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

医疗保健中的代理决策 - 法定监护人培训计划的评估：随机对照试验 (PRODECIDE-RCT)

• 批准号: 318728034
• 负责人: Dr. Tanja Richter
• 金额: --
• 依托单位: Institut für Gesundheits- und Pflegewissenschaft
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2016
• 资助国家: 德国
• 起止时间: 2015-12-31 至 2021-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/318728034?language=en
• 关键词: Proxy; decision; making; health; care

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.

背景资料：在德国，约有130万人由法律的监护人代表，60%由志愿者代表，大多数是家庭成员，40%由专业监护人代表。2005年，20%的法律的监护人是因为痴呆症。痴呆症患者可能缺乏决策能力。法律的监护人必须确保他们在医疗保健方面的知情决策权。这些过程是复杂的。但是，我们不得不假设，大多数法律的监护人根本没有为这项任务做好准备。对法律的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，不能预先假定所需的能力。各国的情况也类似。优化代理决策可以改善对痴呆症患者的护理。为此，为专业和志愿法律的监护人举办了一个培训方案，并在以前的一项试点研究中测试了其可行性。培训计划提高了知情决策过程的能力。目标：评估这一培训方案，并制定和试行一项执行战略。研究方法：根据医学研究委员会开发和评估复杂干预措施的框架，将进行一项随机对照试验，并进行六个月的随访和额外的过程评估。干预包括为期两天的培训计划，有四个模块：决策过程和方法，B-D长期护理痴呆症患者的典型干预措施：经皮内窥镜胃造口术（PEG），身体抑制，处方抗精神病药。合格的专业和志愿监护人被随机分配到干预或标准护理。主要结果是对PEG、约束和抗精神病药物的益处和危害的理解，以及由此产生的现实期望，在干预后直接通过问卷进行评估。关键的次要结局指标包括理解的可持续性以及PEG、束缚和抗精神病药物的数量，对所纳入的法律的监护人代表的痴呆症人群进行评估。我们假设，培训计划增强了理解力，导致更现实的期望，从而减少了PEG，限制和抗精神病药物。为准备实施，将开发和试行电子学习模块。目前培训方案的内容将纳入一个学习管理系统。将进行可用性测试。讨论内容：标准化的培训课程和质量标准对于专业和志愿监护人来说是必不可少的，因为他们经常参与与弱势群体一起或为弱势群体做出的决策。应将培训计划纳入法律的监护人的正规教育课程。