De-activation of Implantable Cardioverter Defibrillator (ICD) Therapy in Adult Patients with Heart Failure

De-activation of Implantable Cardioverter Defibrillator (ICD) Therapy in Adult Patients with Heart Failure Document Description Document Type Guideline Service Application Community Heart Failure Specialist Nurses, Palliative Care Consultants, Cardiologists, and Cardiac Physiologists Version 1.2 Ratification Date Review Date September 2016 Lead Author(s) Alison Vaughan Advanced Cardiac Physiologist Dr A Hamaad Consultant Cardiologist Specialising in Devices Rosemary Ashman Head of Cardiac Physiology (reviewed by) Presented for discussion, approval and ratification to Tina Fletcher Joy Barrett Dr J Gupta Dr E Waterhouse Dr R Klezlova Sindy Dhallu Dr S Nambisan Heart Failure Specialist Nurse Heart Failure Specialist Nurse Community Consultant Cardiologist Specialising in Heart Failure Palliative Care Consultant Palliative Care Consultant Specialist Palliative & Cancer Care Palliative care & EOL steering groups GP with Specialist Interest in Palliative Care Change History Version Date Comments 0.1 11/04/2011 Draft Document passed on from Black Country Cardiovascular Network- Heart Failure End of Life Sub Group 0.2 Consultation with Specialist Palliative & Cancer Care Manager 0.3 07/12/2011 Minor changes to text supported by Community Heart Failure Team 0.4 20/12/2011 Minor changes to text 0.5 09/02/2012 Reviewed by group 0.6 20/08/2014 Document forwarded to review team for ratification 0.7 20/10/2014 Reviewed by group. Minor changes to text 0.8 09/12/2014 Reviewed by group. Minor changes to text 0.9 02/01/2015 Reviewed by group. Minor changes to text 1.0 12/02/2015 Reviewed by group 1.1 26/02/2015 Reviewed by group. Changes to text 1.2 08/04/2015 Final Document 1

Link with Standards for Better Health Domains Safety C3, Clinical and Cost Effectiveness D2, Governance C7, C9, C11, D3, D4, Patient Focus C13, C16, D8, D9, D10, Accessible and Responsive Care C17, D11. Link with Trust Purpose and Values statements Enable Patient Choice and preferences, improving patient experience and quality of care by empowering them to contribute to decisions about their future care.. Contents 1.0 Introduction 4 2.0 Background 4 3.0 Scope 5 4.0 Process and Procedures Algorithm 6 4.1 Roles and Responsibilities 7 4.2 Patient Understanding of Device and Outcomes 7 4.3 Initial Assessment 8 4.4 Assessment of Patient Capacity 8 4.5 Competent Patient 9 4.6 Deactivation Process 9 4.7 Informed Consent 10 4.8 Change in Patient Condition 10 5.0 Audit 10 6.0 Training 10 7.0 References 11 8.0 Bibliography 11 Appendices Appendix 1 - Form Request for De-activation of Implantable Cardioverter 12 Defibrillator (ICD) Appendix 2 - GP Letter 13 Appendix 3 - Clinical Tool for Assessing Prognosic Indicators 14 Appendix 4 - Assessing Mental Capacity 15 Appendix 5 Two Stage Functional Test for Capacity Appendix 6 Arrhythmia Alliance Leaflet Implantable Cardioverter Defibrillators (ICDs) in Dying Patients Implantable Cardioverter Appendix 6 please access www.heartrhythmcharity.org.uk to print off document. Pg No 21 2

1.0 Introduction This guidance has been developed by the Pacemaker Department in C.M.U. at Walsall Healthcare NHS Trust, in conjunction with the Black Country Cardiovascular Network Heart Failure (HF) Group. It will support Heart Failure Specialist Nurses (HFSN), Palliative Care Consultants, Cardiologists, and Cardiac Physiologists in the decision to de-activate Implantable Cardiac Defibrillators (ICDs) for patients with HF nearing the end of life (EOL). The aim of the document is to offer a co-ordinated approach to the management of de-activation and therefore reduce preventable anxiety for the patient, family and carers. It will consequently provide clarity for staff involved in the process and will support the course of action leading to de-activation. The document considers the potential need to deactivate the defibrillator function of any device. The pacing functions of devices should not be disabled, even in terminally ill patients, as withdrawing pacing support may introduce additional symptoms and accelerate the dying process. 2.0 Background There is now a wealth of evidence demonstrating the benefits of ICDs for both primary and secondary prevention in carefully selected patients with heart failure. Consequently these patients are more likely to die of other non-arrhythmic causes (Lewis, 2006). However, for patients near the EOL, interventions become more complicated, expensive, and less effective (Basta, 2006). An ICD delivers a shock to the heart to revert it back into its normal rhythm. The experience of having the shock can be very distressing and often induces anxiety and fear. As terminal illness progresses, the risk of arrhythmia increases; progressive HF predisposes patients to hypoxia and electrolyte disturbances, hence patients become more susceptible to ventricular arrhythmias which may therefore result in more frequent shocks (Lewis et al 2006). Recent studies clearly indicate that there is psychological harm and potential physical pain when defibrillators deliver either appropriate or inappropriate shocks at the end of life, leading to a more uncomfortable death (Lewis et al 2006) (Goldstein et al 2004). These shocks are certainly intrusive for dying patients; the Gold Standards Framework eloquently supports the right to choose comfort care; furthermore Lewis et al (2006) concurs that shocks are inconsistent with comfort care goals at the EOL and concludes that quality of life (QOL) may decline as illness progresses and goals may therefore shift from prolonging life to maximising QOL, rendering shock therapy undesirable. The General Medical Council (2006) guidance for withholding and withdrawing life prolonging treatments clearly identifies that life has a natural end, and that health professionals need to recognise that the point may come in the progression of a patient s condition where death is drawing near. They advocate that clinicians do not attempt to prolong the dying process with no regard for the patient s wishes, where known; supporting the need for an up- to- date assessment of the benefits of treatment in order to strengthen the decision of whether to continue to treat. 3

3.0 Scope This guideline applies directly to Heart Failure Specialist Nurses, Palliative Care Consultants, Consultant Cardiologists and Cardiac Physiologists; the patients General Practitioner (GP) will obviously be included in decisions about the patients EOL care plan as required. The guidance will enable specified health professionals to support patients to make a decision regarding the withdrawal of ICD therapy. ICD deactivation requires a specific level of competence; within Walsall Healthcare NHS Trust Cardiac Physiologists have been suitably trained to carry out this procedure. This may be either as a permanent deactivation or as a temporary switch-off. Therefore these guidelines are recommended as good practice guidance. An algorithm has been developed (page 6) which links and further underpins the detail within the document and will guide the health professional in the deactivation process. 4.0 Processes and Procedures 4

ALGORITHM: DEACTIVATION OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THERAPY Assessment of patient s condition and likely prognosis is made by the Heart Failure team responsible for coordinating the patient s care in consultation with Consultant Cardiologist or Palliative Care Consultant (Section 4.1) Prognostic Indicators Identify TERMINAL ILLNESS (Section 4.3) Assess capacity to make decision to deactivate (Refer to local guidelines for assessment of mental capacity) (Section 4.4) Competent Patient Treatment withdrawal discussed. (Refer to Arrhythmia Alliance patient leaflet on ICD in dying patients) (Section 4.5) Patient Lacks Capacity (Section 4.4) Refer to MCA (2005) and local guidelines Patient wishes to continue ICD therapy Deactivation Process Patient has expressed a preference to deactivate ICD therapy (Section 4.6) Patient is given the opportunity to reevaluate as appropriate (Section 4.2) Heart Failure Specialist Nurse gains verbal consent on deactivation from Consultant Cardiologist or Palliative Care Consultant Complete ICD deactivation documentation with Consultant signature Decision communicated throughout the patient s care team including any clear expressions not to attempt resuscitation If patient s decision changes at any time further dialogue needs to be undertaken and decision made (Section 4.8) Phone and then Fax documentation to CMU to arrange deactivation of ICD (phone to confirm receipt) Tel. 01922 656583 Safe-haven Fax No. 656204 Cardiac Physiologist discusses arrangement for deactivation, has written consent from Consultant Cardiologist, or has faxed written consent from Palliative Care Consultant and proceeds to deactivate device. HFNS should also attend family home to offer support to the patient and family at time of deactivation. (Section 4.7) Record of withdrawal of therapy is kept in hospital patient notes and in SAP documentation where available 5

4.1 Roles and Responsibilities The Heart Failure Specialist Nurse is responsible for assessing and monitoring the patient s condition; likely prognosis and treatment options will be discussed with the Consultant Cardiologist and GP. The Heart Failure team will take responsibility for coordinating the process to withdraw ICD therapy; subject to all checks and balances outlined in this guidance. In this process it will take into account assessment recommendation by other teams involved in the patient s care, the palliative care team and the patient s GP. The key stages of the decision making process must be recorded on the relevant documentation. Sufficient detail should be included to ensure a clear rationale so the decision can be given if required in the future. Discussion regarding withdrawal should take place between a member of the Heart Failure Team e.g. the Heart Failure Specialist Nurse and the patient. Validity of this discussion should be underpinned by full information being available to the patient. The withdrawal of treatment will then be facilitated through the Cardiac Physiologists at Walsall Healthcare NHS Trust. In doing so the Cardiac Physiologist would be working as part of this team and the deactivation process would be regarded as part of the wider care plan for the patient - the responsibility for which would be with the Consultant led Heart Failure Team. Ideally this should happen in hospital with another member of this team accompanying the Physiologist but this would depend on the circumstances of each case. 4.2 Patient Understanding of Device and Outcomes Autonomous decisions about health care can only be made if the patient is equipped with information to decide the balance of risks against the benefits of treatments. Consequently all health professionals have a duty to assist patients to make informed choices by providing impartial advice about options and outcomes. Advanced care planning is fundamental to this process, therefore, good practice would be to conduct regular reviews on the relevance of treatment with the patient, and when appropriate, introduce the possibility of deactivating the defibrillator function to avoid distressing symptoms (BHF 2007). It is well recognised that cognitive ability diminishes with advancing HF, hence, to ensure that the patient has a full understanding, discussions need to be undertaken as early as possible. Although end of life discussions are seen as sensitive, it is pertinent to undertake these discussions in order to raise awareness of both the benefits of the device and the potential risk of trauma at the end of their natural life. Within Walsall, the process of Advanced Care Planning has been established to enable professionals to document EOL discussions and decisions. It is envisaged that the Advanced Care Planning document will be used to support the de-activation process. The pre-assessment team at Walsall provide patients with information when ICDs are inserted, but further discussion may need to take place at appropriate intervals as HF progresses, enabling pro-active management complying with patient wishes. The HFSN will, as appropriate, utilise an Information leaflet produced by the The Arrhythmia Alliance Implantable Cardioverter Defibrillators (ICDs) in Dying Patients as necessary (Appendix 5) to reinforce and support information given verbally. 6

4.3 Initial Assessment Due to the frequent episodes of decompensation seen in HF patients with subsequent recovery, it is difficult to estimate EOL. Therefore the following criteria of prognostic indicators will be used as a tool to determine that the patient is in the end stage of the condition: - - Sustained deterioration of symptoms; Patient is New York Heart Association (NYHA) Class IV. - At least 3 hospital admissions or 3 emergency home visits with decompensation in the last 6 months. - Worsening oedema despite maximum diuretic and optimum heart failure medication. - Failure to respond within 2-3 days of appropriate change in diuretic or vasodilator drugs - Worsening renal function with no reversible cause. - Sustained hypotension. - All reversible causes have been investigated and excluded i.e. thyrotoxicosis, arrhythmia, recent MI, anaemia, chest infection, non-compliance with medication. - Patient wishes for comfort care only. Modified and based around the Gold Standards Framework Prognostic Indicator Guidance (2006). The Heart Failure Team will make an assessment of the patient s condition and conclude that the patient is deemed to be in the last few weeks of life (Appendix 3). Provision will be made for patients who wish to be referred to St Giles Hospice, to be deactivated on site. 4.4 Assessment of Patient Capacity The Mental Capacity Act (MCA), (2005) provides a legal framework for acting and making decisions on behalf of individuals who lack the mental capacity to make particular decisions for themselves (Mental Capacity Act 2005 Code of Practice). Anyone who claims that an individual lacks capacity must be able to provide proof, and this should be available at de-activation. They need to be able to show on the balance of probabilities that the individual lacks capacity to make a specific decision, at the time that it needs to be made. To help determine whether an individual lacks capacity to make specific decisions, the MCA (2005) sets out a two-stage test of capacity. Refer to local guidelines or the MCA (Appendix 4). Best Interest It is the moral and legal responsibility of the health professional to act in the patient s best interest if proven to lack capacity to make their own decisions. Consideration should be given to whether the ICD is in their best interest given the presenting condition and circumstances. Discussion should take place with the patient s family, taking into account the patient s wishes if known. The BHF (2007) advocate a consensus view based on a multidisciplinary team approach and recommend seeking advice of specialists in palliative care. Refer to MCA (2005). 7

4.5 Competent Patient Adult patients are presumed to be competent to make decisions about their own health care, unless there is evidence to the contrary. They have the legal right to refuse treatment, even life-sustaining treatment, provided they are competent and their decision is informed. Refer to local guidelines. A patient s decision to disable an ICD should be respected as long as the patient understands the facts of the medical condition, can deliberate using deeply held values and beliefs, is able to appreciate the likely consequences of their decisions, and is free of controlling influences (Berger, 2005). 4.6 Deactivation Process Prior to deactivation, discussion should take place between the medical and nursing teams looking after the patient to decide the appropriate time. Regular communication ensures that Palliative Care Consultants and Cardiologists are aware of patients, whose condition is deteriorating or approaching the EOL. A deactivation form should then be completed and signed by the patient and Palliative Care Consultant or Cardiologist (Appendix 1). A Cardiac Physiologist will arrange to see the patient and use a programmer to deactivate the ICD, which is a simple and noninvasive procedure that takes only a few minutes. This will be very much like their clinic visits. All de-activations should occur during day time hours. Walsall The ICD will be deactivated within 3 working days from consultation, and will, wherever possible be linked to a hospital visit. All de-activations should occur during day time hours. Documentation & Record Keeping The request for deactivation form (Appendix 1) will be faxed via a safe-haven (fax number 01922 656204) to the Cardiac Physiologists within CMU. This will be followed up by a telephone call (telephone number 01922 656583) to check receipt of the referral. The Cardiac Physiologist will ensure that the form is signed by the Consultant Cardiologist or Palliative Care Consultant. The Cardiac Physiologist responsible for deactivating the ICD will obtain verbal consent from the patient prior to performing the procedure. Any lack of capacity of the patient will be addressed by documentation showing discussion and understanding of the condition and the action being taken this would normally be the patient s records and agreement by the Heart Failure Team. Deactivation of a defibrillator is not equivalent to turning off a life-supporting ventilator that would cause life to cease and sensitive communication with the family and carers will avoid the perceived burden of them having to make a judgement on life and death 8

A copy of the form will be kept in the patient hospital notes and in the Single Assessment Process documentation where available. A copy of the completed form will be retained by the Cardiac Physiologist to be kept in the patient s Device notes and a copy will be forwarded by safe-haven fax (01922 724126) to the Community Heart Failure Team to integrate into their documentation. A standard letter (appendix 2) will be sent to the GP from the Community Heart Failure Team. Do Not Attempt Resuscitation (DNAR) When an ICD is deactivated a resuscitation decision should also be made. At the very least definitive plans for a resuscitation decision should be drawn up once it has been decided that an ICD is to be deactivated. DNAR is a separate area of discussion and therefore needs to be identified as such and clearly documented to this effect. However, maintaining an ICD in active defibrillation mode is inconsistent with a DNAR order and is rarely justified (BHF 2007), equally necessitating detailed explanation to enable informed decisions. 4.7 Informed Consent The decision to withdraw treatment should be an informed choice made by the patient, providing they have capacity to make the decision. To ensure that legal and ethical issues are considered the patient must be fully informed of their options. The patient s right to request withdrawal of life sustaining medical interventions including ICDs is both legal and ethical. Withdrawal of a life sustaining medical intervention with the informed consent of the patient or legal surrogate is not physician assisted suicide or euthanasia (Harrington et al, 2004). Therefore it will be the responsibility of the health professional to review the rationale for ICD treatment, reassess the patient s understanding of the device usage, and how it relates to their previously agreed care objectives (BHF 2007). 4.8 Change in Patient Condition During the last weeks/days of life the Heart Failure Nurse will visit the patient as required, each time reassessing the patient s condition. If there is a notable improvement in symptoms of heart failure which trigger the Nurse to believe that death may not be imminent or the patient wishes to change their decision, then discussion to re-activate the ICD should take place involving the patient, Nurse and Cardiologist 5.0 Audit Heart Failure Nurse Group reflection of individual cases will be undertaken in order to learn and enhance the provision of this service. Areas for possible data collection are: Number of patients expressing DNAR during the advanced care planning process Numbers of patients requiring deactivation procedure in a 12 month period Numbers of patients having deactivation at home Numbers of patients having deactivation at hospital Number of days taken for deactivation 9

Following discussions, number of patients declining deactivation and reasons for decline 6.0 Training It is expected that the Heart Failure Team should have a recognised advanced level of communication skills in palliative care. The Cardiac Physiologists involved in the deactivation process will have been previously trained and assessed to a recognised level of competence, and will continue to undertake on-going continual professional development. 7.0 References Arrhythmia Alliance Patient Information Leaflet: Implantable Cardioverter Defibrillators (ICDs) in Dying Patients. www.heartrhythmcharity.org.uk Basta, L.L. (2006) End of Life and Other Ethical Issues Related to Pacemaker and Defibrillator Use in the Elderly. The American Journal of Geriatric Cardiology, 15 (2), pp114-117 Berger, J.T. (2005) The Ethics of Deactivating Implanted Cardioverter Defibrillators. Annals of Internal Medicine, 142 (8), pp 631-4. British Heart Foundation (BHF) (2007) Implantable Cardioverter Defibrillators in Patients who are reaching the End of Life: A Discussion Document for Health Professionals, BHF. General Medical Council (GMC) (2006) Withholding and withdrawing life-prolonging treatments: Good practice in decision-making. www.gmc-uk.org/guidance/current/library/witholding_lifeprolonging_guidance.asp#11 Gold Standards Framework (2006) Prognostic Indicator Paper vs. 2.25 www.goldstandardsframework.nhs.uk/content/gp_contract/prognostic%20indicators%20 Guidance%20Paper%20v%2025.pdf 8.0 Bibliography Cheshire & Merseyside Cardiac Network (2007) The Decision to Withdraw Implantable Cardioverter Defibrillator (ICD) Therapy in an Adult Patient: Protocol. www.cmcsn.nhs.uk/document_uploads/guidelines/decision%20to%20withdraw%20icd %20Therapy%20in%20an%20Adult%20Patient.pdf Goldstein, N.E., Lampert, R., Bradley, E., Lynn, J., Krumholz, H.M. (2004) Management of Implantable Cardioverter Defibrillators in End-of-Life Care. Annals of Internal Medicine, 141 (11), pp 835 839 Haxby, E.J. (2008) Consent and Lack of Capacity, British Journal of Cardiac Nursing. 3 (12) pp 559 563 10

Lewis, W.R., Luebke, D.L., Johnson, N.J., Harrington, M.D., CFostantini O., Aulisio, M.P. (2006) Withdrawing Implantable Defibrillator Shock Therapy in Terminally Ill Patients, The American Journal of Medicine, 119 (10) pp 892 896. Sears, S.F., Sowell, L.V., Kuhl, E.A., Handberg, E.M., et al. (2006) Quality of Death: Implantable Cardioverter Defibrillators and Proactive Care. Pace, 29 pp 637-642 Harrington MD, Luebke DL, Lewis WR, Aulisio MP, Johnson NJ. (2004) Fast Facts and Concepts #112: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AT END OF LIFE. End-of-Life/Palliative Education Resource Center. www.eperc.mcw.edu Mental Capacity Act (2005) Office of Public Sector Information. www.opsi.gov.uk/acts/acts2005/ukpga_20050009_en_1 11

Appendix 1 Out of Hospital Request for Deactivation of Implantable Cardioverter Defibrillator (completed form to CMU Pacemaker: Tel. 01922 656583 Safe-haven Fax No. 656204) Patient Name: Date of Birth: Address: GP Details: Date and time of request: Address where patient is currently located: Where deactivation to take place: Reason for request: Describe assessment of patient s current condition, likely prognosis and treatment options. (Take account of current guidance on good clinical practice and the views of the multidisciplinary team; consider if second opinion is necessary/would be helpful.) Signature of Heart Failure Nurse: Print name: Date: Signature of authorising Consultant: Print name: Date: Date and time of deactivation: Manufacturer/Type of Device: Mode: Base Rate: Signature of Advanced Cardiac Physiologist: Print Name: Date: Copy to: Patient Notes (Hospital), Devices File, Community Heart Failure Team, GP 12

Appendix 2 Date GP Name GP Addres Community Heart Failure Team Heart Care 12 Portland St Walsall WS2 8AB Tel: 01922 638121 Fax: 01922 724126 Dear Dr RE: Patient Name, DOB, Unit No. Address Under the care of Dr The above patient is now considered to be in end stage heart failure. Following discussion between the Heart Failure Specialist Nurse, patient name and the Consultant Cardiologist, the decision to deactivate the Implantable Cardioverter Defibrillator (ICD) has been made. A copy of the ICD deactivation request form is attached for your records. Yours sincerely Community Heart Failure Nurse Walsall Healthcare NHS Trust 13

Appendix 3 Clinical Tool for Assessing Prognostic Indicators Name: Address: Date of Birth: National Ins. No: GP: This is a tool to be used as an aid to determining end stage heart failure, rather than a definitive list Patient choice must be considered and respected at all stages of the disease management process. Sustained deterioration of symptoms; Patient is New York Heart Association (NYHA) Class IV At least 3 hospital admissions Or 3 emergency home visits in the last 6 months with decompensation of heart failure Worsening Oedema: Despite maximum diuretic and optimum HF medication Failure to respond within 2-3 days of appropriate change to diuretic or vasodilator drugs. Worsening renal function with no reversible cause Sustained Hypotension All reversible causes have been investigated and excluded i.e. thyrotoxicosis, arrhythmia, recent MI, anaemia, chest infection, non-compliance with medication Patient wishes for comfort care only End stage cancer Further Comments: Clinician Signature: Print Name: Date: Designation: NB: Ensure patient is placed on GP Supportive Care Register (Modified from the Gold Standards Framework, 2006) 14

Appendix 4 Guidelines for Assessing Mental Capacity to make a decision Core principles of the MCA 1. A person must be assumed to have capacity unless it is established that they lack capacity. 2. A person must not be treated as unsuitable to make a decision unless all practicable steps to help him to do so have been taken without success. 3. A person is not to be treated as unable to make a decision merely because he makes an unwise decision. 4. An act done, or decision made, under this Act for, or on behalf of a person who lacks capacity must be done, or made, in his best interests. 5. Before the act is done, or the decision is made, regard must be had to whether the purpose for which it is needed can be as effectively achieved in a way that is less restrictive of the person s rights and freedom of action. What triggers an assessment? Mental capacity should be presumed, take into account the person s behaviour, circumstance and concerns raised by other people. Presumption of capacity Any assessment of a person s capacity must consider the following factors: 1. Are they understand the information. 2. Can they retain the information related to the decision to be made. 3. Can they use or assess the information while considering the decision. 4. They must have the ability to communicate that decision- this could include alternative forms of communication such as blinking an eye, or squeezing a hand when verbal communication is not available. If the person being assessed is unable to do any one of the above, they are unable to make the decision for themselves. Right to be supported Provide all relevant information. Consult with family and other people who know the person well on the best way to communicate. Be aware of any cultural, ethnic or religious factors. Make the person feel at ease by selecting an environment and time that suits them. Be aware that circumstances may change and an assessment of capacity may have to be reviewed. Unwise/ eccentric decisions Even though a person s decision may seem unreasonable, irrational, unusual or eccentric, it may nevertheless make sense in the context of the person s religious and personal beliefs and values. Accordingly the person should not necessarily be assumed to be incompetent. It may be helpful to include a third person to mediate if unsure about the decision. But an unwise decision may be evidence of incompetence- it may, for example, reveal that a patient is incapable of understanding the consequences of their decision UK Clinical Ethics Network 2011 15

Assessment of Capacity No Does the person have an impairment of, or a disturbance of their mind or brain? Reassess Yes Does the person understand relevant information about the decision to be made? No Yes Is the person able to retain that information? No Yes Is the person able to weigh and use the information as part of the decision making process? No Yes Is the person able to communicate this decision by any means? Yes No Person has capacity Is there a potential to regain capacity or gain skills to decide? Yes Wait for recovery and or provide support to enhance capacity No Person lacks capacity Complete best interests process 16

Appendix 5 Two Stage Functional Test for Capacity (Appendix 1) Patient/User Name: DOB Patient ID No: (NHS or Social Care) 1.1.1 STAGE ONE DIAGNOSTIC THRESHOLD Does the patient/service user have an impairment of or disturbance in the functioning of the mind or brain? Yes No If the answer is No then capacity is not at issue. If Yes then record nature of disturbance by applying a tick in the applicable condition as listed below. Neurological disorder Learning disability Mental disorder Dementia Stroke Head injury Delirium or unconsciousness Substance use Other (please record) NATURE OF DECISION (capacity must be assessed on a decision by decision basis) Record in the space below the nature of decision at issue for the person being assessed. 1.1.2 STAGE TWO TEST See core policy for guidance on test criteria. Please circle appropriate answer. 1) Does the person understand the information relevant to the decision? Yes No 2) Can the person retain the information for long enough for the decision to be Yes No made? 3) Can the person use or weigh the information to make a choice? Yes No 4) Can the person communicate the decision? Yes No Answering No to any question above indicates lack of capacity. The assessor must record below evidence in relation to the above assessment outcome. The assessor should refer to Mental Capacity Act Code of Practice chapters 3 and 4 and include: 1. The key elements of the decision and what information the person was given to make the decision. 2. The strategies used to help the person understand the relevant information including the involvement of significant others. 3. How the person conveyed their decision. 4. How optimum timing and environment / location were used to ensure the person felt at ease. 17

1.1.3 REASONS FOR ANSWERS CONTINUED 1.1.4 OUTCOME If hand writing continue on a separate sheet if necessary, if typing box will expand attach sheets together Does the patient have capacity to make this decision at this time? Yes No If the answer is No then complete the Appendix 2. 18

Assessor s details Name (print): Signature: Designation: Date: Time: Best Interests Checklist for Use by Health and Social Care Staff Working with Person Lacking Capacity in Relation to a Decision (Appendix 2) Patient/User Name: DOB: DECISION Record in the space below the decision for which person lacks capacity......... CHECKLIST Please circle appropriate answer 1) Has an advance decision or advance refusal been made about the decision in question (only in relation to healthcare decision), and is it still relevant? Yes No If the answer is Yes then no further assessment is necessary 2) Have you considered whether it is likely that the person may have capacity at some time in future and whether a delay in decision- making will allow them to make that decision themselves? 3) Have you encouraged as far as is practicable that person s involvement in actions undertaken on their behalf or in any decisions affecting them? 4) Have you considered as much as is practicable the person s past and present wishes and preferences about the matter in question? 5) Have you considered any relevant written statement the person may have made when they did have capacity? 6) Have you considered the beliefs and values that would be likely to influence the person s attitude to the decision in question, i.e. religious, cultural and lifestyle choices? 7) Have you taken into account other factors that the person would be likely to consider in relation to the matter, i.e. emotional bonds or family obligations in deciding how to spend money or where to reside? 8) Have you considered alternative actions that produce less restriction on the person s rights and freedoms? 9) Have you consulted and taken into account the views of other key people as to what would be in a person s best interests and gathered information on their wishes, feelings, values, beliefs? Yes No Yes No Yes No Yes No N/A Yes No Yes No Yes No 19

a) Anyone named in advance as someone to be consulted? Yes No N/A b) Carers, family, spouses or partners? Yes No N/A c) Others with an interest in their welfare, friends, voluntary workers, other professionals? Yes No N/A d) Any Lasting Power of Attorney? Yes No N/A e) Any Deputy appointed by the Court of Protection? Yes No N/A If there are any conflicts in the above consultations, there needs to be an attempt to reach a consensus. However, the decision maker makes final decision. If there is an answer No in question 2 to 9, then staff should question whether they are acting in best interests. If no one is available to consult and/or if there is serious conflict of opinion and the decision and eligibility relates to decisions identified in Section 4 of the local policy and procedure, then an IMCA referral should be considered. Staff should evidence their consultations in the space below: (continue on a separate sheet where necessary but firmly attach it to this document) If hand writing continue on a separate sheet if necessary, if typing box will expand attach sheets together 20

Name and job title of worker: Name... Job title:..... Signature. Date of Decision Making/Best Interests Consideration. 21