This document summarizes a presentation given by Joe Selby on the Patient-Centered Outcomes Research Institute (PCORI). It discusses PCORI's mission to fund comparative clinical effectiveness research that is guided by patients and other stakeholders. Key points include: PCORI's focus on research questions of interest to patients and providers; its criteria for funding proposals, including patient-centeredness and engagement; and its plans to significantly increase funding for such research over time. Examples are given of funded pilot projects involving community health centers.

1. Joe Selby MD, MPH
PCORI Executive Director
8th Annual Weitzman Symposium
Community Health Center, Inc
May 16, 2013
Transforming Health Care

2. Source: Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research.
PUBLIC LAW 111–148—MAR. 23, 2010.
“The purpose of the Institute is to assist
patients, clinicians, purchasers, and policy-
makers in making informed health
decisions by advancing the quality and
relevance of evidence concerning the manner
in which diseases, disorders, and other health
conditions can effectively and appropriately be
prevented, diagnosed, treated, monitored, and
managed through research and evidence
synthesis that considers variations in patient
subpopulations and the dissemination of
research findings with respect to the relative
health outcomes, clinical effectiveness, and
appropriateness of medical treatments,
services.
Purpose
Of
PCORI
PCORI’s Broad Mandate

3. 3
PCORI’s Board of Governors
P3
PCORI Board of Governors, March 2012 in Baltimore, MD

4. 4
What Does PCORI Mean By Patient-
Centeredness?
Does the proposed research compare
treatment options that matter to patients; are
these realistic choices faced by patients or
other decision-makers?
Does the research focus on outcomes of
interest to patients and their caregivers,
including health, health-related quality of life,
function, symptoms, safety from medical
harm, survival and satisfaction with care?

5. 5
PCORI’s Mission – Through Engagement
Mission
The Patient-Centered Outcomes Research Institute
(PCORI) helps people make informed health care
decisions, and improves health care delivery and
outcomes, by producing and promoting high integrity,
evidence-based information that comes from research
guided by patients, caregivers and the broader health
care community.
5www.pcori.org

6. 6
PCORI’s Rationale for Engagement
Advise Us on what PCORI
Should Study:
Tell Us How We Are Doing
Review Proposals and
Partner in Research
Help Us Share the Findings
Patients
and
Stakeholders
• Topic generation
• Research prioritization
 Merit Review
 Participate in research
How can we improve on what we
are doing and how we are doing
it?
 Dissemination

7. 7
PCORI Review Criteria
1.
Impact of the condition on the health of
individuals and populations –
burden in terms of prevalence, suffering, costs
2.
Potential for the study to improve healthcare and
outcomes –
likelihood that this study’s findings could change current practice
3. Technical merit –
research plan, analytic methods, research team, environment
4.
Patient-Centeredness -
relevance of the study question and the outcomes to patients
5.
Patient and stakeholder engagement –
inclusion of relevant patients and stakeholders on research team

8. 8
PCORI Funding – Approximate
2012
2013
2014
2015
....
2019
$150,000,000*
$300,000,000
$500,000,000
$500,000,000
$500,000,000
* 20% each year goes to AHRQ/HHS 8

9. 9
PCORI’s National Priorities and Research
Agenda
9
Assessment of Prevention, Diagnosis, Treatment Options
• Comparisons of alternative clinical options; identifying patient differences in response to
therapy; studies of patient preferences for various outcomes
Improving Healthcare Systems
• Improving system support of patient self-management, coordination of care for complex
conditions, access to care; comparing alternative strategies for workforce deployment.
Communication & Dissemination Research
• Understanding and enhancing shared decision-making; alternative strategies for
dissemination of evidence; exploring opportunities to improve patient health literacy
Addressing Disparities
• Understanding differences in effectiveness across groups; understanding differences in
preferences across groups; reducing disparities through use of findings from PCOR
Accelerating PCOR and Methodological Research
• Improving study designs and analytic methods of PCOR; building and improving clinical
data networks

10. 10
Improving Healthcare Systems –
from PCORI’s Funding Announcement
10
Research that compares alternative system-level approaches to improving:
- patients’ access to care;
- receipt of appropriate evidence-based care;
- quality of care;
- decision-making based on personal values;
- coordination of care across healthcare settings,
the efficiency of healthcare delivery.
Strategies of interest include, but are not limited to:
novel applications of health information systems,
incentives directed at clinicians, patients and systems;
payment reforms, such as value-based purchasing, bundled
payments and accountable care organizations;
reconfigurations (redesign) of care, such as the patient-centered
medical home;
new and extended roles for allied health professionals

11. 11
Addressing Health Disparities –
from PCORI’s Funding Announcement
11
Research that compares:
Interventions to reduce or eliminate disparities in patient-centered outcomes,
including health, healthcare, and patient-reported outcomes.
practices that address contextual factors such as socioeconomic, demographic,
or community factors and their impact on patient-centered health outcomes.
benefits and risks of treatment, diagnostic, prevention, or service
options across different patient populations.
strategies to overcome patient, provider, or systems level barriers (e.g.,
language, culture, transportation, homelessness, unemployment, lack of
family/caregiver support)
best practices within various patient populations for information sharing and
shared decision-making.

12.  Addresses practical questions – especially those of interest
to patients and providers – usually head-to-head
comparisons
 Conducted in ―typical‖ patients and ―typical‖ care delivery
settings
 Considers the full range of outcomes of interest to patients
and clinicians
 Considers possible differences in treatment effectiveness in
patient subgroups – what works for whom?
 May be RCTs or observational studies
 But NOT cost-effectiveness or cost comparison studies
Comparative Clinical Effectiveness Research
– PCORI Style

13. 13
PCORI’s Broad Solicitations for Research Funding
13
#1: Investigator-Generated Pathway – ―BROAD‖
Diverse portfolio addressing
high-priority questions

14. PCORI Projects Involving CHC’s
14
• Pilot Project: Tucson, Arizona
Integrating and Comparing Community-Based
Participatory and Conjoint Analysis
• Pilot Project: Los Angeles, California
A Modified Delphi Approach to Defining a Patient-
Centered Community Health Center
• Pilot Project: Boston, Massachusetts
Developing an Analytic Tool to Assess Patient
Responses
• Addressing Disparities Cycle I: Tuscaloosa, Alabama
Reducing Disparities with Literacy-Adapted
Psychosocial Treatments for Chronic Pain

15. A Modified Delphi Approach to Defining a Patient-
Centered Community Health Center (Pilot Project)
15
Primary Investigator and Institution: Robin Clarke, MD
University of California, Los Angeles
Award Amount: $307,985
Description: Evaluates the theories, evidence, and practices of enabling services, such
as providing transportation to appointments, conducting case management
assessments, or performing community outreach. Goals of the study are to:
 Define a specific standard of care for each category of enabling service that will
facilitate active investigation of how these patient-centered services affect the
health care delivered to underserved patients.
 Improve the implementation, diffusion, and reimbursement of enabling services.
 Reshape how the existing patient-centered medical home paradigm applies to
practices caring for low-income patients.
Featured Project Strength:
 Creates a new research method that incorporates community health
center providers and patients to define what the standards of care are for
these services.
 Addresses barriers to care that affect approximately 25 million
Americans.

16. Engaging Stakeholders to Improve Depression
Management in a Tribal Health System (Pilot Project)
16
Primary Investigator and Institution: Renee Robinson, PharmD,
Southcentral Foundation
Award Amount: $604,301
Description: Project will develop, test, and refine a tool to support decision making
within a tribally-owned health care organization, using depression as example condition.
There are three specific aims:
 Identify stakeholder preferences and needs that influence depression treatment
decisions in Alaska Native and American Indian people.
 Develop a tool to help translate and integrate evidence-based guidelines, and
stakeholder preferences and needs into depression management decisions.
 Determine impact of the stakeholder-centered tool on health, service utilization, and
outcomes.
Featured Project Strengths:
 Studies an issue with high prevalence in an underserved community.
 The results will be applicable to other chronic health concerns, and other
racially and ethnically diverse populations with persistent health
disparities.

17. 17
Cycle I Awards
17
• Assessment of Prevention, Diagnosis and Treatment Options: Ann Arbor, Michigan
Selection of Peritoneal Dialysis or Hemodialysis for Kidney
Failure: Gaining Meaningful Information for Patients and
Caregivers
• Communication and Dissemination Research: Jacksonville, Florida
Shared Medical Decision Making in Pediatric Diabetes
• Communications and Dissemination Research: University Heights, Iowa
Extension Connection: Advancing Dementia Care for
Rural and Hispanic Populations
• Assessment of Prevention, Diagnosis and Treatment Options: Rochester, Minnesota
Shared Decision Making in the Emergency Department:
The Chest Pain Choice Trial

18. 18
Reducing Health Disparities in Appalachians with
Multiple Cardiovascular Disease Risk Factors
18
Primary Investigator and Institution: Debra Moser, DNSc, RN, FAAN
Kentucky University
Award Amount: $2,092,473.60
Description: Compares the effects of two approaches in reducing risk of
cardiovascular disease. Comparison is between the current standard of care
and the standard of care supplemented by culturally appropriate self-care tools.
 Examines four-month and one year impact of various measures, including tobacco
use, blood pressure, BMI, and the number of recruited people who stay with the
program.
 Study involves 300 individuals from Appalachian Kentucky who do not have a
primary care provider, and otherwise are not able to receive the standard of care
without intercession, and are at risk by having two or more modifiable risk factors.
factors.
Featured Project Strengths:
 This study will have a substantial impact on cardiovascular health
because it will provide needed patient-centered risk reduction to a major
at-risk population living in an environment where risk reduction is difficult.
 The potential for application to other environments and high-risk
populations is high.
Debra Moser

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Creating a Clinic-Community Liaison Role in Primary
Care: Engaging Patients and Community in Health Care
Innovation
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Primary Investigator and Institution: Clarissa Hsu, PhD
Group Health Cooperative
Award Amount: $1,564,384
Projected Completion Date: December 31, 2015
Description: Works with patients to design role for a clinic-community
liaison to link healthcare clinics with community. Strategy aims to increase
patients’ ability get what they need from both their community and their healthcare. The
specific goals are to:
 Create new ways to involve patients in designing their own healthcare by
developing processes and tools to help patients contribute ideas for how care
should be designed.
 Design and test a new clinic-community liaison role for primary care teams by
focusing on the prevention and treatment of chronic conditions.
Featured Project Strengths:
 This project follows up on an extremely promising intervention, drawing
upon existing data and methodologies.
 It is highly patient centered and focused on "real-world" perspective.
Clarissa Hsu

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Location of PCORI’s First 104 Awards
20
Total: 124

21. 2121
PCORI Engagement Awards

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Purpose
Build community
Form or strengthen reciprocal relationships between
researchers and non-research communities
Support capacity building, co- learning, and the development of
a sustainable infrastructure to facilitate ―research done
differently‖
Accelerate proposal submission (or re-submission)
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23. 23
PCORI Engagement Awards – coming July
2013
Proposed by participants at October 2012 Transforming
Patient-Centered Research patient engagement workshop
Intended to provide resources to non–research entities for
community development, capacity building, or for
infrastructure development for engagement in research as
partners.
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Design
24

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Pre-Engagement/Community-Building Projects
(Up to $15,000 for 6 months)
Available to individuals,
consumer/patient organizations,
clinician(s) or researcher(s) or a
combination of the above to
support:
 Community building
 Creation of structure and
communication strategies
 Develop an understanding of
PCORI, and ―research done
differently‖
25

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Partnership and Infrastructure Development
Projects (Up to $30,000 for 1 year)
Available to emerging
research/non-research
partnerships to support:
 Data network development
 Development of infrastructure
 Generation of research
questions through community
events, town hall meetings, etc.
 Minimum 50% of funds go to
non research partner(s)
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Proposal Development Projects
(Up to $50,000 for 1 year)
Available to advanced
research/non-research
partnerships- including those who
submitted PCORI proposals and
were not funded - to support:
 PCORI research proposal
(re)submission
 Research partnership skill
development
 Minimum 50% of funds go to non
research partner(s)
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Connect with PCORI
www.pcori.org
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