Inaugural Town Hall Cycle February 11, 2016

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Limited PCORI Funding Announcement: Dissemination and Implementation of PCORI Funded Patient-Centered Outcomes Research Results and Products in Real World Settings Inaugural Town Hall Cycle 1 2016 February 11, 2016

Agenda I. Welcome II. Background i. About PCORI ii. D&I Science III. Programmatic Requirements IV. Administrative Requirements V. Questions Submitting Questions: Submit questions via the chat function in Meeting Bridge. Ask a question via phone (an operator will standby to take your questions).

Communication and Dissemination Research Team Jean Slutsky Chief Engagement and Dissemination Officer Bridget Gaglio Senior Program Officer Chris Gayer Program Officer Michelle Henton Program Associate Sarah Chew Program Assistant Bill Lawrence Senior Program Officer

Background: About PCORI

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.

Our Mission 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.

Authorizing Legislation The purpose of the Institute is to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis... and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services... -- from PCORI s authorizing legislation

Background: D&I Science

Background There is a gap between: What we know optimizes healthcare delivery AND What actually gets implemented in everyday practice D&I addresses this gap by seeking to: Create, evaluate, report, disseminate, and integrate evidence-based strategies in clinical and public health practice settings to improve health and prevent disease

Definitions Dissemination is the.. intentional, active process of identifying target audiences and tailoring communication strategies to increase awareness and understanding of evidence, and to motivate its use in policy, practice, and individual choices 1 The purpose of dissemination is to spread and sustain knowledge and the associated evidence-based interventions Passive dissemination, sometimes called research diffusion, is an untargeted dissemination process whereby new evidence is absorbed and acted upon by a small body of highly motivated recipients 2 1 Mathematica Framework: http://www.mathematicampr.com/~/media/publications/pdfs/health/pcori%20di%20framework%20draft.pdf. 2 Lomas J. Diffusion, dissemination, and implementation; who should do what? Ann N Y Acad Sci. 1993;703:226-35; discussion 235-7.

Definitions cont. Implementation is the.. deliberate, iterative process of integrating evidence into policy and practice through adapting evidence to different contexts and facilitating behavior change and decision making based on evidence across individuals, communities, and healthcare systems 4 4 Brownson RC, Colditz GA, Proctor EK. Dissemination and implementation research in health: translating science to practice. New York: Oxford University Press, Inc.; 2012

Limited PCORI Funding Announcement: Dissemination and Implementation of PCORI Funded Patient-Centered Outcomes Research Results and Products in Real World Settings

Purpose and Objectives Purpose: This announcement is designed to give PCORI awardee teams an opportunity to propose investigator initiated strategies for disseminating and implementing their research results and products. PCORI Objectives: To increase the use of PCORI research results and products by diverse end users To incorporate PCORI research results into patient and stakeholder decision making To learn about effective strategies and barriers/facilitators of success for disseminating and implementing patient-centered outcomes research (PCOR)

D&I Activities We Aim to Fund We seek to fund projects: designed to actively disseminate and implement research results and products using approaches that are informed and guided by established dissemination and implementation models and frameworks in the context of real world settings

D&I Activities We Do Not Fund We do not fund projects which: Propose a dissemination plan that is dependent upon passive dissemination strategies (publications, presentations to heterogeneous audiences) as its primary dissemination method Aims to develop and/or validate a new tool or system for patients and/or clinicians without the primary purpose of actively disseminating or implementing evidence. Tools and systems proposed to serve as the primary mechanism for active dissemination and implementation of evidence will be considered.

Specific Areas of Interest The examples provided below are intended to be illustrative, not exhaustive or prescriptive. Areas of interest include, but are not limited to the following: Translation/adaptation of the content/delivery mechanism of effective CER results/products to improve their penetration and use at the policy, health systems, clinical practice, caregiver, and patient levels Development, demonstration, and evaluation of processes or products to incorporate PCORI research results into decision making settings for patients, providers, policy makers and other stakeholders

Specific Areas of Interest Demonstration of the capacity and ability to take research results and products found effective through PCORI research studies to scale in diverse settings and populations De-implementing or reducing the use of strategies and procedures that are not evidence-based, have been prematurely widely adopted, or are harmful or wasteful, in place of evidence-based approaches

Programmatic Requirements The proposed project should meet all of the following requirements: Center dissemination and implementation efforts around research findings or products emerging from PCORI-funded research awards Utilize active dissemination and implementation strategies in real world contexts and settings Receive endorsement from relevant patient organizations, clinician organizations, payer/purchaser consortia, and other stakeholders with significant influence upon the targeted end users of this dissemination and implementation effort Address an important research gap that is being filled with the research results and products of PCORI-funded research awards Have strong interest from and support by host delivery systems and settings.

Administrative Requirements: Eligibility PCORI Research Awardees: Applications associated solely with PCORI Engagement Awards and Pipeline to Proposal Awards are not eligible Personnel: The proposed PI s must either be the PI of the original PCORI-funded project, or if not, then the PI of the current application must include a letter of support from the original PCORI-funded research project PI Organization: Applications may be submitted by a private sector research organization, including any nonprofit or for-profit organization, as well as public sector research organizations, including university or college hospital or healthcare systems, laboratory or manufacturer, or unit of local, state, or federal government

Administrative Requirements: Eligibility Timing: Applicants are required to submit a draft PCORI final research report pertaining to their PCORI research award prior to submission of a full application to this announcement Applicants may submit the mandatory LOI prior to the submission of their draft PCORI final research report LOI is non-competitive Full applications submitted prior to the submission of the draft PCORI final research report pertaining to the PCORI research award will be administratively withdrawn Applicants will be eligible to submit their application to this announcement for up to two years after the submission of their draft PCORI final research report

Complete a Mandatory Letter of Intent (LOI) Letters of intent are non-competitive and will not be scored during LOI review. Letters of intent are a mandatory prerequisite for submission of a full application. Applicants who fail to submit a letter of intent will not be permitted to submit a full application to the corresponding award cycle. LOIs will be screened by a minimum of two PCORI staff for responsiveness and to ensure compliance with administrative guidelines. Nonresponsive LOIs and those not adhering to administrative guidelines will not be invited to submit a full application. 3 page limit (does not include references)

Complete a Mandatory Letter of Intent (LOI) Address all required sections of the LOI template: Title of project Description of the research results and/or products to be disseminated Objective and specific aims Description of the setting in which dissemination will take place and end users Identification of the evidence gap the research results and products fills and the significance of the finding in the context of existing literature Description of methodological approach for disseminating the research finding or product Description of dissemination evaluation plan including measurable indicators of success Patient and stakeholder engagement in the planning and implementation of this dissemination effort.

Funds Available Available Funds: $2,000,000 per cycle Total Direct Cost Per Project : $300,000 Maximum Project Period: 2 years 23

Greater Than Budget/Time Requests Requesting funding for a project with a budget that exceeds the PFA limits Requesting funding for a project that exceeds the PFA time limit Must be submitted at the time of LOI submission Justification is required Complete the Greater Than Budget/Time template 24

Key Information Key Information Cycle: Cycle 1 2016 Merit Review: September 2016 Full Announcement: Dissemination and Implementation of Patient-Centered Outcomes Research Institute (PCORI) funded Patient- Centered Outcomes Research (PCOR) Results and Products in Real-World Settings Awards Announced: November 2016 Online System Opens: February 1, 2016 Earliest Start Date: January 2017 Status: OPEN Total Direct Costs: $300,000 Applicant Town Hall Session: February 11, 2016 Letter of Intent (LOI) Deadline: March 2, 2016 Funds available up to: $2,000,000 per cycle Maximum Project Period: 2 years Application Deadline: June 6, 2016

What Can I Do Now to Prepare? 1. Review the full dissemination and implementation funding announcement and begin to formalize a plan with your team of researchers and patient/stakeholders that's within the scope of that announcement. 2. Familiarize yourself with the PCORI draft final research reporting instructions and to talk with your program officer about any questions you may have about those instructions. PCORI Draft Final Research Reporting Instructions http://www.pcori.org/sites/default/files/pcori-draft-final-research-report- Instructions.pdf

Applicant Resources: PCORI D&I Materials D&I Resources available at: http://www.pcori.org/funding-opportunities/programmatic-funding/otherprogrammatic-awards-and-funding/dissemination-and

Applicant Resources: Where Can I Find Help? Visit pcori.org/apply Application Guidelines FAQs PCORI Online User Manuals For technical assistance PCORI Helpdesk: pfa@pcori.org For programmatic assistance Disseminationpfa@pcori.org

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.