August 2, 2017 Sarah Madrid Co-Chair, HCSRN Patient Engagement in Research SIG Institute for Health Research, Kaiser Permanente or Colorado A presentation of the Southern California Regional Dissemination, Implementation and Improvement Science Webinar Series Provided by the UCLA CTSI

1. Creating a Patient Engagement Workbook
for Research Teams
SARAH MADRID
CO-CHAIR, HCSRN PATIENT ENGAGEMENT IN RESEARCH SIG
INSTITUTE FOR HEALTH RESEARCH, KAISER PERMANENTE OF COLORADO
DISSEMINATION, IMPLEMENTATION & IMPROVEMENT SCIENCE WEBINAR SERI ES:
AUGUST 2, 2017

2. o Scientific Interest Group since 2014
• Today: 117 members representing 13 HMORN member organizations, the VA,
PCORI, and other academic research institutions
o Mission of the SIG:
Improve the HCSRN’s capacity to meaningfully engage patients as members of
research teams to increase the value and applicability of research findings for
patients, and to enable them to make informed healthcare decisions and achieve
better health outcomes.
[HCSRN: Healthcare Services Research Network]

3. o Develop a community of engagement practice among HMORN researchers,
patients and other stakeholders
o Conduct baseline and follow up assessments of engagement resources
available in member organizations
o Consult on building engagement infrastructure within member organizations
o Consult on planning for and implementing patient engagement in all phases of
research
o Recruit patient partners as members of the SIG
o Identify best practices for measuring the engagement of patient partners

4. Purposes of Survey:
1. Elicit engagement practices of HMORN research teams
2. Identify best practices in engagement
3. Develop a tool for research teams

5. o Roles and Stages of Engagement
o Identification/Recruitment/ Screening
o IRB Oversight
o Organizational Support
o Compensation/Contracting/Hiring
o Training – Patient Partners and
Research Team
o Data Sharing
o Feedback and Evaluation/Retention
Results of survey used to create a
user’s manual for researchers
preparing to engage patients in
research.

6. As a basis for customization to individual research teams or
research shops
Examples:
o include organization-specific templates for contracting or hiring
o add decision flows for determining appropriate compliance
trainings depending on intensity or duration of engagement
o incorporate organizational standards for compensation

7. I. Why Engage Patient Partners on
This Study?
OUTCOME: Reasons for engagement are clearly articulated
Justify the need for engaging
patients on the research team: Notes:
Is engagement required for the
study proposal?
How will the patient perspective
enhance the study?
At what stages of the research
process will patients be engaged?
How much will it cost to engage
patients on the study? (see following
slides)
Do the benefits of engagement
outweigh the costs?

8. Estimating Costs of Engagement:
How much time will it take to:
Identify and recruit patient
partner(s)
Train patient partner(s) and
research team
Consult with IRB/Compliance
Consult with HR, IT, Sponsored
Projects, or Member Relations
Evaluate the impacts of engagement
on project and research team
Other

9. Estimating Costs of Engagement (cont.):
Consider costs of: Notes:
Compensating patient partner(s)
Reimbursing partner(s)’ expenses
(transport, parking, mileage, etc)
Travel for patient partner(s) to
conference(s) to present study
findings
Other

10. II. Define the role(s) of patient partner(s)
on the team:
Outcome: Clear role statement(s) for patient partner(s)
Roles #
Stage(s) of
Research Define the roles and list the responsibilities
Investigator/Co-
Investigator
Consultant
Advisory panel member
Focus group member
Research staff: who will have primary responsibility for communicating with patient partner(s)?

11. III. Engagement Logistics
OUTCOME: Logistics are thought through; preparations begun
For each patient partner to be engaged, answer the following:
How often will s/he be needed and for
how long?
When will s/he be needed?
Where will s/he need to go?
How many weeks/months/years will
s/he be needed?
How much will s/he be compensated?
In person or virtual participation?
What kind of contract(s) will be needed?

12. Compensation Considerations
List any limitations or compensation
restrictions
NB: Compensation should be proportional to the role(s)
played by the patient partner(s)
Organizational restrictions?
Budget limitations?
Equity with other team members?
Other?

13. Compensation Considerations (cont.)
Context? Contracting?
• Adopt compensation rates used
in other studies – adequate?
• Any relevant organizational
requirements?
• Use the government consultant
rate? (recommended by PCORI)
• Volunteer basis (not recommended)?
• Will you reimburse participant
travel? (recommended by
PCORI)
• Consulting/service agreement?
• Confidentiality issues?

14. IV. Identification & Recruitment of Patient
Partners
OUTCOME: Clear description of patient partner you want to target
Define any inclusion or exclusion criteria for recruiting patients to the team
according to the specific needs of the study:
Disease burden/ health
condition/ experience?
Particular demographic
or other
characteristic(s)?
Other inclusion or
exclusion criteria?

15. V. Recruitment: assess options and needs of study
OUTCOME: Recruitment strategy(ies) that best fits study needs
Options: Options:
Existing patient panels or patient
support groups
Social media
Referrals from clinicians/providers Internal patient registry
Health system broadcast
communications to members
Online “matching” registry
Flyers in clinics Flyers at disease specific
fundraisers/community events
Referrals from/network with community
organizations
Local media advertising

16. VI. IRB/Compliance
OUTCOME: Clear guidelines to meet any IRB oversight requirements, or to
receive formalized exemption
Review recruitment and engagement plans with
IRB: Notes:
Does IRB require oversight or review of patient
engagement?
What documentation is required by IRB for patient
partners on your research team?
Are you accessing PHI in your identification or
recruitment processes?
What are the potential risks – and benefits - to the
patient(s) in joining the research team?

17. Focus Group
Stakeholder Advisory
Panel
SCOPE OF WORK?
Research Team Collaborator:
- data collection
- instrument development
- community gatekeeper
- data analysis review and/or
interpretation
- dissemination activities
- research question generation
-conference attendance and/
or presentation
- manuscript development/
report writing
FREQUENCY of
PARTICIPATION?
One Time Episodic On-going Intense On-going
Gift card
Confidentiality
agreement if needed
MoU or 1 Day Service
Agreement
Stipend or Gift card
Independent
Contractor Service
Agreement [ICSA]
Stipend
COMPENSATION?
C o n t i n u u m o f E n g a g e m e n t
INPUT? DATA
Advice/Opinion/
Guidance/Perspective
USE of INPUT?
Conduct Research
I.e., analyze, publish
data
Design, Interpretation
and Improvement of
Processes

18. VII. Other Departments
OUTCOME: Organizational approvals in hand, and cooperation in preparing
for patient partners
Review the implications of your recruitment and engagement plans with:
Sponsored Projects office
Human Resources
IT
Governance or Member
Relations

19. VIII. Prepare to Screen Promising Candidates
Note: Characteristics of the ideal candidate(s) will depend on specifics of
your study. Over-recruit to accommodate attrition during screening.
OUTCOME: Prepared to select best candidate(s) for positions
Select screening method(s):
Personal interviews (phone or in-
person)
Survey or questionnaire administered
remotely
Previous participation on a study
Prepare screening questions:

20. IX. Screening Practices (1/2)
Guidelines to Avoid Bias: Comments:
Patient(s) shows ease expressing self,
including when opposing views are aired
No apparent desire for a platform to
communicate dissatisfaction
Previous experience in a similar capacity
(e.g., in a school, faith community, etc.)
Isn’t already “savvy” about negotiating the
health system (depends on role(s) – not
necessarily a disadvantage)
Is the study topic controversial? If so, determine whether patient holds extreme views for or
against the topic. If so, how will that affect her/his participation?

21. Screening Practices (2/2)
Communicate Logistics:
Role on study
Expectations for
participation
Study timeline
Time requirements
Compensation
Training
Ground rules
Answer patient(s)’ questions; give her/him time to consider participation.
OUTCOME: confirmed patient partner(s) who understand all aspects and
expectations of participation.

22. X. Research Team Training
OUTCOME: research team is prepared to work respectfully and effectively
with patient partners.
Train current research team members in preparation for working with patient team members
Review goals of engagement and role
requirements for patient(s)
Clarify expectations for patient(s)
engagement
Review any institutional restrictions
(e.g., on information sharing)
Emphasize the rules of engagement;
the patient(s)’ expertise is her/his
experience as a patient

23. 6 Meta-Criteria
for successful
engagement:
1. TRUST
2. RESPECT
3. ACCOUNTABILITY
4. LEGITIMACY
5. FAIRNESS
6. COMPETENCE
Lavallee DC et al., “Stakeholder
engagement in CER: how will we measure
success?” JCER, 1(5), 1-11 (2012)

24. XI. Formalize
OUTCOME: patient partner(s) is assured that her/his participation is official,
and integration into research team is initiated.
Complete on-boarding formalities with patient partner(s):
Collect information for initiating the
compensation mechanism
Execute any contractual mechanism(s),
including confidentiality agreements
Provide organizational employee information
as needed, including email address and
password(s)
Establish data sharing protocols

25. XII. Train Patient Partner(s)
OUTCOME: Patient partner(s) can be fully engaged in the study, feel useful
and valued, and share her/his expertise willingly
Conduct as needed for your particular study:
IRB/HIPAA/Human Subject training
Health plan or organizational information; required health system training(s)
Develop ground rules for participation, including grounds for termination
Specifics of study; context, background, design, etc.
Specific role(s) on the study and responsibilities for both research staff and patient partner(s)
Timeline and logistics of participation: when, where, how long, how often
Value of patient(s)’ perspective, importance of speaking up, especially in disagreement or when
unclear on an aspect of the study
Training materials: glossary, acronym list, study abstract (if available), other
Organizational policies (dress code, etc.)

26. Retention of Patient Partner(s)
Honesty, Transparency, and Respect
Communication = the key to retention
Establish and maintain close relationships with the patient partner(s)
Send regular updates on project progress unless patient partner(s) attends frequent,
regular meetings with the rest of the research team
Ask patient partner(s) what you can do for them to enhance the benefits to them of
participation.
Maintain good partner relationships throughout lifetime of study, from pre-proposal
through closeout and beyond.
Hold team buildings to enhance communication and relationships among all team
members (FOOD helps!)

27. XIII. Monitoring and Evaluation
OUTCOME: Patient partner(s) feels heard and respected as valued study team member(s)
Schedule a regular opportunity for patient partner(s) to provide feedback on their
experiences.
Should be a “safe” space for truthful feedback
Establish clear ground rules for facilitated group discussions
Online or written evaluation
Provide feedback to patient partner(s) on her/his participation
Respond to patient partner concerns or issues
End the patient partner’s participation if necessary
At the final evaluation, ask patient(s)’ preferences for being contacted again in the future
for information updates or possible participation in other studies

28. Assessing Impact of Patient Engagement in Research: effects on the research process
COREComponentsby
ResearchStage
Overarching
Principles(common
toALLstages)
DesiredOutcomesby
ResearchStage
IMPACTFLOW
Stage 1:
developing the
research
question
- measurable
Stage 2:
developing the
research proposal
- Balance of
scientific rigor and
incorporation of
partner
suggestions
Stage 3:
administrative
pre-launch
- shared
responsibilities
Stage 4: recruitment and
data collection
- methods implemented
with integrity
-adaptability
- meet pts where they are
- ensure truly “informed”
consent
Stage 5: data
analysis
- timeliness
- examine real world
implications
Stage 6: dissemination
and implementation:
Diverse methods used;
timely dissemination,
translation and
adoption; Legitimacy of
results; relationships
with partners sustained
Question
reflects, is
relevant,
meaningful and
impactful to the
community and
its stakeholders,
and is
understood by
all
Scientific rigor,
including plans
for data sharing,
dissemination &
implementation
, and
assessment of
impact
Appropriate
training; shared
responsibility for
ethics/protections;
shared development
of IRB, HR, training,
and budget;
transparent consent
forms/language
Anticipates participant issues;
methods are feasible for
participants and respect
diversity; Clear, engaging,
transparent materials,
messaging, methods for
recruitment that foster fair,
ethical, and informed consent;
tailored incentives; unbiased
methods ensure diverse
sampling
Share data and
information iteratively
with partners;
incorporate partner
interpretations on data,
solicit potential
community stigmas;
community relevance;
protect/respect
community
Timely, far-reaching messaging
done thru multiple channels;
process AND results
disseminated; translated/
adopted appropriately;
sustained partner relationships;
partners as advocates/
champions; no undue
evaluation burden on partners
Patient Centeredness – reflects/respects patient needs, preferences, experiences
Plain Language – all information is accessible to all partners
“Teamness” - shared responsibility for study; partner insights validated/incorporated
Check assumptions: researchers and partners
Outcomes have meaning/value to partners and community
Capacity Building – partners gain skills and knowledge through experience and/or training
Relevant
question
Improved study
design
Relevant
proposal
More effective
methods
Better and
sustained
recruitment
Higher quality
data
Improved data
interpretation
More legitimate
results
Higher chance of
translation/adoption
Results communicated
more broadly/
effectively
Improved clinical
practice and health
outcomes

29. XIV. Closure: End of Study
OUTCOME: Opportunity for all team members to reflect on value of study
and relationships developed
Sun-setting suggestions:
Share study results if patient partner(s) hasn’t been involved in later stages of study
Make a formal expression of gratitude for patient partner(s)’ contributions, e.g.,
provide a certificate of participation for patient partner(s)
Hold a team gathering to debrief on successes/challenges, and to celebrate a job well
done
Ask partner to provide a summary of her/his experience, including high and low
points, motivation for participating, and value of it personally and for the research.

30. Acknowledgements:
• Ellis Dillon, Leah Tuzzio: co-chairs of the HCSRN Patient Engagement in Research
Scientific Interest Group (PER SIG)
• PER SIG membership (to join this listserv, contact Sarah.Madrid@kp.org)
• Note: Flow diagram on p.17 is a product of collaboration with Borsika Rabin.
• Note: Flow diagram on p.28 is a product of the HCSRN Impact Assessment
Workshop, Oct. 26-28, 2016. We thank Ellis Dillon, Bob Greenlee, Jacquetta
Hinton, Deb Multerer, Gina Napolitano, Heather Olden, Mary Schramke, Ursula
Salas, Leah Tuzzio, and Neely Williams for their collaboration on the workshop
and the flow diagram.

31. Sarah Madrid
Sr. Project Manager, Institute for Health Research,
Kaiser Permanente of Colorado
Sarah.Madrid@kp.org
303-614-1358 (T)
http://www.hmoresearchnetwork.org/en/Tools%20&%20Materials/
Plan_Field/HMORNPatientEngagementWorkbook.pdf