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SCHEDULE 2 – THE SERVICES A. Service Specifications Mandatory headings 1 – 4: mandatory but detail for local determination and agreement Optional headings 5-7: optional to use, detail for local determination and agreement. All subheadings for local determination and agreement Service Specification No. NDCCG 12 Service DVT management and treatment in Primary Care Commissioner Lead North Derbyshire CCG Provider Lead General Practice Period 1st April 2015 – 31st March 2018 Date of Review Annual 1. Population Needs 1.1 National/local context and evidence base National and Derbyshire priorities are to provide access to high quality services as close as possible to patient’s home, transferring some services from secondary to primary care. Venous thromboembolic (VTE) diseases cover a spectrum ranging from asymptomatic deep vein thrombosis (DVT) to fatal pulmonary embolism (PE). They are the result of a blood clot (a thrombus) forming in a vein and then dislodging to travel in the blood (an embolus). If the blood clot dislodges and travels to the lungs, this can lead to a potentially fatal PE. Even if blood clots are non-fatal, they can still result in long-term illness, including venous ulceration and development of a post-thrombotic limb (chronic pain, swelling and skin changes in the affected limb) and have a significant impact on quality of life. Thrombophilia, an inherited or acquired disorder in which the blood is prone to clot abnormally, and cancer are major risk factors for blood clots. Other risk factors include a history of DVT, age over 60 years, recent surgery/serious injury, obesity, prolonged travel, acute medical illness, immobility and pregnancy. Figures (from 2010/11i) show that over 56,000 people - around 1000 per week - were diagnosed with blood clots in their legs or lungs. However, diagnosis is often far from straightforward and in many cases they are only diagnosed post-mortem (in 2007 nearly 17,000 recorded deaths in England and Wales mentioned DVT or PE as either the primary cause of death or a contributory factorii). Evidence suggests that as many as 50% of people in whom a blood clot in the leg is left untreated will go on to develop a blood clot in their lung. 75% of patients with suspected DVT present during working hours (O’Shaunessy 2000) and up to 40% of referrals can be expected to be negative (Walsh et al. 2002). Effective assessment tools (Wels two-level scores and D-Dimer test kits) can be safely used within primary care to determine where the probability of DVT is unlikely, thus reducing unnecessary referrals and aiding alternative diagnoses. This specification follows NICE guideline CG144 for diagnosis and treatment of DVT. i. Hospital Episodes Statistics for 2010/11 ii. Office for National Statistics 2. Outcomes 2.1 NHS Outcomes Framework Domains & Indicators Domain 1 Domain 2 Domain 3 Domain 4 Domain 5 Preventing people from dying prematurely Enhancing quality of life for people with long-term conditions Helping people to recover from episodes of ill-health or following injury Ensuring people have a positive experience of care Treating and caring for people in safe environment and protecting them from avoidable harm 2.2 Local defined outcomes Improve patient experience Provision of services closer to home for appropriate patients, lessening travel to acute services – patients treated at the initial point of contact People with suspected DVT have diagnostic investigations completed within 24 hours of first clinical suspicion to ensure prompt treatment if the diagnosis is confirmed and avoid unnecessary repeat doses of anticoagulants if the diagnosis is excluded Enable early diagnosis and treatment of DVT Enable early consideration of alternative diagnosis To reduce the number of inappropriate referrals to acute departments: o Reducing pressure on acute departments o Less time required for general practice to administer referrals o Promote efficient use of acute services , freeing up resources to be reinvested where needed (The specification outlines the service to be delivered between 8am and 6.30pm Monday to Friday) 3. Scope 3.1 Aims and objectives of service 3.2 To deliver a primary care service to patients for the diagnosis and management of DVTs Point of care service using the two-level Wells clinical Assessment tool Provide point of care D-dimer tests Prevention of unnecessary hospital referral of patients unlikely to have a DVT and alternative diagnosis considered Patients who are medium to high risk following the Wells score and those patients who are low risk but have a positive D-dimer result will be referred to acute departments for further investigations Reduce unnecessary pressure on acute services Service description/care pathway Diagnosis If a patient presents with symptoms of DVT, primary care will carry out an assessment of the general medical history and a physical examination to exclude other causes (those exclusions in 3.4 should be referred following alternative guidelines/pathways) If a DVT is suspected, patients will be scored against the two-level modified Wells Diagnostic Algorithm to estimate the clinical probability of DVT (See Appendix 1 for Wells score tool) Offer patients in whom DVT is still suspected and with a likely two-level DVT Wells score either: o o A proximal leg vein ultrasound scan carried out within 4 hours of being requested or A D-dimer test and an interim 24 hour dose of a parenteral anticoagulant (low molecular weight Heparin – LMWH) (if a proximal leg vein ultrasound scan cannot be carried out within 4 hours) and a proximal leg vein ultrasound within 24 hours of being requested Repeat the proximal leg vein ultrasound scan 6-8 days later for all patients with a positive Ddimer test and a negative proximal leg vein ultrasound scan. Offer patients whom DVT is suspected and with an unlikely two-level DVT Wells score a D-dimer test and if the result is positive either: o a proximal leg vein ultrasound scan carried out within 4 hours of being requested or o an interim 24 hour does of parenteral anticoagulant (if a proximal leg vein ultrasound scan cannot be carried out within 4 hours) and a proximal leg vein ultrasound scan carried out within 24 hours of being requested Diagnose DVT and treat Treatment of DVT Early mobilisation Anticoagulation - Treatment with LMWH/Warfarin/Rivarixoban continues Compression stockings Exercise Rest and elevation of leg Simple analgesia Good hydration Take into consideration alternative diagnosis in patients with: an unlikely two-level DVT Wells score and o a negative D-dimer test or o a positive D-dimer test and a negative proximal leg vein ultrasound scan a likely two-level DVT Wells score and o a negative proximal leg vein ultrasound scan and a negative D-dimer test or o a repeat negative proximal leg vein ultrasound scan Advise patients in these two groups that it is not likely that they have a DVT and discuss with them the signs and symptoms of DVT and when and where to seek further medical help. 3.3 Population covered North Derbyshire CCG General Practice registered adult patients with suspected or confirmed DVT or PE. (See exclusions in 3.4) Healthcare professionals should follow the Department of Health’s advice on consent and code of practice for the Mental Capacity Act. Good communication with patients should be supported by evidence-based written information tailored to the patient’s needs. Treatment and care, and the information given to patients about it, should be culturally appropriate and be accessible to people with additional needs such as physical, sensory, learning disability or those that do not speak or read English. 3.4 Any acceptance and exclusion criteria and thresholds This specification does not include: Children or young people under 18 years Women who are pregnant or breastfeeding Patients with co-existent serious medical pathology Severe acute venous obstruction (phlegmasia cerulea dolens) Patients in significant pain Significant renal impairment (creatinine in excess of 200 umol/l) Liver failure Known IV drug users Patients who have had a previous pulmonary event Patients with complex heart failure Patients with malignant disease with active chemotherapy Patients with current severe psychiatric or mental illness Adverse reactions to Heparin Known Heparin allergy of heparin-associated thrombocytopenia Patients with active bleeding: o active peptic ulceration o liver disease (PT > 2s beyond normal range)/clotting problem o uncontrolled hypertension (diastolic >110mmHg, systolic>200mmHg) o angiodysplasia o recent eye or CNS surgery (within one month) o recent haemorrhagic stroke (within one month) o thrombocytopenia (platelet count below 100 x 10/1 Housebound patients who rely on hospital transport to access ultrasound Patients with symptoms of more than 2 weeks duration 3.5 Interdependence with other services/providers Where a patients Wells score or D-dimer result requires referral, the provider will complete the appropriate referral to the acute DVT department. . 4. Applicable Service Standards 4.1 Applicable national standards (e.g. NICE) Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing (Nice Guideline 144) 4.2 Applicable standards set out in Guidance and/or issued by a competent body (eg Royal Colleges) Full article “Evaluation of D-dimer in the diagnosis of suspected Deep Vein Thrombosis” by P Wells et al is published in The New England Journal of Medicine. It can be found at http://www.nejm.org/doi/full/10.1056/NEJMoa023153#t=article (See also Appendix 2) 4.3 Applicable local standards Staff undertaking diagnostic tests, assessments and initiating and administering treatment must be adequately trained and supervised as determined by the Practice The Practice must have adequate mechanisms and facilities, including premises and equipment, as are necessary to enable the proper provision of this service The Practice will utilize existing mechanisms to report adverse incidents The practice shall comply with Children and Adult Safeguarding procedures Treatment will be provided in accordance with the Mental Capacity Act 2005 Practices will ensure details of Wells scores and D-dimer results are recorded in the patient’s life long record along with diagnosis The Practice will be required to submit six monthly audits of the service. In addition, the service will be subject to monitoring as part of the annual review of the contract. Audits will record: a) Number of patients presenting with suspected DVT b) Number of patients with suspected DVT referred immediately without a D-dimer c) Number of patients with Wells score 1 or less d) Number of patients with Wells score 2 or more e) Number of patients having D=dimer tests following a Wells score f) Number of normal D-dimer test results g) Number of positive/raised D-dimer test results h) Number of patients referred to acute DVT departments 5. Applicable quality requirements and CQUIN goals 5.1 Applicable Quality Requirements (See Schedule 4 Parts [A-D]) 5.2 Applicable CQUIN goals (See Schedule 4 Part [E]) Detailed in main BOS Specification 6. Location of Provider Premises Services will be delivered from all General Practices in North Derbyshire CCG. 7. Individual Service User Placement Appendices: Appendix 1 Title Wells two-level clinical assessment tool Document Two-level Wells score.docx 2 Evaluation of D-dimer in the diagnosis of suspected Deep Vein Thrombosis evaluation of diagnosis Wells et al.pdf Glossary of terms: D-dimer test – D-dimer is a product formed in the body when a blood clot (such as those found in DVT or PE) is broken down. A laboratory or point-of-care test can be done to assess the concentration of D-dimer in a person’s blood. The result of the D-dimer test can be used as part of probability assessment when DVT or PE is suspect ted Wells score – Clinical prediction rule for estimating the probability of DVT or PE. There are a number of versions of Wells scores available. Nice guideline 144 recommends the two-level DVT Wells score and the two-level PE score.