Broad PFAs Letter of Intent Applicant Town Hall Cycle: Spring 2015 - - PowerPoint PPT Presentation

Broad PFAs

Letter of Intent Applicant Town Hall

Cycle: Spring 2015

February 12, 2015

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Agenda

Submitting Questions:

Submit questions via the chat function in Meeting Bridge. Ask a question via phone (an

• perator will standby to take

your questions).

Introductions About PCORI Research Goals Research Areas of Interest Programmatic Requirements Administrative Requirements Applicant Resources

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Introductions

Bridget Gaglio, MPH, PhD Program Officer, Communication and Dissemination Research Stanley Ip, MD Senior Program Officer, Clinical Effective Research Beth Kosiak, PhD Program Officer Improving Healthcare System Soknorntha Prum, MPH Contracts Associate Contracts Management and Administration

About PCORI pcori.org

Why PCORI?

• For all the advances it produces,

research still has not answered many questions patients face.

• People want to know which

treatment is best for them.

• Patients and their clinicians need

information they can understand and use.

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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.

Our Mission

Broad PFAs: Research Goals

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Our Work Answers Patients’ Questions

Given my personal characteristics, conditions and preferences…

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What does PCORI look for?

Focus on Comparative Clinical Effectiveness Research (CER)

CER includes:

• Studies that compare health outcomes and the clinical effectiveness, risks, and

benefits of two or more approaches to healthcare All applicants should:

• Explain how the research is comparative
• Name the comparators
• State why the comparisons are important to decision-makers

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Research We Do Not Fund

Examples of CEA

• Research that conducts a formal CEA in the form
• f dollar-cost per quality-adjusted life-year

(including non-adjusted life-years) to compare two or more alternatives

• Research that directly compares the overall costs
• f care between two or more alternative

approaches as the criterion for choosing the preferred alternative

Based on PCORI’s authorizing legislation, PCORI is not permitted to fund studies

• f cost-effectiveness analysis (CEA).

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Research We Do Not Fund

Other types of research we do not fund

• development of practice guidelines
• coverage recommendations
• payment
• r policy recommendations

NOTE: PCORI does fund studies that explore the burden of costs on patients—for example,

• ut-of-pocket costs.

Broad PFAs: Overview and Research Areas of Interest

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Assessment of Prevention, Diagnosis, and Treatment Options

• Comparative studies in prevention, screening, diagnosis, treatment, and

long-term management that have not been adequately addressed previously.

• Consideration of treatment effect modifiers, including demographic,

biological, clinical, socioeconomic and other factors, within proposed studies.

• Comparative studies addressing rare diseases.

Available Funds: Up To $32 Million Total Direct Cost: $2 million Maximum Project Period: 3 years

Assessment of Prevention, Diagnosis, and Treatment Options

Research Areas of Interest

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• High priority topics as identified by systematic reviews, evidence of gaps in

clinical guidelines, or other credible evidence reviews.

• Comparisons of the effectiveness of two or more strategies for prevention,

treatment, screening, diagnosis, or management that are known to be efficacious but have not been adequately compared in previous studies.

• Areas deemed non-responsive to the PFA:
• Studies to establish efficacy for a new clinical strategy
• Pilot studies intended to inform larger efforts
• Studies to develop decision aids
• Studies of the natural history of disease
• Studies comparing the roles of community health workers or patient

navigators

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Improving Healthcare Systems

• Major categories of innovation
• Information technology (IT) or other

electronic technologies

• Organizational structures and policies

(such as standing orders)

• Financial and behavioral incentives for

patients and providers

• Personnel (including multidisciplinary

teams, peer navigators, community health workers)

Available Funds: Up To $16 Million Total Direct Cost: $ 5 Million in large awards / $1.5 Million in small awards Maximum Project Period: 5 years in large awards/ 3 years in small awards

Improving Healthcare Systems

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Research Areas of Interest

• What are the effects of systems changes on the following broad outcomes?:
• Patients’ access to care, high quality of care, support for self-care, and

coordination of care across healthcare settings

• Professional decision-making on the basis of patients’ personal values
• Experiences that are important to patients and their caregivers
• Efficiency of healthcare delivery, as measured by the amount of

ineffective, duplicative, or wasteful care provided to patients

• Testing practices that combine evidence-based guidance (e.g.

Choosing Wisely) with systems incentives and/or redesign to simultaneously elicit patient preferences and reduce harms faced by patients

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Communication and Dissemination Research

The Communication and Dissemination Research (CDR) program seeks to fund projects that address critical knowledge gaps in the communication and dissemination process:

• 1. the communication and dissemination of research results to patients, their

caregivers, and clinicians

• 2. the communication between patients, caregivers, and clinicians

To enable patients and caregivers to make the best possible decisions in choosing among available options for care and treatment.

Available Funds: Up To $8 Million Total Direct Cost : $1.5 million Maximum Project Period: 3 years

Communication & Dissemination Research

Research Areas of Interest

• Communication strategies to promote the use of health and health care CER

evidence by patients and clinicians

• Dissemination strategies to promote the use of health and health care CER

evidence by patients and clinicians

• Explaining uncertain health and health care CER evidence to patients and

clinicians

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Addressing Disparities

• Inform the choice of strategies to reduce or eliminate disparities
• Focus on areas of importance where there are critical disparities that

disadvantage members of a particular group and limit their ability to achieve

• ptimal, patient-centered outcomes
• We are not interested in studies that describe disparities; instead we want

studies that identify best options for eliminating disparities

Available Funds: Up to $8 Million Total Direct Cost: $1.5 Million Maximum Project Period: 3 years

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Addressing Disparities

Research Areas of Interest

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• Compares evidence-based interventions to reduce or eliminate disparities in patient-

centered outcomes (PCOs), including health, health care, and patient-reported

• utcomes; for example, by accounting for possible differences at the patient, provider,
• r systems level, we are interested in research to determine which interventions can

be most effective for eliminating disparities in outcomes

• Compares benefits and risks of treatment, diagnostic, prevention, or service options,

with a focus on eliminating disparities

• Compares and identifies best practices for tailoring evidence-based interventions to

patient populations at risk for disparities

• Targeted Populations of Interest:
• Racial and ethnic minority groups
• Low-income groups
• Residents of rural areas
• Individuals with special healthcare needs, including individuals with disabilities
• Patients with low health literacy/numeracy and/or limited to English proficiency
• LGBT persons

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Differences between the PFAs

Program Area Total Direct Cost Limit Project Duration Limit Greater than Request

Programmatic Requirements

PCORI Methodology Standards

• Intended to provide helpful guidance to researchers and those who use

research results

• Provide guidance for both project protocols and reporting of results
• Used by PCORI to assess the scientific rigor of applications

Cross-cutting Standards

• Formulating research questions
• Patient-centeredness
• Data integrity and rigorous analysis
• Preventing and handling missing data
• Heterogeneity of treatment effects

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Patient-Centeredness vs. Patient Engagement

• Patient engagement is about having patients as partners in research as
• pposed to merely subjects.
• Active engagement between scientists, patients, and stakeholders
• Community, patient, and caregiver involvement already in existence or a

well-thought out plan

• Patient-Centeredness is a component of what PCORI is looking for in research

applications.

• Does the project aim to answer questions or examine outcomes that

matter to patients within the context of patient preferences?

• Research questions and outcomes should reflect what is important to

patients and caregivers

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Patient and Stakeholder Engagement

• Participating in formulation of research questions
• Defining essential characteristics of the study participants,

comparators, and outcomes

• Monitoring study conduct and progress
• Drafting a plan for disseminating research results

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What PCORI looks for when reviewing LOIs?

• Importance and relevance of the topics to PCORI priorities, as evidenced by

critical gaps identified by clinical guidelines developers and/or recent relevant systematic review.

• Clarity and credibility of applicants’ responses to the LOI questions
• Programmatic fit and balance

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Administrative Requirements

Applicant Eligibility

• Any private sector (non-profit or for-profit) research organization
• Any public sector research organization (university or college hospital or

healthcare system, laboratory or manufacturer, unit of local, state, or federal government)

• Non-domestic components of organizations based in the US and foreign
• rganizations may apply, as long as there is demonstrable benefit to the US

healthcare system and US efforts in the area of patient-centered research can be clearly shown.

• Individuals are not permitted to apply.

Submit a Letter of Intent (LOI)

This is a competitive LOI screening process:

• LOIs will be reviewed for responsiveness and programmatic fit
• Only those LOIs deemed most responsive to this PFA will be invited to

submit a full application New screening LOI process for Spring 2015 cycle:

• PCORI Online Pre-screen Questionnaire

Complete a Letter of Intent (LOI)

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• Refer to the PCORI Online User Manual: Submitting a Letter of Intent
• Pre-Screen Questionnaire
• PI and Contact Information
• Project Information
• Key Personnel
• Templates and Uploads
• Refer to the PFA-specific LOI Template to address the program’s areas of

interest

• Please make sure to address all required sections of the LOI template
• Please refer to the specific PFA as each program has its own unique

characteristics and requirements

Complete a Letter of Intent (LOI)

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• Address all required sections of the LOI template:
• Objectives or Specific Aims
• Condition Burden and Impact
• Gap Analysis
• Methods or Study Design
• Description of Patients
• Description of Outcomes
• Power calculations
• Effect Size
• Sample Size
• Comparators
• Engagement
• Timeline or Duration of Study

LOI Formatting Requirements

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Program Area Page Limit References or Citations

Using the PCORI Online System

• Apply through PCORI Online

(https://pcori.fluxx.io)

• Access the website using Chrome or Safari

browsers only

• Create a new request and begin the LOI
• Designate the LOI with the following

individuals:

• PI, PI Designee, AO, and Financial Officer
• Enter information into all required fields in the

system

• Upload the LOI in the system
• Save information by clicking the ‘Save and

Review’ button on the save and review page and on the side navigation pane

Key Dates

What When

Applicant Resources

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Where can I find help?

Visit pcori.org/apply

• Application Guidelines
• FAQs
• PCORI Online User Manuals
• Sample Engagement Plans

Schedule a Call with a Program Officer

• Submit a request at pcori.org/content/research-inquiry
• Call 202-627-1884 ( programmatic inquiries)
• Submit a request at pcori.org/about-us/contact-us

Contact our Helpdesk

• E-mail pfa@pcori.org
• Call 202-627-1885 ( administrative and

technical inquiries)

Question and Answer (Q&A)

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Q&A

Ask a question via the chat function in Meeting Bridge. Ask a question via phone (an operator will standby to take your questions).

If we are unable to address your question during this time, e-mail the Helpdesk at pfa@pcori.org.