Effect of the use of continuous sedation until death on the patient's relatives wellbeing

Palliative sedation entails the use of sedating drugs to induce a state of
decreased consciousness to alleviate symptoms for patients who are approaching
death. Palliative sedation is used in high frequencies and its use is
increasing. Lowering patients* consciousness is a far-reaching intervention
that has an important impact on the relatives. Relatives consider the procedure
distressing. For instance, it deprives the relatives of the possibility to
communicate with the patient until death and there are often concerns about the
wellbeing of the patient. These factors may affect the wellbeing and the
bereavement of relatives. The KNMG guideline palliatieve sedation contains
recommendations regarding the wellbeing of relatives focused on information,
communication and support.

The proposed study aims to evaluate the recommendations of the guideline
regarding the wellbeing of the relatives according to the following questions:
1) To what extent are the recommendations of the guideline adhered to?
2) What is the effect of the use of palliative sedation on the wellbeing of
relatives during the sedation and after the patient's death?
3) What elements of the use of palliative sedation are associated with the
wellbeing of relatives during the sedation and after the patient's death?
a) Elements relating to the recommendations in the guideline
b) Other elements of the use of sedation

The proposed study concerns three parts ( 'mixed methods approach'):
1. A focusgroup study
2. An interview study
3. A questionnaire study

Two focusgroups are planned with relatives of patients who received sedation
prior to death. The focusgroups are a preparation for the interview study. In
the second part, 30 cancer patients for whom sedation was used prior to their
death will be identified, and the physician, nurse and relative who were most
involved in the care for the patient will be interviewed. Because there are
marked differences between countries in the frequency of sedation, this study
will also be performed in the UK and Flanders. For the third part,
questionnaires will be send out to 525 relatives (175 relatives of sedated
patients matched with 350 relatives of non-sedated patients).
All parts of the study concern a specific type of sedation: continuous sedation
until death.

In this study, no invasive physical procedures will take place. Therefore,
adverse events in the strict sense cannot take place.
However, we can be stirring up a lot of difficult or unresolved issues for all
respondents. Death, dying and bereavement are all sensitive and potentially
upsetting topics to discuss and participation in a study involving these issues
can raise difficult issues. We will draw on this to ensure that the study is
sensitively handled. We will liaise with each organisation to ensure that we
engage in appropriate follow up. This is likely to mean ensuring that we are
available to follow up any questions or issues raised, and e.g. offer relatives
the opportunity to talk to the key physician of the patient if necessary.
Further, we will ensure to inform participants of more formal bereavement
support which they may wish to seek following their research participation.