BACKGROUND Compulsory admission to psychiatric hospital is rising despite serious ethical concerns. Among measures to reduce compulsory admissions, Psychiatric Advance Directives (PAD) are the most promising, with intensive PAD (i.e. facilitated and shared) being the most effective. The aim of the study is to experiment Psychiatric Advance Directives in France. METHODS A multicentre randomized controlled trial and qualitative approach conducted from January 2019 to January 2021 with intent-to-treat analysis. SETTING Seven hospitals in three French cities: Lyon, Marseille, and Paris. Research assistants meet each participant at baseline, 6 months and 12 months after inclusion for face-to-face interviews. PARTICIPANTS 400 persons with a DSM-5 diagnosis of bipolar I disorder (BP1), schizophrenia (SCZ), or schizoaffective disorders (SCZaff), compulsorily admitted to hospital within the last 12 months, with capacity to consent (MacCAT-CR), over 18 years old, and able to understand French. INTERVENTIONS The experimental group (PAD) (expected n = 200) is invited to fill in a document describing their crisis plan and their wishes in case of loss of mental capacity. Participants meet a facilitator, who is a peer support worker specially trained to help them. They are invited to nominate a healthcare agent, and to share the document with them, as well as with their psychiatrist. The Usual Care (UC) group (expected n = 200) receives routine care. MAIN OUTCOMES AND MEASURES The primary outcome is the rate of compulsory admissions to hospital during the 12-month follow-up. Secondary outcomes include quality of life (S-QoL18), satisfaction (CSQ8), therapeutic alliance (4-PAS), mental health symptoms (MCSI), awareness of disorders (SUMD), severity of disease (ICG), empowerment (ES), recovery (RAS), and overall costs. DISCUSSION Implication of peer support workers in PAD, potential barriers of supported-decision making, methodological issues of evaluating complex interventions, evidence-based policy making, and the importance of qualitative evaluation in the context of constraint are discussed. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT03630822. Registered 14th August 2018.

中文翻译：

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针对精神分裂症、I 型双相情感障碍或分裂情感障碍患者的精神科预先指示：随机对照试验的研究方案 - DAiP 研究。


背景 尽管存在严重的道德问题，但强制送入精神病院的人数仍在增加。在减少强制入院的措施中，精神病学预先指示（PAD）是最有希望的，其中强化PAD（即促进和共享）是最有效的。该研究的目的是在法国试验精神病学预先指示。方法 2019 年 1 月至 2021 年 1 月进行的多中心随机对照试验和定性方法，并进行意向治疗分析。场景 法国三个城市的七家医院：里昂、马赛和巴黎。研究助理在基线、入组后 6 个月和 12 个月与每位参与者进行面对面访谈。参与者 400 名经 DSM-5 诊断为 I 型双相情感障碍 (BP1)、精神分裂症 (SCZ) 或分裂情感性障碍 (SCZaff) 的患者，在过去 12 个月内被强制入院，且具有同意能力 (MacCAT-CR)，超过18岁，懂法语。干预措施 邀请实验组 (PAD)（预计 n = 200）填写一份文件，描述他们的危机计划以及他们在精神能力丧失的情况下的愿望。参与者会见到一位协调员，他是一位经过专门培训来帮助他们的同伴支持人员。他们被邀请提名一名医疗代理人，并与他们以及他们的精神科医生分享该文件。常规护理 (UC) 组（预计 n = 200）接受常规护理。主要结果和措施 主要结果是 12 个月随访期间强制入院的比率。 次要结局包括生活质量 (S-QoL18)、满意度 (CSQ8)、治疗联盟 (4-PAS)、心理健康症状 (MCSI)、疾病意识 (SUMD)、疾病严重程度 (ICG)、赋权 (ES) 、恢复 (RAS) 和总体成本。讨论 讨论了同伴支持工作者在 PAD 中的含义、支持决策的潜在障碍、评估复杂干预措施的方法问题、基于证据的政策制定以及在约束背景下定性评估的重要性。试验注册 ClinicalTrials.gov 标识符：NCT03630822。 2018年8月14日注册。