Local Enhanced Service: Primary care management of stable haematological patients Monoclonal Gammopathy of Undetermined Significance (MGUS) 1. Introduction Monoclonal Gammopathy of Undetermined Significance (MGUS) is a common condition, which increases its likelihood with age. About one in 30 people aged 50 years or older will have the condition, this rises to one in 20 people aged over 70 years, and nearly one in 10 people aged over 85 years. It is about 1.5 times more common in men than in women. The disorder also appears to be nearly twice as common in patients of African descent than in Caucasians. This disorder may progress to Myeloma in 1-2% of patients per annum and therefore requires regular monitoring. Chronic Lymphocytic Leukaemia (CLL) is the most common form of leukaemia in the Western World and is often diagnosed by chance following a routine full blood count (FBC). Stage A is the very earliest stage of the disease. Patients are often elderly and trial evidence supports no need for active treatment of early stage disease. The majority of such patients have an extremely good prognosis with slowly progressive disease over many years. Consequently they are ideal patients to be followed up in primary care. Patients with CLL can be more prone to infection and may develop autoimmune haemolytic anaemia and/or immune thrombocytopenic purpura (ITP). 2. Service Aims The aim of this service is to facilitate the management of appropriate patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and/or Stage A Chronic Lymphocytic Leukaemia (CLL) within primary care. Appropriate patients will be considered for primary care management if their disease is stable or does not require active treatment. The service will result in: Reduced number of inappropriate referrals to secondary care services Improved access and shorter waiting times for patients requiring specialist input Care closer to home for stable haematological patients 3. Service Description The care of a patient who meets the criteria contained in the GP Guidelines for the follow-up of stable haematological patients will be transferred to GP Practices in Croydon who have been commissioned to provide this service. Transfer will be by the secondary care consultant following completion of a discharge consultation. Participating GP practices will provide routine follow-ups, including the relevant tests, at the intervals specified in the GP Guidelines. Participating practices will be able to access specialist advice from a local secondary care consultant if needed (via Kinesis in the case of St George s NHS Healthcare Trust and via a dedicated email in the case of Croydon Health Services NHS Trust, Kingston Hospital NHS Trust and Epsom and St Helier University NHS Trust. It will be the responsibility of the GP practice to: Contact the patient by telephone to book their first appointment with the nurse and GP for on-going primary care management, having been reminded to do so at their hospital discharge consultation. It will be at the patient s first appointment with the 1
GP, that the patient will be advised as to when to book future follow-up appointments. Be responsible for ensuring that failsafe and safety netting processes are in place. The Practice shall maintain a register of all patients referred into the service, which will be routinely checked by GP Practice staff. This information will be available at all times to the Commissioner. 4. Operational Service Provision Discharge from Secondary Care Secondary care providers will identify appropriate patients with low risk MGUS and/or stable Stage A CLL for management within primary care and will discharge directly to the patients GP following a discharge consultation. To ensure the patient receives a smooth discharge to primary care, the following checks will be in place at the patient s secondary care discharge consultation: o Check that the patient understands and accepts the new follow-up arrangements o Check with the patient that their GP details are correct o Send a discharge letter, which includes a fax back confirmation to the patients GP (a copy will also be given to the patient at the discharge consultation) Follow-up within Primary Care GPs will be expected to return the fax back confirmation within 1 week of receipt to accept responsibility for the patient s on-going primary care management. Please note: if the GP does not return the fax back confirmation, the relevant secondary care provider will contact the patients GP to confirm receipt. GPs will add patients with low risk MGUS and/or stable Stage A CLL to the flu vaccination list The service will be provided in GP practices in Croydon within surgery hours For both patients with low risk MGUS and/or stable Stage A CLL, if a patient is concerned about their symptoms, the patient should be encouraged to liaise directly with their GP and book an urgent review appointment. Monoclonal Gammopathy of Undetermined Significance (MGUS) Nurse appointment Patient will attend a practice nurse appointment where the following tests for patients with MGUS being managed within primary care. These will be requested every 3 to 6 months (or frequency as prescribed in the patients discharge consultation letter): Full Blood Count (FBC) Urea and Electrolytes (U&E) Calcium Paraprotein levels Urinary Bence Jones protein OR Freelite Serum free light chain estimation for patients with a significant Freelite Serum free light chain component 1 GP appointment 1 week later, the patient will attend a GP appointment to discuss their test results. GPs should monitor the following blood and urine tests in the table below: Blood tests 1 The Serum Freelite Chain blood test is equivalent to the Bence Jones Urine test. 2
Haemoglobin concentration Hypercalcaemia Creatinine and/or urea Paraprotein Freelite Serum free light chain (can be undertaken instead of a urinary Bence Jones test, for patients with a significant Serum Freelite Chain component) Less than 100 g/l Abnormal / deterioration (at discretion of GP) If the concentration of the M-protein increases by more than 25% (a minimum absolute increase of 5 g/l) Increases by more than 25% in either light chain Urine tests Bence Jones Increases by more than 25% Please note: In the event of suspicious symptoms, which could indicate disease progression and/or blood test results exceeding the threshold for referral back into secondary care, the GP should refer directly back to secondary care using the agreed referral proforma or utilise Kinesis (in the case of St George s NHS Healthcare Trust) or the relevant secondary care provider s dedicated rapid access email for advice. Provide patients with advice on disease progression warning signs and symptoms and reiterate the importance of reporting any changes in their condition to their GP Update the patients results in the bespoke patient information leaflet as well as updating the patients practice record Advise patient as to when to book their next review appointment Chronic Lymphocytic Leukaemia (CLL) Blood tests Every 3 to 6 months (frequency as prescribed in patient discharge letter), the GP practice will be responsible for arranging Full Blood Count (FBC) tests for patients with Stage A CLL being managed within primary care GP appointment 1 week later, the patient will attend a GP appointment to discuss their test results. GPs should monitor the blood tests in the table below: Blood tests Haemoglobin concentration White cell count Platelets Lymphocyte count Less than 105 g/l Greater than 50 x 10^9/l Less than 100 x 10^9/l Doubling time of less than 12 months Please note: Patients should be referred back to the appropriate secondary care provider using the agreed proforma in the following instances: o Falling Hb < 105g/l or platelets < 100, o Development of bulky lymph nodes /splenomegaly or B symptoms unintentional weight loss, night sweats and/or unexplained fevers. o Doubling of lymphocyte count within a period of 12 months or less. If the GP requires further advice and support regarding test results and/or whether a re-referral is necessary, the GP should utilise Kinesis (in the case of 3
St George s NHS Healthcare Trust) or the relevant secondary care provider s dedicated rapid access email. GPs should examine the patient for signs/evidence of lymphadenopathy/splenomegaly Patients should receive prompt treatment of infective episodes with antibiotics. Patients with recurrent chest infections should receive routine immunisation of the influenza vaccine +/- pneumovax/hib GPs should provide patients with advice on disease progression warning signs and symptoms and reiterate the importance of reporting any changes in their condition to their GP. Update the patients results in the bespoke patient information leaflet as well as updating the patients EMIS record Advise patient as to when to book the next review appointment 5. Eligibility Criteria Inclusion Criteria Patients registered with a GP in Croydon Patients with stable Stage A CLL and/or low risk MGUS who have been identified as being appropriate for primary care management by their local secondary care provider and have received a discharge consultation Exclusion Criteria Patients registered with a GP outside of Croydon Patients who do not have the conditions explicitly referred to in the inclusions criteria 6. Governance and Professional Standards Practices will have the following Clinical Governance processes in place: Named Lead GP On-going training and education Access to advice and support from the relevant haematology consultant Development and maintenance of clinical records and safety netting systems. Annual patient satisfaction surveys Complaints procedure Critical Incident reporting (Significant Events/Serious Untoward Incidents) 7. Monitoring Requirements The South West London Cancer Commissioning Team will be responsible for updating the GP Guidelines for stable haematological patients GP practices should take responsibility for ensuring that staff members delivering this service are appropriately trained and have the necessary skills to provide the service. A webcast educational session which has been developed by local haematology consultants to assist with any training needs. However, if your practice feels that further education and training is required, please feedback to the Commissioner. 8. Performance Monitoring Requirements The named GP stable haematological management lead is required to be the point of contact for the Commissioner for all aspects regarding this service specification. 4
Croydon CCG expects GP providers to report on the following key performance indicators on an annual basis: The NHS number of the discharged patient Date of discharge Disease: Stable Stage A CLL or low risk MGUS Referring Consultant and Trust Number of face-to-face review consultations agreed with the consultant per year Number of face-to-face review consultations offered over the reporting period Number of face-to-face review consultations attended over reporting period Patient continuing in Primary Care (Y or N) Number of referrals back to secondary care over the reporting period Reason for referral back to secondary care (where applicable) Patient offered referral to Croydon CReSS (Y or N) 9. Pricing and Payment 100 per patient claimable in April for the previous quarter s activity, with final payment dependent on an annual report 10. Patient information The South West London Cancer Commissioning Team has produced the following patient information leaflets - please see embedded documents. These should be used to support patient discussions. Please note that it is the patient s responsibility to notify their GP and local secondary care provider at the earliest opportunity if they change address and/or GP Practice. At this point, the patient s follow-up care will transferred back to the local secondary care provider until confirmation has been received from the patient s new GP that their on-going follow-up care will be managed by the new GP practice. 11. LES Evaluation Following the first year of service, the South West London Cancer Commissioning Team will conduct a service audit to determine whether the service is achieving the outlined aims and objectives. Audit results will be communicated back to Croydon CCG. The following would constitute evidence that the LES is effective: Reduction in the number of inappropriate referrals to secondary care services Improved access and shorter waiting times for patients requiring specialist input Patients reporting that they are receiving appropriate care closer to home. 12. Review and Future developments 5
Croydon CCG will evaluate the service at the end of the LES contract period and the data will be used to inform decisions about future service provision. This service specification will be reviewed on an annual basis within the contract period. Croydon CCG reserves the right to withdraw or amend this service and will give a minimum of 3 months notice of any service changes. 13. Signature of Parties The signatures below constitute an agreement between the GP Practice and Croydon Clinical Commissioning Group for the management of stable haematological patients (stable Stage A CLL and low risk MGUS) within primary care for the GP practices own registered patients. This service will be for the period 1 October 2013 to 31 March 2014. By signing this agreement the GP practice is agreeing to the CCG Commissioners extracting data on a regular basis via EMIS Web for this LES for audit and payment purposes. Lead GP Name (Print): Signature: Date: Croydon CCG (Print): Signature: Date: Please note that the LES will only be valid when the practice has received by return a signed copy by Croydon CCG. 6
Appendix 1 Follow Up Pathway for Patients with Stage A CLL or MGUS New Patients Stage A CLL = Chronic Lymphocytic Leukaemia (CLL) MGUS= Monoclonal Gammopathy of Undetermined Significance (MGUS). Patients Discharged from Secondary Care Included: Patients with stable Stage A CLL. Low risk MGUS patients ie asymptomatic, low paraproteins. Excluded: Patients who have learning difficulties or mental health problems will be reviewed individually. Patients with multiple or severe co-morbidities. When initial investigations, treatment and follow-up in secondary care are complete, the patient has a Discharge Consultation with the responsible clinician and CNS. DISCHARGE CONSULTATION Includes: Diagnosis and explanation. What to expect with regard to frequency of blood tests by GP. Blood results that would trigger a referral back to the hospital specialist. Information about the likelihood of disease progression. What to look out for warning signs and symptoms and the importance of reporting to their GP. Supply bespoke patient information leaflets and complete results record Informing the patient that they are responsible for making their own follow-up appointments with GP. PAPERWORK COMPLETED DURING DISCHARGE CONSULTATION: Verify with patient that the GP on the patient record is correct. Discharge letter to inform GP of patient s condition and the subsequent follow-up arrangements required. Copy to patient. This includes:- Trust contact details and a fax back confirmation sheet. GPs are requested to return the confirmation sheet sent back within 24 hours of letter receipt and agree their responsibility for patient follow-up. Trust to contact GP if fax not received within 48 hours. FOLLOW-UP CONSULTATION WITH GP Includes GP reviews blood results and clinical examination results for Stage A CLL patients (lymph nodes). GP to refer back to secondary care via e-mail if there is evidence of disease progression (Blood results that would trigger a referral to a hospital specialists are listed in the GP Guidelines). GP completes specifically designed EMIS templates as a guide for tests, clinical examination (Stage A CLL patients) and safety netting. Provides advice to patients on what to look out for warning signs and symptoms and the importance of reporting to their GP. Updates the results record in the bespoke patient information leaflets Provides date for next review appointment. PATIENT RECALL Patients who are concerned about their symptoms should liaise directly with their GP. In the event of suspicious symptoms which could indicate disease progression, GP to utilise the dedicated rapid access email box. Blood results meeting the threshold for referral back to secondary care trigger the GP to use the dedicated rapid access e-mail box. Following discussion with secondary care specialist, patient may be referred back to secondary care and will be treated as a new patient. Patient will be seen within 14 days if referral required. (Trusts will give guidance about referral back to secondary care and the timelines required i.e. 2-week wait). POST CONSULTATION ACTIVITIES Patient record annotated to show transfer of care to primary care. GOVERNANCE AND REPORTING FRAMEWORK Patient should be fast-tracked back into appropriate clinic within 14 days of GP contact. Dedicated rapid access e-mail box will be accessed at least twice a week. Trust to ensure that necessary cover arrangements are in place. Copies of patient discharge letters will be collated centrally. An audit will be conducted by the TWG after the first year. Results of the audit to be fed back to CCGs. GPs to be informed of any changes to national guidance. GPs to follow the fax back confirmation process. Review Date: November 2013 7