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Aim • Identify remediable factors in the care received by patients • Proposed by the JSC and JCCO as there was a belief that the standard of care was not uniform across the country Expert group • Medical/clinical and haemato- oncologists • Palliative medicine physician • Pharmacist • Chemotherapy nurse • Patient representative Key areas defined • The decision to treat • Prescription and administration • The safety of treatment • End of life care • Communication • Clinical governance Inclusion criteria • • • • Patients aged 16 years or over Solid tumours or haematological malignancies Received chemotherapy, monoclonal antibodies or immunotherapy during the study period Died within 30 days of receiving treatment Data collection • Questionnaire A • Questionnaire B • Casenotes • Organisational questionnaire Advisor groups • All cases anonymised • Clinical/medical/haematooncologists • Palliative medicine physicians • Pharmacists • Chemotherapy nurse specialists • Assessed all aspects of care Overall assessment of care • • • • • Good practice Room for improvement: clinical care Room for improvement: organisational care Room for improvement: clinical care & organisational care Less than satisfactory Cases identified • 47,050 treatment cases • 55,710 deaths from any cause • 1415 cases identified Data returned Recommendation Cancer services managers and clinical directors must ensure that time is made available in consultants’ job plans for clinical audit. They must also ensure that the time allocated is used for the defined purpose. (Cancer Services Managers and Clinical Directors) Classification of hospitals Hospital workload Staffing Emergency admissions facilities General medical support Other specialties onsite • • Critical care – 204/291 Level 3 – 243/290 Level 2 Palliative care – • 81/156 consultant palliative care sessions Resuscitation teams – 11 hospitals did not have one onsite Recommendation Hospitals that treat patients with SACT but do not have the facilities to manage patients who are acutely unwell should have a formal agreement with another hospital for the admission or transfer of such patients as appropriate. (Medical directors) • Aim • Interpretation • Limitations • Results Overall quality of care Room for improvement • Decision to treat • Process of care – Prescribing, dispensing and administration of SACT • Communication – Patient information, medical records • SACT toxicity – Admission, assessment and treatment – Management of neutropenic sepsis • End of life decisions Advisors opinion on the decision to treat Advisors’ opinion 513/546 cases Appropriate Decision 81% Inappropriate Decision 19% Reasons - Poor performance status - Abnormal of investigations INCREASED TOXICITY - End stage disease - Lack of evidence of efficacy DECREASED BENEFIT Decision to treat PATIENT’S DECISION DISCUSSION OF TREATMENT OPTIONS ONCOLOGIST’S ASSESSMENT CLINICAL MANAGEMENT PLAN MDT DISCUSSION Multi-disciplinary team meetings STANDARD The management of all cancer patients should be discussed at regular MDT meetings. Manual for Cancer Services: 2004 MDT discussion 58% CURATIVE treatment intent PALLIATIVE treatment intent 88% 51% FIRST LINE SACT PREVIOUS SACT 43% 73% Tumour and patient characteristics • • • • Tumour type Tumour stage Previous SACT Medical complications of malignancy • Patient’s age • Patient’s performance status • Patient’s co-morbidities Solid tumours Haematological malignancies SACT regimens • Carboplatin and Etoposide • Capecitabine • Gemcitabine and Carboplatin • Oxaliplatin • Carboplatin • R-CHOP and CHOP Performance score Clinical management plan Decision to treat DECISION TO TREAT ADVISOR APPROPRIATE 81% ADVISOR INAPPROPRIATE 19% ONCOLOGIST APPROPRIATE 82% ONCOLOGIST DIFFICULT DECISION 18% DECISION JUSTIFIED 5% QUESTIONABLE 7% PATIENTS CHOICE INAPPROPRIATE DECISION 6% Patient information 433/546 cases Verbal – doctor Org Q Cases >95% 66% Verbal – nurse Chemotherapy leaflet 13% >95% Clinical trial information 27% 4% BACUP booklet >95% 10% Audio-visual information 56% <1% Consent forms 310/546 cases STANDARD Written information should be provided on • treatment intention and expected response rates • acute and possible late side effects • mortality rates Obtaining Consent for Chemotherapy: British Committee for Standards in Haematology Guidelines DOCUMENTATION ON CONSENT FORM Most common side effects 75% Most serious side effects 52% Mortality risk 9% Recommendations NCEPOD supports the Manual for Cancer Services standard that initial clinical management plans for all cancer patients should be formulated within a MDT meeting. (Clinical directors) Recommendations Giving palliative SACT to poor performance status patients grade 3 or 4 should be done so with caution and having been discussed at a MDT meeting. (Consultants) Recommendations Consent must only be taken by a clinician sufficiently experienced to judge that the patient’s decision has been made after careful consideration of the potential risks and benefits of the treatment, and that treatment is in the patient’s best interest. (Clinical directors) Recommendations All deaths within 30 days of SACT should be considered at a morbidity and mortality or a clinical governance meeting. (Clinical directors and consultants) Process of care SACT ADMINISTRATION SACT PRESCRIPTIONS PRE-TREATMENT ASSESSMENTS STAFF - TRAINING AND ACCREDITATION Authorisation to prescribe SACT STANDARD Chemotherapy must be initiated and prescribed only by clinicians who are appropriately accredited and/or experienced Good Practice Guidance for Clinical Oncologists: RCR List maintained Yes Unknown Initiator Prescriber 77% 71% 24/285 28/285 SACT initiators SACT prescribers SACT prescribing accreditation • Independent prescribers n=32 – 6 at the consultant’s discretion – 23 post formal assessment and accreditation – 3 unknown Initiator, prescriber, reviewer Pre-treatment investigations Pre-treatment assessments STANDARDS Toxicity should be recorded for each cycle using the Common Toxicity Criteria The outcomes of treatment should be monitored closely Appropriate action should be taken if - the side-effects are excessive - the cancer progresses. Chemotherapy Guidelines: COIN 2001 Casenotes available 267/278 Documentation of toxicity and tumour response • Toxicity – Record of assessment – 64% – Toxicity checklist – 26/267 • Tumour response – Record of assessment – 54% Prescriptions STANDARD All prescriptions of cytotoxic chemotherapy should be computer generated at least when using regimens from the agreed list. Manual for Cancer Services: 2004 n=426 Route of SACT administration Recommendation All independent and supplementary prescribers (specialist chemotherapy nurses and cancer pharmacists) and junior medical staff should be locally trained/accredited before being authorised to prescribe SACT. (Cancer services managers and clinical directors) Recommendation Junior medical staff at FY1, FY2, ST1 and ST2 grade should not be authorised to initiate SACT. (Clinical directors) Toxicity check lists should be developed to assist record keeping and aid the process of care in prescribing SACT. (Cancer services managers and clinical directors) Safety of SACT delivery LIMIT SACT TOXICITY NURSE CHECKS PHARMACY CHECKS DOSE REDUCTIONS / TREATMENT DELAYS Adjustments to SACT regimen Prescription safety checks STANDARD All cytotoxic chemotherapy prescriptions should be checked and authorised by a pharmacist. Manual for Cancer Services: 2004 Prescriptions checked Yes Unknown Parenteral Oral 97% 73% 21/295 30/295 Prescriptions reviewed 369 Evidence that the prescription had been checked 53% SACT administration safety checks STANDARD Doctors or specialist nurses who administer chemotherapy must perform checks with a colleague to confirm patient identity, drug regimen, dosage, route of administration and frequency. Good Practice for Clinical Oncologists: RCR 2003 POLICY – two nurses to check SACT 89% of organisations EVIDENCE – two nurses checked SACT 71% cases Recommendations All SACT prescriptions should be checked by a pharmacist who has undergone specialist training, demonstrated their competence and are locally authorised/accredited for the task. This applies to oral as well as parenteral treatments. (Clinical directors and pharmacists) Recommendations Pharmacists should sign the SACT prescription to indicate that it has been verified and validated for the intended patient and that all the safety checks have been undertaken. (Pharmacists) Overall opinion on final cycle of SACT • Inappropriate in 154/435 (35%) – Inappropriate decision to initiate final COURSE of SACT – Inappropriate timing or doses of final CYCLE of SACT – Progressive disease • • • • Information for patients who become unwell Admission to hospital and management of sepsis Deaths after SACT and end of life care The need for regular audit Information for unwell patients: standards There should be written information for patients detailing how to seek advice if they become unwell with complications of chemotherapy Manual for Cancer Services: Department of Health 2004 Patients should have access to appropriate advice and care at any time, day or night, should they suffer unexpected consequences of treatment Good Practice Guide for Clinical Oncologists: Royal College of Radiologists Grade 3 and Grade 4 toxicity 220/514 (43%) cases Information for unwell patients: findings • 96% of hospitals provided information to patients about what to do if they become unwell • 43% of patients who died within 30 days of SACT suffered grade 3 or 4 treatment related toxicity Patient delay in reporting side effects Examples of good practice in patient education • Nurse and/or pharmacist led education clinics • Follow up call from hospital to patient • Dedicated phone line for patients to call • • • • Information for patients who become unwell Admission to hospital and management of sepsis Deaths after SACT and end of life care The need for regular audit Hospital admissions after SACT If a patient becomes unwell after receiving SACT due to side effects, progression of disease, or worsening co-morbidity they must be able to get appropriate advice and if necessary admission under the care of an appropriate specialist. Emergency admission policies Emergency admission policies • 85% of patients admitted to hospital within last 30 days of life • Of those 18% (nearly 1 in 5) were not admitted to the hospital in which they received SACT Specialty of first admission during last 30 days of life Time to review by oncologist Appropriateness of specialty for patient’s condition • May depend on the reason patient is unwell • Time to specialist review - may exclude telephone review • Additional training? • Shift in care of emergency admissions? Recommendation In planning the provision of oncology services outside of cancer centres, commissioners should take into account the need for specialist advice to be readily available when patients are admitted acutely. (Cancer services managers) Management of neutropenic sepsis: standards Intravenous antibiotics should be commenced within 30 minutes in 100% of patients who have received recent chemotherapy and who are shocked. Chemotherapy Guidelines: COIN 2001 Management of neutropenic sepsis: standards Every acute hospital should have written guidelines on the diagnosis and management of neutropenic sepsis. All medical staff should be aware of their existence and a copy should be readily available in all relevant clinical areas including Accident & Emergency. Chemotherapy Guidelines: COIN 2001 Management of neutropenic sepsis: standards Networks should agree, document and disseminate guidelines for both prophylaxis and management of neutropenic sepsis …… These patients should be managed by a specialist haemato-oncology MDT. Improving outcomes in haematological cancer: NICE 2003 Neutropenic sepsis policy Recommendation Emergency admissions services must have the resources to manage SACT toxicity These should include:–A clinical care pathway for suspected neutropenic sepsis –A local policy for the management of neutropenic sepsis –Appropriately trained staff familiar with the neutropenic sepsis policy –The policy should be easily accessible in all emergency departments –Availability of appropriate antibiotics within the emergency department (Cancer services managers and clinical directors) • • • • Information for patients who become unwell Admission to hospital and management of sepsis Deaths after SACT and end of life care The need for regular audit Where patients died Effect of treatment on outcome Why patients died Deaths after SACT and end of life care “how we care for the dying is an indicator of how we care for all sick and vulnerable people” (Ivan Lewis care service minister, Department of Health 2008) Do Not Attempt Resuscitation (DNAR) • Hospital trusts are required to have resuscitation policies in place to support people’s choices about future care and treatment DNAR End of life care pathways • Developed for cancer patients • Only found in notes of 57 patients End of life care pathways • Help those with advanced, progressive, incurable illness to live as well as possible until they die • Enable the supportive and palliative care needs of both patient and family to be identified and met throughout the last phase of life and into bereavement • Includes management of pain and other symptoms and provision of psychological, social, spiritual and practical support (National Council for Palliative Care 2006) Recommendation A pro-active rather than reactive approach should be adopted to ensure that palliative care treatments or referrals are initiated early and appropriately: Oncologists should enquire at an appropriate time, about any advance decisions the patient might wish to make should they lose the capacity to make their own decisions in the future. (Consultants) • • • • Information for patients who become unwell Admission to hospital and management of sepsis Deaths after SACT and end of life care The need for regular audit Audit • Neutropenic sepsis in solid tumours was audited in 45% (101/224) hospitals • Neutropenic sepsis in haematological malignancies was audited in 51% (100/196) Audit • Solid tumours: 24% of hospitals • Haematological malignancies: 14% of hospitals • The deaths of only 16% of patients in this study were discussed Which cases were discussed The need for regular audit • Most hospitals held regular audit/clinical governance meetings • About half discussed adherence to NICE guidelines but only a quarter discussed chemotherapy toxicity Recommendations Regular clinical audit should be undertaken on the management of all cases of neutropenic sepsis following the administration of SACT. (Clinical directors) Recommendations All deaths within 30 days of SACT should be considered at a morbidity and mortality or a clinical governance meeting. (Clinical directors and consultants) Thank you www.ncepod.org.uk