PPI and the Digital Medicine System Dr Nathan Cope 16-May-2018, NTW - - PowerPoint PPT Presentation

PPI and the Digital Medicine System

Dr Nathan Cope 16-May-2018, NTW R&D Conference

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NTW R&D annual research conference | 16-May-2018

Disclosure

• Dr Nathan Cope is an employee of Otsuka Pharmaceutical

Europe Ltd.

• Views expressed here are his own and not necessarily that of

his employer.

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NTW R&D annual research conference | 16-May-2018

• 1. What is the Digital Medicine System
• 2. Study summary: Exploring the acceptability and performance of a Digital

Medicine System

• 3. Our co-production strategy with service users

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What will we cover today?

NTW R&D annual research conference | 16-May-2018

Digital Medicine overview

Designed to provides objective and unbiased data to support clinical decision making

PATIENT TAKES TABLET 1 Sensor-tablet & antipsychotic SENSOR SENDS SIGNAL TO PATCH 2 Patch PATCH TRANSMITS INGESTION AND OTHER DATA TO PHONE 3 4 DATA TRANSFERRED TO CLOUD FROM PHONE PATIENT / HCP / CAREGIVER VIEW DATA VIA PHONE/DASHBOARD 5

Web Based Application for HCP/Caregiver Mobile App For Patient SmartPhone Patient SmartPhone (Pre-Cloud Data Transfer)

Data Display

TECHNICAL CALL CENTRE SUPPORT AVAILABLE (PATIENT / HCP / CAREGIVER) No Data Display

NTW R&D annual research conference | 16-May-2018

The Digital Medicine system has been extensively validated through clinical studies and human factor testing

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NTW R&D annual research conference | 16-May-2018 Blue = clinical study Yellow = human factor study Rohatagi et al., 2016

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A Multicentre, 8-week, Single-arm, Open-label, Pragmatic Trial to Explore Acceptance and Performance of Using a Digital Medicine System with Healthcare Professionals and Adult Subjects with Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic

NTW R&D annual research conference | 16-May-2018

Subjects

• N=60 (from a range of different care settings)

Early Intervention caseload Community MH team Assertive

• utreach/ home

treatment team

!

Discharge from hospital

Inclusion/ Exclusion  Smartphone required and able to operate  Skin on torso is free from dermatological problems  Using a depot that is the same compound as oral  Compulsory detained e.g. prisoner Study design Endpoints Primary: Proportion of days with good patch coverage during Secondary: Ingestion adherence Exploratory: 1. EHR analysis to identify indicative costs and outcomes 2. HCP, patient and caregiver utility surveys 3. Patient Activation measures etc.

We’re working with five mental health trusts within England

(Prof Shanaya Rathod)

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NTW R&D annual research conference | 16-May-2018

(Dr Rajesh Nair) (Prof Belinda Lennox) (Prof Sukhi Sergill) (Dr Ward Lawrence)

• Three sites are GDEs1
• Four sites are within Top 10
• f Mental Health sites for

research2

• Represents total care

population of greater than 5 million

1: NTW, Oxford Health, SLaM; 2: NIHR Research Activity League Table 2016/17;

Our study status

NTW R&D annual research conference | 16-May-2018

NTW | If you want to know more, please contact…

• Principle Investigator: Dr Rajesh Nair (Rajesh.Nair@ntw.nhs.uk)
• Research Team: Emily Clare (Emily.Clare@ntw.nhs.uk)

Past Current

Jan 2017 Begin study design conversations 16 May 2018 First patient recruited (target) Feb-Nov 2017 Site engagement (via NIHR and direct) 20 Dec 2017 (1) Submit CTA to MHRA (4x IMPDs) (2) Submit study to HRA Oct/Nov 2018 Target last patient last visit Mar/Apr 2019 Final EHR analysis Apr/May 2019 Analysis and reporting

Planned

Jan 2018 CTA approved Feb 2017 HRA hearing and subsequent approval Mar/Apr 2018 (1) Digital medicine system training (2) Site Initiation Visits Dec 2017 App PPI events 02 Dec 2017 Protocol approved

Our approach to engaging with sites focussed on seeking extensive feedback…

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NTW R&D annual research conference | 16-May-2018

• 1. Understand feasibility
• f conducting study
• 2. Scope requirements

for research study

• 3. Seek service user

(patient) feedback on technology

• Service users
• NHS stakeholders
• Clinicians, pharmacists,

research, commissioners

• Proposals on Digital

Medicine study usage (e.g. 8-12 weeks)

• Study involvement of

carers

• Engage with patients in

a variety of different care settings

• 1. Introductory Kick Off
• 5. Information Governance
• 1. Confirm information

governance issues for Digital Medicine

• 2. Identify areas of IG

concern

• NHS IG and NHS

Research

• Agreement for

electronic healthcare data capture (and how e.g. NHS research capture)

• Promote use of care

team accessing DMS dashboard

• 1. Scope requirements

for research study

• NHS Clinicians
• Adherence data

notification to be provided to primary physician (and other individuals who patient has granted data access to)

• 3. Wider engagement
• 1. Scope requirements

for research study

• 2. Identify how the DMS

dashboard could be utilised operationally

• NHS Clinical staff
• Psychiatrist, Nurse,

Care coordinator, Team leaders

• NHS Research
• Inclusion criteria

broadened out (to reflect current treatment)

• Inclusion of insight/

capability (via PANSS) and whether this improved over 8-weeks

• 4. Care team engagement
• 1. Obtain feedback on

concepts and ideal app technology that supports patients in their mental health journey

• Service users
• Facilitators
• Developed a MoSCoW

requirements for the App (must have, should have, could have, won’t have)

• Advice on training

requirements and needs for carers

• 2. Service user DMS feedback

Service user feedback: What we heard…

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NTW R&D annual research conference | 16-May-2018

“This could assist you [care team] to help me” “This would identify if this medication is right for me” “This would be motivating for my recovery; a supportive tool” “This would give me comfort about medication taking and physical health” Carer Technology

• No concerns on sensor – once

explained

• Principle concern was on

connectivity in North East What if…

• …Decisions about your care were based on unbiased information
• …You were able to get support, even though you may not be able to ask for it
• …You could capture information and share progress in a single place
• …You had a tool to encourage you in your mental health journey

Data

• Data ownership built around the

service user Engagement

• Focus on supportive tool for recovery
• Provide support (education) for

carers Our strategy focussed on: (1) What if… statements (2) Capturing “reactions” from service users (3) Seeking service user advice

• n core components

1 2 3

We’ve conducted PPI events on the app design, seeking feedback on process, language, layout and engagement…

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NTW R&D annual research conference | 16-May-2018

Method Outcome 1. Simulated use approach

• Watch users interact with specific features of

the app and better understand the participants experience e.g. their process and logic for selecting certain items and identify where confusion may arise 2. Task focussed with investigation

• What does this mean to you? What would

you do next? 3. Reimbursed for their time (£10)

• Issue identification that disrupted the

completion of key tasks

• Greater explanation required areas e.g. app

sending notifications; whilst many didn’t want this, all users wanted it once they realised this was essential to receive prompts for medication taking

• App strengths identified e.g. clear simple

imaginary, concise language

OBJECTIVE Obtain feedback on the app technology and assess the completion of specific app tasks Two separate trust-specific event, Dec 2017

Acknowledgements

Clinicians and research staff from study sites

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NTW R&D annual research conference | 16-May-2018

External support And the service users of study sites…