Health Systems PCORnet Demonstration Project: Applicant ... · 1. The project must include at least two health systems that span two or more CDRNs. 2. The project will leverage PCORnet

Health Systems PCORnet Demonstration Project: Applicant Town Hall

Maryan Zirkle MD, MS, MAProgram Officer, Research Infrastructure

Ashton FerraraSpecialist, Contracts Operations

March 14, 2016

Agenda

Submitting Questions:

Submit questions via the chat function in Meeting Bridge.

Ask a question via phone (an operator will standby to take your questions).

Programmatic Overview

Administrative Requirements

Questions and Answers

Programmatic Overview Maryan Zirkle MD, MS, MAProgram Officer, Research Infrastructure

March 14, 2016<< Develop infrastructure for D&I >>

OverviewCDRNs have a unique opportunity to broaden the scope of their research to include topics that are of interest and add value to multiple health systems.

Provides CDRNs the opportunity to test their capacity to conduct collaborative research with health systems leaders across PCORnet.

PCORI will fund up to five research studies informed by outcomes and recommendations from the meetings that occurred to prioritize key topic areas.

Project Budget: $4 million in total costs to fund up to five projects

Project period: Maximum of 1 year

Objectives of this PFAThe Health Systems demonstration project includes the following objectives and guidelines:1. The project must include at least two health systems that span two or

more CDRNs. 2. The project will leverage PCORnet data resources. (Priority will be

given to (1) CDRNs that have data currently organized in the PCORnet Common Data Model Version 3.0 and (2) to proposals that optimize the use of PCORnet Common Data Model Version 3.0), but may also incorporate additional, relevant health system data (e.g. system-level variables, social determinants of health, and genetic determinants of health) as appropriate.

3. Proposed projects will be identified, vetted, and involve iterative review and discussion between researchers, clinicians and health systems leaders.

4. The project will evaluate the impact of the research on PCORnet’scapacity to support collaborative research and extend the breadth of PCORnet’s shared tools and resources (the PCORnet Commons) using PCORnet infrastructure.

Research Topics of Particular Interest Applications should address one of the following areas of interest:

Identifying and managing high healthcare utilizers Identifying and managing the needs of specific populations by diagnoses (e.g., behavioral health) or patient characteristics (e.g., socioeconomic status) Comparative performance of alternative models of healthcare delivery (e.g., accountable care organizations [ACOs])Novel analytical tools and methods (e.g., risk adjustment and predictive modeling) Assessment of value in health care (including quality, safety, and utilization)

Note: Sample questions listed in the PFA are intended to provide additional guidance on the areas of interest, but applications are not required to address one of these sample questions.

Development of the Research Plan

Complete guidance can be found in the PFA and in the Research Plan Template. The following are key pieces to keep in mind during Research Plan development:

Provide a convincing description of the clinical or health system burden imposed by the problem or condition under study Include a justification for the research question’s importance and added value for multiple PCORnet health systems participating in the studyJustify and provide examples of the study’s potential to inform decision making for key stakeholders. Describe the likelihood that findings would be valuable to others, leading to implementation of changes and improvements in practice and patient outcomes. The explanation should identify potential barriers that could hinder adoption of the intervention by othersDescribe how the application addresses outcomes of interest to all participating health systems and, if applicable, describe local or site-specific outcomes of interestDescribe the study plan’s feasibility, including presenting a realistic project timeline with specific scientific and engagement milestones

Development of the Engagement PlanComplete guidance can be found in the PFA and in the Research Plan Template. The following are key pieces to keep in mind during Engagement Plan development:

Describe how the participating health systems communities generated the research question. Input must be included from health systems leaders (e.g., CEOs, Chief Medical Information Officers [CMIOs], and Chief Information Officers [CIOs]) and physician championsProvide a well-justified description of how the research team is interdisciplinary, ensuring that the project will be carried out successfully by researchers, patients, clinicians, physician champions, and other stakeholdersShow evidence of active engagement and iterative review and discussion among scientists, patients, health systems leaders, physician champions, and others throughout the research process (e.g., formulating questions, identifying outcomes, monitoring the study, conducting iterative reviews, disseminating, and implementing), and also show that the frequency and level of patient and stakeholder involvement will sufficiently support the study goalsClearly describe the roles and decision-making authority of all study partners

Development of the Evaluation PlanA significant component of this demonstration projects is to test, evaluate, and report on PCORnet’s collaborative infrastructureApplicants should propose a plan to formally test and evaluate the research project’s impact on PCORnet’s capacity to support collaborative research and engage health systems leaders in rapid-cycle researchComplete guidance can be found in the PFA and in the Research Plan Template. The following are key pieces to keep in mind during Evaluation Plan development:

Describe the study’s collaborative aspects and address how these collaborative aspects provide an opportunity to transform or enhance PCORnet processes or infrastructurePropose a robust approach to sharing project learnings—especially learnings related to the utility and validity of new data elements—with other PCORnet networks and the public through the PCORnet Commons—a repository of shared tools, knowledge, expertise, and infrastructure processes—and the impact of these learnings on PCORnet’s capacity to support an increasing volume and breadth of researchAcknowledge future collaborations with health system research leaders within PCORnet on the finalization of an evaluation framework

Development of the Dissemination PlanComplete guidance can be found in the PFA and in the Research Plan Template. The following are key pieces to keep in mind during Dissemination Plan development:

Identify who will make decisions or use the findings produced by this study, such as local and national stakeholdersDescribe a plan for disseminating study findings outside of PCORnet beyond publication in peer-review journals and at national conferencesPresent a credible plan through which findings could be feasibly disseminated and implemented quickly within PCORnet (including at the local hospital or clinic level and at the leadership level including health systems leaders and clinical leaders), resulting in improvements in healthcare system, practice and patient outcomesOutline clearly the roles of patient and stakeholder partners (including health systems leaders and clinical leaders) in the planning of disseminating the study’s findings

Selection of Key PersonnelEach application must propose one Lead PI and at least two co-PIs

Lead PI: Primary experience or expertise in health research or CER and be either a health systems participant or a PCORnet participant. The Lead PI must contribute a minimum of 40 percent Full-Time Equivalent (FTE). The Lead PI must be a full-time employee of the prime applicant. One co-PI: Primary experience or expertise as a health systems leader. The co-PI must contribute up to 5 percent FTE. One co-PI: Primary experience or expertise as a physician champion. The co-PI must contribute up to 5 percent FTE.

Health systems leaders, physician champions, and other key stakeholders must also be involved throughout the research process

Criterion for Merit ReviewCriterion 1. Potential for study to fill critical gaps in evidence and generate actionable evidence

Criterion 2. Potential for the study findings to be rapidly adopted into clinical practice and improve delivery of care

Criterion 3. Scientific merit (research design, analysis, and outcomes)

Criterion 4. Patient-centeredness

Criterion 5. Patient and stakeholder engagement

Administrative Requirements

Preparing your application for submission –

Getting Prepared- Re-read the funding announcement for which you

are applying- http://www.pcori.org/funding-opportunities/announcement/limited-

pcori-2016-funding-announcement-health-systems-pcornet

- Review the PCORI Research Plan Template

► Research Strategy► Engagement Plan► Evaluation Plan► Dissemination & Implementation Potential► Replication & Reproducibility of Research and Data

Sharing► Protection of Human Subjects► Consortium Contractual Arrangements► References Cited► Appendix

Research Plan Template

Research StrategyMaximum 5 pages in lengthUse the Research Plan Template as your guide- Background- Significance- Study Design or Approach- Patient Population

- Recruitment Plan- Estimated Racial/Ethnic and Gender Enrollment Table

- Research Team and Environment

PLEASE provide all the information requested, as outlined in the template.

PageLimit

5

Research Template – Page limits

Engagement Plan – 2 pagesEvaluation Plan – 2 pagesDissemination and Implementation Potential – 2 pagesReplication and Reproducibility of Research and Data Sharing – 2 pagesProtection of Human Subjects – 5 pagesConsortium Contractual Arrangements – 5 pagesReferences Cited – 10 pagesAppendix (Optional) – 25 pages

PCORI Online: Application

► PI and Contact Information► Project Information► Key Personnel► Milestones► Templates and Uploads► Save and Review

Start early!

Download the PFA-specific Research Plan Template, found on theFunding Opportunities page on PCORI website.

Go into PCORI Online, use Chrome or Safari browsers to access the system.

DUE DATE FOR APPLICATION:

April 19, 2016 –BY 5:00 P.M. (ET)

SUBMITTING AN APPLICATION

Complete the required fields and upload the required documents:

Research Plan Template – Note Page limits as outlined in the Template

People and Places Template

Budget Template

Letters of Support

DUE DATE FOR APPLICATION:

April 19, 2016 –BY 5:00 P.M. (ET)

SUBMITTING AN APPLICATION

People and Places Template: Biosketch

You may use the NIH biosketch or PCORI’s formatBiosketches are required for all key personnelList all partners within the Key Personnel sectionPatient/Stakeholder Biosketch

PageLimit

5 Per person

People and Places Template:Project / Performance Site(s)

Demonstrate that the proposed facilities have the appropriate resources required to conduct the project to plan, within budget, and on time.Provide a description of the facilities that will be used during the project, including capacity, capability, characteristics, proximity, and availability to the project.

Professional Profile/Biosketch

Budget Templates

Three budget sections must be submitted as part of the online application process:

Detailed Budget Budget Summary Budget Justification

NOTE:A detailed budget is needed for each year of the project. Complete each budget section for the prime applicant and any/each subcontractor.

Budget and Period Limitations

Funds & BudgetTotal costs: $4 million over the life of the project

Includes direct and indirect costsIndirect costs: up to 40%Institutional base salary up to $200,000Indirect costs are capped on subcontracts / sub awardsThe limit for Scientific Travel is $10,000 over the duration of the project. There is no cap on Programmatic TravelPeriod of Performance1 year

Detailed Budget

• Personnel• Consultant • Equipment• Supplies• Travel• Other Expenses• Consortium/Contractual Direct Costs• Consortium/Contractual Indirect Costs• Prime Indirect Costs

Budget JustificationProvide a narrative that fully supports and explains the basis for the information found in the Detailed Budget

Provide sufficient detail to understand the basis for costs, the reason that the costs are necessary, and an explanation for major cost variances

– Provide justification as to why the costs are reasonable for the work to be performed

Provide a breakdown of costs proposed for each consortia or contractor

Must specify any other sources of funding that are anticipated to support the proposed research project

Provide quotes, indirect cost rate letter, and fringe benefit policy

Letters of SupportAll letters of support should be addressed to the PI and institution to demonstrate the commitment of key personnel and supporting organizations to your proposed project.

Letters of support should clearly reflect the substantive involvement and material contribution to be provided by the signatory parties, and are meant to substantiate the commitment of collaboration of all forms.

Letters of support should be organized in the following manner:- Letters of organizational support

- Letters of collaboration

- Letters confirming access to patient populations, data sets, and additional resources

Common Application Errors

Using the wrong browser, access PCORI Online via Chrome or Safari browsers

Not entering information into all required fields in the system

Not clicking the ‘Save’ button

Having multiple people working on the application at the same time

Having the incorrect file extension, only PDF files can be uploaded

Not choosing the correct document type from the drop-down menu

AO is unable to view the application

Tips for Success

Adhere to the PFA and Application GuidelinesTalk to a Program Officer if you have questionsStart and submit earlyDownload PCORI’s Online User Manual for Submitting an Online ApplicationEnsure that all team members can see the application in the systemInform your AO of your intent to submitSubmit the completed application before the due date or on it by 5:00 PM ET

Resources

Additional Application ResourcesRefer to the funding opportunities page in our Funding Center (http://www.pcori.org/funding/opportunities) for the following resources:

PFA and Application Guidelines

PCORI Online User Manuals

Applicant Training: http://trainings.pcori.org/applicationtrainingspring2015/story.html

General Applicant FAQs: http://bit.ly/applicant_faqs

PCORI Online: https://pcori.fluxx.io/

Research Methodology: http://www.pcori.org/node/4020

Submission and Key DatesWhat When

Applicant Town Hall March 14, 2016

Application Deadline April 19, 2016 by 5:00pm ET

Merit Review Dates May 2016

Awards Announced June 2016

Earliest Start Date July 2016

Questions and Answers

Submit questions via the chat function in Meeting Bridge

Ask a question via phone (press *7)

Contact Us:• Schedule a call at http://www.pcori.org/content/research-inquiry• Call 202-627-1884 ( programmatic inquires)• E-mail us at [email protected]• Call 202-627-1885 ( administrative and technical inquires)• E-mail us at [email protected]

Thank You