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

背景：在德国，大约有130万人有法定监护人，60%是志愿者，主要是家庭成员，40%是专业监护人。2005年，20%的法定监护人的指定是由于痴呆症。痴呆症患者可能缺乏决策能力。法定监护人必须确保其在医疗保健领域知情决策过程中的权利。这些过程是复杂的。然而，我们必须假设大多数法定监护人根本没有为这项任务做好准备。法定监护人既没有具体的资格标准，也没有标准化的培训课程。因此，所需的能力不能被预先假定。许多国家也有类似的情况。优化代理决策可以改善对痴呆症患者的护理。为此目的，开展了一项专业和志愿法律监护人培训方案，并在以前的试点研究中检验了其可行性。培训计划提高了在知情决策过程中的能力。目标：评估本培训计划，并制定和试点实施策略。方法：根据医学研究理事会制定和评估复杂干预措施的框架，进行随机对照试验，随访6个月，并进行附加过程评估。干预包括为期两天的培训计划，包括四个模块：决策过程和方法，B-D痴呆患者长期护理的典型干预措施：经皮内镜胃造口术（PEG），身体约束，处方抗精神病药物。符合条件的专业和志愿监护人被随机分为干预组和标准组。主要结果是理解peg、约束和抗精神病药物的利弊，以及由此产生的现实预期，在干预后直接通过问卷进行评估。关键的次要结果测量包括理解的可持续性和peg、约束和抗精神病药物的数量，对所包括的法定监护人所代表的痴呆人群进行评估。我们假设，培训计划提高了理解力，导致了更现实的期望，从而减少了peg、限制和抗精神病药物。为准备实施，将开发和试点电子学习模块。目前的培训内容将被整合到学习管理系统中。将进行可用性测试。讨论：标准化的培训课程和质量标准对于经常参与弱势群体决策的专业和志愿监护人来说是必不可少的。将培训方案纳入法定监护人的正规教育课程。

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.