Approaches to advance care planning for persons with dementia and their family caregivers: a cluster-randomized controlled trial.

In primary care practice, preferences for future care are often not discussed
with persons with dementia. There is no evidence-based standard for general
practitioners (GPs) to guide advance care planning (ACP) with persons with
dementia. Research has indicated some beneficial effects in persons with
dementia. ACP facilitates decision making and may increase control over care
and treatment at the end of life. Since it is advised to start ACP early in
case of dementia, GPs are well positioned to initiate ACP. There are different
approaches to ACP, and up until now, there is lack of research on the effect of
different ACP approaches and in subgroups.

We aim to assess the effects of two approaches of ACP (detailed advance
treatment orders versus global goal setting and coping based) on wellbeing of
persons with dementia. In addition, we will assess effects on decisional
conflict, self-efficacy to interact with physicians, and the perception of
family caregivers on physician-family communication. We aim to determine if
these effects differ by the readiness of the person with dementia or family
caregiver to engage in the particular ACP intervention. We will also explore
whether these effects differ among subgroups. In addition, we will explore
associations of various variables (e.g. gender, religion, coping strategies
etc.) with the readiness of the person with dementia and the family caregiver
to engage in the particular ACP intervention.

Cluster-randomized trial with separate control group of participants not
clustered with practices.

Both interventions include multiple interactive training sessions, forms to
document results of ACP, and prompting of persons with dementia and their
family caregiver by providing a question prompt list on palliative care in
dementia. The contents of the training and forms match the focus of the
respective intervention.

For GPs, there is no risk in study participation as there is no harm to the
relationship, being responsible for applying the interventions in a
person-centred manner. The burden for GPs is considerable, mainly due to
advance care planning consultations which, for most GPs, will be consultations
additional to usual care. The burden for the GPs consists of approaching
persons with dementia and family caregivers from their practice for study
inclusion and responding to some research-related questions later on. The main
burden for the GPs randomized to one of the two intervention groups is that
they will attend two training sessions, and are requested to conduct ACP. While
the burden is increased for the GPs, we are introducing good research practice
on ACP with dementia, which is currently not given much attention to in regular
care. To all GPs, we lower the burden by selecting eligible persons with
dementia from their GP practice and by giving complete and ready-to-send
packages to the GP practice which they can send to the interested persons with
dementia. We will also request accreditation points for the training.

For persons with dementia and family caregivers the risk is minimal. The burden
consists of completing the questionnaires and an interview, and for persons
with dementia and family caregivers in the intervention groups, attending one
or more ACP consultations with the GP (which they may refuse).

This study on ACP for persons with dementia is of importance as this will
result in more knowledge about different approaches to ACP in dementia. A
better understanding is possible through inclusion of persons with dementia
only. Persons with dementia allocated to the intervention groups may benefit as
there will be more opportunities during ACP consultations where they could
express their preferences, possibly resulting into increased wellbeing.