation of the septum and somatic afferents in the rabbit. American Journal of Physiology, 1979 Brickman et al. Classically conditioned blood pressure decreases induced by electrical stimulation of posterior lateral hypothalamus in rabbits. Psychophysio logy, 1977 Brickman et al. Responses of anterior hypothalamic neurons to stimulation of aortic nerve and caudate nucleus in rabbits. Experimen tal Neurology, 1977

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Scie

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insi

ght:

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uman

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ore

inte

resti

ng

than

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its.

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Memory Disorders ClinicGeriatric PsychiatryBiological PsychiatryExperimental Neurology

Chronic Fatigue Syndrome ClinicPsychosomaticsClinical Infectious DiseaseJ of Chronic Fatigue SyndromeChronic Fatigue & Related Immune Deficiencies… research practice research practice research practice …

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Behavioral MedicinePsychophysiology Am J of PsychiatryJ of Clinical Psychology in Medical Settings

Kidney Transplant ConsultationJournal of UrologyPediatric NephrologyBritish Journal of UrologyGeneral Hospital PsychiatryDialysis and Transplantation

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University Behavioral HealthPsychiatric ServicesQuality of Life & Pharmacoeconomics

… research practice research practice research practice …

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Let’s look back a few years…

IS THIS SOMETHING NEW?

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1948 -- First randomized controlled trial: Effects of streptomycin versus placebo on pulmonary tuberculosis.

Ushered in the era of Evidence Based Medicine

TheGOLDStandardFor Efficacy

… some not so obvious …

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Fast Forward 66 years to 2005

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Contradicted and Initially Stronger Effects in Highly Cited Clinical Research.Loannidis JPA. JAMA. 2005;294(2):218-228

Of 49 highly cited original clinical research studies, • NEJM, Lancet, JAMA (1990-2003)• 45 claimed that the intervention was effective. • 1000 citations in the literature• 16% were contradicted by subsequent studies• 16% found effects that were stronger than those of

subsequent studies• 24% remained unchallenged

Is the gold beginning to loose some of its luster?

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Rothwell, PM. The Lancet, Volume 365, Issue 9453, Pages 82 - 93, 1 January 2005

Relevance [of an RCT] depends on external validity (or generalizability).

Can the results be applied to a definable group of patients in a particular clinical setting in routine practice?Can the results of an RTC be applied to the uninsured?

External validity of randomized controlled trials: “To whom do the results of this trial apply?”

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Fast Forward 9 Years. What is happening today?

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PCORnet: turning a dream into reality. Collins FS, Hudson KL, Brigg JP & Lauer MSJ Am Med Informatics Association , Editorial, May 20, 2014

• The vast majority of ongoing clinical trials are too small to provide evidence relevant to patients and clinicians.

• Too often, patients and caregivers seeking information on how best to improve their health or the health of their loved ones find that biomedicine does not have answers for questions they ask.

• The current clinical research system does not produce high-quality evidence quickly enough to support health care decision making.

…last month, Francis Collins (Director of the NIH) wrote:

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By Ariana Eunjung ChaPublished: April 15, 2014

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OCHIN / HCN Harvard University Medical SchoolUniversity of Pittsburgh The Children’s Hospital of PhiladelphiaThe Chicago Community Trust Vanderbilt University Medical CenterKaiser Foundation Research Inst. Weill Medical College of Cornell ULouisiana Public Health Institute University of Kansas Medical Center

University of California San Diego

PCORnet: a network of networks that originates in healthcare systems and securely collect “real-time,” “real-world” health information during the routine course of patient care.

PCORI Awards $93.5 Million to Develop National Network to Support More Efficient Patient-Centered Research WASHINGTON, Dec. 17, 2013

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Patient-Centered Outcomes Research (PCOR) helps people and their caregivers communicate and make informed healthcare decisions, allowing their voices to be heard in assessing the value of healthcare options.

“Given my personal characteristics, conditions and preferences, what should I expect will happen to me?”

“What are my options and what are the potential benefits and harms of those options?”

“What can I do to improve the outcomes that are most important to me?”

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Backup slidesDo Not use

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It is easy to read some of the signposts…1796 Vaccines -- Dr. Edward Jenner successfully

prevented a young English boy from getting smallpox.

1846 Anesthesia -- Dentist William T.G. Morton demonstrated ether.

1928 Antibiotics -- Sir Alexander Fleming left a petri dish of Staphylococci bacteria uncovered and later noted that the bacteria had been killed by a mold.

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Moderator: Richard Taaffe

Three Perspectives:

The Center CEO – Richard TaaffeThe Network CEO – Abby SearsThe Clinician Researcher – Andrew Brickman

CMO Discussant -- St. Anthony Amofah

Rethinking Clinical Research

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Are pragmatic approaches new to CHCs?

Randomized clinical trials

Pragmatic Trials Continuous Quality Improvement

Retrospective Data Observational Studies

Cluster DesignsPCOR

PCMH

Care Management

Med Home [GE]

RCTs

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There is a pressing need for practical clinical trials that are more relevant to clinicians and decision-makers …

Practical Clinical Trials for Translating Research to Practice: Design and Measurement Recommendations

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Funded PCORI Clinical Data Research networks: who are they? • Networks of academic health centers, hospitals & clinical practices

• Networks of non-profit integrated health systems

• Networks of Federally Qualified Health Centers (FQHCs) serving low-income communities

• Networks leveraging NIH and AHRQ investments (CTSAs)

• Inclusion of Health Information Exchanges

• Wide geographical spread

• Inclusion of under-served populations

• Range from 1M covered lives to 28M

Clinical & Translational

Science Awardees

Health Information Exchanges

Safety Net

ClinicsIntegrated Delivery Systems

Academic Health

Centers