Proxy-decision-making in health care - Evaluation of a training program for legal guardians: a randomised controlled trial (PRODECIDE-RCT)

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Background: In Germany approximately 1.3 million people are represented by legal guardians, 60% by volunteers, mostly family members, 40% by professional guardians. In 2005 20% of designations of legal guardians were due to dementia. People with dementia may lack decision-making capacity. Legal guardians have to ensure their right of informed decision-making-processes in healthcare. These processes are complex. However, we have to assume that most legal guardians are not at all prepared for this task. Neither concrete eligibility criteria nor standardized training courses exist for legal guardians. Therefore, required competencies can't be presupposed. A similar situation has been stated for various countries. Optimizing proxy-decision-making may improve care of people suffering from dementia. For this purpose a training program for professional and volunteer legal guardians was conducted and tested for feasibility in a previous pilot study. The training program enhances competences in informed decision processes. Objectives: To evaluate this training program, and to develop and pilot a strategy for implementation. Methods: According to the Medical Research Councils framework for the development and evaluation of complex interventions, a randomized-controlled trial with six month follow-up and additional process evaluation will be conducted. The intervention comprises a two-day training program with four modules: A Decision-Making Process & Methods, B-D typical interventions in long-term care for people suffering from dementia: Percutaneous Endoscopic Gastrostomy (PEG), Physical Restraining, Prescribing Antipsychotics. Eligible professional and volunteer guardians are randomized either to the intervention or standard care. Primary outcome is comprehension of benefits and harms of PEGs, restraints, and antipsychotics and resulting realistic expectations, assessed by questionnaires directly after the intervention. Key secondary outcome measures comprise sustainability of comprehension and the number of PEGs, restraints and antipsychotics, assessed for the group of demented people represented by the included legal guardians. We hypothesize, that the training program enhances comprehension, leads to more realistic expectations and consequently reduces PEGs, restraints, and antipsychotics. To prepare implementation, e-learning-modules will be developed and piloted. Contents of the current training program will be integrated into a learning management system. A usability-test will be conducted. Discussion: Standardized training courses and quality criteria are indispensable for professional and volunteer guardians who are regularly involved in decision-making with and for a group of vulnerable persons. The training program should be implemented into the regular educational curricula for legal guardians.