Service Specification

Transcription

1 Service Specification Management of stable Prostate Cancer patients within the community Release: Final Date: 1 st February 2011 Author: Bali Maman Service Improvement Facilitator NHS Derbyshire County Owner: Jennifer Stothard Head of Commissioning Cancer and End of Life Care Services NHS Derbyshire County Document Reference: Service Specification (v4) Page 1 of 15

2 Document Information Document location : This document is only valid on the day it was printed. Authorship: This document has been prepared by: Name Designation Organisation Bali Maman Service Improvement Facilitator Derbyshire County PCT Revision history: The current version of this document supersedes all previous versions. Revision date Summary of changes Version 21/08/09 Feedback from GPOG incorporated V1.0 Aug/Sep 2009 Feedback from Primary Care Commissioning Board V1.0 11/09/09 Feedback from Patient support group incorporated V1.0 Nov 2009 Feedback from Chesterfield PBC incorporated V1.0 Nov 2009 Feedback from Erewash PBC incorporated V1.0 22/10/10 Review of Service Spec to align with Basket of Services work V2.0 15/12/10 Amendment following final Clinical Reference Group review V3.0 1/2/11 Amendment to include expected activity levels V4.0 Approvals: This document requires the following approvals: Name Designation Signature Date of Issue Version Jackie Pendleton Assistant Director, Primary 26/2/2010 V1.0 Care Commissioning GPOG GPOG 19/2/2010 V1.0 Distribution: This document has been distributed to: Recipient Distributed as part of The Basket of Services Date of Issue Version Date for Service Specification to be reviewed: Date of review Name Designation and Organisation 1 September 2011 Bali Maman Service Improvement Manager Page 2 of 15

3 Contents: Section Page Document information 2 1 Introduction 4 2 Definition of service 4 3 Overall aims 4 4 Key objectives 4 5 Key outcomes 4 6 National context 5 7 Local context, demographics, needs 5 8 Service outline 6 9 Model for the service pathways / 6 interfaces 10 Client group served / eligibility / access 7 criteria 11 Quality targets 7 12 Output and outcome measure 7 requirements 13 Service monitoring, evaluation and review 8 process / timescales 14 Workforce / staffing 8 15 Clinical and corporate governance 9 16 Policies / protocols / legal requirements 9 17 Appendices 9 18 References 15 Page 3 of 15

4 1 Introduction: Currently the majority of patients with prostate cancer are managed within secondary care (1). NICE guidelines published in 2008 (2) recommend that those men with stable PSA who have had no significant treatment complications should be offered follow up outside hospital. Analysis of the patients currently attending hospitals for follow-ups have been conducted and a cohort of patients that meet the recommendations have been identified for follow-up in primary care. 2 Definition of service: The service to be provided is 6 monthly follow-up consultations for patients with established locally advanced prostate cancer who are stable on treatment. The consultation will cover a review of the patients PSA test results, symptoms and side effects of treatment. 3 Overall aims: The aims of this service are to move the care of locally advanced prostate cancer patients stable on treatment out of the acute hospital and into primary care. The aims support the Primary Care Trust strategic objectives of moving care closer to home and delivery of productivity savings. 4 Key objectives: The objectives of this service are to: Provide routine follow up management of patients with locally advanced prostate cancer stable on treatment To identify patients whose disease has progressed and ensure rapid referral back into secondary care for review (see appendix X for referral triggers) To reduce the cost associated with management of patients (including service delivery costs and better utilisation of resources through reduction in Do not attends (DNA s).) To provide a locally accessible service for patients 5 Key outcomes: Increase in 5 year survival rates for men within NHS Derbyshire County diagnosed with prostate cancer This service will assist in meeting the Cancer Services overall objective of reducing under 75 mortality rate for males within NHS Derbyshire County diagnosed with prostate cancer Increase in patient satisfaction in relation to access and convenience Page 4 of 15

5 6 National context: This service is in line with: NICE guidelines published in 2008 (2). Cancer Reform Strategy Delivering Care in the appropriate settings (3). Delivering Care Closer To Home Department of Health (4). 7 Local context, demographics, needs: Prostate cancer is one of the most common cancers in men with approximately 35,000 new cases in England and Wales and 10,000 deaths. The disease is predominantly associated with older men but around 20% are men under 65 years of age. As the incidence of prostate cancer is high and five-year survival rates are around 70% many men are alive who have been diagnosed with prostate cancer. An estimated 215,000 men are alive in the UK having received a diagnosis of prostate cancer. Deprivation incidence gradients have been reported for both and England and Wales and Scotland, with higher rates in the least deprived populations. These deprivation gradients have widened during the 1990s due to the greater relative increase in incidence for men in the most affluent groups and are likely to be influenced by accessibility and uptake of PSA testing. 5 The average annual incident rate for men with diagnosed with prostate cancer within NHS Derbyshire County is 425 (average annual number of cases ), the one year survival rate is 92.6% and the five year survival rate if 70% of all men diagnosed 8 Service outline: The service is to provide a follow-up consultation every 6 months for patients with established locally advanced prostate cancer, stable on treatment. The consultation is to include a review of the patients PSA test, symptoms and side effects of treatment. Patients in secondary care with locally advanced prostate cancer stable on treatment will be identified and discharged from acute hospital care via discharge letter to their GP. Upon receipt of the discharge letter the patients care is transferred to the primary care provider who will take formal responsibility and accountability for the on-going care of the patient. The primary care provider will ensure:-. A register is kept of all patients with locally advanced prostate cancer patients stable on treatment to be managed within primary care; Page 5 of 15

6 Each patient on the register is contacted to arrange a review consultation within primary care with a 6 monthly frequency; Any patient failing to make an appointment or failing to attend for the review consultation will be followed up. Should a patient no longer wish to receive follow-up, this should be documented clearly in the patient s records and the reason stated; Each patient on the register to have a named GP who will take responsibility for managing the care of the patient; The agreed protocols for management of patients with locally advanced prostate cancer stable on treatment will be adhered to for the management of every patient. It is the provider s responsibility to ensure that the protocols used reflect the most up to date version; Specialist advice will be sought wherever required; All patients will be informed of the results of any tests. 9 Model for the service pathways / interfaces: Process for managing stable prostate cancer patients in primary care Patient identified as suitable for follow up in primary care Patient discharged from secondary care once established on treatment with a proven remission. (Use discharge letter template) GP practice organises follow-up appointment PSA blood test taken Patient consultation (As per protocol template attached) Refer back to 2ary care? No Yes Continue monitoring in primary care Refer back to 2ary care as per protocol Page 6 of 15

7 10 Client group served / eligibility / access criteria: The service will be for those patients identified within acute hospital care with locally advanced prostate cancer who are stable on hormone manipulation and appropriate for management within a primary care setting. The service should not currently be provided to patients with Hormone Relapsed Prostate Cancer (HRPC) or those patients on an Active Surveillance regime. The primary care provider will be responsible for contacting the patients discharged from acute care to arrange the initial, and all subsequent, appointments for review consultations. The expected activity levels for the service are based on estimates of 634 patients for the population of Derbyshire (735,875). It is expected that the majority of patients will need to be seen twice a year. If the eligibility criteria changes to encompass a wider range of patients, then the costings of the Basket will be reviewed. 11 Quality targets: The service will only be commissioned from appropriate providers who can demonstrate that they have achieved, or are working towards, Care Quality Commission (CQC) registration requirements and compliant with the essential standards relating to quality and safety Incident reporting - Any Serious Untoward Incident must be reported to the Primary Care Clinical Quality team within 24 hours as per NHSDC Guidelines using the PCT`s incident reporting form. This is in addition to the practitioner s statutory obligations. Each provider will identify a Clinical lead for this service. 12 Output and outcome measure requirements: Measurement metrics Number of patients listed on GP register with locally advanced prostate cancer stable on treatment (Read codes Xalma, etc) Number of patients listed on GP register with locally advanced prostate cancer stable on treatment re-referred into secondary care (read code 8HZ0) Number of consultations held within primary care for patients listed on GP register with locally advanced prostate cancer stable on treatment Number of DNA s coded for patients listed on GP register with locally advanced prostate cancer stable on treatment Page 7 of 15

8 13 Details of service monitoring, evaluation and review process / timescales: Data required Number of patients listed on GP register with locally advanced prostate cancer stable on treatment Number of patients listed on GP register with locally advanced prostate cancer stable on treatment re-referred into secondary care Number of consultations held within primary care for patients listed on GP register with locally advanced prostate cancer stable on treatment Read code Xalma etc Frequency and Timing Annual Mode System report 8HZ0 Annual System report Annual System Report Number of DNA s coded for patients listed on GP register with locally advanced prostate cancer stable on treatment Annual System report 14 Workforce / staffing: All providers delivering the service need to have appropriate training and accreditation. A training module has been created to provide accreditation and can be accessed via the following website following a search on Cancer of the Prostate. A certificate will be provided upon completion of all 10 modules. As a minimum, modules 1 and 4 should be completed. A record of completion of the accreditation training should be maintained for all practitioners providing the service. The responsibility of establishing and maintaining the record of training is with the lead clinician for the service. 15 Clinical and corporate governance: Any GP practice delivering this service will be expected to be working towards the Care Quality Commission (CQC) registration and be compliant with the essential standards for quality and safety. 16 Policies / protocols / legal requirements: Page 8 of 15

9 Delivery of the service will be in line with the provider service operational policy. 17 List of Appendix Appendix 1 Example of a discharge letter Appendix 2 - Protocol for GP led management of patients with established locally advanced prostate cancer, stable on treatment Appendix 3 Prostate Coding Appendix 4 - Trigger for re-referral to secondary care Page 9 of 15

10 Appendix Discharge letter template Dear Dr. Your patient was diagnosed with locally advanced prostate cancer in. Features of his disease at diagnosis included T(insert 3 or 4 as appropriate, a Gleason sum score of (x + x) and a presenting PSA of Hormone manipulation has been achieved by (orchidectomy or LHRH a) and his PSA has fallen to.ng/ml It is likely that his PSA will remain suppressed for some time now (the average length of time that a PSA will remain suppressed is 2 years). It is therefore perfectly reasonable for his follow up care to be provided in primary care. I enclose a copy of the protocol for GP- led management of patients with established locally advanced prostate cancer, stable on treatment. This group of patients should be seen at 6 monthly intervals (following discharge) with a PSA test (with the results placed in the context of the patient s PSA history), symptom review and review of side effects of treatment. The triggers for re-referral back to secondary care are: 3 successive rises in PSA (over a 12 month period) If the PSA nadir is greater than 10 ng/ml, a doubling of PSA from nadir. Symptoms of bladder outflow obstruction bothersome enough to merit treatment Symptoms of metastatic disease (bone metastases for example) Best Wishes Page 10 of 15

11 Appendix Protocol for GP led management of patients with established locally advanced prostate cancer, stable on treatment. Hormone manipulation will be by LHRH analogue, bilateral orchidectomy or anti-androgen. Patients with disease thought not to secrete PSA (and who did not have a high PSA before starting treatment) will not be discharged. Patients with known metastatic disease at diagnosis will not be discharged. North Trent Guidelines suggest these patients should be seen at 6-month intervals as at present. GPs would need to do the same. RISKS Missing signs of progression and opportunity for timely, appropriate intervention. Risk low in this group. Protocol Patient will be discharged from secondary care once established on treatment with a proven remission (fall of presenting PSA and improvement in any presenting symptoms such as those associated with lower urinary tract). To be seen by GP, with PSA test at 6 monthly intervals Purpose of GP consultation (please see notes below) 1. Review of PSA in context of presenting, pre-treatment PSA and PSA nadir (the lowest PSA value after starting hormonal treatment) 2. Ensure patient compliance with treatment (i.e. LHRHa given on time) 3. Review of lower urinary tract symptoms 4. Review of possible symptoms associated with metastatic disease. 5. Review of side effects of treatment 1.Review of PSA in context of presenting, pre-treatment PSA. More than 90% of patients with locally advanced prostate cancer will respond to hormone manipulation. The average length of response is 2 years although there are many patients who are in remission for many more years (and obviously some who are in remission for a short time only). However, if the patient lives long enough, it is inevitable that the disease will become hormone resistant (sometimes called hormone refractory). There are many prostate cancer specific treatment options available to those with Hormone Resistant Prostate Cancer (HRPC) (quite separate from those offered by general palliative care) and when the patient develops HRPC, he should be referred back to Nicky James, UNSON in secondary care. PSA measurement in these patients is no longer indicated or indeed relevant in there further management Definition of HRPC 3 successive rises in PSA from nadir (lowest PSA value) A doubling of PSA from nadir for those whose PSA did not ever fall to below a value of Ensure patient compliance with treatment. Many patients are elderly. Others have other problems such as dementia. It is not infrequently discovered that a patient has not been having his LHRH analogues regularly. If this fact is established, and the patient has missed an injection by more than 2 weeks, advice should be sought. It may be that hormone manipulation needs to start from the beginning, with awareness of the risk of a possible tumour flare response. To prevent this when initiating LHRH therapy, we use an anti-androgen (such as cyproterone acetate 100mgs tds) for a week before and two weeks after the Page 11 of 15

12 first LHRH injection. Consideration should be given to the possibility of offering bilateral orchidectomy to those for whom compliance may be a problem. 3. Review of lower urinary tract symptoms It is possible that patients with locally advanced disease may have associated lower urinary tract symptoms. Patients usually report an improvement once hormone manipulation has commenced. However, those who then report bothersome symptoms of bladder outflow obstruction should be investigated. 4. Symptoms associated with metastatic disease It is unlikely if the PSA is well suppressed (must be regarded in the context of PSA history, in particular PSA at diagnosis), that the disease will progress. However there are of course exceptions to this and there should be a low threshold for requesting a bone scan should the patient complain of persistent bone pain, even with a suppressed PSA. 5. Possible side effects of treatment Impotence If this is a significant issue for the patient, he should be referred back to discuss alternative treatments and the implications of them, (i.e. switch from LHRHa to anti-androgen) or possible ED intervention (although often not successful). Hot flushes- A common side effect. If this interferes with quality of life, Evening Primrose Oil can be used with success. Sage is also documented in the literature, taken as a sage infusion. We would advise these as first line therapies. If the hot flushes are severe and are compromising quality of life, provided there is no liver impairment, we would use Cyproterone Acetate 50 mgs OD, having warned the patient of potential impact on liver. We would request Liver Function Tests at 2 weeks and then at 6-monthly intervals, combined with PSA testing. Depression Not infrequently seen. Low threshold for using anti-depressant medication. Lethargy Many patients believe this to be related to the cancer diagnosis itself and are reassured when told that it is likely to be related to the hormone manipulation. Osteoporosis Particularly after long periods of hormone manipulation. Bone density scans are not yet routinely offered, although it is likely that this will be routinely offered in the future. Local reaction to insertion of LHRHa- This is occasionally seen and is usually addressed simply by switching the patient from one preparation to the other (i.e. Zoladex to Prostap or vice-versa). Page 12 of 15

13 Appendix CTV3 - Prostate Coding In line with V2 Codes advised in Prostate LES CTV 3 (TPP SystmOne) XaIma Gleason grading of prostate cancer XaImd Gleason prostate grade 8-10 (high) XaImc Gleason prostate grade 5-7 (medium) XaImb Gleason prostate grade 2-4 (low) 4M5.. TNM tumour staging X70kq Isotope bone scan XE25C PSA - Serum prostate specific antigen level X76XS Urinary symptoms 1A25. Urgency - urination 1A34. Hesitancy 1A33. Micturition stream poor X76Xq Incomplete emptying of bladder X76Y0 Dribbling of urine XE0e5 Haematuria X75rq Bone pain XaIty Sleeping pattern XaFqs Good sleep pattern XaFqr Poor sleep pattern E2273 Erectile dysfunction XaMBP Treatment of erectile dysfunction NEC X766x Lack of libido Appetite symptom Appetite normal Increased appetite Ua1iv Reduced appetite XE0qb Abnormal weight loss XaILA Lifestyle XaA2V Discussion about activity of daily living XaJKJ Drug side effects checked XaIpP Discussed with patient 918F. Has a carer 8HZ0. Referral needed 9N1l. Seen in prostate clinic Compiled April 2010 Page 13 of 15

14 Appendix Trigger for re-referral to secondary care 3 successive rises in PSA (over a 12 month period) If the PSA nadir is greater than 10 ng/ml, a doubling of PSA from nadir. Symptoms of bladder outflow obstruction bothersome enough to merit treatment. Symptoms of metastatic disease (bone metastases for example) Referral back to Urology Referrals should be made as Urgent and the following should be included within the referral letter/template Title - Re-referral of Prostate cancer patient receiving Primary Care follow up. The name of the previous urologist who provided the patients care Reason for referral back into secondary care Page 14 of 15

15 18 References (1) National Institute for Clinical Excellence (NICE). Prostate Cancer Diagnosis and Treatment February (2) National Institute for Clinical Excellence (NICE). Improving Outcomes in Urological Cancers. The Manual (3) Department of Health. Cancer Reform Strategy Delivering Care in the Appropriate Settings gitalasset/dh_ pdf (4) Department of Health. Delivering Care Closer to Home cuments/digitalasset/dh_ pdf (5) Cancer Research UK (6) Cancer Factsheet Derbyshire County PCT Trent Cancer Registry Page 15 of 15