Communication and Dissemination Research (CDR) Funding Announcement - - PowerPoint PPT Presentation

Communication and Dissemination Research (CDR) Funding Announcement Town Hall Webinar

Bridget Gaglio, Senior Program Officer William Lawrence, Senior Program Officer

August 25, 2016

Presentation Outline

CDR Funding Announcement Overview LOI Responsiveness Common LOI pitfalls Discussion, Q + A

Submitting Questions:

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CDR Team

Jean Slutsky Chief Engagement and Dissemination Officer Bridget Gaglio Senior Program Officer Chris Gayer Program Officer Michelle Henton Program Associate Kim DiGioia Program Associate Bill Lawrence Senior Program Officer

The Research We Fund Is Guided by Our National Priorities for Research

Assessment of Prevention, Diagnosis, and Treatment Options Improving Healthcare Systems Communication and Dissemination Research Addressing Disparities Accelerating PCOR and Methodological Research

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Funding Announcement Overview Cycle 3 2016 Published August 15, 2016

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Importance of CDR

Producing information is not enough.

• Clear communication approaches and active

dissemination of findings to all audiences, in easy to understand formats, are critical to increasing the awareness, consideration, adoption, and use of research by patients, caregivers, and healthcare providers

• In other words, information itself is of little use unless:
• It reaches those who need it
• It is clear and comprehensible

CDR Funding Objective

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

CDR Funding Priorities

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

Communication and Dissemination Research

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

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Greater Than Budget/Time Requests

• CDR program is the only program to offer this option
• Must be submitted at the time of LOI submission
• Requesting funding for a project with a budget that exceeds the

PFA limits

• Requesting funding for a project that exceeds the PFA time limit
• Justification is required
• Complete the Greater Than Budget/Time template

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Letter of Intent – Cycle 3 2016 DUE – September 14, 2016 at 5:00 pm ET NOTIFICATION – October 21, 2016

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Sections of the LOI Template

• Principal Investigator Name
• Title
• Gap Analysis
• Communication and Dissemination Issue
• Research Question(s)
• Specific Aims
• Study Design
• Description of Comparators
• Outcomes
• Description of Participants and Study Sites/Setting
• Sample Size
• Engagement

3 page limit

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What’s new in this announcement?

• Inclusion of effectiveness-implementation design trials to compare CER

dissemination strategies while evaluating the potential for implementation in real-world settings

– See page 4 of PFA for more details on effectiveness-implementation hybrid designs

• Clarification on adaptation of efficacious interventions

– See page 6 of PFA for more details – “PCORI expects the efficacy or effectiveness of each intervention to be know. Interventions that have documented efficacy or effectiveness in similar situations may be used – with adaptation if necessary – if the efficacy is well- documented (e.g., with multiple trials or with a systematic review), and sufficiently strong rationale for why the intervention would be expected to be efficacious in proposed new setting(s) and/or population(s) is provided. If an intervention is to be adapted, PCORI expects the majority of the proposed time and budget to aim at establishing comparative effectiveness rather than adapting and validating the interventions.”

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Letter of Intent Responsiveness What does PCORI look for when reviewing LOIs?

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LOI Administrative Review

• Letters of Intent are reviewed based on

criteria detailed in each PFA

• Additional screening for

– Comparative effectiveness research – Does not include a formal cost- effectiveness analysis – Administrative Guidelines

• Only responsive LOIs will be reviewed by

program staff

Comparative Effectiveness Research Inclusion of Cost- Effectiveness Analysis Programmatic Fit

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• 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)

• Programmatic fit and balance

LOI Programmatic Review

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• Describe research that compares two or more strategies

that each have established efficacy. PCORI expects that the efficacy or effectiveness of each intervention be known. – If the efficacy/evidence base is insufficient, then data needs to be provided to document that the intervention is used widely – The application must provide information about efficacy of the interventions and/or dissemination strategies that will be compared; pilot data may be appropriate – Projects that aim to develop new or novel interventions, which lack evidence of efficacy or effectiveness, will be considered out of scope

What CDR looks for when reviewing LOIs

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• “Usual care” (or no specific intervention) may be an

appropriate comparator if this is a realistic choice for patients and other stakeholders, but the clinical characteristics must be specified. – Applications proposing to use usual care as the comparator must justify the choice to use it (e.g., usual care is guidelines-based) and should clearly describe its components that will be used or measured in the research. – A clear description of usual care is necessary to enhance the reproducibility of the research in other settings.

What CDR looks for when reviewing LOIs

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• Describe research that studies the benefits and harms of

interventions and strategies delivered in real-world settings. – PCORI is interested in studies that provide practical information that can help patients and other stakeholders make informed decisions about their health care and health

• utcomes.

What CDR looks for when reviewing LOIs

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• Describe research that is based on outcomes that are

meaningful to the patient population, their caregivers, and family members, and that are likely to guide their decisions. – These outcomes must matter to patients, including measures of shared decision making, patient activation, quality of life, symptoms of disease, relevant physiological measurements, and treatment-related symptoms (side effects)

What CDR looks for when reviewing LOIs

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Patient-Centeredness vs. Patient Engagement

• Patient engagement is about having patients as partners in, not

merely subjects of, research.

• Active engagement between scientists, patients, and other

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
• utcomes that matter to patients?
• Research questions and outcomes should reflect what is

important to patients and caregivers.

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The Engagement Rubric

Planning the Study Conducting the Study Disseminating the Study Results PCOR Engagement Principles

• Study of the natural history of disease
• Instrument development
• Fundamental science or study of biological mechanisms
• Creation of clinical practice guidelines or care pathways
• Payment or policy development
• Developing, testing, and validating new decision aids/tools or clinical

prognostication tools

• Establishing efficacy for a new clinical strategy
• Pilot studies intended to inform larger efforts
• Comparisons of patient characteristics rather than clinical strategy options
• Pharmacodynamics
• Coverage recommendations

PCORI discourages proposals in the following categories and will likely deem them nonresponsive:

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• Not following the instructions
• Comparators that do not have demonstrated efficacy
• Development of a decision aid, mobile app, or other decision support

tool

• Overlap with projects currently funded by PCORI/ CDR program
• Outcomes important to researchers, not to patients or stakeholders

Common LOI Pitfalls

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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 sciencequestions@pcori.org.

Thank You!