Trial design
psychiatric
RECRUITMENT
The ‘Peer-Worker-Facilitated Psychiatric Advance Directive’ study (DAiP) was a multicentre randomized controlled trial conducted in seven mental health facilities of three cities in France (Lyon, Paris and Marseille) between January 2019 and June 2021. Forty treating psychiatrists checked the eligibility criteria and referred eligible participants to research assistants, who validated inclusion criteria, obtained written consent and conducted interviews at inclusion, 6 and 12 months. According to the principle of ‘sector’, which has organized most public psychiatric care in France since the 1960s, the participating psychiatrists were both inpatient and outpatient (the same team ensures continuity). Only six of them were strictly outpatient. All psychiatrists at each participating mental health facility were fully informed about the study at the time of its implementation. No special training or incentives were given to participating psychiatrists. The follow-up period was 12 months after an 18-month recruitment.The study was registered on Clinicaltrials (NCT03630822). The study was conducted in compliance with the Declaration of Helsinki, sixth revision; Good Clinical Practice guidelines and local regulatory requirements. The trial was approved by the local ethics committee (2018-A00146-49).