IBD REGISTRY ROADSHOW 2017
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- Regina Norman
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1 IBD REGISTRY ROADSHOW 2017 FRIDAY 2 ND JUNE 2017 LONDON These meetings have been funded by Celltrion Healthcare, Dr Falk Pharma UK Ltd, Janssen, Napp Pharmaceuticals Ltd, Takeda Ltd, Tillotts UK Pharma Ltd, with no input into the meeting programme.
2 Co-Chairs: Stuart Bloom, Consultant Gastroenterologist University College London Kay Greveson, Lead IBD Nurse Specialist Royal Free Hospital
3 Roadshow objectives Update on biologics audit and QI programme using the IBD Registry Provide protected time for IBD teams to plan for Registry participation Offer support with the adoption process, wherever you are on the pathway Give the chance for you to contribute ideas and opinions on future Registry development
4 Agenda 2.00pm Welcome and introduction Co-chairs: Stuart Bloom & Kay Greveson 2.15pm Where are we now and where do we want to get to? Facilitated by Dovetail 2.30pm The 2017 IBD landscape Stuart Bloom 3.10pm Working to embed quality improvement Susan Murray 3.30pm Making the most of your local data Kay Crook 3.50pm 4.10pm 4.30pm Tea break Practicalities of IBD Registry participation ask the expert Moving on up how to get to the next step on the ladder Stuart Bloom Susan Murray Kay Greveson Kay Crook Mark Allan Facilitated by Dovetail 5.30pm Feedback and conclusions Stuart Bloom & Kay Greveson 6.00pm Meeting close
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6 Thank you to our sponsors Celltrion Healthcare Dr Falk Pharma UK Ltd Janssen Napp Pharmaceuticals Ltd Takeda Ltd UK Tillotts UK Pharma Ltd Logistics support has also been provided by Tillotts None of the companies had any influence over programme content.
7 Progress More than 70 sites in England have signed up for a trust subscription
8 Where are we now and where do we want to get to? Claire Munro & Nicola Brett Dovetail
9 The IBD Registry Adoption Ladder 1: No awareness/lack of knowledge 2: One of the IBD team understands the benefits and wants their team involved. 3: The IBD Team understands the benefits and want to get involved 4: The IBD Team have identified a leader for IBDR 5: The IBD Team have chosen a system 6: The IBD Team has formally registered to participate. 7: Data entry system Live & Trust registered with NHS Digital 8: IBD Team members becoming familiar with data entry 9: IBD Team are entering some data locally & submitting some data to NHS Digital 10: The IBD Team are entering patient data & submitting data to NHS Digital each quarter.
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11 The 2017 IBD Landscape Stuart Bloom
12 Outline Audit & Registry ongoing data collection for QI using the IBD Registry to collect the data Registry systems IBDR 2017 objectives What s in it for you and your patients? Research Support
13 Outline Audit & Registry ongoing data collection for QI using the IBD Registry to collect the data Registry systems IBDR 2017 objectives What s in it for you and your patients? Research Support
14 Aims of the IBD Registry Creating a UK-wide repository of pseudonymised IBD adult and paediatric patient data for prospective quality assurance, audit and research purposes. This will: Drive continuous improvement in patient care & access to care across the UK Provide local, regional & national data in order to better define the pattern of colitis and Crohn s disease Improve understanding of long term outcomes Inform commissioning and service design Support IBD research
15 Aims of the IBD Registry Creating a UK-wide repository of pseudonymised IBD adult and paediatric patient data for prospective quality assurance, audit and research purposes. This will: Drive continuous improvement in patient care & access to care across the UK Provide local, regional & national data in order to better define the pattern of colitis and Crohn s disease Improve understanding of long term outcomes Inform commissioning and service design Support IBD research
16 Previously in IBD: Focus was on collecting data for audit Specified data collected in a defined time period. Analysed nationally and results fed back in a report for local QA and to stimulate local QI. Biologics audit introduced continuing data collection, but still with an audit focus Some IBD Teams used the system as their database for managing their biologics, but it was not the primary purpose.
17 Registry Approach Local service development Introducing the routine use of an electronic record holding IBD clinical data Using that data to manage patient care and inform service delivery Registry secondary use of the data Audit (national benchmarking for QA) Using the national data to support QI Pharmacovigilance Research Enter data once and use for multiple purposes
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20 IBD Audit > IBD Registry 2016/17 was the year of transition from the IBD Audit to the IBD Registry: Sites were asked to establish a Registry-compatible system and to take back their historic biologics data for transfer into the Registry system The final IBD Audit biological therapies report was published. RCP web tool was closed in January RCP QI work continues to September Registry re-launched the Biologics Audit (more later)
21 Where are we now? Participation Registered sites: 191 IBD Registry Site Participation Live sites: 91 Web Tool = 55 PMS = 22 Other = 13 Pipeline sites: 9 Web Tool = 2 PMS = 5 Other = WEB TOOL May-15 Aug-15 Sites submitting Nov-15 Data Feb-16 Sites registered May-16 NHS Digital Aug-16 Live Nov-16 sites Feb-17 May-17
22 Data submission status NHS Digital registrations: 56 Web Tool = 29 PMS = 17 Other = IBD Registry Growth 30,000 25,000 Data submitted: ~24, ,000 15,000 10,000 5,000 0 May-15 Oct-15 Jan-16 Apr-16 Jul-16 Sep-16 Nov-16 Dec-16 Jan-17 Feb-17 Apr-17 Total records submitted NHS Digital registrations Live sites Sites submitting data 0 * further ~5,000 to be submitted
23 Web Tool uptake Web Tool uptake and participation Number of records entered on Web Tool Number of Web Tool sites entering data 0 0 Time Total records Imported records Sites entering data 52/58 sites entered data using the Web To
24 Outline Audit & Registry ongoing data collection for QI using the IBD Registry to collect the data Registry systems IBDR 2017 objectives What s in it for you and your patients? Research Support
25 Step 1 Core IBD dataset Demographics Consent Diagnosis Contacts Disease Classification Disease Scores Medication Biologics Surgery Cancer Admissions
26 Existing EPRs if Registry-compliant Local IBD Patient Management Systems Web Tool Local EPRs and Databases Bioresource system InfoFlex Patient Management System EMIS Gastroenterology (was Ascribe) Web-based Tool (InfoFlex) NHS Digital Linking to NHS routine activity data - HES NHS Digital Pseudonymisation of patient data Annually Quarterly
27 Choosing a system Locally-installed PMS: Greater functionality Can be interfaced with hospital systems (e.g. PAS, letters, pathology etc) Can be adapted to local wishes to some extent Upfront cost and IT often slow to implement Registry Web Tool: Less functionality Cannot be interfaced with local hospital systems Speed dependent on local internet No customisation possible Quick to implement and lower cost
28 EPR system costs Locally installed system: InfoFlex PMS from CIMS approx. 13,250* covering installation, PAS integration, 3-year licence) [*There are sometimes additional local costs] EMIS for Gastroenterology ask for quote Registry Web Tool: Minimal IT requirement - 1,000 pa (data usually transferable to InfoFlex or EMIS)
29 Outline Audit & Registry ongoing data collection for QI using the IBD Registry to collect the data Registry systems IBDR 2017 objectives Establish funding model Focus on biologics data collection Focus on reporting to IBD Teams What s in it for you and your patients? Research Support
30 Registry Funding model Subscription for Audit participation and a cost recovery charge for use of the Web Tool Registry-initiated research projects Charitable Grants (e.g. CCUK) Projects using the Registry for data capture and analysis Professional/academic (e.g. BSPGHAN Pinpoint) Investigator-led/Industry-funded (e.g. VEST) Industry Grant Support
31 2017/18 rationale for biologics focus Registry data will have statistical validity when we have near complete data on a given set of patients with a common set of data points Data on biologics has real value for clinical teams, managers and commissioners, patients and potential funders Building on the success of the IBD Audit biologics data collection
32 2017/18 objective A near complete register of patients on biological therapies in as many IBD units as possible with their historic data from RCP audit with all new patients being entered routinely with a realistic set of data points common to all patients KPIs focused on the improvement messages from the last RCP report
33 2017/18 Biologics Audit/QI Selection of 7 KPIs for benchmarking based on findings in final report. Data collection on all current biologics patients. Quarterly cycle: Data submitted by IBD Teams June/Sept/Dec/March Registry feedback back to IBD Teams/Boards each quarter. Audit remains in Quality Accounts in England Trusts must pay a subscription to participate
34 Biological therapy KPIs Pre-treatment checks Was the patient screened before starting on a biological therapy? Was a formal assessment of disease activity recorded at the point the decision was made to commence a biological therapy? Is there a record of Registry consent being discussed with the patient? Post-induction review (approximately 3 months after the date of the initial treatment) Did a post-induction review take place? Was a formal assessment of disease activity recorded at this time? 12-month review (approximately 12 months after the date of the initial treatment) Did a 12-month review take place? Was a formal assessment of disease activity recorded at this time?
35 Outline Audit & Registry ongoing data collection for QI using the IBD Registry to collect the data Registry systems IBDR 2017 objectives What s in it for you and your patients? Research Support
36 The benefits of an EPR Patient information more readily accessible than in the paper notes Summary page for each patient Information does not get lost Information available in multiple places EPR supports efficient working and safety processes such as MDT, blood monitoring, cancer surveillance etc Patient can receive instant summary or GP letter Potential for patient portal access
37 Registry Reporting All sites submitting data: Quarterly reporting on patient data in Registry Annual reporting of HES data (England) (unplanned admissions and A&E attendances initially Trusts subscribing to Biologics Audit: Quarterly reporting of biologics KPIs with national comparators (for Quality Accounts) Web Tool only (at present): will have instantly available charts from May 2017: Basic profile of all patients entered Run charts on KPIs comparing participating site to the average of all sites using the web tool.
38 - with IBD events added Onset of symptom s IBD diagnosis Biologics started
39 How to progress locally? 1. Choose a system Registry support available by telephone or attending team meeting 2. Receive the appropriate Registry starter pack Obtain the necessary local approvals (also funding and IT support if choosing the locally-installed PMS) 3. Arrange for your RCP biologics data to be imported or converted to make data entry easier 4. Consider your IBD Service priorities and plan how you will approach entering the data Backfill Routine data entry Will you start with the Biologics Audit data? Do you have other priorities?
40 Information Governance Consent is not required for the primary purpose data collection Consent is required for the secondary use because we are using Patient Identifiable Data To prevent two registry records for the same patient treated in two different hospitals To enable the linkage to HES data (HES = Hospital Episodes Statistics)
41 Existing EPRs if Registry-compliant Local IBD Patient Management Systems Web Tool Local EPRs and Databases Bioresource system InfoFlex Patient Management System EMIS Gastroenterology (was Ascribe) Primary purpose: consent not required Web-based Tool (InfoFlex) England only NHS Digital Linking to NHS routine activity data - HES NHS Digital Pseudonymisation of patient data Annually Quarterly Secondary purpose: consent required Section 251
42 Information Governance At present there is a s251 exemption and patient data can be submitted to the Registry provided the consent posters and information leaflets are displayed (= opt out) BUT Establishing a system to obtain consent from patients during the coming year is important
43 Please use the Registry consent pack
44 Outline Audit & Registry ongoing data collection for QI using the IBD Registry to collect the data Registry systems IBDR 2017 objectives What s in it for you and your patients? Research Support
45 How can you be involved? All data contributes to IBD research Healthcare utilisation and economics Outcomes and value of biologics All data contributors will be acknowledged. FUTURE: When the Registry has matured, any researchers can apply to access the data. NOW: Research projects using the Registry infrastructure to capture data.
46 Registry projects Biosimilar pharmacovigilance study Anaemia service evaluation Outcomes based research: VEST study
47 Outline Audit & Registry ongoing data collection for QI using the IBD Registry to collect the data Registry systems IBDR 2017 objectives What s in it for you and your patients? Research Support
48 Registry support General support implementation, IG, software etc Mark Allan Data Manager Simone Cort Registry Admin Support Technical support Infoflex PMS users: InfoFlex CIMS HELP DESK on For users of other systems: Contact your supplier s help desk
49 Funding support for IBD Teams Data entry grants from industry fund Round 1: 12 sites awarded 2,000 each to fund data entry over 20 week period mostly biologics but some aiming for complete register of demographics & diagnosis. Round 2: Applications being assessed now. Still time to apply (deadline 17 th June) To apply,
50 IBDR Industry Working Group Industry Working Group set up June 2016 to co-design solutions and develop framework for collaboration. The group has been looking at how industry partners can help to accelerate the uptake of the Registry as well as advising on a framework for funding. Currently setting up a small network of field based personnel to support IBD teams with Registry queries.
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52 Inflammatory Bowel Disease programme Working to embed quality improvement Susan Murray Programme manager May June 2017
53 Outline IBD audit 10yrs and the need for continued improvements Current quality improvement projects IBD registry - data visualisation
54 IBD audit : Improvements Round Round Inpatient care audit UC mortality rates have halved over 3 rounds of audit 1.7% 0.8% Significantly fewer readmissions for UC over 3 rounds of audit 51.1% 33.6% Organisational audit Sites with at least some IBD nurse specialist provision 56% 78% Sites with a designated Gastroenterology ward on site 67% 93% Biological therapies audit Patients entering remission (at first follow up after 12 weeks) 62% 73% Number of adverse events reported by patients (at any follow up treatment) 6% 5%
55 Summary of the past 10yrs IBD audit at RCP IBD audit to IBD Registry -1 st Mar 17 Biologics audit data made available for transfer to IBD Registry
56 Essential that we continue to improve quality of care
57 Current QI Developing QI champions for IBD Improve screening rates (Biologics) IBD Registry - data visualisation Supporting materials /Webinars
58 Developing QI champions training QI June Nov 3 x1 day face to face Webinars/coaching 8 IBD teams across UK
59 QI hub training course More training opportunities to come Managing barriers Leadership and networking
60 Improving screening for biologics Biologics 2016 report - 60% of patients adequately screened - Identifying processes set up to ensure adequate screening - Sharing some case studies from across the UK
61 An example of achieving an adequate process for pre treatment screening for biological therapies Dr decides patient need Bgx HBI score? Dr prints out electronic form and stickers for specific blood tests HIV, Hep B, Hep C, Varicella and Chest Xray. Form is signed by Dr. Patient has tests same day and books appointment to see nurse within 2 weeks Nurse counselling and review of results for appropriateness to start Bgx. If screening adequate appointment for infusion clinic Patient receives Bgx at infusion clinic and reviewed in 12 weeks
62 Next up.data visualisation on web tool Delivered first through the IBD Registry Web tool. (Infoflex platform) Will be trialled via the IBD Registry web tool Not yet available on the PMS
63 What does it look like?
64 What does it do? Performance against standards
65 Why data visualisation? Provides feedback on performance against standards Highlights performance over time Ability to track, identify ups and downs Prompt review of practice and improvement in process New in IBD well established in other diseases
66 Making improvements
67 Learning from other audits National Hip fracture data base (NHFD) National Emergency Laparotomy audit (NELA)
68 Find out more Opportunity to view on Registry web Feedback (survey) Webinars to support
69 Current KPI s a focus to improve Was the patient screened before starting on a biological therapy? Was a formal assessment of disease activity recorded? Is there a record of Registry consent being discussed with the patient?
70 Current KPI s a focus to improve At 3 and 12 months.. Did a post induction review take place? Was a formal assessment of disease activity recorded at this time?
71 How the IBD audit captured improvements Round Round Round Round Organisation of services ü ü ü ü Round Inpatient care ü ü ü ü Paediatric patients included ü ü ü ü Primary care perspective of IBD Inpatient experience ü ü Biological therapies ü ü ü ü Focus on quality improvement ü
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73 IBD Registry Kay Crook Paediatric IBD Nurse Specialist 2 nd June 2017 St Mark's Hospital and Academic Institute
74 IBD Registry All biological patients added Plan to upload all IBD patients within the next year IT engagement St Mark's Hospital and Academic Institute
75 Data Entry Teaching opportunity - IT system to find the data - Disease activity tools HBI, MAYO - Understanding IBD - Treatment pathways - Terminology Consent - Blueteq St Mark's Hospital and Academic Institute
76 Biological Service Number of biological patients Variety of Biologics used New Starters Demonstration of need for bigger infusion unit St Mark's Hospital and Academic Institute
77 Pharmacy Biological Switch - Numbers of patients to switch - Identification of patients - Brand of biologic St Mark's Hospital and Academic Institute
78 Research Identification of patients suitable for research projects Utilisation of data i.e. perianal patients on humira St Mark's Hospital and Academic Institute
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80 Practicalities of Registry participation ask the experts
81 Moving on up: how to get to the next step on the ladder Dovetail
82 Feedback and discussion
83 IBD Roadshow continues at: BIRMINGHAM Friday 9 th June Chairs: Dr Matt Brookes & Mel Love GLASGOW Autumn 2017 Chair: Dr Ian Arnott
84
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