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

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

The Research We Fund Is Guided by Our National Priorities for Research Assessment of Communication and Improving Healthcare Prevention, Diagnosis, Systems Dissemination Research and Treatment Options Accelerating PCOR and Methodological Addressing Disparities Research 4

Funding Announcement Overview Cycle 3 2016 Published August 15, 2016 5

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 9

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 10

Letter of Intent – Cycle 3 2016 DUE – September 14, 2016 at 5:00 pm ET NOTIFICATION – October 21, 2016 11

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 12

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.” 13

Letter of Intent Responsiveness What does PCORI look for when reviewing LOIs? 14

LOI Administrative Review • Letters of Intent are reviewed based on criteria detailed in each PFA • Additional screening for Comparative Effectiveness Research – Comparative effectiveness research Inclusion of Cost- Effectiveness Analysis – Does not include a formal cost- effectiveness analysis Programmatic Fit – Administrative Guidelines • Only responsive LOIs will be reviewed by program staff 15

LOI Programmatic Review • 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 16

What CDR looks for when reviewing LOIs • 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 17

What CDR looks for when reviewing LOIs • “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. 18

What CDR looks for when reviewing LOIs • 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 outcomes. 19

What CDR looks for when reviewing LOIs • 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) 20

Patient-Centeredness vs. Patient Engagement  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?  Research questions and outcomes should reflect what is important to patients and caregivers.  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 21

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

PCORI discourages proposals in the following categories and will likely deem them nonresponsive: • 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 23

Common LOI Pitfalls • 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 24

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!