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 1 2017

January 31, 2017

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

Maricon Gardner, CRA Associate, Contracts Operations Danielle Whicher, PhD, MHS Program Officer Clinical Effectiveness and Decision Science Bridget Gaglio, MPH, PhD Senior Program Officer Clinical Effectiveness and Decision Science Mira Grieser, MHS Program Officer Healthcare Delivery and Disparities Research Jeanne Murphy, PhD, CNM Program Officer Healthcare Delivery and Disparities Research Greg Martin Deputy, Chief Engagement and Dissemination Officer

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 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.

Communication and Dissemination Research

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

Communication & Dissemination Research

• 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

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

• 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

• Patient-Centeredness

– Research questions and outcomes reflect what is important to patients and caregivers and consider patient preferences.

• Patient Engagement

– Project includes active engagement among scientists, patients, and stakeholders. – Project includes community, patient, and caregiver involvement.

Patient-Centeredness vs. Patient Engagement

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Addressing Engagement

• Applicants should consult with patients and other stakeholders on their

decisional dilemma and evidence needs or reference previously documented decisional dilemmas in preparation for the submission of LOIs and applications.

• State the specific clinical decision(s) and/or treatment choice(s)

confronted by the decision makers, and explain how the findings from the proposed research will inform those decisions.

• State why this decision, such as choosing between specific treatment

strategies, is important to patients and their caregivers.

• Document the uncertainty faced by patients, clinicians, and other

decision makers in making this decision.

• Identify the stakeholders you consulted in determining that the proposed

study addresses their evidentiary needs for decision making.

• Indicate your commitment to continuing to engage them actively in the

conduct of the study.

Addressing Engagement

Several approaches to engagement can succeed. PCORI provides many engagement resources for applicants:

• Sample Engagement Plans:

http://www.pcori.org/sites/default/files/PCORI-Sample- Engagement-Plans.pdf

• Engagement in Research website page:

http://www.pcori.org/funding-opportunities/what-we-mean- engagement

• PCORI’s Methodology Standards PC-1 to PC-4:

http://www.pcori.org/assets/PCORI-Methodology- Standards1.pdf

Administrative Requirements

Application Requirements: Who Can Apply?

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• Any private sector research organization
• Any public sector research organization
• Foreign Organizations
• Nondomestic Components of Organizations based in the US

Non-Profit Organizations For Profit Organizations

Universities/ Colleges

Hospitals or Healthcare Systems

Laboratories

Local, State,

• r Federal

Government

NOTE

PI must be an employee of the prime applicant

• institution. Individuals are not eligible to submit

research applications to PCORI.

• Begin the LOI as soon as possible.
• Navigate to PCORI Online

(https://pcori.force.com/engagement)

• Log into the PCORI system early to address additional LOI

questions.

• Please only use Chrome, Safari browsers and Firefox to

access the system.

• The PI and the AO cannot be the same individual.
• PCORI Online Training Resources

Using the PCORI Online System

• Refer to the PCORI Online: Pre-Award User Guide for Research Awards
• 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.

Complete a Letter of Intent (LOI)

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• Address all required sections of the LOI template:
• Specific Aims
• Background
• Significance
• Approach
• Study Design
• Engagement Approach
• Study Population and Setting
• Comparators
• Outcomes
• Analytic Plan
• Sample Size and Power

Complete a Letter of Intent (LOI)

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

Broads PFA LOI requirements

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.