**1. Introduction**

The number of donors is inadequate although the need of organ transplant has increased over recent decades [1–4]. Most of the organs available for transplantation come from deceased

© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. © 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

rather than living donors. Then, patients who have been declared brain death are the largest source of transplantable organs. The consensus rate improvement of solid organ donation from deceased donors is considered one of the main strategies to increase the availability of organs for transplantation. Unfortunately, a low percentage of people register their donation wishes in life. Furthermore the laws concerning individual consent expressed previously in life are dissimilar in different countries; above all, the population's adhesion to the law may not be comparable so that family members are often the only ones that can express consent to organ donation. Although the main factor limiting the number of donations from brain-dead potential donors is the low rate of consent from their families. Furthermore, in the clinical practice, even when the patient has registered their will on the organ donors' registry and there is no legal obligation to obtain consent from the relatives, if a relative denies the consent, organ donation may not proceed [5, 6]. The consensus rate improvement of solid organ donation from deceased donors is considered one of the main strategies to increase the availability of organs for transplantation. They get the bad news about the possibility and then of their loved one's death in a short time. The settings where family members receive this information are intensive care or emergency areas, unfamiliar, unknown and often confusing places. Several studies examined the reason why some potential donors' families refuse consent, while the others analyzed a series of "modifiable" factors related to meeting with the family(s) especially. Kerri Barber et al. in 2006 reported the results of an interesting audit of all deaths in intensive care units (ICUs) from 1 April 2003 to 31 March 2005 regarding 341 intensive care units in 284 hospitals in the United Kingdom [7].

a sense of urgency, the feeling of not being competent to decide and a sense of despair and crisis and the need for an agreement between all relatives. The ethical considerations regarding the possibility of helping others, the integrity of the body and life after death reveal the emotions and personal motivations coming into play going beyond the event itself and the immediate and concrete decisions that family members are called to take [11]. Vincent A et al. also reported the common reasons for family refusal: relatives not wishing surgery to the body (concerns regarding disfigurement), feelings that the patient has suffered enough, feeling incompetent regarding the patient's wishes, disagreements among the family group, religious/cultural reasons, dissatisfaction with the health-care staff and process, concerns over delay to the funeral/burial process, inability to accept death, lack of understanding of brain death, concerns regarding integrity of process and the fact that they were emotionally

Family-Centered Care to Improve Family Consent for Organ Donation

http://dx.doi.org/10.5772/intechopen.74781

91

The same authors pointed out that several studies come to the conclusion that following ele-

**4.** Imparting specific information (e.g. regarding the nature of brain death)

**6.** Guaranteeing staff involvement in a planned process of the organ donation request

particular, Italy shares with Spain the following key points regarding transplantation

Italy as a whole is undoubtedly the country that has developed a model similar to the Spanish one. Spain has become a reference point for European and global solid organs donation and transplantation with the highest donation rates. Italy has a cultural and health structure similar to Spain and it is needed to create an organizational structure since the 1999 law [13, 14]. In 1988, the Council of Europe Committee of Experts on Transplantation (SP-CTO) was established. The Committee included more than 30 countries with observatories from Canada, Japan and Israel and was incorporated by the Eastern countries for which it represented the only contact with the great Western countries' transplant referents for many years. The Organización Nacional de Trasplantes (ONT) held the presidency of this Committee for 7 years (1995–2000 and 2003–2005). The majority of the documents you need as a basis for the preparation of the Commission and the European Parliament actions on transplants have been processed in Spain. Following the approval of Article 157 of the Amsterdam Treaty, the European Union has developed the European directives on transplantation, guaranteeing the quality and safety of the tissue and cell organs. In May 2003, the Executive Council of the World Health Organization (WHO) accepted to set up an international group of experts to examine the issues related to transplants, including xenotransplantation. Spain is the promoter of a punctual organization in the field of transplants that Italy has been sharing. In

exhausted themselves.

ments could be useful [12]:

**1.** Guaranteeing the right timing of a request

**2.** Guaranteeing an appropriate setting

**5.** Guaranteeing adequate staff training

**3.** Providing emotional support

Among the relatives of 2320 potential heart-beating donors who were approached for donation consent, 41% refused. The main reason for refusal is the knowledge of the desire not to donate expressed by the deceased person in life (16%). In the last 20 years different studies have emphasized how privacy and request timing, the involvement in the patient care team that gives information to the family of at least one member of the staff of organ procurement and a care to brain death significance explanation are key factors to improve relationships [8–10]. Furthermore several authors pointed out that religious, cultural and social beliefs play an important role in the family's decision-making process. Besides, concerns on exact time of death and body integrity after death and emotional vulnerability are equally crucial. The process is also influenced by education, income, sex and age of the family members [6, 7, 9, 10]. There are many relationship elements and emotions involved in the donation process. Ignoring family's emotions without taking care of the relational aspects can hamper fully aware choices. De Groot and colleagues in 2015 reported the results of a qualitative research in a group of donors' relatives regarding the decision-making donation process. We reported the main results of this research in this context. The authors confirm how the stressful sudden event, the interaction with unknown people, the difficulty of mourning and making a decision for the loved one whose loss is being wept over are determinant factors in the decision-making process of the family. The occurrence rapidity does not allow us to be aware of the reality we are experiencing and of any decisions that must, in any case, be taken. The potential donors' relatives describe the decision-making process as complex mainly because they had to make a decision on behalf of the deceased (surrogate decision). The conditions that might contribute to this complexity are the feeling of having limited time and a sense of urgency, the feeling of not being competent to decide and a sense of despair and crisis and the need for an agreement between all relatives. The ethical considerations regarding the possibility of helping others, the integrity of the body and life after death reveal the emotions and personal motivations coming into play going beyond the event itself and the immediate and concrete decisions that family members are called to take [11]. Vincent A et al. also reported the common reasons for family refusal: relatives not wishing surgery to the body (concerns regarding disfigurement), feelings that the patient has suffered enough, feeling incompetent regarding the patient's wishes, disagreements among the family group, religious/cultural reasons, dissatisfaction with the health-care staff and process, concerns over delay to the funeral/burial process, inability to accept death, lack of understanding of brain death, concerns regarding integrity of process and the fact that they were emotionally exhausted themselves.

The same authors pointed out that several studies come to the conclusion that following elements could be useful [12]:


rather than living donors. Then, patients who have been declared brain death are the largest source of transplantable organs. The consensus rate improvement of solid organ donation from deceased donors is considered one of the main strategies to increase the availability of organs for transplantation. Unfortunately, a low percentage of people register their donation wishes in life. Furthermore the laws concerning individual consent expressed previously in life are dissimilar in different countries; above all, the population's adhesion to the law may not be comparable so that family members are often the only ones that can express consent to organ donation. Although the main factor limiting the number of donations from brain-dead potential donors is the low rate of consent from their families. Furthermore, in the clinical practice, even when the patient has registered their will on the organ donors' registry and there is no legal obligation to obtain consent from the relatives, if a relative denies the consent, organ donation may not proceed [5, 6]. The consensus rate improvement of solid organ donation from deceased donors is considered one of the main strategies to increase the availability of organs for transplantation. They get the bad news about the possibility and then of their loved one's death in a short time. The settings where family members receive this information are intensive care or emergency areas, unfamiliar, unknown and often confusing places. Several studies examined the reason why some potential donors' families refuse consent, while the others analyzed a series of "modifiable" factors related to meeting with the family(s) especially. Kerri Barber et al. in 2006 reported the results of an interesting audit of all deaths in intensive care units (ICUs) from 1 April 2003 to 31 March 2005 regarding 341

Among the relatives of 2320 potential heart-beating donors who were approached for donation consent, 41% refused. The main reason for refusal is the knowledge of the desire not to donate expressed by the deceased person in life (16%). In the last 20 years different studies have emphasized how privacy and request timing, the involvement in the patient care team that gives information to the family of at least one member of the staff of organ procurement and a care to brain death significance explanation are key factors to improve relationships [8–10]. Furthermore several authors pointed out that religious, cultural and social beliefs play an important role in the family's decision-making process. Besides, concerns on exact time of death and body integrity after death and emotional vulnerability are equally crucial. The process is also influenced by education, income, sex and age of the family members [6, 7, 9, 10]. There are many relationship elements and emotions involved in the donation process. Ignoring family's emotions without taking care of the relational aspects can hamper fully aware choices. De Groot and colleagues in 2015 reported the results of a qualitative research in a group of donors' relatives regarding the decision-making donation process. We reported the main results of this research in this context. The authors confirm how the stressful sudden event, the interaction with unknown people, the difficulty of mourning and making a decision for the loved one whose loss is being wept over are determinant factors in the decision-making process of the family. The occurrence rapidity does not allow us to be aware of the reality we are experiencing and of any decisions that must, in any case, be taken. The potential donors' relatives describe the decision-making process as complex mainly because they had to make a decision on behalf of the deceased (surrogate decision). The conditions that might contribute to this complexity are the feeling of having limited time and

intensive care units in 284 hospitals in the United Kingdom [7].

90 Organ Donation and Transplantation - Current Status and Future Challenges


Italy as a whole is undoubtedly the country that has developed a model similar to the Spanish one. Spain has become a reference point for European and global solid organs donation and transplantation with the highest donation rates. Italy has a cultural and health structure similar to Spain and it is needed to create an organizational structure since the 1999 law [13, 14]. In 1988, the Council of Europe Committee of Experts on Transplantation (SP-CTO) was established. The Committee included more than 30 countries with observatories from Canada, Japan and Israel and was incorporated by the Eastern countries for which it represented the only contact with the great Western countries' transplant referents for many years. The Organización Nacional de Trasplantes (ONT) held the presidency of this Committee for 7 years (1995–2000 and 2003–2005). The majority of the documents you need as a basis for the preparation of the Commission and the European Parliament actions on transplants have been processed in Spain. Following the approval of Article 157 of the Amsterdam Treaty, the European Union has developed the European directives on transplantation, guaranteeing the quality and safety of the tissue and cell organs. In May 2003, the Executive Council of the World Health Organization (WHO) accepted to set up an international group of experts to examine the issues related to transplants, including xenotransplantation. Spain is the promoter of a punctual organization in the field of transplants that Italy has been sharing. In particular, Italy shares with Spain the following key points regarding transplantation

• The health status of a country or region is also affected by a good functioning of the donation transplantation system. This is conditioned and conditions a good quality health system

With regard to all that was mentioned above, we believe that optimizing the relationship with the potential donors' relatives might represent the main organ procurement strategy. The

Family-Centered Care to Improve Family Consent for Organ Donation

http://dx.doi.org/10.5772/intechopen.74781

93

The past two decades witnessed an increasing interest in the importance of health-care humanization. The recent guidelines suggest organized interventions and approaches aimed at supporting the families of critical patients. The objectives are twofold: to reduce the impact of serious illness and to prepare family members for decision-making and assistance needs. An international consensus recognized a new definition: "family" and "familycentered care" to identify this approach. The term "family" intends to identify a group of individuals who support the patient and with whom the patient has a significant relationship. "Family-centered care" is a respectful and responsive approach to health-care that meets the needs and values of individual families and is mainly characterized by: family presence in the ICU, family support and communication with family members. Family members will not only be present within the ICU but also actively participate in the care process. It is recommended that validated tools exist to optimize communication quality, medical understanding and reduce family decision-making conflicts, in setting the ICU up. Care practitioners must apply standardized and agreed communication approaches with family members of deceased patients and above all for those who died with brain-death criteria, especially [16]. Seaman J.B. and colleagues in Annals ATS (2017) suggest that the goals of clinician-family communication should be diversified and concern different aspects [17]. We very much share the elements discussed by these authors and we comment on some of them that seem relevant and in line with our choices. First of all, it is about establishing trust. The most important element of the quality of care for seriously ill patients' family members is the condition of trust in the care team. Sharing the decision-making process requires trust in the care team and at the same time allows to achieve a more stable relationship with the family members. Because family members can decide (when they are called on to do so) they must understand what has happened (and what the clinical consequences are), the effect of the choices on the beloved and the risks and benefits of the shared pathway. The second one is providing emotional support. ICU patients' family members have high levels of emotional stress and experience intense negative emotions such as fear and anxiety. These feelings are exacerbated by the communication of the bad news (death or threat of death) and by the decision-making process itself. Research in the neuropsychological field suggests that strong negative emotions such as fear and anxiety do not allow processing information detaching the subject from the reality (as already mentioned above). Therefore, attention to the relationship also allows us to devote a time to recognize emotions and reflect on them. Third element is conveying clinical information. Clinicians should take into account that family members should be informed in a clear, simple and precise manner regarding the diagnosis, prognosis and possibilities of patient treatment. Families need to be involved in the decision-making process. Lack of correct information can lead family members not to take the right decisions for the patient as well as being a source of stress and frustration. The authors confirm the importance of the interdisciplinary team role (involving psychologists, social workers, volunteers, care coordinators and communication facilitator) to improve family satisfaction and

intensive care setting is the place where this relationship can be created.

decrease psychological symptoms.

• A training program is needed for intensive care and operating theaters' doctors who work with potential and receiving donors

Spain has collaborated very actively organizing different types of courses some of which specifically concern family members' interviews. The proximity between Italy and Spain and the similarity of the language facilitate the collaboration process between the two countries. Italy currently has a three-level (national, regional and hospital) transplant system organization and a training system that follows the Spanish model. Initially, the percentage of refusal to donate was quite high; currently, the percentage of waste is about 30% and it has been stable for some years. We believe we can still do a lot to reduce this waste amount. The WHO provides technical support for the correct development in the field of transplants, promotes international cooperation and continues the examination and collection of global data on allogeneic transplantation safety, quality, efficacy and ethics.

The work strategy adopted to implement donations is based on a process called global base of knowledge about transplant (GKT) defined in resolution WHA57.18. The GKT consists of four lines of work that require progressive development and includes the following aspects:


To find out more about the world situation regarding organ transplants, we recommend the website [2].

No religious beliefs preclude organ donation; people usually refer to personal conscience. The national frame guarantees quality and safety for the donor and the receiver [15].

With regard to all that was mentioned above, we believe that optimizing the relationship with the potential donors' relatives might represent the main organ procurement strategy. The intensive care setting is the place where this relationship can be created.

• The health status of a country or region is also affected by a good functioning of the donation transplantation system. This is conditioned and conditions a good quality health system

• A training program is needed for intensive care and operating theaters' doctors who work

Spain has collaborated very actively organizing different types of courses some of which specifically concern family members' interviews. The proximity between Italy and Spain and the similarity of the language facilitate the collaboration process between the two countries. Italy currently has a three-level (national, regional and hospital) transplant system organization and a training system that follows the Spanish model. Initially, the percentage of refusal to donate was quite high; currently, the percentage of waste is about 30% and it has been stable for some years. We believe we can still do a lot to reduce this waste amount. The WHO provides technical support for the correct development in the field of transplants, promotes international cooperation and continues the examination and collection of global data on allo-

The work strategy adopted to implement donations is based on a process called global base of knowledge about transplant (GKT) defined in resolution WHA57.18. The GKT consists of four lines of work that require progressive development and includes the following aspects:

• GKT2: It includes allogeneic transplants legislation and organizational systems. The main objective of the registry is to gather information on organs, tissues and cell donation and transplantation activities, as well as information on the legislative and organizational aspects of transplantation all over the world and to make professionals and the general public know them.

• GKT3: It includes response to transplants, risks, survival and surveillance systems, safety aspects and ethical aspects. Creating systems is considered a surveillance priority that guarantees transplants safety, so that any effects and adverse reactions, both in receiving and in living donors, can be communicated to take any necessary measures. From an ethical point of view, it is intended to obtain information on the measures taken from member states to protect the poorest and most vulnerable groups, for example, from organ and tissue trade.

• GKT4: It includes xenotransplantation. Xenotransplantation could be the alternative to the lack of human origin organs and tissues. However, experimental preclinical tests haven't justified human clinical trials yet. Transparency is a fundamental and mandatory requirement for the WHO in donation and transplantation-related practices, as well as in informa-

To find out more about the world situation regarding organ transplants, we recommend the

No religious beliefs preclude organ donation; people usually refer to personal conscience. The

national frame guarantees quality and safety for the donor and the receiver [15].

with potential and receiving donors

92 Organ Donation and Transplantation - Current Status and Future Challenges

tion collected around the world.

website [2].

geneic transplantation safety, quality, efficacy and ethics.

• GKT1: It includes activities and practices in allogeneic transplants.

The past two decades witnessed an increasing interest in the importance of health-care humanization. The recent guidelines suggest organized interventions and approaches aimed at supporting the families of critical patients. The objectives are twofold: to reduce the impact of serious illness and to prepare family members for decision-making and assistance needs. An international consensus recognized a new definition: "family" and "familycentered care" to identify this approach. The term "family" intends to identify a group of individuals who support the patient and with whom the patient has a significant relationship. "Family-centered care" is a respectful and responsive approach to health-care that meets the needs and values of individual families and is mainly characterized by: family presence in the ICU, family support and communication with family members. Family members will not only be present within the ICU but also actively participate in the care process. It is recommended that validated tools exist to optimize communication quality, medical understanding and reduce family decision-making conflicts, in setting the ICU up. Care practitioners must apply standardized and agreed communication approaches with family members of deceased patients and above all for those who died with brain-death criteria, especially [16]. Seaman J.B. and colleagues in Annals ATS (2017) suggest that the goals of clinician-family communication should be diversified and concern different aspects [17]. We very much share the elements discussed by these authors and we comment on some of them that seem relevant and in line with our choices. First of all, it is about establishing trust. The most important element of the quality of care for seriously ill patients' family members is the condition of trust in the care team. Sharing the decision-making process requires trust in the care team and at the same time allows to achieve a more stable relationship with the family members. Because family members can decide (when they are called on to do so) they must understand what has happened (and what the clinical consequences are), the effect of the choices on the beloved and the risks and benefits of the shared pathway. The second one is providing emotional support. ICU patients' family members have high levels of emotional stress and experience intense negative emotions such as fear and anxiety. These feelings are exacerbated by the communication of the bad news (death or threat of death) and by the decision-making process itself. Research in the neuropsychological field suggests that strong negative emotions such as fear and anxiety do not allow processing information detaching the subject from the reality (as already mentioned above). Therefore, attention to the relationship also allows us to devote a time to recognize emotions and reflect on them. Third element is conveying clinical information. Clinicians should take into account that family members should be informed in a clear, simple and precise manner regarding the diagnosis, prognosis and possibilities of patient treatment. Families need to be involved in the decision-making process. Lack of correct information can lead family members not to take the right decisions for the patient as well as being a source of stress and frustration. The authors confirm the importance of the interdisciplinary team role (involving psychologists, social workers, volunteers, care coordinators and communication facilitator) to improve family satisfaction and decrease psychological symptoms.
