Appreciate the opportunity to visit and address you.Always forces me to stop and assess where PCORI has gotten toI find that the thinking I do in preparation gives me a new path forward for next several weeks.Just wish I could figure out how to do thinking earlier than the weekend before the talk!Several assumptions: I’m speaking to a smart and thoughtful group You’ve thought about and care about health care efficiency, getting value for the vast amounts of money we spend You won’t mind thinking with me on a set of questions.
Who are the individuals responsible for carrying out PCORI’s mission?PCORI is governed by a 21-member board that represents everyone in the health care community – patients, caregivers, doctors, nurses, researchers, public health officials, payers and industry.By law, PCORI’s Board is required to include:3 members representing patients and health care consumers5 members representing physicians and providers, including at least 1 surgeon, nurse, state-licensed integrative health care practitioner, and representative of a hospital3 members representing private payers, of whom at least 1 member shall represent health insurance issuers and at least 1 member shall represent employers who self-insure employee benefits3 members representing pharmaceutical, device, and diagnostic manufacturers or developers1 member representing quality improvement or independent health service researchers2 members representing the Federal Government or the States, including at least 1 member representing a Federal health program or agencyThe directors of the National Institutes of Health and the Agency for Healthcare Research and Quality (or their designees)PCORI has established three committees: Program Development Communication, Outreach and Engagement Finance, Audit and AdministrationPCORI also has a 17-member Methodology Committee to help PCORI develop and update methodological standards and guidance for comparative clinical effectiveness and outcomes research.
I want to say a few words about what we mean and why we say that we will engage, intensely and continuously. with patients and other key stakeholders in the research process. First, we want patients to help us decide what to study. This means raising the research questions and then joining with other stakeholders to prioritize those questions. We’ll fund the high priority questions. Then, after we decide what we want to fund, we invite researchers to apply. When we review their applications, there are patients and other stakeholders ON THE REVIEW PANELS.They help identify the highest quality applications, looking especially at whether the resaerch got the questions right. But beyond the review, we will have patients participating on the research teams. In fact, you don’t get funded if you don’t have relevant patients and other relevant stakeholders involved in the entireproject. Why?? Beucase we think that will increase the chances that the research is actually relevant and sticks to its purpose ofanswering patient-driven questions. And why do we do all of that?? Because we bFinally, our Advisory Panels will have….
What is the purpose of the Research Agenda?The Research Agenda describes the types of research questions that can be addressed under each of the five priorities. The agenda also outlines nine criteria, taken from PCORI’s establishing legislation, which will be used to evaluate research proposals. Studies that meet most or all of these criteria will be those most likely to be funded.Why doesn’t the Research Agenda name specific conditions or treatments that PCORI is interested in funding or studying?PCORI believes there are important comparative clinical effectiveness research questions to be answered across a wide range of conditions. Focusing on a narrower set of diseases or conditions at the start of PCORI’s research funding would mean that some patients and health care issues might have no chance of benefitting from PCORI’s existence. Also, there are issues that affect patients across a variety of conditions. For example, we have heard from the patient focus groups about challenges with communication and interaction with their providers. These are problems that are not specific to one condition, but have been identified by a variety of patients as being important to them. Involving patients and other stakeholders in a meaningful process of considering which conditions or questions deserve more PCORI funding is important and will begin immediately and continue throughout PCORI’s lifetime. However, it will take time to hear all views on these issues, to weigh the input, and to begin making these choices. This must be done in a transparent manner so that all can understand how we reached the narrower, targeted set of research questions we focus on. Over time, PCORI’s research portfolio will become more focused, but PCORI will continue to reserve a portion of its funding for addressing the broader set of possible questions that patients, researchers and stakeholders may raise.
Engagement: Bullet 1: collaborative relationship with the Center for Excellence in Rural Health-Hazard and HomePlace. The director and the vast majority of the staff are long-time residents of Appalachia and they have built up a firm foundation of trust and accountability with local residents. In particular, the staff at HomePlace, who are largely lay community health workers, have unparalleled success in identifying, recruiting and retaining those individuals most in need of assistance with healthcare
Purpose is really two fold. To respond to the needs identified by workshop participants as well as to address PCORI’s need to accelerate funding of quality proposals and to “produce” Define community Define non research partner to include patients, caregivers, advocacy organizations, community members, clinicians and other stakeholders who will use the information generated by PCORI
Workshop participants identified the need /gap for micro-contracts
Design and Available Funding PCORI expects to award a total of $1.8 million dollars annually to fund projects in three different categories—Pre-engagement/Community Building Projects, Partnership and Infrastructure Development Projects, and Proposal Development Projects—that follow a logic model and progressive “framework for success” for engagement in research.
Discuss the fiscal agent opportunityAwardees are expected to submit a proposal for a Partnership and Infrastructure Development Project.
Awardees expected to submit a proposal for Proposal Development project
Joe Selby MD, MPHPCORI Executive Director8th Annual Weitzman SymposiumCommunity Health Center, IncMay 16, 2013Transforming Health Care
Source: Affordable Care Act. Subtitle D—Patient-Centered Outcomes Research.PUBLIC LAW 111–148—MAR. 23, 2010.“The purpose of the Institute is to assistpatients, clinicians, purchasers, and policy-makers in making informed healthdecisions by advancing the quality andrelevance of evidence concerning the mannerin which diseases, disorders, and other healthconditions can effectively and appropriately beprevented, diagnosed, treated, monitored, andmanaged through research and evidencesynthesis that considers variations in patientsubpopulations and the dissemination ofresearch findings with respect to the relativehealth outcomes, clinical effectiveness, andappropriateness of medical treatments,services.PurposeOfPCORIPCORI’s Broad Mandate
3PCORI’s Board of GovernorsP3PCORI Board of Governors, March 2012 in Baltimore, MD
4What Does PCORI Mean By Patient-Centeredness?Does the proposed research comparetreatment options that matter to patients; arethese realistic choices faced by patients orother decision-makers?Does the research focus on outcomes ofinterest to patients and their caregivers,including health, health-related quality of life,function, symptoms, safety from medicalharm, survival and satisfaction with care?
5PCORI’s Mission – Through EngagementMissionThe Patient-Centered Outcomes Research Institute(PCORI) helps people make informed health caredecisions, and improves health care delivery andoutcomes, by producing and promoting high integrity,evidence-based information that comes from researchguided by patients, caregivers and the broader healthcare community.5www.pcori.org
6PCORI’s Rationale for EngagementAdvise Us on what PCORIShould Study:Tell Us How We Are DoingReview Proposals andPartner in ResearchHelp Us Share the FindingsPatientsandStakeholders• Topic generation• Research prioritization Merit Review Participate in researchHow can we improve on what weare doing and how we are doingit? Dissemination
7PCORI Review Criteria1.Impact of the condition on the health ofindividuals and populations –burden in terms of prevalence, suffering, costs2.Potential for the study to improve healthcare andoutcomes –likelihood that this study’s findings could change current practice3. Technical merit –research plan, analytic methods, research team, environment4.Patient-Centeredness -relevance of the study question and the outcomes to patients5.Patient and stakeholder engagement –inclusion of relevant patients and stakeholders on research team
8PCORI Funding – Approximate2012201320142015....2019$150,000,000*$300,000,000$500,000,000$500,000,000$500,000,000* 20% each year goes to AHRQ/HHS 8
9PCORI’s National Priorities and ResearchAgenda9Assessment of Prevention, Diagnosis, Treatment Options• Comparisons of alternative clinical options; identifying patient differences in response totherapy; studies of patient preferences for various outcomesImproving Healthcare Systems• Improving system support of patient self-management, coordination of care for complexconditions, access to care; comparing alternative strategies for workforce deployment.Communication & Dissemination Research• Understanding and enhancing shared decision-making; alternative strategies fordissemination of evidence; exploring opportunities to improve patient health literacyAddressing Disparities• Understanding differences in effectiveness across groups; understanding differences inpreferences across groups; reducing disparities through use of findings from PCORAccelerating PCOR and Methodological Research• Improving study designs and analytic methods of PCOR; building and improving clinicaldata networks
10Improving Healthcare Systems –from PCORI’s Funding Announcement10Research 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, bundledpayments and accountable care organizations;reconfigurations (redesign) of care, such as the patient-centeredmedical home;new and extended roles for allied health professionals
11Addressing Health Disparities –from PCORI’s Funding Announcement11Research 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 serviceoptions across different patient populations.strategies to overcome patient, provider, or systems level barriers (e.g.,language, culture, transportation, homelessness, unemployment, lack offamily/caregiver support)best practices within various patient populations for information sharing andshared decision-making.
Addresses practical questions – especially those of interestto patients and providers – usually head-to-headcomparisons Conducted in ―typical‖ patients and ―typical‖ care deliverysettings Considers the full range of outcomes of interest to patientsand clinicians Considers possible differences in treatment effectiveness inpatient subgroups – what works for whom? May be RCTs or observational studies But NOT cost-effectiveness or cost comparison studiesComparative Clinical Effectiveness Research– PCORI Style
13PCORI’s Broad Solicitations for Research Funding13#1: Investigator-Generated Pathway – ―BROAD‖Diverse portfolio addressinghigh-priority questions
PCORI Projects Involving CHC’s14• Pilot Project: Tucson, ArizonaIntegrating and Comparing Community-BasedParticipatory and Conjoint Analysis• Pilot Project: Los Angeles, CaliforniaA Modified Delphi Approach to Defining a Patient-Centered Community Health Center• Pilot Project: Boston, MassachusettsDeveloping an Analytic Tool to Assess PatientResponses• Addressing Disparities Cycle I: Tuscaloosa, AlabamaReducing Disparities with Literacy-AdaptedPsychosocial Treatments for Chronic Pain
A Modified Delphi Approach to Defining a Patient-Centered Community Health Center (Pilot Project)15Primary Investigator and Institution: Robin Clarke, MDUniversity of California, Los AngelesAward Amount: $307,985Description: Evaluates the theories, evidence, and practices of enabling services, suchas providing transportation to appointments, conducting case managementassessments, or performing community outreach. Goals of the study are to: Define a specific standard of care for each category of enabling service that willfacilitate active investigation of how these patient-centered services affect thehealth care delivered to underserved patients. Improve the implementation, diffusion, and reimbursement of enabling services. Reshape how the existing patient-centered medical home paradigm applies topractices caring for low-income patients.Featured Project Strength: Creates a new research method that incorporates community healthcenter providers and patients to define what the standards of care are forthese services. Addresses barriers to care that affect approximately 25 millionAmericans.
Engaging Stakeholders to Improve DepressionManagement in a Tribal Health System (Pilot Project)16Primary Investigator and Institution: Renee Robinson, PharmD,Southcentral FoundationAward Amount: $604,301Description: Project will develop, test, and refine a tool to support decision makingwithin a tribally-owned health care organization, using depression as example condition.There are three specific aims: Identify stakeholder preferences and needs that influence depression treatmentdecisions in Alaska Native and American Indian people. Develop a tool to help translate and integrate evidence-based guidelines, andstakeholder preferences and needs into depression management decisions. Determine impact of the stakeholder-centered tool on health, service utilization, andoutcomes.Featured Project Strengths: Studies an issue with high prevalence in an underserved community. The results will be applicable to other chronic health concerns, and otherracially and ethnically diverse populations with persistent healthdisparities.
17Cycle I Awards17• Assessment of Prevention, Diagnosis and Treatment Options: Ann Arbor, MichiganSelection of Peritoneal Dialysis or Hemodialysis for KidneyFailure: Gaining Meaningful Information for Patients andCaregivers• Communication and Dissemination Research: Jacksonville, FloridaShared Medical Decision Making in Pediatric Diabetes• Communications and Dissemination Research: University Heights, IowaExtension Connection: Advancing Dementia Care forRural and Hispanic Populations• Assessment of Prevention, Diagnosis and Treatment Options: Rochester, MinnesotaShared Decision Making in the Emergency Department:The Chest Pain Choice Trial
18Reducing Health Disparities in Appalachians withMultiple Cardiovascular Disease Risk Factors18Primary Investigator and Institution: Debra Moser, DNSc, RN, FAANKentucky UniversityAward Amount: $2,092,473.60Description: Compares the effects of two approaches in reducing risk ofcardiovascular disease. Comparison is between the current standard of careand the standard of care supplemented by culturally appropriate self-care tools. Examines four-month and one year impact of various measures, including tobaccouse, blood pressure, BMI, and the number of recruited people who stay with theprogram. Study involves 300 individuals from Appalachian Kentucky who do not have aprimary care provider, and otherwise are not able to receive the standard of carewithout 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 healthbecause it will provide needed patient-centered risk reduction to a majorat-risk population living in an environment where risk reduction is difficult. The potential for application to other environments and high-riskpopulations is high.Debra Moser
19Creating a Clinic-Community Liaison Role in PrimaryCare: Engaging Patients and Community in Health CareInnovation19Primary Investigator and Institution: Clarissa Hsu, PhDGroup Health CooperativeAward Amount: $1,564,384Projected Completion Date: December 31, 2015Description: Works with patients to design role for a clinic-communityliaison to link healthcare clinics with community. Strategy aims to increasepatients’ ability get what they need from both their community and their healthcare. Thespecific goals are to: Create new ways to involve patients in designing their own healthcare bydeveloping processes and tools to help patients contribute ideas for how careshould be designed. Design and test a new clinic-community liaison role for primary care teams byfocusing on the prevention and treatment of chronic conditions.Featured Project Strengths: This project follows up on an extremely promising intervention, drawingupon existing data and methodologies. It is highly patient centered and focused on "real-world" perspective.Clarissa Hsu
20Location of PCORI’s First 104 Awards20Total: 124
22PurposeBuild communityForm or strengthen reciprocal relationships betweenresearchers and non-research communitiesSupport capacity building, co- learning, and the development ofa sustainable infrastructure to facilitate ―research donedifferently‖Accelerate proposal submission (or re-submission)22
23PCORI Engagement Awards – coming July2013Proposed by participants at October 2012 TransformingPatient-Centered Research patient engagement workshopIntended to provide resources to non–research entities forcommunity development, capacity building, or forinfrastructure development for engagement in research aspartners.23
25Pre-Engagement/Community-Building Projects(Up to $15,000 for 6 months)Available to individuals,consumer/patient organizations,clinician(s) or researcher(s) or acombination of the above tosupport: Community building Creation of structure andcommunication strategies Develop an understanding ofPCORI, and ―research donedifferently‖25
26Partnership and Infrastructure DevelopmentProjects (Up to $30,000 for 1 year)Available to emergingresearch/non-researchpartnerships to support: Data network development Development of infrastructure Generation of researchquestions through communityevents, town hall meetings, etc. Minimum 50% of funds go tonon research partner(s)26
27Proposal Development Projects(Up to $50,000 for 1 year)Available to advancedresearch/non-researchpartnerships- including those whosubmitted PCORI proposals andwere not funded - to support: PCORI research proposal(re)submission Research partnership skilldevelopment Minimum 50% of funds go to nonresearch partner(s)27