Psychiatric advance directives for people living with schizophrenia, bipolar I disorders, or schizoaffective disorders: Study protocol for a randomized controlled trial - DAiP study.

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.

Effect of Psychiatric Advance Directives Facilitated by Peer Workers on Compulsory Admission Among People With Mental Illness: A Randomized Clinical Trial.

Importance: Reducing the use of coercion in mental health care is crucial from a human rights and public health perspective. Psychiatric advance directives (PADs) are promising tools that may reduce compulsory admissions. Assessments of PADs have included facilitation by health care agents but not facilitation by peer workers. Objective: To determine the efficacy of PADs facilitated by peer workers (PW-PAD) in people with mental disorders. Design, Setting, and Participants: A multicenter randomized clinical trial was conducted in 7 French mental health facilities. Adults with a DSM-5 diagnosis of schizophrenia, bipolar I disorder, or schizoaffective disorder who had a compulsory admission in the past 12 months and the capacity to consent were enrolled between January 2019 and June 2020 and followed up for 12 months. Interventions: The PW-PAD group was invited to fill out a PAD form and meet a peer worker who was trained to assist in completing and sharing the form with relatives and psychiatrists. Main Outcomes and Measures: The primary outcome was the rate of compulsory admission at 12 months after randomization. The overall psychiatric admission rate, therapeutic alliance, quality of life, mental health symptoms, empowerment, and recovery outcomes were also investigated. Results: Among 394 allocated participants (median age, 39 years; 39.3% female; 45% with schizophrenia, 36% bipolar I disorder, and 19% schizoaffective disorder), 196 were assigned to the PW-PAD group and 198 to the control group. In the PW-PAD group, 27.0% had compulsory admissions compared with 39.9% in the control group (risk difference, -0.13; 95% CI, -0.22 to -0.04; P = .007). No significant differences were found in the rate of overall admissions, therapeutic alliance score, and quality of life. Participants in the PW-PAD group exhibited fewer symptoms (effect size, -0.20; 95% CI, -0.40 to 0.00), greater empowerment (effect size, 0.30; 95% CI, 0.10 to 0.50), and a higher recovery score (effect size, 0.44; 95% CI, 0.24 to 0.65), compared with those in the control group. Conclusions and Relevance: Peer worker-facilitated PADs are effective in decreasing compulsory hospital admissions and increasing some mental health outcomes (self-perceived symptoms, empowerment, and recovery). Involving peer workers in the completion of PADs supports the current shift of mental health care from substitute decision-making to supported decision-making. Trial Registration: ClinicalTrials.gov Identifier: NCT03630822.