Patient Centered Outcomes Research Institute What Does PCORI Want?

Patient Centered Outcomes Research Institute What Does PCORI Want? Prepared by Dr. Lenore Arab, Robin Faria, and Deborah Herman Rapid Response Team Grant Submission Unit (RRT GSU) Tuesday, February 25 th, 2014

Dr. Judy Gasson Sr. Assoc Dean Research, SOM Director, JCCC Dr. Steve Dubinett Sr. Assoc Dean Translational Research Director, CTSI Director, Dr. Lenore Arab The Rapid Response Team Grant Submission Unit (RRT GSU) Dr. Lenore Arab RRT Director Robin Faria RRT Director of Operations Deborah Herman Scientific Coordinator Jane Skerritt Administrative Communication Coordinator Director of Operations, Robin Faria Scientific Coordinator, Deborah Herman

RRT Supports 6 Major Grant Preparation Milestones Search for new FoAs multiple times a week and upload onto our website Individualized outreach to potential PIs Awareness of Potential Funding Revision & Resubmission RRT suggests new opportunities for unfunded proposals Identify researchers and find collaborators Talent Search Brainstorming & Viability Assessment Mock Review RRT provides support in facilitating internal and external review processes RRT invites and hosts structured brainstorming sessions involving potential investigators from all CTSI institutions. Writing & Budget Preparation RRT grant management software Tailored time and people management Automated task assignments and preset deadlines for 85 tasks Automated email notifications Real-time project access Shared document functionality

RRT Mission The UCLA CTSI Rapid Response Team Grant Submission Unit (RRT GSU): supports the grant application process provides administrative support and infrastructure streamlines processes creates successful collaborations provides grant management support, tools, and software Services offered free of charge

Grant Proposal Management Software Grant Proposal Management Software Grant Time Management Helpful Reminders Task Notifications Shared Documents Reports Review Facilitation Technical Support Document Tracking

RRT Software Secure Document Storage and Sharing Automatic emails for all project members Control permission of specific folders/docs Version tracking

The Goal More team science More successful large NIH grants submitted and funded More PCORI

PCORI Opportunities CER Interest Listserv for PCORI and other CERopportunities Support for PCORI applications Advice and assessment of appropriateness PCORI review criteria Budgetary considerations

Path to PCORI Funding IDEA Foundation Grant (to test feasibility) Did it work? Yes No R21 No Did it work? Yes R01 No Did it work? Yes PCORI

Revised PCORI Review Criteria 1. Impact of the condition on the health of individuals and populations 2. Potential for the study to improve health care and outcomes 3. Technical merit 4. Patient-centeredness 5. Patient and stakeholder engagement

Changes in PCORI Review Process Simplified criteria and requirements for written critiques 2-year standing panels to enhance reviewer consistency Expanded merit reviewer application to match reviewers better with applications *From: http://www.pcori.org/blog/on-contracts-improving-our-application-review-process-2/

Feedback for Patient-Powered Research Network (PPRN) Submission Criticisms/Weaknesses Strengths

What is Patient Engagement to PCORI? Criticisms/Weaknesses: Weak patient involvement No clear participation/collaboration Patient involvement in governance not clear Research on and participation by patients are not the same thing Patients should be at the planning table Focus Groups are not good enough Need to build from existing relationships

What Does PCORI Like to See? PPRN Application Strengths Achievable goals Strong leadership Leveraging of existing resources/relationships Engagement from partners outside of research community/university Emphasis on diversity Clear and obvious patient engagement Preliminary data, evidence-based, beta testing, proven ideas

Acute Upcoming PCORI Deadlines (Will be Repeated Every 3 Months) Topic LOI Due App Due Amount Assessment of Prevention, Diagnosis and Treatment Options 03/07/14 05/06/14 $2M direct for 3 Years Improving Healthcare Systems 03/07/14 05/06/14 $5M direct, 5 Yrs (large studies) $1.5M direct, 3 Yrs (small studies) Communication and Dissemination Research 03/07/14 05/06/14 $1.5M direct for 3 Years Addressing Disparities 03/07/14 05/06/14 $1.5M direct for 3 Years Improving Methods for Conducting Patient- Centered Outcomes Research 03/07/14 05/06/14 $750K direct for 3 Yrs (methods) $500K direct, 2 Yrs (PROMIS) Obesity Treatment Options Set in Primary Care for Underserved Populations 03/07/14 05/06/14 $10M total for 5 years Pragmatic Clinical Studies and Large Simple Trials to Evaluate Patient-Centered Outcomes 03/07/14 08/08/14 $10M direct for 5 Years The Effectiveness of Transitional Care 03/07/14 05/06/14 $15M total for 3 Years Eugene Washington Engagement Awards Rolling Rolling $200K total for 2 Years

PCORI: $10 mio Pragmatic Clinical Studies and Large Simple Trials to Evaluate Patient-Centered Outcomes 1. Bipolar disorder in children, adolescents, and young adults 2. Ductal carcinoma in situ 3. Cardiovascular disease risk in racial and ethnic minorities 4. Progression of episodic acute back pain into chronic back pain 5. Migraine headaches in Adults 6. Symptomatic osteoarthritis, including joint replacement 7. Antipsychotic use in children, adolescents and young adults Investigators encouraged to complete inquiry form for other topic areas

PCORI: Engagement Awards 1. Knowledge Awards 1. Build knowledge on how consumers of healthcare information receive and make use of PCOR/CER Findings 2. Training and Development Awards 1. For training Non-Usual Suspects (patients, community) 2. Increase capacity to engage in PCOR/CER 3. Dissemination Awards 1. Support disseminating information 2. Encourage adoption of PCORI-funded research results 3. Support best practices for engaging patients and other stakeholders in research Up to $250,000 for two years

PCORI Success at UCLA Title PI Amount Long-Term Outcomes of Community Engagement to Address Depression Outcomes Disparities Using Telehealth to Deliver Developmental, Behavioral, and Mental Health Services in Primary Care Settings for Children in Underserved Areas A Modified Delphi Approach to Defining a Patient- Centered Community Health Center Developing Patient-Centered Outcomes for Dementia: Goal Setting and Attainment Is MyPlate.gov Approach to Helping Overweight Patients Lose Weight More Patient-Centered? Ken Wells $2,064,163 Tumaini Coker $1,661,626 Robin Clarke $307,985 David Reuben $1,050,000 William James McCarthy $1,930,206

Levels of RRT Service Full Service No pre-existing team Uses most or all of RRT s provided services Heavy RRT involvement and effort Specialized Support RRT assigned clearly defined subset of tasks Application team is pre-existing Heavy RRT involvement and effort in specialized areas (biosketches, letters of support, meeting coordination) RRT-Lite Applications do not meet full RRT criteria RRT has higher priority applications Available to smaller application (R01s) and new investigators Support includes initial first meeting and use of RRT Software

Amount Grant Topic Status $52M DARPA UCLA Program in Systems-Based Neurotechnology Pending $32M R01 Phase II Study of an anti-amyloid vaccine in prodromal FAD mutation carriers Not Funded $20M P50 Tobacco Center of Regulatory Science at UCLA Partially Funded $12M U54 UC BRAID Center for Accelerated Innovation Funded $12M U54 The UCLA BD2K Center: A Computational Framework Enabling Precision Medicine Pending $5M U54 Network for the Study of Pediatric Intestinal Failure (NSPIF) Pending $3.2M CMS UCLA Alzheimer s and dementia care: comprehensive, coordinated, patient-centered $3M U01 Partnership for Academic Innovations in Regulatory Science (PAIRS) $2M PCORI Long-Term Outcomes of Community Engagement to Address Depression Outcomes Disparities $1M CIRM Using human induced pluripotent stem cells to improve our understanding of Idiopathic Pulmonary Fibrosis Funded Pending Funded Funded

Success By the Numbers: First Two Years Applications Submitted with RRT Support Total: 23 6 Not Funded 5 Funded for over $18.5M 4 active but not submitted as of end of 2013 8 Submitted (funding status unknown as of end of 2013) Note: 40 additional FOAs identified by RRT with outreach to departments and potential PIs

Contact us at: RRT@mednet.ucla.edu or (310) 267-4258 to get started

Brainstorming Meeting: Example Rare Diseases Clinical Research Consortia (RDCRC) for Rare Diseases Clinical Research Network (U54) Brainstorm Meeting September 18, 2013 RRT Staff Members: Lenore Arab, Robin Faria, Joanne Wu

Brainstorming Meeting: Example Brainstorm Invitees Martin Martin Robert Venick Miguel Sandoval Erica Stanley Lenore Arab (RRT) Joanne Wu (RRT)

Brainstorming Meeting: Example Brainstorm Agenda Introductions Background to the RFA (PowerPoint Presentation) RRT Software Timeline Next Steps