Opening a Pipeline to Patient-Centered Research Proposals

December 3, 2014

Webinar/Teleconference

Opening a Pipeline to Patient-Centered Research Proposals 1

1:00 – 1:10 pm Welcome and Introductions

1:10 – 1:15 pm Origins of the Pipeline to ProposalInitiative

1:15 – 1:25 pm

Overview of the Pipeline to Proposals Awards

1:25 – 1:30 pmHow to Submit an LOI

1:30 – 1:45 pmHow to Submit an Application

1:45 – 2:00 pmLive Q&A Ask a question via the

chat function.

Agenda

Webinar Learning Objectives

To inform patients, caregivers, and other stakeholders of the Pipeline to Proposals Awards opportunity, particularly the Tier I awards;To train potential applicants on how to apply for Tier I funding, and address relevant questions; and To inform the public on other ways to get involved with PCORI including the Engagement Awards, merit review and Advisory Panels

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“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 findingswith respect to the relative health outcomes, clinical effectiveness, and appropriateness of the medical treatments, services...”

— from Patient Protection and Affordable Care Act

PCORI was Created in the Affordable Care Act, 2010

Compares two or more options — for screening, diagnosis, treatment

Considers the range of clinical outcomes relevant to patients

Conducted in real world populations and settings

Attends to differences in effectiveness and preferences across patient subgroups

Often requires randomized trial design

Does not include cost-effectiveness analysis

By Statute, PCORI funds “Comparative Clinical Effectiveness Research”

PCORI 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 researchguided by patients,caregivers and the broader health care community.

Pictured: PCORI Board of Governors 6

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We Emphasize Engagement as a Path to Practical, Useful Research

Pipeline Origin

Proposed by participants at October 2012 Transforming Patient-Centered Research patient engagement workshop

Workshop participants identified that few resources have been directed to non-research entities for community development, capacity building, or for infrastructure development for engagement in research as partners

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The Purpose/Mission of the Pipelines:Helping communities…

Develop research

partnerships among unlikely candidates to identify health

issues that affect their community

Build strong partnerships

between researchers, patients, and

other stakeholders to create a PCOR/CER question to address a

health issue

Create a high-quality PCORI

research proposal with

a strong engagement

plan that leads to…

Funded research that

results in desired health outcomes for

patients in their community

To Get From This To This Then This And Finally This

9

Plan Study Conduct Study Disseminate Study Results

PCORI Research Process

P2P Awards Strengthen the PCORI Research Enterprise

.

Implement Study Results

1) P2P helps foster capacity building for PCOR in the community before a study plan is even developed. This enables underserved/minority and

otherwise “missing” communities to actively engage in the research

process

2) It has been shown that when patient partners are engaged early

on and throughout the research process, they are more likely to help

in the implementation and dissemination of study results in their

communities

Pre-planning

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The Pipeline to Proposal Initiative is Three-Tiered Award System

Tier IUp to $15,000Up to 9-month

term

Tier IIUp to $25,000

Up to 12-month term

Tier IIIUp to $50,000

Up to 12-month term

PCORI Funding Announcement

Researchers who unsuccessfully submitted a PFA and need to improve proposal

Or submissions to other PCOR/CER

Funders

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Build relationships, develop infrastructure, and create channels for communication

Mature partnerships, develop research infrastructure, and define research questions and priorities

Develop and submit a patient-centered research proposal with equal participation from patients, stakeholders, and researchers

The three award tiers build on each other, with each successive step incrementally growing the community, increasing the levels of patient and stakeholder engagement, and strengthening the capacity to conduct patient-centered research.

Tier ITier II

Tier III

The Three Award Tiers

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Regional Breakdown for Pipeline Awards

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Pipeline Award Program Offices (PAPOs)

PAPOs will assist in the administration and management of the Pipeline to Proposal Awards.

Because PCORI has a limited headquarters workforce, the operational, programmatic, and fiscal duties associated with Pipeline Awards will be subcontracted to PAPOs. The selected organizations all have public health, healthcare, or research familiarity, research, capacity-building, and award management experience.

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P2P InfrastructurePipeline to Proposal Award Offices

Tier I, Cycle 2Nationwide Rollout

Program Start Date: May 2015

Tier I, Cycle 1Pilot Phase with only the West PAPO, CHPHE

Program Start Date: February 2014

The National PAPO works on nationwide projects

PCORI

National PAPO

10 Awardees

PAPO (West)

30 Awardees

10Awardees

PAPO(Midwest)

10 Awardees

PAPO(Northeast)

10 Awardees

PAPO(South)

10 Awardees

15Opening a Pipeline to Patient-Centered Research Proposals

The ultimate goal of a Tier I Award is to form a team of patients and researchers (other non-researcher stakeholders are also encouraged) who are focused on a common health issue and to demonstrate a commitment eventually to develop a patient-centered research proposal.

Proposed Award Activities in Tier I

In Tier I, Awardees will:

Build relationships with other patients, researchers, or stakeholders who are focused on the same health issue. Activities may include holding workshops, conferences, and meetings.

Create a communication plan to help connect community members. Activities may include setting up a website with an inbox for receiving messages.

Develop a governance or guidance structure such as an advisory council for making strategic decisions. Activities may include drafting a strategic plan or forming an advisory board

Complete PCORI Awardee training, which will include information about how to engage patients and stakeholders in research projects

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PCORI Does Not Fund Pipeline to Proposal Projects That….

Study cost-effectiveness Study causes of disease Do not measure patient-centered outcomes Do not compare approaches to improving patient-centered outcomes

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??/??/1311/15/13

When to Apply for a Tier I Award

3/31/15 5/1/15

The graphic below shows the important dates for the Tier I Award program.

12/23/14 2/16/15

??/??/1311/15/13LOI Portal

Closes and

Applicationportal opens

Last day to submit proposal

Awards announced

Projected start date

11/24/14 3/31/15 5/1/1512/23/14 2/16/15

LOIportal opens

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Submitting an LOI

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LOI Introduction

To apply for funding through the Pipeline to Proposal Awards program, you must register and have an account in the PCORI Pipeline to Proposal Awards Online Application System. Follow the instructions below to do this. If you experience technical difficulties using the PCORI Pipeline to Proposal Awards Online Application System, please contact us at p2p@pcori.org.

Please note the following before you begin:

You must register in the PCORI Pipeline to Proposal Awards Online Application System regardless of whether you have applied for PCORI funding in the past.

Remember to save your work before closing the browser window or your work will be lost. To save your work, click the “Save Draft” button at the bottom of the Letter of Inquiry (LOI) form.

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Step 1: Register and Create an Account

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Go to the PCORI Pipeline to Proposal Awards Online Application System.

• Complete the “User Account Information” to register and create your account. All fields (aside from middle initial) are required.

• Your email address will be your username.

• Click the “Create Account and Continue” button. You will be taken to a landing page with LOIs that are open for your submission.

Step 2: Prepare Your Letter of Inquiry

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• Log in to the PCORI Pipeline to Proposal Awards Online Application System, if necessary (see Step 1, above).

• Click the title of the LOI you would like to complete, if applicable.

• Complete your LOI form. All fields marked with an asterisk (*) are required.

• Click the “Save Draft” button located at the bottom of the form to save your work as you go.

Step 3: Save and Return to Your Letter of Inquiry & Navigating the Dashboard

• You can save and return to continue working on your LOI at any time.

• To save your work, click the “Save Draft” button at the bottom of the LOI form. Please be sure to do this before closing the browser window or your work will be lost.

• Once you have successfully saved, you may leave the system and return to your LOI at any time.

• NOTE: draft LOIs will be saved in the system for 21 days, after which time they will be deleted.

• To return to your draft LOI, log in to the system

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• Hover over the “Dashboard” link at the top right of the screen. Click the “My Submissions” link.

Step 4: Review and Submit Your Letter of Inquiry

• Once you’ve completed all sections, you are ready to submit your LOI.

• Review your LOI fully before submission. You will not be able to make any changes after it is successfully submitted.

• To submit your LOI to PCORI, simply click the “Submit” button at the bottom of the form.

• From the submission confirmation screen, you may click on the link to be taken back to your dashboard.

• Additional guidance can be found by visiting this page -http://www.pcori.org/sites/default/files/PCORI-P2P-Awards-LOI-User-Manual.pdf

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Invitation to Apply for a Tier I Award

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Tier IUp to $15,000

Up to a 9-month term

Who Can Apply

An individual patient, other healthcare stakeholder, or researcher—or group of patients, stakeholders, or researchers

• A focus on a particular health issue• Interest in developing questions that can be addressed by

comparative effectiveness research (CER)• Not eligible or equipped to apply for funding from most other research

funding sources

What to Include

Demonstrated success in a past community-building project (health-related or non-health-related)

• How you engaged the community and formed partnerships to achieve your goal

• How you used relationships and partnerships to overcome obstacles

Basic Eligibility Requirements

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Additional Applicant Requirements

In addition to the basic eligibility requirements, you must have the following experience and/or meet the following mandatory requirements to apply:

Complete the Pipeline to Proposal Awards: Training for Tier I Applicants:Commit to taking PCORI Pipeline Tier I Awardee training Be willing to work closely with and engage in regular communication with the Intermediate Funder Agree to participate in forums to share experiences and lessons learned with other Tier I Pipeline Awardees Be willing to provide reports giving details on the activities that have taken place during the contract period

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P2P: Tier Design

Tier IIUp to $25,000

12 months

Tier IUp to 15,000

9 monthsTier III

Up to $50,00012 months

PCORI Funding

Announcement

Independent Funding Call

Independent Funding Call

Evaluation needed to move onto

Tier II

Or other PCOR/CER Research

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Review Process and Criteria for Tiers I and II

Tier I1. Program Fit - does this fit the

spirit of the Pipeline to Proposal Awards?

2. Project Plan and Timeline3. Past Partnership or

Community Engagement Experience

4. Budget/Cost ProposalReviewers will come from PCORI Ambassadors, Merit Reviewers, and PCORI Staff

Tier II

1. Adherence to Contract Requirements during the Tier I project period

2. Intent to continue Partnership Development

Reviewers will come from PCORI Staff and PAPO

Pipeline to Proposal Awardees who enter at Tier I will have an opportunity to develop theirpatient/stakeholder/researcher partnership over a 21-month period.

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Important Dates for the Tier I Cycle 2 Awards

30

Applicationportal opens

Deadline for application questions

Last day to submit proposal

Awards announced

Projected start date

12/23/14 3/31/15 5/1/151/25/15 2/16/15

Opening a Pipeline to Patient-Centered Research Proposals

Award Application

The image below shows the first screen you will see on the PCORI Tier I Pipeline to Proposal Awards application.

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Applicant Information

If there are updates to the contact information of the primary or secondary applicant(s) and organization(s) (if applicable) previously entered at the LOI phase, you may make them in the Full Proposal form. If you do not have edits, you may leave this section blank.

Update information about the project lead, if necessary:

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Project Overview

Provide additional details about your project. All fields in this section are required. (Required fields are marked with a red asterisk.) Word limits are noted next to each textbox.

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Project Overview (cont’d)

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Project Overview (cont’d)

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Project Overview (cont’d)

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Required Uploads

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Optional Uploads

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Authorized to Submit?

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Step 3: Save and Return to Your Full Proposal

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You can save and return to continue working on your Full Proposal at any time.

• To save your work, click the “Save Draft” button at the bottom of the Full Proposal form. Please be sure to do this before closing the browser window or your work will be lost.

• Once you have successfully saved, you may leave the system and return to your Full Proposal at anytime. o NOTE: draft Full Proposals will be saved in the system for 21

days, after which time they will be deleted.

• To return to your draft Full Proposal, log in to the system.

Step 4: Review and Submit Your Full Proposal

Once you’ve completed all sections, you are ready to submit your Full Proposal. • Review your Full Proposal fully before submission. You will not be able to make any

changes after it is successfully submitted. • To submit your Full Proposal to PCORI, simply click the “Submit” button at the bottom

of the form. • From the submission confirmation screen, you may click on the link to be taken back to

your dashboard.

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Viewing and Printing Your Submitted Full Proposal

To print your submitted Full Proposal, go to your dashboard (see above for instructions). Click on the “Active” tab. (Note: you will be taken to this tab automatically by clicking on the link in the automatic submission message, shown above.)Click on the title of the project you would like to view.

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Are You Ready to Apply?

PCORI Tier I Pipeline to Proposal Award Checklist

Use the checklist below to assess your readiness to apply for a PCORI Tier I Pipeline to Proposal Award.

I am an individual or I represent a group of patients, stakeholders, or researchers and I/we are focused on a health-related issue.

The health issue I am focused on could lead to a comparative effectiveness research (CER) question. (The CER does not need to be identified right now.)

I can demonstrate how I have been successful in previous community engagement. (This does not need to be healthcare related.)

I want to create a patient-researcher partnership with the intention of working together to eventually submit a proposal for a patient-centered CER.

I can explain how I would use the funding. I am willing to complete all the Tier I award requirements, including:

• Commit to taking PCORI Pipeline Tier I Awardee training • Be willing to work closely with and engage in regular communication with my Regional Pipeline Award Program Office

• Agree to participate in forums to share experiences and lessons learned with other Tier I Pipeline Awardees

• Be willing to provide reports giving details on the activities that have taken place during the contract period

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Visit Our Website

Please visit the Tier I applicant training site at: http://www.pcori.org/content/pipeline-proposal-awards-initiative

This site provides you with helpful application tips, further guidance on completing the application, and knowledge checks.For other Engagement opportunities please visit – Eugene Washington Engagement Awards –

http://www.pcori.org/content/eugene-washington-pcori-engagement-awards

Get Involved with PCORI –http://www.pcori.org/content/get-involved

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Question and Answer Session

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Thank You for Joining Us!

Please complete the brief survey about the webinar.Your feedback is important to us and we look forward to refining our efforts based on your experience.

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