Service Change Process. Gateway 1 High-level Proposition. Innovation project name: Patient Self-Monitoring/Management of Warfarin

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Allyson Barrett
5 years ago
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1 Service Change Prcess Gateway 1 High-level Prpsitin Innvatin prject name: Patient Self-Mnitring/Management f Warfarin NHS Bury Please describe the service change being prpsed. Please describe what service(s) will change and hw, hw many patients are affected by the service. Summarise the evidence, ratinale r drivers fr the change, and the anticipated benefits fr patients and hw these will be measured e.g. Reduces Health inequalities Prmtes wider health Imprves Access Imprves Integratin Other Backgrund The availability f new ral anticagulants has put increased fcus n the management f patients with atrial fibrillatin. Patients with AF are at 5-6 times greater risk f strke cmpared t the general ppulatin, but anticagulatin remains subptimal; accrding t the latest upladed GRASP-AF data 35% f patients in Bury with a CHADS2 scre >1 are nt receiving anticagulatin. The reasns are multiple; variatins in the quality f care, reluctance by GPs t recmmend warfarin, available capacity f anticagulatin clinics and the reluctance f patients t take warfarin due t cncerns with the drug and the incnvenience f regular mnitring. Nw mre than ever we need t ffer patients greater chice and cntrl f their care whilst als needing t identify cst savings and prductivity pprtunities. Fllwing the publicatin f the NICE TA n Dabigatran and Rivarxaban and the agreement f lcal guidance fr anticagulatin f patients with AF it is expected that the number f patients prescribed a NOAC and the assciated csts will rise slwly but steadily. Self-mnitring r self-management f warfarin prvides an alternative t the existing anticagulatin service mdel, ffering patients greater freedm and cntrl and with demnstrable imprvement in health utcmes. Service Overview Patient self-mnitring enables the patient t test their wn INR and reprt t their anticagulatin clinician fr dse adjustment. This gives the patient mre freedm t travel and avids the disruptin t wrk and hme life that ptentially frequent visits t anticagulant clinics creates. Patient self-management ges a step further, empwering the patient t determine the dse adjustment with the supprt f dsing charts and with access t advice if required. It is prpsed that these ptins are ffered t suitable patients wh are either well cntrlled but wuld prefer t self-mnitr due t the incnvenience f attending clinics, patients wh are nt well cntrlled wh wuld appear t benefit frm self-mnitring as an alternative t initiating an NOAC and patients wh have requested a NOAC as an additinal and mre cst effective alternative.

2 Eligibility * Patients well cntrlled wh wuld prefer t self-mnitr * Patients ut f range (any value) wh wuld appear t benefit frm PSM (Clinician/Patient Decisin) Patient Selected Out f range INR <1.5 & >3.5 2 x weekly mnitring Pre-PSM INR result Training Appintment Self mnitring cmmences INR 2-3 fr fur weeks? INR within x weekly mnitring Guide sheet fr dse adjustment and telephne supprt available Yes N Halve Mnitring Enhanced telephne supprt & 2 x weekly mnitring INR 2-3 fr fur weeks? N INR 2-3 fr fur weeks? Yes N Yes Gradually reduce t frtnightly mnitring (r maintain at frtnightly) Cntinue 2x weekly mnitring and supprt. Once cnsistently in range gradually reduce mnitring. After 3-6 mnths if still nt well cntrlled cnsider NOAC / N treatment as per CHADS2 scre 6 9 mnths clinic review with calibratin Time in Range: <70%: Cnsider NOAC r n treatment as per CHADS2 scre 70-79%: Patient chice t either cntinue PSM r initiate NOAC ³80%: Cntinue PSM

3 Evidence A Cchrane review was published in 2010 which included 18 clinical studies ttalling 4,723 participants. The review cncluded that bth patient self-mnitring and self-management imprves utcmes cmpared t standard mdels; thrmbemblic events were halved (RR 0.50, 95% CI ) and in the 16 trials that reprted infrmatin n mrtality, all-cause mrtality was reduced by 36% (RR 0.64, 95% CI 0.46 t 0.89). Twelve trials reprted imprvement in the percentage f mean INR measurements within therapeutic range. The reprt cncluded that selfmnitring r self-management can imprve the quality f ral anticagulant therapy, leading t fewer thrmbemblic events and lwer mrtality, withut a reductin in the number f majr bleeds. Health Inequalities All cardivascular diseases disprprtinately affect peple within lwer sci-ecnmic grups. An interventin which acts t imprve cardivascular utcmes therefre acts t reduce health inequalities. The prevalence f AF increases with age rising mre sharply after age 65. Presently nly patients wh can affrd t purchase mnitrs themselves have the pprtunity t self-manage. Number f peple benefiting The prpsal seeks funding fr 30 mnitrs thus benefiting 30 patients, with a view t expanding the pilt fllwing evaluatin. If fully implemented it has the ptential t benefit at least 30% f patients receiving anticagulatin fr AF. Cst Each mnitr csts 300 plus VAT. The Cnnect devices fr transfer f data will be prvided free f charge (up t 30, usual price 65 + VAT). Training and initial patient reviews up t three mnths will be prvided free f charge Subsequent fllw-up will be at a lesser frequency than patients receiving usual care. On an n-ging basis a tariff will need t be agreed with the cmmunity anticagulatin service prviders fr prvisin f telephne dsing advice and 6-9 mnth review/equipment calibratin. Test strips: 2.81 per test (apprximately 112 per annum based n 40 tests) If apprved frm when culd this service be implemented? 4-6 weeks frm the date f apprval. If this is a pilt hw lng will it run ( max 6mnths) 6 mnths

4 Please summarise the ptential impact f the service change in key areas 1. Measures f Success Please identify hw the service success will be measured in terms f Quality and safety, Innvatin, Patient experience, Prductivity, Perfrmance, Savings Imprved Clinical Outcmes Imprved clinical utcmes will be measured by time in therapeutic range. This data will be cllected and transferred by the XS Cnnect device. Patient experience will be assessed using the LTC6 questinnaire (pre-implementatin and at 6 mnths) Other measures t evaluate the pilt will include: Percentage f patients ffered self-management and reasns fr nt ffering self-management Take-up rate f self-management and reasns fr declining Percentage f patients cmpleting training Percentage f patients passing the assessment Percentage f patients cntinuing t self-manage at 3 and 6 mnths Testing frequency and assciated csts Percentage f patients requiring additinal advice n dsing and frequency f cntact All related clinical events i.e. reprted minr and majr bleeds, thrmbtic events 2. Wrkfrce Please bullet pint key rles and respnsibilities, skills mix and practitiners required. 1 GP Lead 1 Nurse Practitiner 3. Finance including capital Demnstrate the: Set up csts; Surces f funding; Sustained funding; Each mnitr csts 300 plus VAT. The Cnnect devices fr transfer f data will be prvided free f charge (up t 30, usual price 65 + VAT). Training and initial patient reviews up t three mnths will be prvided free f charge Subsequent fllw-up will be at a lesser frequency than patients receiving usual care. On an n-ging basis a tariff will need t be agreed with the cmmunity anticagulatin service prviders fr prvisin f telephne dsing advice and 6-9 mnth review/equipment calibratin. Prpsed fixed cst f 100 per patient per annum Test strips: 2.81 per test (apprximately 112 per annum based n 40 tests) Warfarin (average) = 31 per annum Ttal Pilt csts (6 mnths) Unit Cst Units Ttal Mnitrs ,800 Cnnect devices Test Strips , mnth review/telephne supprt ,000 Warfarin Ttal 16,416 Cst per patient 547

5 Given that the ttal cst is heavily influenced by the mnitrs, it is mre cst effective in the lng term: Cst Over Tw Years: Unit Cst Units Ttal Mnitrs ,800 Cnnect devices Test Strips , mnth review/telephne supprt ,000 Warfarin ,860 Ttal 25,404 Cst per patient per year 423 As a benchmark it wuld cst 612 per year fr NOAC prescribing plus 50 fr review, ttal 662 per patient per year. 4. Infrmatin Technlgy The CnnectXS device will be prvided free f charge. It is a USB which cllates and graphs the INR data and testing frequency which is then ed by the patient t the clinician. 5. Use f estates and facilities The pilt is prpsed t be perated at Tttingtn Health Centre. Given that the eligible patients wuld usually attend fr INR mnitring, clinical space will be required less frequently than utilising this mdel hwever a rm is required fr the delivery f grup training. 6. Impact n ther services E.g. Pathlgy, Radilgy, primary r secndary care. Hw was this identified? The pilt will nly affect Tttingtn Health Centre. If it were t be expanded then it wuld affect all cmmunity anticagulatin services and wuld reduce the demand n clinic time. There wuld be n impact n pathlgy r ther services. 7. Data recrding requirements Imprved clinical utcmes will be measured by time in therapeutic range. This data will be cllected and transferred by the XS Cnnect device. Patient experience will be assessed using the LTC6 questinnaire (pre-implementatin and at 6 mnths) Other measures t evaluate the pilt will include: Percentage f patients ffered self-management and reasns fr nt ffering selfmanagement Take-up rate f self-management and reasns fr declining Percentage f patients cmpleting training Percentage f patients passing the assessment Percentage f patients cntinuing t self-manage at 3 and 6 mnths Testing frequency and assciated csts Percentage f patients requiring additinal advice n dsing and frequency f cntact All related clinical events i.e. reprted minr and majr bleeds, thrmbtic events

6 8. Cntracts Rll-ut f the pilt wuld require changes within the cmmunity anticagulatin specificatin. This is presently being reviewed. 9. Other (please describe) Please cnfirm membership f the bidder team Nicla Harrisn Public Health Dr Rb Stkes GP and CCG Clinical Gvernance Lead

Commissioning Policy: South Warwickshire CCG (SWCCG)

Commissioning Policy: South Warwickshire CCG (SWCCG) Cmmissining Plicy: Suth Warwickshire CCG (SWCCG) Treatment Indicatin Criteria FreeStyle Libre Flash Cntinuus Glucse Mnitring System Type I Diabetes Prir apprval must be requested frm the Individual Funding