Aims Although shared decision-making (SDM) has the potential to improve health outcomes, psychiatrists often exclude patients with more severe mental illnesses or more acute conditions from participation in treatment decisions. This study examines whether SDM is facilitated by an approach which is specifically adapted to the needs of acutely ill patients (SDM-PLUS). Methods The study is a multi-centre, cluster-randomised, non-blinded, controlled trial of SDM-PLUS in 12 acute psychiatric wards of five psychiatric hospitals addressing inpatients with schizophrenia or schizoaffective disorder. All patients fulfilling the inclusion criteria were consecutively recruited for the trial at the time of their admission to the ward. Treatment teams of intervention wards were trained in the SDM-PLUS approach through participation in two half-day workshops. Patients on intervention wards received group training in SDM. Staff (and patients) of the control wards acted under ‘treatment as usual’ conditions. The primary outcome parameter was the patients' perceived involvement in decision-making at 3 weeks after study enrolment, analysed using a random-effects linear regression model. Results In total, 161 participants each were recruited in the intervention and control group. SDM-PLUS led to higher perceived involvement in decision-making (primary outcome, analysed patients n = 257, mean group difference 16.5, 95% CI 9.0–24.0, p = 0.002, adjusted for baseline differences: β 17.3, 95% CI 10.8–23.6, p = 0.0004). In addition, intervention group patients exhibited better therapeutic alliance, treatment satisfaction and self-rated medication compliance during inpatient stay. There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up. Conclusions Despite limitations in patient recruitment, the SDM-PLUS trial has shown that the adoption of behavioural approaches (e.g. motivational interviewing) for SDM may yield a successful application to mental health. The authors recommend strategies to ensure effects are not lost at the interface between in- and outpatient treatment. Trial registration: The trial was registered at Deutsches Register Klinischer Studien (DRKS00010880).

BackgroundShared decision making (SDM) is a model of how doctors and patients interact with each other. It aims at changing the traditional power asymmetry between doctors and patients by strengthening the exchange of information and the decisional position of the patient. Although SDM is generally welcomed by mental health patients as well as by mental health professionals its implementation in routine care, especially in the more acute settings, is still lacking. SDM-PLUS has been developed as an approach that addresses both patients and mental health professionals and aims at implementing SDM even for the very acutely ill patients.MethodsThe SDM-PLUS study will be performed as a matched-pair cluster-randomized trial in acute psychiatric wards. On wards allocated to the intervention group personnel will receive communication training (addressing how to implement SDM for various scenarios) and patients will receive a group intervention addressing patient skills for SDM. Wards allocated to the control condition will continue treatment as usual. A total sample size of 276 patients suffering from schizophrenia or schizoaffective disorder on 12 wards is planned.The main outcome parameter will be patients’ perceived involvement in decision making during the inpatient stay measured with the SDM-Q-9 questionnaire. Secondary objectives include the therapeutic relationship and long term outcomes such as medication adherence and rehospitalization rates. In addition, process measures and qualitative data will be obtained to allow for the analysis of potential barriers and facilitators of SDM-PLUS.The primary analysis will be a comparison of SDM-Q-9 sum scores 3 weeks after study inclusion (or discharge, if earlier) between the intervention and control groups. To assess the effect of the intervention on this continuous primary outcome, a random effects linear regression model will be fitted with ward (cluster) as a random effect term and intervention group as a fixed effect.DiscussionThis will be the first trial examining the SDM-PLUS approach for patients with schizophrenia or schizoaffective disorder in very acute mental health inpatient settings. Within the trial a complex intervention will be implemented that addresses both patients and health care staff to yield maximum effects.Trial registrationGerman Clinical Trials Register DRKS00010880. Registered 09 August 2016.

Zusammenfassung Ziel der Studie Wir untersuchen die alltagsrelevanten und klinischen Auswirkungen der aktuellen Corona-Krise auf Menschen mit vorbestehenden psychischen Erkrankungen. Methode Neben der klinischen Untersuchung wurde den Patienten, die sich derzeit in unserer stationären oder ambulanten Behandlung befinden, ein standardisierter Fragebogen zur subjektiven Belastung und psychiatrischen Versorgung ausgehändigt. Ergebnisse Mehr als die Hälfte der Befragten sah eine Verschlechterung der psychischen Erkrankung durch den Ausnahmezustand. Schwerer Erkrankte waren stärker belastet. Schlussfolgerung Patienten mit psychischen Erkrankungen stellen in der gegenwärtigen Krise eine besonders vulnerable Gruppe dar. Es bedarf einer Anpassung der psychiatrischen und psychotherapeutischen Versorgung; spezifische Belastungen müssen bei Patienten mit allen Diagnosegruppen aktiv erfragt werden.