October 4th, 2017

PATIENTS – SCIENCE – INDUSTRY

Influencing Policy, Activating Patients, Harnessing Industry

Derick Mitchell

My talk

• What is IPPOSI?

• How are patient voices changing health innovation?

• IPPOSI Survey (QUIZ)

The patient advocate perspective

Ingrid BrindleHawton-Thornley Medical Centre PPG

IPPOSI-HISI Patient-led WorkshopNov 2016

IPPOSI? Who?IPPOSI

A patient-led organisation that works with patients, government, industry,

& science to put patients at the heart of health innovation

IPPOSI Priorities

20

Actively advocate for improved + equitable

patient access to Health Innovation

Promote meaningful patient involvement in

Health Research and Policy

Our Resources

INFORM ENGAGE EMPOWER

Incorporating the patient voice

• Hierarchical Rhetoric

• ‘Walking the walk’ at the highest possible level

Challenges:• Decision-makers never want to change their processes

• Patients are not trained in health policy, dialogue

• Many patient orgs are not focused on policy/R&D issues

“The perfect is the enemy of the good”

IPPOSI & The European Patients Academy

• EUPATI produces Expert Patients on Medicines Research & Development

• Provides Training & Education

• Disseminates through national platforms

The project received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.

www.eupati.eu

18+ EUPATI National Platforms

• Bring all stakeholders together in countries

• Address educational needs in R&D

• Disseminate EUPATI’s training material

National platforms now established in:

AT, BE, FR, DE, IE, IT, LU, MT, PL, ES, CH, UK, DK, SK, PT, NO, RO, GR

Additional platform initiatives ongoing in Serbia, Brazil, Japan

Roles change as a result of EUPATI course- creating patient leadersRole Before EUPATI After

Member of patient organisation, not actively involved 17% 2%

Active role in a patient organisation 62% 71%

Leadership role in a patient organisation 62% 71%

Employee of a patient organisation 25% 23%

Volunteer role in a patient organisation 60% 67%

Presenting at conferences, workshops etc. 63% 83%

Advising a pharmaceutical company 13% 44%

Advising a regulatory agency 21% 42%

Advising a reimbursement agency 4% 8%

EUPATI Fellows are increasingly taking leadership roles and are engaging with pharma, regulators and HTA bodies.

Role changes also imply identity shifts.

Practical “Roadmap” on patient involvement in medicines R&D

Research design

and Planning

Design of Protocol

Informed Consent Study reporting

Post-study communication

Patient Info

Leaflet

Trial steering committee

Investigators Meeting

Level of expertise in the disease area required:

mediumhigh

Data Monitoring Committee Practical

considerations

Health Technology Assessment

Protocol

Synopsis

Research

priorities

Setting

research

priorities:

Information to

trial participants

Research conduct and

operations

Regulatory affairs

Dissemination,

communication,

post-approval

Source: Geissler, Ryll, Leto, Uhlenhopp (2017)Therapeutic Innovation & Regulatory Science. (doi: 10.1177/2168479017706405)

Fundraisingfor research

Ethics Review

First Irish Patient Education Programme

7-month-pilot programme in Health Innovation

3 Modules – Clinical Trials, Regulatory Affairs, HTA Practices

3 Education Partners - UCD, TCD, HPRA

1 elearning website: www.patientsinvolved.ie

21 Students from 9 counties - 36 applications

Building a new Irish health research environment

Patient & Public Involvement (PPI)

2014 - PPI paper - Irish Health Research Forum

2016/17 - PPI reviewers - HRB

2017 - PPI Ignite Funding – HRB + IRC

2017 – Scientific Advice – Patient Involvement – HPRA

Building a new Irish healthcare environment

2008 - National Strategy for Service User Involvement in Health and Social Services (DoHC & HSE)

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2016 – Values in Action, QID Cultures of Person-centeredness (HSE)

2016 – Mental Health Local Recovery Groups (HSE)

2016 – Privacy Impact Assessment for Individual Health Identifier (eHealth Ireland)

2017 - National Patient Experience Survey - Hospitals (HIQA, HSE, DoH)

2017 - National Clinical Effectiveness Committee – PPI Values (DoH, NCEC)

2017 –Personas for Electronic Health Records (eHealth Ireland)

2017/18 - Patient Narrative Project on Person-centered care (CSPD-HSE, IPPOSI)

Health Information?

Development of Electronic

Health Records

(10 years)

National Education / Training on EHRsFor clinicians, nurses and Patients By clinicians, nurses and Patients

Capacity Building / Empowerment of patients Link to self-management programmes

OPPORTUNITIES FOR PATIENT INVOLVEMENT TO ADDRESS THE FOLLOWING CHALLENGES

EHR Design + Roll-outPatient Portal

Other building blocks Decision-making boards

Promoting Partnerships Communication

Openness & Transparency

Advocating for essential building blocksReal-Time information

Informed Consent Bi-directional flow of information

Tracking patient outcomes

Public Trust + ConfidenceWho, When, Why?

Consent – How?Special Considerations for individual groups

Data Linkage & Sharing

TrustPatient Experience

Education and Training

CollaborationCommunication

TimingSharing

CommunityAccess

Consent

Data Quality

What we have learned…

• Trust is vital - patients must believe that their data is secure and only used for the purposes they consented to

• Equally, create the situation where patients are the drivers of their data, ensuring it is utilised to improve their health

What do we need to enable use (& re-use) of patient data?

• Good Education

• Legal Frameworks

• SOPs

• Framework of Engagement

Everyone to understand the potential and know how to make the most of it

What would a framework of engagement for use (& re-use) of patient data look like?

Engages

Empowers

Educates

Evaluates

Evolves

A unique framework that enables structured, effective, meaningful, ethical, innovative, and sustainablepatient engagement

(and demonstrates the ‘return’ on this engagement for all players)

The Patient Narrative Project

Reference: Phelan A., Rohde D., Casey M., Fealy G., Felle P., Lloyd H. & O’Kelly G. (2017) Patient Narrative Project for Person-Centred Co-ordinated Care. UCD, IPPOSI & HSE, Dublin.

Phase 1:

Person-centered, co-ordinated care

Person centered co-ordinated care

Phase 1

What people in Ireland want to experienceduring their care when they require anumber of health services at one time orover time

Phase 2 + 3

A framework that will hear peoples’ experiences of using more than one health service at a time

11 Focus

Groups

2 Online

Surveys

4 Regional

Workshops

Output: Statements (19) + Definition (1)

Online Survey

+ System

Partnerships

Themes Emerging From Phase 1

My healthcare

experiences

Healthcare I am

confident in

My journey through

healthcare

My healthcare experiences

• Staff communicate with me in a way that I understand.

• I have up-to-date information on my health condition(s), treatments, and available support services.

• Staff help me to understand the choices and services available to me now and for my future care.

• Healthcare staff listen to me so that they understand my world and what is important to me.

• I am treated with empathy, respect and dignity in all dealings with healthcare staff.

• In partnership with healthcare staff, I make choices based on what I prefer and my goals.

• If I choose, my information can be shared securely with relevant healthcare staff.

• I do not have to repeat myself each time I meet new healthcare staff involved in my care.

• I can contact the relevant healthcare staff to ask questions that are important to me and I get timely responses to my questions.

• Decisions about my care include me as much as I want and involve my carers if I choose.

Phase 2

• http://www.hse.ie/yourvoicematters

• Survey Live Sept-Oct. 2017 • Proof-of-Concept• Producing data on patients’ experience of care when they use

more than one health service during this period

• Target: • 1000 stories nationally, particularly in relation to older people

people with chronic conditions

• Channel through Integrated Care Programmes HSE

By end of 2017… By end of 2018…

A ‘tried and tested’ framework

• To hear a high volume of patients’ experiences through the online survey

• To use data to influence service design, delivery and improvement of integrated care

• A qualitative and quantitative evaluation of the proof of concept within the context of the HSE;

Integration into ‘business as usual’

• Framework (incl. resource implications) to be integrated into a ‘business as usual’ model

• Quality and Patient Safety Structures at CHO level will be essential

• QID publication: ‘Quality and Safety Committees; Guidance and resources’

Wed. Oct. 25th, 2017

• eHealth Ecosystem Event• Radisson Blu, Golden Lane, D2• 1pm-5pm

• Highlights • Projects in Ireland that empower

patients to manage their own health• Ways that patients should be

involved in the innovation process

The patient advocate perspective?

“You’re looking at the macro picture and you have to, but somewhere out there are all these microchips and we’re making up the macro picture.”

“Are we just the collateral damage while you all get some years to sort out this business? If the Troika wanted it, you would be doing it tomorrow.”

Paul CareyMove4Parkinson’s

IPPOSI Round-table with Dept. of HealthMay 2015