ACP – Advanced Care Planning: italian experience

1. ACP – Advanced Care Planning: italianexperience 16th Annual Allied Professionals Forum Scottish Event Campus 6 December 2018 Glasgow, Scotland, UK

2. Law n. 219 Dec. 22, 2017 Art. 4. - Advance Directives of Treatment (ADT) 1. Any adult and capable of understanding and wanting, in anticipation of a possible future incapacity to self-determination and after having acquired adequate medical information on the consequences of his/her choices, can, through the ADT, express their wishes regarding health treatments, as well as consent or refusal with respect to diagnostic tests or therapeutic choices and to individual health treatments. He/she also indicates a person of his trust, hereinafter referred to as the "trustee", who takes his/her place and represents him/her in relations with the physician and with the healthcare facilities 6. The ADT must be drawn up by public deed or by certified private deed or by private deed delivered personally by the settlor to the civil status office of the municipality of residence of the settlor himself, who provides the record in a special register, where established, or at health facilities 16th Annual Allied Professionals Forum Scottish Event Campus 6 December 2018 Glasgow, Scotland, UK

3. Before the Law N. 219… Advanced Care Planning (ACP) • It is the process that promotes the emergence and sharing of values, existential objectives and preferences of people in reference to their future therapeutic choices • It requires strong doses of communication between the sick person and his/her loved ones (if so desired) and health professionals • For years, in Australia, UK, Canada, USA, there were specific legislations 16th Annual Allied Professionals Forum Scottish Event Campus 6 December 2018 Glasgow, Scotland, UK

4. Before the Law N. 219… Advanced Care Planning (ACP) • Reduction of stress on health workers • Decreased litigation related to medical responsibility • Hospitalization rates reduction • Improvement of appropriateness and decrease in health expenditure • Improvement of quality of care • Increase of residual life quantity 16th Annual Allied Professionals Forum Scottish Event Campus 6 December 2018 Glasgow, Scotland, UK

5. Law n. 219 Dec. 22, 2017 Art. 5. - Shared Care Planning 1. In the relationship between patient and doctor referred to in Article 1, paragraph 2, regarding the evolution of the consequences of a chronic and debilitating disease or characterized by unstoppable evolution with poor prognosis, a shared care planning can be realized between the patient and the doctor, to whom the doctor and the health team are obliged to comply if the patient finds himself/herself in the condition of not being able to give his consent or in a condition of incapacity. 4. The consent of the patient and the possible indication of a trustee, referred to in paragraph 3, are expressed in written form or, in the event that the patient's physical condition does not allow it, through video-recording or devices that allow the person with disability to communicate, and are included in the medical record and in the electronic health record. Treatment planning can be updated with the progressive evolution of the disease, at the request of the patient or at the suggestion of the doctor.

6. Law n. 219 Dec. 22, 2017 AISLA wishes the drafting of the ACP as: The ADT are an expression of the unilateral initiative of a "person", regardless of a care relationship with a doctor (Article 4) while the planned Shared Care Planning (ACP - Article 5) concerns a process that originates and evolves "in the relationship between doctor and patient ". Art.1 - Paragraph 8 The time of communication between doctor and patient is a time of care.

7. In 2014… AISLA Health communication is not carried out in a single moment but in a process that takes place and develops at every meeting between the sick person and the health care staff who is in charge of the care and assistance, what is defined as taking charge. And it is in this communication path that the right of the patient to govern the flow of information concerning him/her must be taken into consideration. This process involves the identification of a time for knowledge, one for processing the acquired information and finally another for the choice of the proposed treatments.

8. Gruppo di lavoro AISLA Medical-ScientificCommission Mario Sabatelli, Adriano Chiò, Claudia Caponnetto, Christian Lunetta, Jessica Mandrioli, Maria Rosaria Monsurrò, Paolo Volanti, Letizia Mazzini, Nicola Ticozzi, Gabriele Mora, Ettore Beghi, Giuseppe Borghero, Michele Vitacca, Nadia Cellotto, Gabriella Restagno, Francesca Luisa Conforti, Caterina Bendotti, Maria Teresa Carrì, Mario Melazzini Consultants Prof. Penasa - Constitutionalist, University of Trento. Dr. Olivieri – Anesthetist, University of Novara Prof. Barbisan– Bioethicist, University of Padova Prof. Spagnolo – Bioethicist, Catholic University of the Sacred Heart, Roma Coordination Dr. Daniela Cattaneo, Palliative Care specialist, AISLA onlus.

9. In 2014… AISLA Only the sick person, in fact, can assess whether the health interventions that are proposed are proportionate to their condition and therefore not detrimental to their dignity and their conception of quality of life. On the one hand, the duty of the health professional to inform the patient and obtain his/her consent or dissent to the procedures, and on the other the right of the patient to decide which treatment to undergo or not to undergo. But if the health competence in the care and assistance of the sick person as well as the availability of the means are the conditions for the patient to exercise his/her will, all the means (aids, PEG, NIV, tracheostomy, treatments end-of-life palliatives) must be presented and made available. However, the sick person may at some point in his/her history consider that the first accepted means may no longer be appropriate to his/her condition.

10. The work of AISLA from 2014 to today ... Shared Care Planning Documents (SCP)

11. The AISLA ACP • The undersigned…………………………………………………………………… • in full possession of my psychic and mental faculties ascertained by the • Dr. …………………………………………..on ………………. • RECALLED THAT:: • in article 32, paragraph 2 of the Constitution, it is stipulated that "No one may be subjected to health treatment unless by law, with the prohibition of health treatments that conflict with respect for the human person"; • that this principle is also referred to in Articles 2 and 13 of the Constitution and Articles 1.2 and 3 of the Charter of Fundamental Rights of the European Union • that the Law 22 December 2017 n, 219 (Official Gazette No. 12 of 16/01/2018) "Rules on informed consent and advance treatment provisions" protects the right to life, health, dignity and self-determination of the person; • that according to the aforementioned medical treatment is legitimate only if based on the patient's consent; • it is the principle of "Informed Consent" which states that the will of the individual must always be at the basis of the therapeutic choices

12. The AISLA ACP • 4 DOCUMENT FORMS: • Consent to Invasive Ventilation • Dissent to Invasive Ventilation • Waiver of Invasive Ventilation • Waiver of the Invasive Ventilation in case of Locked-in

13. The AISLA ACP • Consent to Invasive Ventilation • DICHIARO • il mio consenso informato alla ventilazione artificiale nella forma invasiva in quanto la ritengo adeguata al mio vissuto. • Sono stato inoltre informato e sono consapevole: • che le volontà qui espresse potranno da me essere cambiate e definite in un nuovo documento. • che potrò rinunciare al trattamento di ventilazione artificiale, anche dopo aver fatto la tracheostomia, se nel tempo dovesse rappresentare una gravosità per me insostenibile e quindi configurarsi come un trattamento non più adeguato al mio vissuto. • che la rinuncia al trattamento di ventilazione artificiale con preventiva sedazione farmacologica profonda non costituisce un atto di eutanasia ma rientra nel mio diritto alla consensualità dei trattamenti.

14. The AISLA ACP • Dissent to Invasive Ventilation • AWARE • to be suffering from Amyotrophic Lateral Sclerosis • that there are no specific treatments for this advanced disease that can change the course of the disease • that ongoing respiratory failure is not reversible or modifiable • that non-invasive ventilation will however become ineffective over time • that the non-use of invasive artificial ventilation (tracheostomy) will not allow me to live • of the benefits and limitations of invasive artificial ventilation and in particular that this treatment prolongs survival but that the disease will continue to progress • that invasive artificial ventilation is a health treatment that the patient can freely renounce • that the renunciation of the treatment of invasive artificial ventilation does not constitute an euthanasia • that the will expressed here will be able to be changed and defined in a new document • DECLARE • my informed dissent of invasive artificial ventilation as I consider it unsuitable for my experience, constituting for me an unbearable gravity

15. The AISLA ACP • Waiver of Invasive Ventilation • AWARE • to be suffering from Amyotrophic Lateral Sclerosis • that there are no specific treatments for this advanced disease that can change the course of the disease • that the respiratory insufficiency in place is not reversible nor modifiable • that the renunciation of invasive artificial ventilation (tracheostomy) will not allow me to live • of the benefits and limitations of invasive artificial ventilation and in particular that this treatment prolongs survival but that the disease will continue to progress • that invasive artificial ventilation is a health treatment that the patient can freely renounce • that the renunciation of the treatment of invasive artificial ventilation does not constitute an euthanasia • that the will expressed here will be able to be changed and defined in a new document • DECLARE • my dissent informed to continue artificial ventilation in the invasive form as this treatment is a burden no longer sustainable and is considered by me not appropriate with respect to my experience.

16. The AISLA ACP • Waiver of the Invasive Ventilation in case of Locked-in • AWARE: • to be suffering from Amyotrophic Lateral Sclerosis • that there are no specific treatments for this advanced disease that can change the course of the disease • that the respiratory insufficiency in place is not reversible nor modifiable • of the benefits and limitations of invasive artificial ventilation and in particular that this treatment prolongs survival but that the disease will continue to progress • that invasive artificial ventilation is a health treatment that the patient can freely renounce • that the disease can further evolve, compromising the ocular musculature, thus preventing me from communicating with the outside world and expressing my wishes • that the condition described in the previous point is called "Locked-in" • that the renunciation of invasive artificial ventilation by tracheostomy will not allow me to live • that the renunciation of the treatment of invasive artificial ventilation does not constitute an euthanasia • that the will expressed here will be able to be changed and defined in a new document • DECLARE • my informed dissent, if I will complain a "Locked-in“condition, to continue the artificial invasive ventilation as I consider it not appropriate to my experience, constituting this condition a burden for me unsustainable

17. The AISLA ACP • The bases of the ACP are: •   Awareness: •   of the current clinical picture and the evolution of the disease •   of the intangibility of the disease •   Severity for the SAME of the treatments •   The application of the ACP is NOT configured as an euthanasia •   The fiduciary representative • Furthermore the patient declares that the choice is not motivated by: •   Conditions of non-freedom in the manifestation of will; •   From the presence of symptoms of suffering that have not been previously treated; •   That has had a long process of reflections with at least 2 doctors • In case of refusal or renunciation of the means the pc. it requires to deal in advance with the state of physical suffering that will occur with a treatment of drug sedation.

18. Since 2014… AISLA learning 1 13 • 64 training courses on Palliative Care, ACP, Sedation • 1740 health area learners (Doctors, nurses, FKR, psychologists, social workers, etc.) • Courses Locations 2 1 15 1 4 6 1 2 1 4 3 1 3 6

19. Survey on Italian Healthcare Professionals regarding APC Graphs

20. Thank you!!! http://www.aisla.it/la-pianificazione-condivisa-delle-cure/ Christian Lunetta christian.lunetta@centrocliniconemo.it Stefania Bastianello sbastianello@aisla.it