Guide to Informed Decision-making in Health Care 2nd edition. Disclaimer The information within the Guide to Informed Decision-making in Health Care is intended as a guide to good clinical practice. The law and service delivery environment is constantly evolving, so while every attempt has been made to ensure the content is accurate, it cannot be guaranteed. The information within this document should not be relied upon as a substitute for other professional or legal advice. ISBN 9781921707391 State of Queensland (Queensland Health) 2017 This work is licensed under a Creative Commons Attribution Non-Commercial 2.5 Australian license. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc/2.5/au/ In essence, you are free to copy, communicate and adapt the work for non-commercial purposes, as long as you attribute the Patient Safety and Quality Improvement Service, Queensland Health and abide by the license terms. For further information, contact: Patient Safety and Quality Improvement Service Clinical Excellence Division PO Box 2368 Fortitude Valley BC 4006 Phone: (+61) (07) 3328 9430 Email: [email protected] Website: www.health.qld.gov For permission beyond the scope of this license contact: Intellectual Property Officer Queensland Health GPO Box 48 Brisbane Queensland 4001 Phone: (+61) (07) 3234 1479 Email: [email protected] 2 Foreword Patient-centred care is widely recognised as a core dimension of a quality modern health service. Fundamental to informed decision-making is a two-way dialogue between patients and their health practitioners about the benefits, risks and alternatives of treatment, taking into account the patient’s personal circumstances, beliefs and priorities. A well informed patient can actively participate in the decision-making process about their care, and better understand the likely or potential outcomes of their treatment. Informed decision-making also provides an additional layer of vigilance and protection against errors which may result in adverse events. Performed well, the informed decision-making process builds trust, prevents harm and reduces surprise and distress if complications or adverse events do occur. The provision of informed consent by a patient reflects the end point of a process of engagement between the patient and at least one health practitioner who has provided information to the patient to assist making an informed decision in relation to their health care. While consent forms are often necessary for risk management, completing the form is the final step in documenting a patient’s decision about consent; completing a consent form does not constitute the entire informed decision-making process. This Guide to Informed Decision-making in Health Care (Guide) documents the broadening approach to informed patient decision-making in Queensland Health and is intended to be contemporaneous with and reflect the national and international ethical, medico-legal and service delivery environment as it evolves and relates to Queensland. It guides good clinical practice within the prevailing legal framework in how to implement the principles of informed decision-making in clinical practice. It is not, and cannot be, exhaustive. Reflected within this Guide is the often complex ethical, legal, policy and practical framework of contemporary health care in which public sector health services are delivered. Such health care is delivered in a multidisciplinary team environment in which medical practitioners, dentists, nurses and other allied health practitioners, who each have differing roles and responsibilities in the provision of health care, provide care to patients. It also acknowledges that the environment, in which health practitioners provide health services, continues to evolve in light of changes in modern practice, community expectations and legislation. In addition to this Guide, the Patient Safety and Quality Improvement Service continues to support and assist health practitioners with the process of informed decision-making by providing web-based procedure specific consent forms and corresponding patient information sheets for frequently performed procedures within Queensland Health. This second edition of the Guide contains updates following the introduction of the Hospital and Health Boards Act 2011 and the establishment of independent Hospital and Health Services. Each Hospital and Health Service has a Human Resource (HR) Unit who can provide further and specific advice around local process issues with respect to informed consent. I would like to personally thank the staff of the Patient Safety and Quality Improvement Service, key clinical groups, consumers, legal advisors and other stakeholders for their contribution to the development and revision of this innovative Guide. Kirstine Sketcher-Baker Executive Director Patient Safety and Quality Improvement Service Clinical Excellence Division January 2017 3 Contents Introduction ..................................................................................................................................................... 6 Background ................................................................................................................................................. 6 Purpose ................................................................................................................................................... 6 Division of the Guide ................................................................................................................................ 6 Part 1: The general informed decision-making process ............................................................................... 8 1.1 What is health care? .......................................................................................................................... 8 1.2 What is meant by informed decision-making and informed consent? ................................................. 8 1.3 Why is it necessary to obtain consent? .............................................................................................. 9 1.4 What health care requires consent? ................................................................................................... 9 1.5 When should consent be obtained in writing? .................................................................................. 10 1.6 What process of informed decision-making needs to be followed? ................................................... 11 1.7 Is this adult patient able to make a decision about health care themselves? .................................... 18 1.8 What if there is doubt about a patient’s capacity to give consent or their capacity appears borderline or fluctuates? ......................................................................................................................................... 20 1.9 Can a patient or decision-maker decline or withdraw consent to health care? .................................. 21 1.10 Can information be withheld from a patient? .................................................................................. 22 1.11 What is the lifespan of a written consent? ...................................................................................... 23 1.12 Who is responsible for obtaining patient consent in an environment of shared care and multidisciplinary teams? ......................................................................................................................... 24 1.13 What are the organisational responsibilities of the health care facility? .......................................... 29 Part 2 Informed decision-making and consent for adults who lack or have impaired capacity to make decisions ................................................................................................................................................... 29 2.1 When consent isn’t required for an adult who has impaired capacity to consent .............................. 30 2.2 Who can consent for adult patients who have impaired capacity? (Substitute decision makers) ...... 32 2.3 The withholding and withdrawing of life-sustaining measures in an acute emergency from adult patients who lack capacity to consent .................................................................................................... 37 2.4 Is there health care which is prohibited completely or prohibited unless certain requirements are met? ....................................................................................................................................................... 40 Part 3 Informed decision-making and consent for children and young persons.......................................... 41 3.2 Informed decision-making for urgent and life-saving health care to children and young persons ...... 48 3.3 Examination of a child or young person without the consent of parents under the Child Protection Act 1999 ....................................................................................................................................................... 50 3.4 When is consent from a parent, guardian or child/young person not enough? .................................. 50 Part 4 Informed decision-making and consent in specific health care situations ........................................ 51 4.1 Do patients need to give informed consent to intimate examinations?.............................................. 51 4.2 What are the consenting issues for mental