INCORPORATING 

STAKEHOLDER ENGAGEINTO VA RESEARCH: WHAT WE CAN LEARN THE PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE (PCORI)?Susan Zickmund, PhD, Director, Qualitative, Evaluation Engagement Core, VA Pittsburgh, CHERP
Goal for the Workshop

 Discuss the unique role of stakeholder engag

PCORI applications as well as lessons that caused for VA HSR&D research. 

2
Audience

 Those interested in:

 the paradigm shift in patient-centered rese

the core of the PCORI mission.

 how PCORI’s radical redefinition of the pati

role in research may alter our views on stakengagement within HSR&D research. 

3
Paradigm Shift

...suggestions from experiences working with a dozen applications.
Overview

1. Describe how stakeholder engagement in PC

constitutes a new approach.

2. Discuss a model for stakeholder engagement 

may be tailored to HSR&D research.

5
Audience Poll

How familiar are you with the PCORI funding mechanism?

 Very familiar (PI or Co-I on a submitted proposa Somewhat familiar. Not familiar.
PART 1. STAKEHOLDER 

ENGAGEMENT AND PATIENT-CENTERED RESEARCHA New Model for Health Research
Definition of Stakeholde

Engagement

 “Stakeholder engagement is the process by 

organization involves people who may be afby the decisions it makes or can influence the implementation of its decisions.”*

 “Our Mission: PCORI helps people make inf

healthcare decisions...that comes from reseaguided by patients, caregivers, and the broa

healthcare community.”** 

*Stakeholder Engagement,” Wikipedia, http://en.wikipedia.org/wiki/Stakeholder_engageme**PCORI Funding Announcement: Improving Healthcare Systems, 2013 http://www.pcori.org/aAugust-2013-Improving-Healthcare-Systems-052013.pdf
Definition of Patient-Center

Care...

“...focuses on the patient and the individual’s parhealth care needs. The goal of patient-centered hcare is to empower patients to become active parin their care.”April Reynolds, “Patient-Centered Care,” American Society of Radiologic Technologies, (2009)
Patient-Centered Research

 “...focuses on the patient-centered approach, 

into account issues such as patient preferences experiences...”

Amos Peter Lee, “Patient-Centered Research,” Physiotherapy (2012), 98, 180.
Relevance to VA HSR&D

 The VA:

 is the largest integrated healthcare system in the  focuses on improving the health and well-being 

specific population.

 embeds a core of Health Services Research and 

Development (HSR&D) researchers within it.

 has a mission of improving the healthcare system 

enhancing patient care. 
Relevance to VA HSR&D

 The VA

 is at the forefront of qualitative, mixed methods 

 emphasizes the voice of the patient.

 has Centers of Innovation (COINs) which focus o

partnering with VA Operations.

 has the goal of aligning research priorities w

healthcare system’s needs.
Timely
Patient-Centered, Stakehold

Oriented

David Atkins, Director, HSR&D, “Director’s Letter.” Jeff Murawsky, “Practicing, Teaching, and Researching in an Era oTransformational Change.”Saul J. Weiner, “The Individual, Research, and Transformational CForum, October 2013. http://www.hsrd.research.va.gov/publications/forum/oct13/oct13-2.cfm
Challenges

 “However, the simultaneous engagement of pa

clinicians, and other stakeholders in research is potentially complex and costly.” 

Sara J. Knight, Deputy Director, HSR&D, “Accelerating Innovation and Translation thPartnership: Collaborative Research to Enhance and Transformation and Excellence Centers of Innovation (COIN), Forum. August 2013.http://www.hsrd.research.va.gov/publications/internal/forum07_13.pdf
Potential Solution

 Strengthen patient-centered research using a 

model of stakeholder engagement.
PART 2. EXPLORING T

NEW MODEL OF PATIENGAGEMENT WITHIPCORI
Not Research as Usual

 PCORI redefines research to best interface w

needs and values of patients and other stake
Grounded in PCORI’s Mast

Questions
PCORI and Stakeholder 

Engagement

“A defining principle of PCOR is ensuring that patient’s voice and perspective drive every step research process, including prioritizing the resequestions, designing and conducting the researimplementing the results in practice.

”

“Request for Proposal—Literature Review,” PCORI, http://www.pcori.org/assets/PCORI-Patient-Centeredness-Literature-Review-RFP1
Patients are the Most Critic

Stakeholders

 While there is a focus on multiple stakeholde

emphasizes patients the most. 
Viewing Patients on a Contin
Levels of Engagement

http://www.healthcareenewsletters.com/archives/CEUN-20121
Criteria for PCORI Proposals

 “Does the proposal describe how patients an

stakeholders were or will be identified and ein the research? 

 What are the roles of patients and key stake

in formulating the study’s hypotheses and desin the study’s conduct and dissemination of re

 What roles do patients and stakeholders hav

planned dissemination or implementation pla
Patient Engagement Across the R

Process
What does Engagement acro

Research Process Entail?

 Preparatory Stage

 Agenda setting and obtaining funding

 Execution Stage

 Study design and procedures Study recruitment Data collection

 Translational Stage

 Dissemination Implementation Evaluation Data analysis

Eliciting Patient Perspectives in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review (report p

Centered Outcomes Research Institute, 2012)http://www.pcori.org/assets/Eliciting-Patient-Perspective-in-Patient-Centered-Outcomes-Research-A-Meta-NarrativReview1.pdf
A. Soliciting Patient Input into 

National Agenda

 PCORI reaches out to patient populations to 

topics for funding.

 Holds public comment periods on the draft 

agenda.

 Sent themes to PCORI Board of Governors.
B. Redefining the Investigative 

 To be responsive to PCORI’s mission, a study 

have a patient investigator.

 Involving patients in the research team is me

profoundly change how a study is developed
Patient Roles

 Patient Principal 

Investigator (PI) along with traditional PI investigators.

 Co-Investigators.

 Advisory board 

multiple patienincluded (or alpatients).

 Participatory a

research approlong history of involvement.
PCORI Example: 

Investigator

 “Stakeholders and patients will be compensate

Investigators. With their commitment and obviodedication, the stakeholders are written into thas co-Investigators and will be compensated. Twritten letters of support and submitted bioske

http://www.pcori.org/assets/2013/11/PCORI-Sample-Engagement-Plans.pdf
PCORI Example: 

Patient Advisory Panel

 “Intervention Design. For designing...the cliniccommunity liaison role, patient and community 

will be engaged through participation in the pcentered design team and community advisory 

http://www.pcori.org/assets/2013/11/PCORI-Sample-Engagement-Plans.pdf
Personal Experience

 A patient on a team can ground the discussio

world concerns.

 A patient helps break the research bubble.
Patients Team Members

 NIH Commons ID (if Co-PI) and a Federalwid

Assurance (FWA).

 NIH-style biosketch. Letter of support. Salary, with budget / budget justification.
C. Redefining the Developme

Topics/Specific Aims

 Need to show that the research is responsive 

patient and other stakeholder needs and not superimposed upon them.

 Questions: What role have patients played 

selection of the research topic?

 Questions: What role have patients played 

creation of the specific aims?

 Questions: What role have patients played 

selection of study outcomes?
Topics/Specific Aims

 Preliminary qualitative 

work to show that the topic is important to patients.

 Show that the specific 

aims were given to stakeholders and that they helped revise them.

 Shows that pat

chose the outco

 Track all of this 

throughout the 
PCORI Example: 

Selection of Research Top

“Stakeholders and patients have been involved froconceptualization. When the Funding announcemreleased...Dr. Lindquist, the PI, was extremely inas this is a common issue that arises among the ssees in her geriatrics clinics. She contacted Ms. Msenior citizen patient who receives care at an arehospital and clinics...”http://www.pcori.org/assets/2013/11/PCORI-Sample-Engagement-Plans.pdf
PCORI Example: 

Development of Proposa

“Stakeholders and patients have been involved writing of this grant proposal. Each of the stakeholders above has written a part of the rplan...Numerous phone calls and emails have connected this panel of stakeholders and patieinto producing a thoroughly discussed grant proposal. Dr. Lindquist then performed editorito make this grant proposal cohesive and provguidance on the testing phases.”http://www.pcori.org/assets/2013/11/PCORI-Sample-Engagement-Plans.p

Personal Experience

 Area of most radical change from PCORI. Requires exploratory data before writing the 

aims.

 Requires (typically qualitative) data on patie

desired outcomes.
D. Data Collection

 The data collection section is more similar to 

and VA HSR&D style of proposal.

 Important to show that interventions, decision 

(etc.) have been tailored to the unique needs study stakeholders. 

 Qualitative approaches are frequently used 

process. 
PCORI Example: 

Involvement in Data Collect

 “Stakeholders and patients plan to be involved 

3 years of the study. Each of the stakeholders patients asked and expected to be involved duthree years of the study....They will be instrumrecruiting seniors and caregivers from their organizations...”

http://www.pcori.org/assets/2013/11/PCORI-Sample-Engagement-Plans.pdf
E. Dissemination

 Patients need to be a part of the disseminati Often combined with a discussion of an orga

that a patient is affiliated with.
PCORI Example: 

Patients and Disseminatio

 “Stakeholders and patients will be active in the 

Dissemination of the APHS Tool or subsets. Upocompletion of the RCT, the stakeholders will mediscuss the findings and further dissemination. will disseminate the tool to seniors nationally thnational community network for seniors...We ato disseminate through national nursing associawhich Ms. McM. is a current board member.” 

http://www.pcori.org/assets/2013/11/PCORI-Sample-Engagement-Plans.pdf
F. Reviews

 PCORI incorporates patients into the review p Patients and other stakeholders are assigned 

of the proposals and provide their own specireview.

 This does not focus on a review of the scien
PART 3. HOW APPLIC

IS THE PCORI MODEL THE VA HSR&D?
Larger Questions

Should the VA HSR&D embrace part/all of the model?

 If so, what parts should be focused on firs

“The development of these and other principles ostakeholder engagement and of new conceptual frameworks for partnered research are essential diverse stakeholders participate in research proce

Sara J. Knight, Deputy Director of HSR&D, “Accelerating Innovation and TranslatiStrategic Partnership: Collaborative Research to Enhance and Transformation and (CREATE) and Centers of Innovation (COIN), Forum August 2013.http://www.hsrd.research.va.gov/publications/internal/forum07_13.pdf
VA Engagement

 Engagement can begin by fully expanding 

stakeholder engagement to include Operatiopartners.

 Example: A new study includes interviews wit

administrative, clinical, and operational stakeacross the length of the study.
Beyond Investigators to Opera

and Patients

 An immediate switch to a PCORI model? A gradual model of expanding the inclusion 

stakeholders in HSR&D research?

 Could involve a tiered approach:

 Research funding priorities.  Data collection.  Dissemination Team members.  Topic/specific aims. Review process (HSR&D Scientific Merit Review 

etc.)

Conclusion

 PCORI applications place patients and stake

at the center of the research process in a wanew to many investigators.

 The VA may consider this an approach to bes

increase patient and Operations-centered rewithin HSR&D.
WHITE BOARD QUEST

SHOULD HSR&D USE PCORI MODEL FOR ENGAGEMENT?IF YES, WHAT SHOULTHEY INCORPORATE F
Questions?

Susan Zickmund, PhD

Director, Qualitative, Evaluation And Stakeh

Engagement Core

Center for Health Equity Research and Prom

VA Pittsburgh Healthcare System

University of Pittsburgh, Department of Me

Susan.Zickmund@VA.Gov