ELECTROCONVULSIVE THERAPY (ECT) POLICY

Transcription

1 ELECTROCONVULSIVE THERAPY (ECT) POLICY Version: 5 Ratified by: Senior Management Team Date ratified: January 2017 Title of originator/author: Title of responsible committee/group: ECT Lead Consultant Clinical Governance Group Date issued: January 2017 Review date: January 2020 Relevant Staff Groups: Mental Health Medical Staff and ECT Clinic Staff This document is available in other formats, including easy read summary versions and other languages upon request. Should you require this please contact the Equality and Diversity Lead on V5-1 - January 2017

2 DOCUMENT CONTROL Reference Version NA/Aug15/ECT 5 Status Final Author ECT Lead Consultant Updates to DVLA guidance and addition of new Guidelines for Amendments Patient Referral and Escort Duties, plus Amendments to reflect Equality and Diversity. Document objectives: The purpose of this document is to provide a policy to ensure safe and consistent provision of ECT reflecting current best practice and legal requirements. Intended recipients: Mental health medical and nursing staff. Committee/Group Consulted: IQUIS Best Practice Group, CPRG Monitoring arrangements and indicators: The Trust s ECT service is subject to ongoing monitoring via the national ECTAS scheme. Training/resource implications: Training requirements as recommended by the ECTAS scheme. Clinical governance Approving body and date Date: November 2016 Group Formal Impact Assessment Impact Part 1 Date: August 2016 Clinical Audit Standards YES Date: TBA Ratification Body and date Senior Managers Operational Group Date of issue January 2017 Review date January 2020 Contact for review Lead Director ECT Lead Consultant Medical Director Date: January 2017 CONTRIBUTION LIST Key individuals involved in developing the document Name Dr N Airey Dr C Mortimore Dr J Hendry Dr H Elhamoui Nick Woodhead Members Members Paul Watts Designation or Group ECT Clinic Lead Consultant Psychiatrist ECT Clinic consultant psychiatrist ECT Clinic associate specialist psychiatrist ECT Clinic Doctor in Training Mental Health Act Coordination Lead IQUIS Best Practice Group Clinical Governance Group Head of Mental Health Nursing V5-2 - January 2017

3 CONTENTS Section Summary of Section Page Doc Document Control 2 Cont. Contents 3 1 Introduction 4 2 Purpose & Scope 4 3 Duties and Responsibilities 4 4 Explanation of Terms Used 5 5 ECT Procedures 6 6 Training Requirements 14 7 Equality Impact Assessment 14 8 Monitoring Compliance and Effectiveness 15 9 Counter Fraud Relevant Care Quality Commission (CQC) Registration Standards References, Acknowledgements and Associated documents 12 Appendices 17 Appendix A ECT Clinic Protocol 18 Appendix B Clinical Audit Standards 24 Appendix C Royal College of Psychiatrists Patient Leaflet 27 Appendix D Consent Form 1 Patient Agreement to ECT 39 Appendix E Consent Form 2 Adults who are unable to consent to ECT 44 Appendix F Appendix G Consent Form 3 Confirmation of Consent to ECT (completed by ECT clinic staff) 51 Day Patient Aftercare Form (completed by ECT clinic staff) 52 Appendix H ECT Session Record 53 Appendix I ECT Competencies for Doctors (RCPsych 2013) 54 Appendix J ECT Guidelines for Patient referral and Escort Duties V5-3 - January 2017

4 1. INTRODUCTION 1.1 Electroconvulsive Therapy (ECT) is a well established, high effective and safe treatment for severe mental illness, including severe treatment resistant depression, treatment resistant mania and also catatonia. The use of ECT in selected patient groups is recommended by the Royal College of Psychiatrists and is supported by National Institute for Clinical Excellence (NICE) Clinical Guidelines. 1.2 ECT can be a life saving treatment when other options are unavailable because of contraindications, other clinical factors or where other treatments have been ineffective. 1.3 ECT involves the application of an electrical current to the brain to induce an epileptic fit. The treatment is undertaken under a general anaesthetic, with a muscle relaxant to modify the seizure. 2. PURPOSE & SCOPE 2.1 The purpose of this policy is to ensure that the Trust provides a high quality, safe and effective ECT service, which meets legal obligations and nationally agreed standards. 2.2 The Policy and the ECT protocol (Appendix A) provide assurance that the Trust meets legal requirements in relation to capacity and consent and the use of the Mental Health Act (MHA) and Mental Capacity Act (MCA). It also sets standards in relation to the ECT Clinic facilities, the assessment and preparation of patients, the administration of ECT, anaesthetic practice, recovery and monitoring and special precautions in particular patient groups. Clinical audit standards for ECT (Appendix B) are based on national guidance including relevant NICE Clinical Guidelines (Technology Appraisal 59, 2003 and Clinical Guidelines 90, Depression in Adults, 2009). 2.3 The Royal College of Psychiatrists provides an Electroconvulsive Therapy Accreditation Service (ECTAS). This service oversees the national accreditation of ECT clinics according to agreed standards in line with both the ECT handbook (Royal College of Psychiatrists, 2013) and with NICE. The procedures and requirements of this policy meet ECTAS standards. 3. DUTIES AND RESPONSIBILITIES 3.1 The Trust Board has overall responsibility for procedural documents and delegates responsibility as appropriate. 3.2 The Lead Director is the Medical Director. V5-4 - January 2017

5 3.3 The Author is the ECT Clinic Lead Consultant Psychiatrist and will be responsible for producing written drafts of the document, for consulting with others and amending the draft as appropriate. The document will be reviewed at least every three years or sooner if there is a major change to law, legislation or circumstances arise which have significant impact on this document. 3.4 Responsibility for implementing the policy is devolved to Heads of Division. 3.5 The Head of Corporate Business has responsibility for holding the central database of procedural documents, including this policy, and for providing quarterly reports to the Regulation Governance Group highlighting which policies are due for review. The Corporate Governance Team also has responsibility for dissemination of the final document and archiving old versions. 3.6 All medical, pharmacy and inpatient nursing staff including temporary staff are individually responsible for their actions including complying with this policy. All staff who may be involved in the use of ECT must adhere to this policy and appendices, including all ECT Clinic staff and also inpatient and community staff who refer patients for ECT. 3.7 The Improving the Quality of Mental Health Inpatient Services Best Practice Group has responsibility for undertaking audit and signing off key recommendations. 4. EXPLANATION OF TERMS USED ECT ECTAS IQUIS Electroconvulsive Therapy Royal College of Psychiatrists Electroconvulsive Therapy Accreditation Service Improving the Quality of Mental Health Inpatient Services Best Practice Group MHA Mental Health Act (1983) MCA Mental Capacity Act (2005) Section 58 The Section of the MHA dealing with treatment requiring consent or a second opinion. Section 58A deals specifically with ECT. Section 62 The Section of the MHA dealing with emergency treatment. V5-5 - January 2017

6 SOAD Second Opinion Appointed Doctor, authorised by the Care Quality Commission to provide an independent second medical opinion on whether it is appropriate for medical treatment for mental disorder to be given under the MHA. 5. ECT PROCEDURES 5.1 Consent and capacity Patients undergoing ECT are provided with appropriate written information to allow them to give informed consent (Appendix C). The patient must be able to understand the information given to them and it must be in a language or format they can easily understand; this may necessitate the use of a professional interpreter. Trust consent forms comply with Department of Health guidelines: Consent Form 1 for consenting patients with capacity (Appendix D) and Consent Form 2 for patients lacking capacity (Appendix E). Consent status is confirmed before each individual ECT treatment (Appendix F) ECT must be considered together with capacity and consent within the current legal framework, which includes the Mental Capacity Act (2005) and the Mental Health Act (1983 with 2007 amendments). Procedures for detained patients (Section 58A and Section 62 of the MHA), are described in paragraphs below, including the use of Forms T4 & 6, the role of the Second Opinion Appointed Doctor (SOAD) and the implications of a valid Advanced Directive Patients who have capacity and are refusing cannot be given ECT regardless of their legal status (except under Section 62 if ECT is immediately necessary to either save the patient s life or prevent a serious deterioration in their condition). This additional safeguard for ECT was introduced in Section 58A (2007 amendments) which states that If the patient is capable of understanding the nature, purpose and likely effects of the treatment, then ECT cannot be given without his consent. If the patient lacks capacity then ECT must be certified as "appropriate" and must not conflict with an advance decision (which the registered medical practitioner concerned is satisfied is valid and applicable) or with a decision made by a donee or deputy or by the Court of Protection Capacity Assessment: The Mental Capacity Act (2005) states that there should be an initial presumption that every adult has capacity. In order to have capacity to make a particular decision the patient must be able to: understand the information relevant to the decision. retain that information long enough to make a decision. weigh up the pros and cons of the information and come to a decision and communicate their decision. V5-6 - January 2017

7 A valid and applicable advance decision refusing ECT must be respected; it holds the same status as a refusal by a capacitated patient. If it relates to life saving treatment, then the advance decision must be made by a person with the capacity to do so, in writing, signed by the author and witnessed. It must also relate specifically to the treatment being considered and contain the words even if life at risk. If a person lacks capacity then an Independent Mental Capacity Advocate (IMCA) must be appointed when the decision being made concerns ECT and the person has no-one (or only paid carers) who can be consulted as part of the best interests decision making process. It is not permissible to assume consent in informal patients who lack capacity, but who appear to comply with treatment. Compliance does not equate to consent Patients with Capacity who are Consenting to ECT: Outpatients and informal inpatients must sign the Trust Consent Form (Consent Form 1, Appendix D) Detained patients under Section 2, 3 or 37 of the Mental Health Act (MHA) must sign the Trust Consent Form (Consent Form 1, Appendix D) and the Approved Clinician in charge of treatment must also complete and sign Form T4 (Section 58A(3)) No detained child or young person under 18 may be given ECT for mental disorder unless it is approved by a SOAD (the Approved Clinician cannot authorise). Ongoing consent cannot be assumed and before each treatment the ward staff, and particularly the doctor, must ensure the consent remains valid. The ECT clinic staff will also check with the patient that they continue to consent to treatment (Appendix F) Patients lacking Capacity: Informal Patient: the doctor will need to comply with the Mental Capacity Act and may consider whether use of the Mental Health Act / SOAD is indicated. Until then Consent Form 2 (Appendix E) must be completed, which involves the family +/- an informal second opinion. Emergency ECT can be given on a best interest basis in to save the patient s life. Detained Patient: ECT may be given if approved by a SOAD on Form T6 (Section 58A(5)), a process that includes consideration of any valid Advanced Directive. If awaiting the SOAD would jeopardise the patient s life, one or two emergency treatments may be given under the provisions of Section 62. The Royal College of Psychiatrists position is that it is good practice for the Approved Clinician in charge of treatment to discuss the case with a colleague and document this discussion in the notes i.e. treat as a second opinion. A separate Section 62 Form must be completed for each individual ECT treatment. If there is a delay in the SOAD attending despite a timely request, it is permissible to complete further Section 62 forms to ensure that ECT treatment continues until properly sanctioned. If capacity returns during the V5-7 - January 2017

8 course of treatment, then further treatments cannot be given, unless the patient consents (they must sign the Trust Consent Form 1 (Appendix D)) and the Approved Clinician completes Form T Summary table of Consent and Capacity with required forms: Assessment of patients over 18 years for ECT in England and Wales. Legal Status Has Capacity? Resisting or objecting? Recommended action Yes No Treat under normal rules of written consent (Consent Form 1, Appendix D) Yes Yes Cannot treat with ECT Informal No No It may be possible to treat under Section 5 of the Mental Capacity Act. Independent opinion (informal) advised. (sign consent form 2, Appendix E) No Yes Not appropriate to use the Mental Capacity Act. If ECT is to proceed, the patient may need to be detained under the Mental Health Act + SOAD Yes No Treat with written consent that must be certified on (form T4) Detained (where Part IV of the Mental Health Act applies) Yes Yes Cannot treat with ECT except to save life or prevent serious deterioration (Section 62) No No Treat if approved by SOAD from CQC on (Form T6) No Yes Treat if approved by SOAD from CQC on (Form T6) (From the royal College of Psychiatrists ECT Handbook, 3rd edition, 2013) Statutory forms are available on the Trust intranet or from ) (click here to download all forms): V5-8 - January 2017

9 Form T1: is used as consent to treatment for invasive procedures. Form T2: is for detained but consenting patients for medication. Form T3: is the SOAD Certificate for approving medication [Form T4 to T6 apply only to ECT]. Form T4: Is for use in a detained patient, who has capacity and is consenting to ECT treatment. Form T5: Concerns ECT treatment in the under 18 years of age. Form T6: Is the SOAD Certificate for those lacking capacity Complete records are made on the patient electronic record (RiO). However, all consent forms are also retained in paper format in the ECT clinic files along with the ECT Prescription and Record Sheets (Appendix H). 5.2 Preparation of the patient for ECT Preparation for ECT is crucial and must include the patient s own consultant in the referring medical team (or another psychiatrist on the Specialist Register) giving a full explanation of the procedure to the patient and, whenever applicable to the family / carer. This explanation must include discussion of potential benefits and risks, including side effects. Information must be given to the patient in a language or format they can easily understand; this may necessitate the use of a professional interpreter Informed consent must be obtained from the patient before commencing the course of ECT (see 5.1 above). An entry must be made in the Electronic Patient Record confirming assessment of capacity, the provision of relevant information and the consenting process. All relevant paperwork (Consent Forms and Forms T4 or T6) must accompany the patient to the clinic Since some medical conditions can increase the risk associated with ECT, it is important that all patients being considered for ECT are clinically evaluated before treatment. The information given to the patient during the consent procedures must include relevant individual risk factors as well as more general information. All patients must have had a comprehensive physical assessment and clinical investigations as indicated. These include an ECG for all patients over 50 (or, in younger people, if there are cardiac or respiratory problems). A Full Blood Count, Urea & Electrolytes and Creatinine should be taken in all patients. All this information must be documented in the Specialist ECT Assessment forms (Assessment>Specialist>ECT>Preparation for ECT) Other clinical investigations should be undertaken as appropriate, including Chest X-ray, blood Glucose, Clotting Studies and Sickle Test Patients must have all relevant documentation entered into the Rio Core Assessment, Care Plan and Specialist ECT Assessment forms. V5-9 - January 2017

10 5.2.6 All patients must be graded by the prescribing doctor, as per the ASA (American Society of Anaesthesiologists) Guidelines. Details of this grading system can be found on the ECT Prescription Sheet (See Appendix H) The doctor at the ECT clinic or the patient s usual consultant (or their deputy) must prescribe each individual ECT treatment on the appropriate Trust form (ECT Prescription Sheet - Appendix H). The ECT Clinic medical staff will determine the dose of ECT to administer (See ECT Protocol Appendix A, Section 6) The patient s own consultant (referring medical team) must indicate whether they wish the patient to receive unilateral or bilateral treatment; this must be documented on Consent Form 1 (Appendix D), along with the maximum number of treatments to be given. These decisions may be taken in collaboration with one of the ECT clinic doctors Referrals for ECT must be made in writing using the Trust ECT Clinic address ( ECT in the Global Address List). Referrals must be made at least two working days in advance and the referral must be acknowledged and accepted by the ECT Clinic team prior to the patient being sent for ECT The referring medical team must inform the ECT clinic staff of any special consideration regarding the patient (e.g. physical needs or disturbed behaviour), and highlight any potential problems Every effort should be made to identify and treat (or at least stabilise) physical conditions prior to ECT. In high risk patients an appropriate medical or surgical opinion should be sought to clarify the degree of risk and to identify ways of minimising the risk. An anaesthetic opinion may be sought at this stage. There should be discussion with the ECT Clinic team. In some patients it may be necessary to administer ECT in a general hospital site (i.e. Musgrove Park Hospital). Although ECT is generally a low risk procedure, cardiac and neurological risk factors are relevant in that, in addition to the anaesthetic itself, the ECT itself has direct physiological effects: (a) sinus bradycardia, sometimes asystole and then a compensatory tachycardia and (b) increase in intracranial pressure, cerebral blood flow and cerebro-vascular permeability. Patients with unstable cardiac disease and space occupying cerebral tumours leading to raised intracranial pressure are therefore at increased risk Cardiac pacemakers must be checked before ECT commences. Other relevant conditions include oesophageal reflux, insulin dependent diabetes, advanced glaucoma, and also bone / joint disease conferring an increased risk of fracture On the day of treatment, the patient must be nil by mouth from midnight, although they can take their morning medications with a few sips of water. If the patient is receiving medication likely to reduce seizure activity, the ECT clinic staff should be informed and whenever practical the anticonvulsant dose should be minimised prior to starting a course of ECT. Omission of a regularly prescribed V January 2017

11 benzodiazepine for the whole day prior to ECT is generally not recommended and can sometimes lead to withdrawal symptoms and agitation. However, benzodiazepine night sedation should generally be omitted on the evening prior to ECT. On arrival in the ECT Clinic the patient will be encouraged to empty their bladder. 5.3 Environment and facilities ECT is provided at Wellsprings Clinic on the Cheddon Road campus in Taunton. The ECT suite consists of separate entrance and exit, with a waiting area, treatment room, recovery area and post-recovery sitting room. This is a purposebuilt facility and meets ECTAS standards. ECT is conducted on Tuesday and Friday mornings The ECT Suite must be equipped to provide safe treatment. Equipment must include: an ECT machine of modern design, serviced as per the manufacturer s guidelines and possessing a dual-channel EEG facility (Thymatron) a tipping trolley for all patients, bottled oxygen, and back-up cylinders, resuscitation equipment (including equipment and resuscitation drugs as stated in the Trust Resuscitation Policy and other medications as advised by the Head of Medicines Management), a defibrillator, an electro-cardiograph suction in both the treatment room and recovery area ECT is given in accordance with the ECT machine manufacturer s guidelines and the stimulus dosing guidelines (See ECT Protocol Appendix A, Section 6). 5.4 Staffing Safe ECT requires a well trained multidisciplinary team who meet the training requirements set out in Section 5.4 and Section Anaesthetic staff There must be a Consultant or Associate Specialist Anaesthetist and also dedicated support from an Operating Department Assistant, dually-trained anaesthetic nurse or another professional deemed to be qualified by the Head of the Department of Anaesthesia. The anaesthetic cannot be performed by a trainee anaesthetist. V January 2017

12 5.4.4 Nursing staff Nursing cover for safe ECT requires the presence of registered mental health nurses who meet the competencies and training requirements stated in Section 6. The minimum staffing requirement is a lead clinic nurse and at least one other registered mental health nurse. Additional nursing staff may be required depending on the nature and number of patients treated in the ECT clinic session Inpatients must be conveyed to the ECT clinic by a registered nurse who will remain with them in the waiting area, during treatment in the recovery room and following recovery. The nurse accompanying the patient to ECT must be familiar with the legal status and the physical and mental state of the patient. Outpatients do not need to be escorted by a registered nurse but must be accompanied by a named responsible adult in all cases; however this is subject to individual risk assessment (See ECT Protocol, Appendix A, Section 1). Nursing staff in the ECT Clinic must complete the Day Patient Aftercare Form (Appendix G) before the patient leaves the department Nursing staff in the ECT clinic will be under the supervision of the Lead Clinic Nurse. If the Lead Clinic Nurse believes that the number of staff or patients compromise safe practice, he/she will consult with the anaesthetist and psychiatrist with a view to cancelling the session Patients are nursed on a 1:1 basis in recovery, until fully-oriented and safe to sit up. They will then be escorted to the ECT Clinic lounge, where they will be offered refreshments, as appropriate. Patients will be retained in this area until they are feeling well enough to return either to the inpatient environment, or if an outpatient, to return home The Lead Clinic Nurse is responsible for preparing the treatment room and recovery area and to ensure that: clean linen is available for trolleys suction and oxygen is available, and functioning, in the recovery and treatment areas resuscitation equipment, drugs, and defibrillator are available equipment in above has been checked and this has been recorded in the ECT and recovery room checklist the ECT machine is checked and prepared for use, and electrolyte gel is ready for the electrodes anaesthetic drugs and bite blocks are available together with monitoring equipment the pre-operative checklist is completed for each patient, and pulse blood pressure and temperature is recorded the identity of patients receiving treatment is confirmed with the patient and the escorting nurse or the accompanying responsible adult and a name band attached the ECT Prescription and Consent Form are valid V January 2017

13 a record of treatment is maintained in the ECT record folder situated in the ECT Clinic Nursing staff are responsible for caring for the recovering patient as follows: recognise the deteriorating patient and inform the Lead Nurse and anaesthetist of any relevant change in the patient s condition recognise a threatened airway and respond appropriately record physiological observations (oxygen saturation, pulse, blood pressure respiratory rate and temperature) initially once every 5 minutes allow the patient to sleep until the effect of the anaesthetic has worn off re-orientate the patient to reality as his/her level of consciousness increases. ease the patient to a sitting position on the side of the bed once the patient s observations are satisfactory, at least two staff must walk the patient to the lounge area and offer refreshments assist the patient with personal appearance, re-arranging clothing, replacing teeth etc. Continue to observe the patient and assess for physical complaints such as headache, pain, dizziness etc. and report any concerns to the ECT Clinic doctor for analgesia or any other appropriate intervention re-assess physiological observations and ensure these are satisfactory prior to removing the iv cannula and allowing the patient to leave the department Medical staff The ECT Clinic psychiatrist must be trained and competent in ECT procedures. Competency to perform ECT is determined by the ECT Clinic Lead Consultant. At present, there are no national standards for competency in delivering ECT, so the Trust accepted standards devised by the Scottish ECT Network. These are appended at Appendix I. The Royal College ECT handbook now contains similar competency standards. The Trust s ECT Clinic Lead Consultant will themselves have demonstrated competency in ECT within their CPD Portfolio ECT is routinely delivered by consultant psychiatrists or associate specialists in psychiatry as well as advanced psychiatric trainees undertaking a special interest session. Core psychiatric trainees working on the campus will be encouraged to learn about the safe administration of ECT and develop competencies needed for unsupervised practice The ECT Clinic psychiatrist is required to remain in the ECT Suite until all patients are fit to leave Consultant and associate specialist psychiatrists will have ECT recognised within their Job Plans The Royal College of Psychiatrists position is that referring doctors who consent patients must be competent in the theory and practices of ECT. In Somerset V January 2017

14 consent must be undertaken by the referring consultant or by another psychiatrist on the Specialist Register. 5.5 Documentation There is a dedicated ECT section on RiO (Assessments > Specialist > ECT) and this must be completed for each patient referred for ECT. Some paper records are also used in parallel with the electronic system: Patient Information Sheets (Appendix C) Patient Consent Forms (Appendices D - E) ECT Prescription and Record Sheets (Appendix H) The RIO forms provide a framework for the key actions and decisions required for deciding on and arranging safe and effective ECT. There are six fields which follow the patient through treatment. These are listed below and must be completed by the staff listed in brackets below: Deciding on ECT (Referring Medical Team on referral) Pre-treatment Update (Referring Medical Team twice weekly prior to each ECT treatment) Pre-treatment Update (Referring Nursing Team on the morning before each ECT treatment) ECT Treatment (ECT Clinic Nursing Staff on arrival in the ECT Clinic) ECT Treatment (ECT Medical Team after completion of each ECT treatment) Summary of ECT Course (Referring consultant / medical team at the end of a course of ECT) 6. TRAINING REQUIREMENTS 6.1 To provide good quality, safe ECT, it is essential that all ECT Clinic medical and nursing staff attend the annual conference run by The Royal College of Psychiatrists, at a frequency no less than every other year. 6.2 All ECT clinic staff are required to undergo Immediate Life Support training (ILS) and to have an annual refresher. 6.3 Competency requirements have been adopted for medical staff in line with Royal College of Psychiatry recommendations (Appendix I). 6.4 Nursing staff should be trained and competent in performing an electrocardiogram (ECG). 7. EQUALITY IMPACT ASSESSMENT 7.1 All relevant persons are required to comply with this document and must demonstrate sensitivity and competence in relation to the nine protected characteristics as defined by the Equality Act In addition, the Trust has V January 2017

15 identified Learning Disabilities as an additional tenth protected characteristic. If you, or any other groups, believe you are disadvantaged by anything contained in this document please contact the Equality and Diversity Lead who will then actively respond to the enquiry. 8. MONITORING COMPLIANCE AND EFFECTIVENESS 8.1 Process for Monitoring Compliance 8.2 Audit of this policy is incorporated into the Trust Clinical Audit plan and appropriately prioritised according to an agreed system for determining the frequency of audit. Clinical audit standards are included in Appendix B. These standards are based on the recommendations in the NICE Technology Appraisal (TA59, 2003) and, for patients with depressive illness, the NICE Clinical Guidelines on Depression in Adults (CG90, 2009). The responsibility for undertaking audit and signing off key recommendations is held by the Medical Audit Group and is overseen by the Clinical and Social Care Effectiveness Group. 8.3 The ECT Clinic and the operation of this policy are also subject to external evaluation and accreditation by ECTAS. 8.4 Complaints which are relevant to ECT are reviewed and amendments made to this policy as appropriate. Any learning points are forwarded to the IQUIS Best Practice Group and disseminated across the Trust as appropriate. 8.5 Clinical incidents, national ECTAS standards and other learning points are discussed in the ECT Business Meeting and amendments are incorporated into this policy when indicated. Any learning points are forwarded to the IQUIS Best Practice Group and disseminated across the Trust as appropriate. 9. COUNTER FRAUD 9.1 The Trust is committed to the NHS Protect Counter Fraud Policy to reduce fraud in the NHS to a minimum, keep it at that level and put funds stolen by fraud back into patient care. Therefore, consideration has been given to the inclusion of guidance with regard to the potential for fraud and corruption to occur and what action should be taken in such circumstances during the development of this procedural document. 10. RELEVANT CARE QUALITY COMMISSION (CQC) REGISTRATION STANDARDS 10.1 Under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Part 3), the fundamental standards which inform this procedural document, are set out in the following regulations: Regulation 9: Person-centred care Regulation 10: Dignity and respect Regulation 11: Need for consent V January 2017

16 Regulation 12: Regulation 13: Regulation 15: Regulation 16: Regulation 17: Regulation 19: Regulation 20: Safe care and treatment Safeguarding service users from abuse and improper treatment Premises and equipment Receiving and acting on complaints Good governance Fit and proper persons employed Duty of candour 10.2 Under the CQC (Registration) Regulations 2009 (Part 4) the requirements which inform this procedural document are set out in the following regulations: Regulation 11: Regulation 12: Regulation 16: Regulation 17: Regulation 18: Regulation 22A: General Statement of purpose Notification of death of service user Notification of death or unauthorised absence of a service user who is detained or liable to be detained under the Mental Health Act 1983 Notification of other incidents Form of notifications to the Commission (although this is in Part 5, it relates to regulations in Part 4) Detailed guidance on meeting the requirements can be found at eeting%20the%20regulations%20final%20for%20publishing.pdf Relevant National Requirements See section 11 below 11. REFERENCES, ACKNOWLEDGEMENTS AND ASSOCIATED DOCUMENTS References National Institute for Clinical Excellence, Technology Appraisal 59, Guidance on the use of electroconvulsive therapy. April National Institute for Clinical Excellence, Clinical Guidelines 90, Depression in Adults. The Treatment and Management of Depression in Adults. Updated edition. October 2009 The Royal College of Psychiatrists ECT Handbook, Third Edition, Cross reference to other procedural documents Consent and Capacity to Consent to Treatment Policy Hand Hygiene Policy Infection Prevention and Control Policy Learning Development and Mandatory Training Policy Record Keeping and Records Management Policy Resuscitation Policy Risk Management Policy and Procedure Staff Mandatory Training Matrix (Training Needs Analysis) Untoward Event Reporting Policy and procedure Serious Incidents Requiring Investigation V January 2017

17 All current policies and procedures are accessible in the policy section of the public website (on the home page, click on Policies and Procedures ). Trust Guidance is accessible to staff on the Trust Intranet. 12 APPENDICES 12.1 For the avoidance of any doubt the appendices in this policy are to constitute part of the body of this policy and shall be treated as such. Appendix A Appendix B Appendix C Appendix D Appendix E Appendix F Appendix G Appendix H ECT Clinic Protocol Clinical Audit Standards Royal College of Psychiatrists Patient Leaflet Consent Form 1 Patient Agreement to ECT Consent Form 2 Adults who are unable to consent to ECT Consent Form 3 Confirmation of Consent to ECT (completed by ECT clinic staff) Day Patient Aftercare Form (completed by ECT clinic staff) ECT Session Record Appendix I ECT Competencies for Doctors (RCPsych 2013) V January 2017

18 APPENDIX A SOMERSET PARTNERSHIP NHS FOUNDATION TRUST ECT CLINIC PROTOCOL CONTENTS 1. OUTPATIENT ECT 2. DRIVING 3. UNILATERAL VERSUS BILATERAL TREATMENT 4. CONTINUATION AND MAINTENANCE 5. DISCONTINUATION OF ECT 6. STIMULUS DOSING GUIDELINES (THYMATRON EGX) 7. MANAGEMENT OF LONG FITS 8. COGNITIVE ADVERSE EFFECTS 1. OUTPATIENT ECT 1.1 Extra care needs to be taken with outpatients undergoing ECT. Outpatients must be escorted both to and from the ECT clinic by a named responsible adult. The named responsible adult and/or the patient must confirm in writing that they will observe the limitation on drinking alcohol, operating machinery and signing legal documents 24 hours following discharge. Outpatients must be escorted from the waiting room through ECT and recovery by registered nurse, ODA (Operating Department Assistant) or doctor. 1.2 Appendix J provides details concerning the roles and responsibilities of the member of staff escorting the patient to ECT. A registered nurse will be required unless the patient is progressing well, is reasonably settled and there are no specific identified risks. 1.3 As the patient will be coming from their own environment, extra care must be taken to ensure that the patient has been nil by mouth. As part of the pre-ect work up, outpatients and their carers will have been provided with the Trust s leaflet on Outpatient ECT. The community staff, and clinic staff, must ensure that the patient on leaving the ECT Clinic is returning to a place where there is an appropriate adult to care for them, and that they must not operate machinery during the remainder of the day. Patients should be advised not to drive for a 3 month period. The ECT Clinic nurse must complete the Day Patient Aftercare Form ( - Appendix G). 1.4 The Patient s consultant must assess the patient s suitability to undergo ECT on an outpatient basis. 1.5 The patient s consultant must explain nature of the treatment to the patient and ensure consent form is completed. V January 2017

19 1.6 The patient s consultant must ensure all physical investigations are carried out prior to treatment (e.g. bloods, ECG). 1.7 A member of the CMHT must visit the patient at home to assess home environment and determine suitability for outpatient ECT (e.g. family support). 1.8 A member of the CMHT must ensure the patient is aware of the need to refrain from eating and drinking from midnight prior to treatment. 1.9 Travel arrangements must be made to ensure the patient is accompanied to and from hospital The date for the commencement of ECT must be arranged between the patient, CMHT staff (usually the care coordinator), ECT clinic staff and the patient s consultant The patient must have an up-to-date Care Plan. The Rio Core Assessment must include all relevant information, e.g. diagnosis, current medication, allergies, physical health, support at home etc. The patient should be advised to bring with them any medications or inhaler that they may require On arrival for first treatment, the patient must be seen and assessed by the anaesthetist The patient must remain in the ECT Clinic for at least two hours following treatment or longer if it is felt by staff that they are not in a fit condition to travel. 2. DRIVING 2.1 Royal College of Psychiatrists guidance is that patients should not drive for three months after completing a course of ECT. This is in line with general guidance for depression. Patients are required to inform DVLA about the nature of their illness, and that they are receiving ECT treatment. 2.2 Patients receiving maintenance ECT in whom depression is in remission for 3 months need only refrain from driving for 48 hours after each ECT treatment. 3. UNILATERAL VERSUS BILATERAL TREATMENT 3.1 The choice of unilateral -v- bilateral electrode placement remains a decision largely to be taken by the patient s own consultant from the referring medical team. The Royal College of Psychiatrists Patient Information Leaflets (Appendix C) makes reference to electrode placement and this issue must be discussed with the patient when obtaining consent. 3.2 Unilateral electrode placement confers a lower risk of cognitive adverse effects. However, the potential advantage that unilateral ECT confers in terms of side V January 2017

20 effects is offset by the requirement for an increased dose to achieve an equivalent therapeutic effect and often a greater number of treatments need to be given due to a slower onset of action. 3.3 More information can be found in the Royal College of Psychiatrists ECT Handbook (2 nd Edition). It is recommended that the patient s medical staff liaise with staff at the ECT Clinic when deciding on electrode placement and that there should be flexibility during the course, i.e. moving from unilateral to bilateral or vice-versa depending on the clinical state of the patient. 4. CONTINUATION AND MAINTENANCE TREATMENT 4.1 Continuation ECT is defined as ECT used to prevent relapse of an index episode of illness. It is prophylactic ECT used over the first 6 months of remission. 4.2 Maintenance ECT is defined as ECT used to prevent further episodes or recurrence of illness over a longer period. Maintenance ECT is usually reserved for those whose illness recurs after continuation ECT. It may also be considered for patients who express a preference for it. 4.3 Continuation ECT should be considered for patients who have a relapsing or refractory depression that has previously responded well to ECT, but for whom standard pharmacological and psychological continuation treatment is ineffective or inappropriate. Indictors include: the index episode responded well to ECT there is early relapse (0-6 months) despite adequate continuation drug treatment or an inability to tolerate continuation drug treatment the patient s attitude and circumstance are conducive to safe administration past history of repeated relapse because of poor adherence to medication patient preference 4.4 Continuation and maintenance ECT requires a properly documented assessment of the potential risks and benefits of treatment for which valid informed consent has been obtained. Patients who are considering continuation treatment will have the personal experience of previous ECT, which will help them to weigh the potential benefits and adverse effects of treatment. 5. DISCONTINUATION OF ECT 5.1 ECT will be discontinued for a variety of reasons. These include: satisfactory therapeutic response withdrawal of patient consent. deteriorating physical health posing unacceptable anaesthetic risk. development of unacceptable side-effects. 5.2 The decision to discontinue treatment must be made by the patient s own consultant in the referring medical team, together with the patient and, if V January 2017

21 appropriate, their carer. This information must be communicated to ECT Clinic staff and the information concerning discontinuation must also be included on the dedicated ECT field in RiO (i.e. in Summary of the ECT Course ). 5.3 The aim of ECT should be remission of symptoms with a minimum of side effects. Some improvement in symptoms of depression after 6 treatments predicts subsequent remission. The majority of remissions occur before the ninth treatment. However 40% of patients who have not responded after six treatments go on to remission. No definitive advice can be given to cease ECT if there is no response after six treatments, but if there has been no response at all at that stage, then the referring consultant may wish to reassess the need for ECT and consult with the patient. A patient who has had no response at all after 12 treatments is unlikely to have a sustained response to ECT. The decision to stop ECT needs to be taken in the context of the severity of the condition, the range of other treatments still available and the clinical risks in the individual patient. 5.4 Assessment of satisfactory response should include a validated standardised clinical instrument. The most practical is the Clinical Global Impression (CGI) scale. This has the advantage that it is not specific to any one disorder. The CGI should be used at baseline, during the course of ECT and when treatment has been completed. Outcome measures must be done by the referring clinical team. 6. STIMULUS DOSING GUIDELINES (THYMATRON DGX) 6.1 Best practice dictates that patients receiving ECT undergo a stimulus dosing regime. The observed seizure is timed to the end of bilateral lower limb movement. The ECT machine allows for EEG monitoring of the seizure length. EEG seizures should have at least two of the following three elements: a recruitment phase, 3 per second spike and wave activity and post-ictal suppression (compared to the baseline test EEG). The aim is to induce a bilateral modified seizure of at least 15 seconds duration 6.2 The aim is to establish the lowest energy setting for an effective seizure. A seizure occurs at Seizure Threshold (ST), with effective ECT needing a higher dose, the Treatment Dose (TD). For bilateral ECT the TD is times the ST and for unilateral ECT the TD is 5-8 times the ST. V January 2017

22 6.3 FIRST STIMULATION: LEVEL % Age under 25 Female Unilateral 1 5 Female bilateral; Male Unilateral 2 10 Male Bilateral Add one level: if on benzodiazepines/anticonvulsants; if ECT within one month; aged 65+. (these are NOT additive). 6.4 SECOND STIMULATION: If inadequate seizure on first stimulation after 20 seconds, add one level and re-stimulate. 6.5 THIRD STIMULATION: If inadequate seizure on second stimulation after 20 seconds, add a further 2 levels. No more than 3 stimulations are to be given per treatment session. 6.7 NEXT TREATMENT SESSION: If seizure occurred on the first or second stimulation, this shows the ST. The TD will be the ST +1 level for Bilateral ECT and the ST +3 levels for Unilateral. If the seizure occurred on the third stimulation, then re-stimulate at 2 levels lower to try and establish the ST. If no seizure was elicited on the third stimulation, add one level and continue titration. 6.8 THIRD AND SUBSEQUENT TREATMENTS: ST rises during treatment. If the duration of the seizure reduces by 20% or more, increase by one level. If cognitive side effects are problematical reduce by one level or consider changing to unilateral stimulation. For poor response increase by 1 level (2 levels for Unilateral). Note: EEG should be the standard, not clinical observation. Thymatron EEGs have an ictal line to assist in interpretation. With an EEG, it is prudent to run off a baseline measure before application of ECT. 7. MANAGEMENT OF LONG FITS 7.1 A seizure of above two minutes duration should be terminated with Diazemuls or more of the anaesthetic drug, whichever the Anaesthetist prefers, this medication should be drawn up at 90 seconds so it is ready to be given at 120 seconds. V January 2017

23 8. COGNITIVE ADVERSE EFFECTS 8.1 Cognitive adverse effects are a major concern for many patients. Orientation and memory should be assessed before and at intervals throughout the course of treatment, then again at the end of treatment. Severe depressive illness, particularly in older adults, can affect memory, and tests of memory carried out before and after ECT may show improvements, presumably because the memory deficits associated with depression have improved in response to treatment. 8.2 Electroconvulsive therapy causes dysfunction in a wide variety of cognitive skills that is over and above that caused by the patient s pre-existing depression. This is clearly and significantly present in the first few days after ECT but then begins to improve and usually remits within 2-3 weeks of the end of a course of ECT. However, autobiographical memory can be affected by ECT for up to 6 months after the end of an ECT course; there are also reports of more severe and more persistent dysfunction 8.3 Specific standardised tools do not exist. It is recommended that teams responsible for the patient s on-going care ask the patient about any memory difficulties and document these discussions. Evidence can be collected from simple assessments such as the Folstein Mini Mental State Examination. Observed deterioration in cognitive function must be the subject of discussion between ECT clinic staff and the patient s own consultant in the referring medical team. Possible interventions include ceasing the ECT, reducing the dose, changing from bilateral to unilateral stimulation and reducing the frequency of the treatments. V January 2017

24 Appendix B ECT CLINICAL AUDIT STANDARDS Standard Compliance Exceptions Reserved to certain diagnostic groups. ECT should only be used in the treatment of severe depressive illness, catatonia, and prolonged/severe manic episodes. If used to treat a schizophrenic illness, the guidelines as stated within the definitions must be followed Reserved to certain serious situations. ECT should only be used where adequate trials of alternative treatment have proved ineffective and/or where the condition is potentially life-threatening Documented risk/benefit analysis. A risk/benefit analysis should be carried out prior to any course of ECT 100% None 100% Patient choice 100% None Definitions (e.g. any interpretations, directions, or instructions on where/how to find information, plus relevant service where applicable) ECT is very occasionally used in those with a schizophrenic illness, who are markedly unwell, and who have failed to respond to a range of conventional treatments. Use of ECT in these cases must be endorsed by a second senior doctor and discussed with family members (and these discussions are to be documented). If a patient has previously had a positive experience and positive response to ECT, their electing for this treatment should be taken into account. Risks are increased in pregnancy, older people, children and young persons. The risk assessment should include risks associated with anaesthetic, current co morbidities, anticipated adverse events, including cognitive impairment, and the risk of no treatment V January 2017

25 ECT CLINICAL AUDIT STANDARDS Standard Compliance Exceptions Definitions (e.g. any interpretations, directions, or instructions on where/how to find information, plus relevant service where applicable) 4 Consent procedures. Valid consent should be obtained and consent procedures should involve advocates/carers where appropriate and should take into account advance directives 100% Valid consent will not be obtainable where the patient lacks capacity, and may not be obtained where treatment is under the Mental Health Act None 5 6 Provision of information to patient and others. Information should be provided to the patient and where appropriate to advocates/carers, which includes information about general and specific risks of ECT, and indicates that the patient is able to withdraw consent at any point. Reassessment after each treatment. The patient's condition should be reassessed after each treatment 100% None None 100% None None 7 Reassessment of cognitive status. Cognitive function should be reassessed on an ongoing basis and at least at the end of any course of treatment 100% None None V January 2017

26 ECT CLINICAL AUDIT STANDARDS Standard Compliance Exceptions 8 Repeat courses of ECT. A repeat course of ECT should only be considered where the diagnostic criteria for treatment are met and the patient has previously responded well to ECT, or where all other options are less satisfactory 100% None None Definitions (e.g. any interpretations, directions, or instructions on where/how to find information, plus relevant service where applicable) 9 Individuals having ECT should be asked to comment on adequacy of consent procedures, information and reassessment. User satisfaction with procedures should be carried out on a routine basis 100% None None 10 Treatment should be stopped if a response is achieved, adverse effects occur or the patient withdraws consent 100% Valid consent will not be obtainable where the patient lacks capacity, and may not be obtained where treatment is under the Mental Health Act The reasons are to be recorded in progress notes detailing the adverse effects 11 ECT should not be used as a maintenance treatment for depressive illness 100% Good past response to ECT and failure to respond to all other reasonable treatment options, with patient consent Patient choice should be an important factor in agreeing to maintenance ECT. V January 2017