Empowering patients with dementia to make legally effective decisions: a randomized controlled trial on enhancing capacity to consent to treatment

Objectives: As our society ages, the incidence of age-related diseases increases and with it the number of medical treatments that require informed consent. Capacity to consent is often categorically questioned in persons with dementia (PwD) without appropriate assessment, depriving them of their right to autonomous decision-making. Supportive structures for PwD that comply with legal requirements are lacking. The EmMa project tried to overcome this shortcoming by developing and testing possible supportive measures to enhance the informed consent process for PwD. Method: These enhanced consent procedures (ECPs) were tested in a randomized controlled trial with 40 PwD. It was hypothesized that strengths-based ECPs could improve capacity to consent to a drug treatment in PwD as measured with a semi-structured interview. Results: Against the expectations, no effect of the ECPs on capacity to consent could be found, but the ECPs improved understanding of information in PwD. Conclusion: To empower PwD in clinical settings, however, all aspects of capacity to consent should be targeted with specific aids that are implemented carefully and selectively. More research on possible aids for ECPs is urgently needed in order to enable ethically and legally robust informed consent. In particular, effective ways to improve both reasoning and appreciation are yet to be found.

Automated summary

With an aging society and increasing incidence of age-related diseases, the issue of informed consent becomes more prevalent. Persons with dementia often have their capacity to consent questioned without proper assessment, depriving them of their right to make autonomous decisions. The EmMa project aimed to address this issue by developing and testing supportive measures to enhance the informed consent process for persons with dementia. The results showed that while the enhanced consent procedures did not affect capacity to consent, they did improve understanding of information in persons with dementia. The conclusion suggests that a more targeted and careful approach is needed to empower persons with dementia in clinical settings.