PPI and the Digital Medicine System Dr Nathan Cope 16-May-2018, NTW R&D Conference 1 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. 2 NTW R&D annual research conference | 16-May-2018
What will we cover today? 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 3 NTW R&D annual research conference | 16-May-2018
Digital Medicine overview Designed to provides objective and unbiased data to support clinical decision making DATA TRANSFERRED TO 1 PATIENT TAKES TABLET 4 CLOUD FROM PHONE PATCH TRANSMITS INGESTION No 3 AND OTHER Data DATA TO Display Sensor-tablet & PHONE antipsychotic PATIENT / HCP / CAREGIVER VIEW 5 DATA VIA PHONE/DASHBOARD Patient Patch SmartPhone (Pre-Cloud Data Data Transfer) Display SENSOR SENDS 2 SIGNAL TO PATCH Mobile App For Patient Web Based Application SmartPhone for HCP/Caregiver TECHNICAL CALL CENTRE SUPPORT AVAILABLE (PATIENT / HCP / CAREGIVER) NTW R&D annual research conference | 16-May-2018
The Digital Medicine system has been extensively validated through clinical studies and human factor testing Blue = clinical study Yellow = human factor study Rohatagi et al., 2016 5 NTW R&D annual research conference | 16-May-2018
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 Study design Subjects • N=60 (from a range of different care settings) Early Community Intervention MH team caseload ! Assertive Discharge outreach/ home from treatment team hospital Endpoints Inclusion/ Exclusion Smartphone required and able to operate Primary: Proportion of days with good patch coverage during Skin on torso is free from dermatological problems Secondary: Ingestion adherence Using a depot that is the same compound as oral Exploratory: Compulsory detained e.g. prisoner 1. EHR analysis to identify indicative costs and outcomes 2. HCP, patient and caregiver utility surveys 3. Patient Activation measures etc. 6 NTW R&D annual research conference | 16-May-2018
We’re working with five mental health trusts within England • Three sites are GDEs 1 (Dr Rajesh Nair) • Four sites are within Top 10 of Mental Health sites for ( Prof Belinda Lennox) research 2 • Represents total care population of greater than 5 (Prof Sukhi Sergill) million (Dr Ward Lawrence) (Prof Shanaya Rathod) 1: NTW, Oxford Health, SLaM; 2: NIHR Research Activity League Table 2016/17; 7 NTW R&D annual research conference | 16-May-2018
Our study status Past Current Planned Dec 2017 Feb 2017 Mar/Apr 2018 App PPI events HRA hearing (1) Digital medicine and subsequent system training approval (2) Site Initiation Jan 2017 02 Dec 2017 20 Dec 2017 Oct/Nov 2018 Apr/May 2019 Visits Begin study Protocol (1) Submit CTA to Target last Analysis and design approved MHRA (4x IMPDs) patient last visit reporting conversations (2) Submit study to HRA Feb-Nov 2017 Jan 2018 16 May 2018 Mar/Apr 2019 Site engagement (via CTA approved First patient recruited Final EHR analysis NIHR and direct) (target) 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 ) NTW R&D annual research conference | 16-May-2018
Our approach to engaging with sites focussed on seeking extensive feedback… 1. Introductory Kick Off 2. Service user DMS feedback 3. Wider engagement 4. Care team engagement 5. Information Governance 1. Understand feasibility 1. Obtain feedback on of conducting study 1. Scope requirements 1. Confirm information concepts and ideal app 2. Scope requirements for research study governance issues for technology that 1. Scope requirements for research study 2. Identify how the DMS Digital Medicine supports patients in for research study 3. Seek service user dashboard could be 2. Identify areas of IG their mental health (patient) feedback on utilised operationally concern journey technology • • Service users NHS Clinical staff • o Psychiatrist, Nurse, NHS stakeholders • • Service users NHS IG and NHS • o Clinicians, pharmacists, NHS Clinicians Care coordinator, Team • Facilitators Research research, leaders • commissioners NHS Research • Proposals on Digital • Developed a MoSCoW • Inclusion criteria • Agreement for • Adherence data Medicine study usage requirements for the broadened out (to electronic healthcare notification to be (e.g. 8-12 weeks) App (must have, should reflect current data capture (and how provided to primary • Study involvement of have, could have, won’t treatment) e.g. NHS research physician (and other • Inclusion of insight/ carers have) capture) individuals who patient • Engage with patients in • Advice on training • Promote use of care capability (via PANSS) has granted data a variety of different requirements and and whether this team accessing DMS access to) care settings needs for carers improved over 8-weeks dashboard 9 NTW R&D annual research conference | 16-May-2018
Service user feedback: What we heard… 1 What if… Our strategy focussed on: (1) What if… statements • …Decisions about your care were based on unbiased information (2) Capturing “reactions” from • …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 service users • …You had a tool to encourage you in your mental health journey (3) Seeking service user advice on core components “This would give me 2 “This would be motivating “This would identify if this “This could assist you comfort about medication for my recovery; a medication is right for me” [care team] to help me” taking and physical supportive tool” health” Carer 3 Data Technology Engagement • No concerns on sensor – once • Data ownership built around the • Focus on supportive tool for recovery • Provide support (education) for explained service user • Principle concern was on carers connectivity in North East 10 NTW R&D annual research conference | 16-May-2018
We’ve conducted PPI events on the app design, seeking feedback on process, language, layout and engagement… OBJECTIVE Obtain feedback on the app technology and assess the completion of specific app tasks Two separate trust-specific event, Dec 2017 Method Outcome • Issue identification that disrupted the 1. Simulated use approach o Watch users interact with specific features of completion of key tasks • Greater explanation required areas e.g. app the app and better understand the sending notifications; whilst many didn’t want participants experience e.g. their process and logic for selecting certain items and this, all users wanted it once they realised this identify where confusion may arise was essential to receive prompts for medication 2. Task focussed with investigation taking • App strengths identified e.g. clear simple o What does this mean to you? What would you do next? imaginary, concise language 3. Reimbursed for their time (£10) 11 NTW R&D annual research conference | 16-May-2018
Acknowledgements Clinicians and research staff from study sites External support And the service users of study sites… 12 NTW R&D annual research conference | 16-May-2018
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