Supported Decision-Making in Persons With Dementia: Development of an Enhanced Consent Procedure for Lumbar Puncture

Abstract

The right to make autonomous decisions is enshrined in law. However, the question how persons with cognitive deficits can be enabled to make autonomous decisions has not been satisfactorily addressed. In particular, the concept of supported decision-making and its implementation into practice has been poorly explored for persons with dementia (PwD).This article describes the empirical development and implementation of support tools to enhance informed consent processes (so called enhanced consent procedures/ECP) for PwD on whether to undergo lumbar puncture. In the end of the process of pilot testing and further development of the tools, the following tools were defined: (1) Standardized Interview Structure, (2) Elaborated Plain Language, (3) Ambience and Room Design, (4) Keyword Lists, (5) Priority Cards, (6) Visualization, and (7) Simplified Written Informed Consent (Patient Information), as well as the general attitude (8) Person-Centered Attitude of the facilitator. As the development, implementation and evaluation of ECP tools is one objective of the transnational ENSURE project, we also include an overview of future empirical procedures. So far, our findings can serve as a selection of possibilities to support PwD in decision-making and help practitioners achieve an appropriate balance between the autonomy and protection of PwD in complex decision-making situation. Future studies should address the question if the proposed set of tools is effective to enhance informed consent processes in PwD.

Das kombinierte Modell der Entscheidungsassistenz

“…Die empirische Evidenz für die Effektivität von Maßnahmen der Entscheidungsassistenz bei psychischen Erkrankungen ist zwar noch begrenzt [ 18 ], aber in diesem Kontext kann z. B. an verbesserte Einwilligungsverfahren und die Einbeziehung von Genesungsbegleitern oder anderen Assistenzpersonen gedacht werden [ 19 ].…”

Attitudes and Viewpoints Toward Prevention Trials in Alzheimer’s Disease

“…It was previously shown that, for example, uncertainties about lumbar punctures could be reduced by means of standardized video education (Babapour Mofrad et al, 2021). Proposals for supported decision-making with persons with dementia were also published recently (Wied et al, 2021) and could serve as a helpful tool for obtaining informed consent even in cases of already established cognitive impairment, thereby enabling autonomy. However, the concerns about lumbar punctures highlight the importance of replacing this examination with serum parameters in the future (Nabers et al, 2018).…”

Project DECIDE, part II: decision-making places for people with dementia in Alzheimer’s disease: supporting advance decision-making by improving person-environment fit

“…As in our previous studies, the presentation of information will be standardised for both the intervention and the control settings in order to ensure as much consistency as possible in everything apart from the ‘place’. Consequently, all support strategies that have proven to be effective in our own and international studies (e.g., elaborated plain language, key word list, time of day: 8–15 o’clock, person-centred attitude), will be used in both places (as recommended in the current AWMF-S2k-guideline “Einwilligung von Menschen mit Demenz in medizinische Maßnahmen”; for a summary of available evidence on SDM for PwAD, see [ 7 , 19 ]).…”

“…Previous research into supported decision-making (SDM) in PwAD has focused on the use of SDM strategies like keyword lists, elaborated plain language, and visualisation to compensate for deficits in verbal retrieval and improve a person’s understanding of information [ 7 ]. We consider SDM to be a communicative process and base our understanding of it on the combined communication model of Haberstroh et al [ 8 ], in which the mentioned strategies support both verbal and non-verbal content aspects of communication.…”