Broad PCORI Funding Announcement Letter of Intent Applicant Town - - PowerPoint PPT Presentation

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Broad PCORI Funding Announcement

Letter of Intent Applicant Town Hall Cycle 3 2016

August 29, 2016

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

Introductions

Kimberly Bailey, MS Program Officer Clinical Effectiveness Research Christopher Gayer, PhD Program Officer Communication and Dissemination Research Gyasi-Moscou- Jackson, PhD, MHS, RN Program Officer Improving Healthcare Systems Greg Martin Deputy Director, Stakeholder Engagement Perrinne Kelley, MPA Administrator, Contracts Operations Contracts Management and Administration Parag Aggarwal, PhD Senior Program Officer Addressing Disparities

About PCORI pcori.org

• 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.

Why PCORI?

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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

Our Work Answers Patients’ Questions

Given my personal characteristics, conditions and preferences…

What does PCORI look for?

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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

Based on PCORI’s authorizing legislation, PCORI is not permitted to fund studies of cost-effectiveness analysis (CEA).

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

PCORI does not fund research whose findings will include

• development of clinical practice guidelines
• coverage recommendations
• payment
• or policy recommendations

Research We Do Not Fund

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

Broad PFAs: Overview and Research Areas of Interest

• 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.

Assessment of Prevention, Diagnosis, and Treatment Options

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

Assessment of Prevention, Diagnosis, and Treatment Options

• 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

Research Areas of Interest

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• Major categories of innovation
• Information technology (IT) or other electronic technologies
• Organizational structures and policies (such as standing orders)
• Incentives for patients (financial, behavioral) and providers

(behavioral)

• Personnel (including multidisciplinary teams, peer navigators,

community health workers)

Improving Healthcare Systems

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

• What are the effects of systems changes on the following broad
• utcomes?:
• 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

Research Areas of Interest

The CDR program seeks to fund comparative effectiveness research (CER) that: – directly compares two or more effective health communication and dissemination interventions or strategies – that engage patients, caregivers, and providers – in the context of real-world clinical-care settings and situations – to enable patients and caregivers to make the best possible choices among available options for care and treatment

Communication and Dissemination Research

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

Communication & Dissemination Research

Focus on CER in the following three key areas:

• 1. Communication strategies to promote the use of health and

healthcare CER evidence by patients and clinicians

• 2. Dissemination strategies to promote the use of health and

healthcare CER evidence by patients and clinicians

• 3. Explaining uncertain health and healthcare CER evidence to

patients and clinicians

Research Areas of Interest

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• 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 optimal, patient-centered outcomes

• We are not interested in studies that describe disparities;

instead we want studies that identify best options for eliminating disparities

Addressing Disparities

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

Addressing Disparities

• 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

Research Areas of Interest

Programmatic Requirements

• 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

Patient-Centeredness vs. Patient Engagement

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• Patient engagement is about having patients as partners in research

as opposed to merely subjects.

• Active engagement between scientists, patients, and stakeholders
• Community, patient, and caregiver involvement already in

existence or a well-thought out plan

• 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

Patient and Stakeholder Engagement

• 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

PCORI Methodology Standards

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Cross-cutting Standards

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

• 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 such as well-described comparators, clear research methods (e.g., study design, sample size, effect size)

• Programmatic fit and balance

What PCORI looks for when reviewing LOIs?

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Responsiveness Review

• Letters of Intent are reviewed based on

criteria detailed in each PFA

• Additional screening for

– Comparative effectiveness research – NON Inclusion of cost-effectiveness analysis – Administrative Guidelines

• Only responsive LOIs will be invited to submit

a full application

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Comparative Effectiveness Research Inclusion of Cost- Effectiveness Analysis Programmatic Fit

Administrative Requirements

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

hospital or healthcare system, laboratory or manufacturer, unit

• f local, state, or federal government)
• Non-domestic components of organizations based in the US and

foreign organizations 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.

Applicant Eligibility

• 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
• f 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
• Analysis of gaps in evidence
• Methods or Study Design
• Decisional Dilemma
• Description of Participants and

Participating Study Site(s)

• Description of Outcomes
• Power calculations
• Effect Size
• Sample Size
• Comparators
• Engagement
• Study Population and Setting
• Duration and Cost of Study
• Real life applicability of

Strategies

• Hypothesized Effect Size

Complete a Letter of Intent (LOI)

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• 3 page limit
• references are not included in the page count

Broads PFA LOI requirements

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

• Convert the document to PDF file
• Upload the LOI in the system

Key Dates

What When

Applicant Resources

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)
• E-mail sciencequestions@pcori.org

Contact our Helpdesk

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

technical inquiries)

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.