Using data to improve a biologics service Dr Ben Parker PhD MRCP Consultant Rheumatologist, Kellgren Centre for Rheumatology, Central Manchester University Hospitals NHS Foundation Trust Honorary Senior Lecturer, Centre for Musculoskeletal Research, University of Manchester
Biologic therapies: the challenges Commissioners Multiple NICE approved agents which to use? Ever increasing costs (Kellgren Centre budget 3.6 million 12/13) Data sharing with NHS Trusts often minimal Every biologics service is different Secondary Care Services evolved not designed Increasing demands on service Hard to follow current evidence base (not NICE compliant) Data collection is hard and time-consuming Threat to prescriber independence?
A Virtual Biologics Clinic: A Quality Improvement Project Aim: To introduce a Virtual Biologics Clinic (VBC) into a single large Academic Teaching Hospital Rheumatology Department Key Drivers: To implement regional RA biologics RA pathway at CMFT To standardise and enhance pre-biologic screening To realise service and cost efficiencies To support translational research in an academic unit and consider every patient for research To collect accurate data on biologics locally GMMMG: Greater Manchester Medicines Management Group
A model of improvement for biologics services Reliable systems and processes Quality data and metrics Integrate research and clinical agenda Improve outcomes
A model of improvement for biologics services Reliable systems and processes Quality data and metrics Integrate research and clinical agenda Improve outcomes
Biologics Service at MRI pre-2013 Nurse co-ordinates OP visit 1 RA patient requiring biologic drug Research Study? No exclusion Criteria? Vaccinations Communicate to GP Administer +/- 2 nd DAS-28 assessment OP visit 2 Funding confirmed Nurse-led OP visit 3 Patient education 1 st Injection supervised Patient starts therapy Physician clinic Nurse clinic Active disease? NICE criteria met? Funding request? Leaflet? NICE criteria? Which drug? Physician and Nurse NICE/BSR guidance Physician preference Clinical indication Co-morbidities Immunology Patient preference route device Infusion capacity Cost Clinical Trial? Observational study? Pre-biologic Safety assessment Ordered: At OP visit 1 or OP visit 2? CXR γifn Others as indicated Malignancy? Results reviewed Nurse co-ordinated Decision communicated Patient Results communicated to Patient Physician Monthly review for 3 months DAS response at 6 months
Improvement methodology used Study Design Mixed methods QI study Measurement & data collection strategy Baseline measures Measurements over time Development of change/intervention Process mapping of current systems Multiple iterations of each intervention - PDSA cycles Change management Communication strategy Spread and dissemination
Greater Manchester Regional Biologics Prescribing Pathway for RA, June 2013 Evidence based but not fully compliant with NICE Harmonised Biologics Pathway for Rheumatoid Arthritis Updated 10 th June 2013 Vanessa Reid 1, Meghna Jani 2, Hector Chinoy 3, Ian Bruce 4 Encourages recruitment into research studies Requirement to monitor impact 1 Specialist Clinical Pharmacist, Manchester Royal Infirmary, CMFT 2 ST5 Rheumatology & Clinical Research Fellow, SRFT 3 Consultant Rheumatologist & Senior Lecturer, SRFT 4 Professor of Rheumatology, Manchester Royal Infirmary, CMFT An example of implementing current research knowledge into the clinic Approval date by GMMMG: 20 th June 2013 Review date: June 2014 http://gmmmg.nhs.uk/html/pathways.html
A Virtual Biologics Clinic at CMFT: new process for biologic initiation OP visit 2 2 nd DAS28/BASDAI score documented Safety/reliability Prescription not issued if: Incomplete checklist Non-pathway adherent unless clearly documented OP visit 1 Patient needs biologic: Active disease NICE criteria Consider for research study Initiate pathway use pack: Begin pre-biologic checklist Order screening tests Choose drug (document clearly) Give drug information Consent for approach by research Information to patient VBC Admin Support Group Education VBC Complete checklist Document pathway adherent reason for non-adherence Confirm funding Clinical trial/study suitability Complete Homecare registration 1 st prescription Issue output documents To GP For notes Next OP appointment 3/12 Homecare: 1 st Injection New documentation Based on GMMMG RA pathway Safety checklist for every patient Clinician specifies therapy and reasons Bespoke ordering screen New standardised GP letter
A model of improvement for biologics services Reliable systems and processes Quality data and metrics Integrate research and clinical agenda Improve outcomes
Outcome Measures Data collected to assess VBC success Measure Title % Complete checklist Weekly in VBC Who will collect the data? How frequently? N new biologic starters screened for trials (all) N RA patients on cheapest drug Cost of RA new starters Median Treatment Delay (all starters) Process Measures VBC use Weekly in VBC Weekly Weekly Weekly in VBC Weekly in VBC % RA patients adherent to pathway Weekly in VBC N new RA biologic starters considered for trials Balancing Measures Staff survey Referrals made to gastro/immunology/chest/other Weekly in VBC Before and after 3 months of VBC 3-monthly
Data collection strategy For QI project Ongoing data collection Paper based (single piece of A4!) Suitable to transfer into: Electronic patient record E-prescribing
Enhanced safety screening checklist Avoids repeat attendances for missed tests Communication tool: Funding stream Education Alerts/safety issues
Mechanism of pathway implementation, communication and data collection tool
Ongoing data collection Focused on: NICE eligibility Confirmation of other funding streams (NHS England) Maintaining research recruitment Biologics database updated live each week Audit tool built into process Single source of information
A model of improvement for biologics services Reliable systems and processes Quality data and metrics Integrate research and clinical agenda Improve outcomes
Who is in the VBC? Consultant Specialist Nurse Research Nurse I hour per week of nurse and consultant time Specialist Pharmacist Administrator
MDT review of all biologic starters What does this offer over and above previous system? VBC Complete safety checklist Document pathway adherent Confirm funding Clinical trial/study suitability Complete Homecare registration 1 st prescription Issue output documents To GP For notes Next OP appointment 3 & 6/12 Valuable research cohort Research nurse in every VBC All active studies within department and region Data collection point Database updated NICE eligibility data collected Mechanism to: Review prescribing Implement regional prescribing guidelines Implement local guidance (e.g. TB, Hep B)
A model of improvement for biologics services Reliable systems and processes Quality data and metrics Integrate research and clinical agenda Improve outcomes
Outcome: average treatment delay (days) VBC initiated LCL: lower confidence limit; UCL: upper confidence limit
Outcome: GMMMG pathway adherence
Outcome: Cumulative recruitment into biologics studies
Outcome: financial impact CCG cost savings 1 st 6 months Additional research Income 1 st 6 months > 90,000 90,00 Enhanced CTIMP recruitment Portfolio study recruitment CTIMP: clinical trial of investigative medicinal product
How else can the data be used? Harmonised Biologics Pathway for Ankylosing Spondylitis and Psoriatic Arthritis Vanessa Reid 1, Madhura Castelino 2, Ben Parker 3, Pauline Ho 4 1 Specialist Clinical Pharmacist, Manchester Royal Infirmary, CMFT 2 ST5 Rheumatology & Clinical Research Fellow, CMFT 3 Consultant Rheumatologist, Manchester Royal Infirmary CMFT 4 Consultant Rheumatologist, Manchester Royal Infirmary, CMFT Dawn Bell 1, Audrey Low 2, P Watson 3, Sahena Haque Non-NICE compliant 4 1 Specialist Clinical Pharmacist, South pathway Manchester Hospital, UHSM 2 ST5 Rheumatology & Clinical Research Fellow, UHSM 3 Consultant Rheumatologist, South Manchester Hospital UHSM 4 Consultant Rheumatologist, South Manchester Hospital UHSM switching between anti-tnf Approval date GMMMG: Review date: supported by data collected through VBC CCG/CSU negotiations: Accurate data Biosimilars, bluteq Clinical Research: Inform recruitment estimates Develop services: Remove admin from nurses More clinic time Group education that can cross specialties http://gmmmg.nhs.uk/html/pathways.html
Tips and challenges Data collection is hard to maintain Make it easy Make it relevant Develop a solution that doesn t add to clinical workloads Design the change to improve workflow/workloads Make it easy to do the right thing, and hard to the wrong thing Utilise other resources Research nurses collect recruitment data If possible, collect cost savings measure Helps with negotiations
Acknowledgements Karen Kemp Vanessa Reid Melissa Aris Neil Wall Kellgren Centre for Rheumatology Haelo/IS4Ac Improvement Science for Academics (IS 4 Ac)