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Resear arch Done Differ erently ently: : The In Ins and Ou d - - PowerPoint PPT Presentation

Resear arch Done Differ erently ently: : The In Ins and Ou d Outs of Pat Patien ient- Ce Centered ed Outco comes mes Resear arch Ayodola Anise, MHS Program Officer, Healthcare Delivery and Disparities Research Program Clinical


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Ayodola Anise, MHS

Program Officer, Healthcare Delivery and Disparities Research Program Clinical Directors Network, Inc. September 27, 2018

Resear arch Done Differ erently ently: : The In Ins and Ou d Outs of Pat Patien ient- Ce Centered ed Outco comes mes Resear arch

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Roadm dmap

  • Inside PCORI
  • Focus on the Addressing Disparities Research Priority Area
  • Research Funding Opportunities at PCORI
  • How We Review Research Proposals
  • Engagement Funding Opportunities at PCORI
  • Q&A
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Inside PCORI

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Abo bout Us Us

  • An independent research institute

authorized by Congress in 2010 and governed by a 21-member Board of Governors representing the entire healthcare community

  • Funds comparative clinical

effectiveness research (CER) that engages patients and other stakeholders throughout the research process

  • Seeks answers to real-world questions about what works best for patients based on their

circumstances and concerns

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Our Mission and Strategic Goals

PCORI helps people make informed healthcare decisions, and improves healthcare delivery and

  • utcomes, by producing and promoting high-integrity, evidence-based information that comes from

re resear search h guide ded d by pa pati tients, ents, care regive vers, s, and d th the e br broade ader r healthcare althcare comm mmuni unity ty. . Our r Str Strat ategic egic Goals: als: Increase quantity, quality, and timeliness of useful, trustworthy research information available to support health decisions Speed the implementation and use of patient-centered outcomes research evidence Influence research funded by others to be more patient-centered

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Given my personal characteristics, conditions and preferences…

PCORI’s Work Answers Patients’ Questions

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Key y Co Comp mponen ents ts of the Research We F Fund

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  • Directly comp

mpare ares s tw two or r more re commonly used

  • pt

ptions

  • ns to screen, prevent, diagnose, or treat

conditions

  • Looks at whether A or

r B is is be bett tter er and for r which h pa pati tients ents

  • Fills

s evide dence ce gaps ps that are important to patients and other key stakeholders

  • Is conducted in re

real al-worl

  • rld

d po popu pulations ations and re real al-world world se setti tting ngs

Co Comp mparative tive Effecti ctiveness veness Resear arch

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Pat Patien ient-Cent Centere erednes dness

  • Aims to answer questions or examine
  • utcomes that matter to patients within the

context of patient preferences and interests

  • Research questions and outcomes reflect

what is important to patients and caregivers

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  • Engages scientists, patients, and other stakeholders in an active and meaningful way throughout

the entire study

  • Influences research to be patient-centered, relevant, and useful
  • Encourages successful uptake and use of research results

Pat Patien ient t and St d Stake kehold holder r Engagement ment

Change ge in St Study dy Inter ervent entions

  • ns

Refocus

  • cus

Outcom comes es Boost Recruit uitmen ment Share e Their eir St Story/Present y/Present St Study dy Findi dings ngs

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Assessment ent of Prevent ention ion, , Diagno gnosis is, , and Treat atmen ent Option

  • ns

Improving Healthcare Systems Communication & Dissemination Research Addressing Disparities Accelerating PCOR and Methodological Research

Our National Priorities for Research

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Assessment of Prevention, Diagnosis, and Treatment Options Research that:

  • Compares the effectiveness and

safety of alternative prevention, diagnosis, and treatment options

  • Determines which ones work best for

different people with a particular health problem

Our National Priorities for Research

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Assessment of Prevention, Diagnosis, and Treatment Options Impr proving ng Healt lthcare hcare Syste tems ms Research that:

  • Compares health system–level

approaches to improving access

  • Supports patient self-care, innovative

use of health information technology, care coordination for complex conditions, and effective workforce deployment

Our National Priorities for Research

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Assessment of Prevention, Diagnosis, and Treatment Options Improving Healthcare Systems Comm

  • mmuni

unication cation and d Diss ssem eminat ination ion Resea esearch

Our Natio ional nal Pr Priorit

  • rities

ies for Resear arch

Research on:

  • Providing information produced by

CER

  • Empowering people to ask for and

use the information

  • Supporting shared decision making

between patients and their providers

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Assessment of Prevention, Diagnosis, and Treatment Options Improving Healthcare Systems Communication and Dissemination Research Add ddre ressing ssing Di Disp spariti rities es

Our Natio ional nal Pr Priorit

  • rities

ies for Resear arch

Research on:

  • Prevention, diagnosis, or treatment

effectiveness

  • Preferred clinical outcomes across

patient populations at risk for disparities

  • Health care required to achieve best
  • utcomes in each population

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Assessment of Prevention, Diagnosis, and Treatment Options Improving Healthcare Systems Communication and Dissemination Research Addressing Disparities Acceler elerating ating Pa Patient tient-Center Centered ed Outc tcom

  • mes

es Resear esearch h and d Method thodologic

  • logical

al Resear esearch

Our Natio ional nal Pr Priorit

  • rities

ies for Resear arch

Research on:

  • Building data infrastructure
  • Improving analytic methods
  • Training researchers, patients, and
  • ther stakeholders to participate in

this research

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Sn Snaps psho hot t of Funde ded d Pr Project jects

Numbe ber r of funded ded awa wards: ds: More than 600 Amou

  • unt

nt awa warded ded: : More than $2 billion Numbe ber r of stat ates es where re we we are re fundi ding ng pr proje jects ts: : 41 (plus the District of Columbia)

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AS OF APRIL 2018

Abo bout Our Research Por Portfolio

  • lio

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PC PCORI RI Funds ds Resear arch on Hi High-Cos Cost, t, Hi High-Imp Impact act He Health alth Co Condi dition tions

PCORI has funded 224 studies determining what works best in care for the 16 highest cost conditions in the United States.

$32,027 $15,920

National Per Capita Expenditure Conditi dition Numbe ber r of PCORI RI Studies dies PCORI RI Inve vestme tment nt

Stroke 10 $41 M Heart Failure 14 $68 M Hepatitis (Chronic Viral B and C) 8 $59 M Chronic Obstructive Pulmonary Disease 17 $89 M Schizophrenia/Other Psychotic Disorders 11 $22 M Chronic Kidney Disease 16 $67 M Asthma 16 $51 M Atrial Fibrillation 3 $5 M Alzheimer's Disease/Dementia 12 $64 M Depression 35 $122 M Cancer 77 $285 M Ischemic Heart Disease 19 $94 M Osteoporosis 1 $14 M HIV/AIDS 4 $8 M Arthritis 13 $43 M Diabetes 29 $68 M

High-cost clinical conditions identified by the Centers for Medicare and Medicaid Services for 2015. The PCORI CER portfolio includes 392 active/completed studies funded as of September 12, 2017. Analysis excludes methods studies, Pilots, PPRNs, CDRNs, and Engagement Awards.

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Focus on the Addressing Disparities Research Priority Area

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Ad Addr dressin ssing g Disp sparit rities ies Resear arch h Pr Priorit

  • rity

y Ar Area Missi ssion

  • n

Guiding Principle

To support comparative effectiveness research that will identify best options for reducing and eliminating disparities

Addressing Disparities Priority Area Mission Statement

To reduce disparities in healthcare outcomes and advance equity in health and healthcare

PCORI’s Vision, Mission, Strategic Plan

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  • Identify high-priority research questions

relevant to reducing and eliminating disparities in health and healthcare outcomes

Iden enti tify fy Res esea earch h Questi tions ns

  • Fund comparative effectiveness research with

the highest potential to reduce and eliminate health and healthcare disparities

Fund Rese search

  • Disseminate and facilitate the adoption of

promising/best practices to reduce and eliminate health and healthcare disparities

Diss sseminat minate Promisin ising/Bes g/Best t Practi tices ces

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Ad Addr dressin ssing g Disp sparit rities ies Por Portfolio

  • lio Goals

ls

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Sn Snaps psho hot t of the Ad Addr dress essing ing Disp sparit arities ies Por Portfolio

  • lio

Numbe ber r of funded ded awa wards: ds: 81 Amou

  • unt

nt awa warded ded: : $250 million Numbe ber r of stat ates es where re we are re fundi ding ng pr projec ects ts: : 25 (plus the District of Columbia)

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Ad Addr dressin ssing g Disp sparit rities ies Pop Popula lations tions of In Interes est

70 70 59 59 27 27 19 19 6 4 Racial/Ethnic Minorities Low-Income Low Health Literacy Rural Persons with Disabilities LGBTQ

# of Projects in Portfolio

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Ad Addr dressin ssing g Disp sparit rities ies Por Portfolio

  • lio by Co

y Condi ditio tion n

Condition ndition # of

  • f Projects

jects

Mental/Behavioral Health 16 Respiratory Diseases 11 Nutritional and Metabolic Disorders 10 Cardiovascular Health 8 Neurological Disorders 6 Multiple/co-morbid chronic conditions 5 Cancer 4 Reproductive and Perinatal Health 2 Liver Disease 2 Functional Limitation and Disabilities 1 Other 16

Total 81 81

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STUDY PROFILE

Long-Term Outcomes of Community Engagement to Address Depression Outcomes Disparities

Project looks at whether a community engagement intervention or technical assistance model will improve clients’ mental health and physical functioning and reduce risk factors for homelessness. It will also identify patient preferences and priorities and assess community capacity to respond to these priorities.

Kenneth Brooks Wells, MD, MPH University of California, Los Angeles Addressing Disparities, awarded December 2012

Engagemen gagement

  • Community agencies collaborate to tailor depression toolkits to

needs and strengths of community.

Methods thods

  • Both a mixed-methods approach and a randomized controlled trial

Resu esults ts

  • The two approaches didn’t differ in people’s depression or mental

health quality of life. People in programs assigned to the coalition approach showed more improvement in physical health quality of life and averaged fewer nights in the hospital for mental health problems.

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Research Funding Opportunities at PCORI

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PC PCORI RI Fundi ding ng Opp pportuniti unities es

Our research funding is awarded through PCORI Funding Announcements. Open opportunities are posted at pc pcori ri.o .org/ap g/appl ply.

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PC PCORI RI Co Comp mparativ ative e Effecti ctiveness veness Research Fundi ding g Opp pportuniti unities es

Broad d Funding ing Anno nouncements uncements Targe geted ed Funding ing Announcements

  • uncements

1 2

http://www.pcori.org/funding-opportunities

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  • Supports research on investigator initiated research topics that address questions of

importance to patients and other stakeholders.

  • The announcement includes 5 different types of awards that align with PCORI’s National

Priorities for Research

  • Awards range from $750,000 – $5,000,000 in direct costs per project and are generally 3

years in duration

  • Upcoming Deadlines
  • Letter of Intent: Nov
  • vembe

ember r 6, 2018; Application: Ja Janu nuar ary y 16,20 2019

  • Letter of Intent: Ja

Januar uary y 31, 2019; Application: Apr pril 24, 2019

Br Broad d Fundi ding ng An Announce ncement ment

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  • Seek research proposals on the highest-priority questions identified through PCORI’s topic

generation and research prioritization process

  • Examples:

– Clinical Management of Hepatitis C Infection – Treatment of Multiple Sclerosis – Management of Care Transitions for Emerging Adults with Sickle Cell Disease

  • Budget and project duration vary by funding announcement

Targeted ed Fundi ding ng An Announce ncement ment

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PC PCORI RI CE CER F R Fundi ding g An Announcement cements Contacting Program Staff

  • http://www.pcori.org/funding-opportunities
  • Broad PCORI Funding Announcements
  • Targeted PCORI Funding Announcements
  • Contact PCORI
  • Progr
  • grammat

ammatic c Inqu quire res: s: Email: sciencequestions@pcori.org Phone: 202-627-1884 Research Inquiry Form: http://www.pcori.org/PFA/inquiry

  • Adm

dminis inistr trati ative ve, , Fin inancial, ncial, or r Techn hnic ical al Inqu quiri iries: es: Email: pfa@pcori.org Phone: 202-627-1885

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How We Review Research Proposals

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Our Merit it Revi view ew Pr Process ess

Pre reliminar liminary y re revi view ew of full ll app ppli licati ations

  • ns.

. Reviewers conduct a preliminary review of applications, providing written critiques and scores for the applications based on our review criteria and scoring system. Eva valuat luate Lett tter ers s of Inte tent.

  • nt. At least two PCORI staff review each Letter of Intent and a

committee of staff members determines which will be invited to submit full

  • applications. Information in the Letters of Intent drives the recruitment of patients,

clinicians, scientists, and other members of the healthcare community who have the appropriate expertise to serve on merit review panels.

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1 2

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Our Merit it Revi view ew Pr Process ess

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Selecti ection

  • n Committe

mittee Review view. . Program staff recommend projects to a Selection Committee that includes members of PCORI’s Board of Governors. The committee identifies a slate of applications for possible funding based on merit review scores, programmatic balance and fit, and PCORI’s strategic priorities. This slate is proposed to PCORI’s Board for consideration and approval.

4

In In-per person son pa panel el re review iew. . Following the preliminary review, a subset of applications move forward and are discussed and scored by the full panel of merit reviewers at an in-person meeting. The perspectives of a wide range of reviewers help us choose projects that are important, practical, and relevant to the audiences who will use the results of our work.

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Pa Patien ent/Oth Other er St Stake keholder r Reviewe wers Scientis tist t Reviewe wers Criterion 1: Potential for the study to fill critical gaps and generate actionable evidence

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

 

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

Criterion 4: Investigator(s) and environment Criterion 5: Patient-centeredness

 

Criterion 6: Patient and stakeholder engagement

 

Our Merit it Revi view ew Pr Process ess

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  • Read

ad PFAs carefully efully

  • Speak/em

peak/email ail with h PCORI RI progr gram am staff f early and as needed

  • Compare your proposal with PCORI

ORI-funded funded stud udies ies on your topic/condition/intervention to identify differences and call out the evidence gaps filled by your proposal

  • Cite systematic

ematic reviews iews and d guide idelines lines that identify current gaps in the evidence and document that the topic is a high-priority for patient and other stakeholder partners, PCORI, Institute of Medicine, or the Agency for Healthcare Quality and Research

Tips ps for Su Subm bmit itting ting LO LOIs Is and Ap d Appl plicat icatio ions ns

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  • Describe the po

potenti ential al for your study to impr prove ve th the qu quality ty of th the e evide idence ce available

  • Highlight how/why this stu

tudy dy is is of

  • f in

interes erest t to patients and other stakeholders

  • Consider appropriate and patient-centered primary and secondary outcomes, including pa

pati tient ent- re repor ported ted and d clinical al outc tcomes

  • mes
  • Identify how your in

inter ervent vention ion comp compon

  • nen

ents ts will address the identified research gap

  • Describe selected inter

erve vention(s) tion(s) and compar parat ator(s

  • r(s)

) and provide evidence of proven efficacy cacy, , effecti ectivene veness, ss, or r wide de-spread spread use se (e.g., cite published literature, conduct pilot study provide data, document use in clinical setting)

  • If usual care is a comparator, describe why it is appropriate and how it will be delivered

constantly

Tips ps for Su Subm bmit itting ting LO LOIs Is and Ap d Appl plicat icatio ions ns

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  • Identify appropriate stakeholder partners that can influence the conduct of CER and the

uptake and use of research findings

  • Describe engagem

gagement ent of patient and stakeholder partners in developing veloping the resear arch h ques estion ion and d prop

  • posal
  • sal
  • Describe how your will engage

gage patients and other stakeholders ov

  • ver the life

e cyc ycle le of f yo your projec ject, from planning and conducting the study to disseminating results

  • Describe roles,

es, respo ponsibi nsibility lity, , and d compensation mpensation of patient and other stakeholder partners

  • Use PCORI’s Engagement Rubric to help structure your engagement plan:

http://www.pcori.org/sites/default/files/Engagement-Rubric.pdf

Tips ps for Su Subm bmit itting ting LO LOIs Is and Ap d Appl plicat icatio ions ns

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Engagement Funding Opportunities at PCORI

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Amoun

  • unt

awa warded ed:

$5 $57 7 mi milli llion

Numb mber er of awa wards: s:

285 285*

*AS OF APRIL 23, 2018

These awards support projects that promote meaningful involvement by patients, caregivers, clinicians, and other healthcare stakeholders in comparative clinical effectiveness research (CER).

Bu Build lding ing a PC PCOR R Co Comm mmunity ity Nation ionwide wide

Our Eugene Washington PCORI Engagement Awards and Pipeline to Proposal Awards are not research awards but opportunities to build patient-centered outcomes research capacity.

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St States es with h funded nded projects

  • jects:

46 46;;;;; ;;;;;;;;;;; ;;;;;;;

(plus us DC and d Puerto

  • Rico)
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Engagement ment Aw Award d Fundi ding ng Opp pportuniti unities es

Engagement agement Awa ward: d: Diss ssem emination nation Initi tiati ative ve

Objective: Actively disseminate PCORI-funded research findings Next Letter of Intent due date: October 1, 2018

Engagement agement Awa ward: d: Conference rence Supp pport

Objective: Convene stakeholders and communicate PCORI-funded research finding to a targeted end-user audience Next Application due date: October 1, 2018

Engagement agement Awa ward: d: Capac pacity ty Building ding

Objective: Develop infrastructure and partnerships for dissemination and implementation of PCORI- funded research findings Next Letter of Intent due date: October 1, 2018

Up to $300,0 ,000 00 2 ye year ars Up to $50,000 000 1 ye year ar Up to $250,0 ,000 00 2 ye year ars

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PC PCORI RI Engagement ment Aw Awards ds Contacting Program Staff

  • https://www.pcori.org/funding-opportunities/research-support-funding-opportunities/eugene-

washington-pcori-engagement

  • Contact PCORI
  • Progr
  • grammat

ammatic c and d Adm dminis inistr trativ ative Inqu quires: res: Email: ea@pcori.org Phone: 202-370-9312

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Q&A

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www.pcori.org @pcori /PCORInstitute PCORI /pcori

Contact Information

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202.827.7694 aanise@pcori.org Ayo yodola dola Anis ise, e, MHS HS, Program Officer