Implementation of guidelines on prevention of coercion and violence (PreVCo) in psychiatry: a multicentre randomised controlled trial.

Background: Interventions to prevent the use of coercion in psychiatric hospitals have been summarized in the 2018 German Association for Psychiatry, Psychotherapy, and Psychosomatic's comprehensive guidelines. Twelve recommendations for implementation of these guideline on psychiatric wards have been deducted and their feasibility has been tested in a pilot study, using external implementation consultants as facilitators. The objective of the PreVCo study was to test their effect in a randomised clinical trial. Methods: Fifty-four psychiatric wards in Germany treating voluntary and involuntary patients were randomly allocated to either an intervention or to a waiting list condition. The intervention consisted of the implementation of three out of 12 suggested recommendations as selected by the ward teams, supported by external study workers. As the primary outcome measure, the number of coercive measures used per bed and month in the final 3 months of the intervention period was determined. Secondary outcomes were the cumulative duration of coercive measures used per bed and months and assaults per bed and month. Achieved guideline adherence was measured by a fidelity scale developed for this purpose during a pilot study for the PreVCo Rating Tool. After a 3-month baseline collection period under routine conditions, randomisation was done after matching wards pairwise according to frequency of coercive measures used and scores on the PreVCo Rating Tool at baseline. The duration of the intervention period was 12 months; control wards received only an initial workshop presentation of the study and completed their PreVCo ratings. We used the Wilcoxon signed rank test and the paired t-test and conducted sensitivity analyses for different periods of observation. Findings: Neither the number of coercive measures used per month and bed nor their cumulative duration nor the number of assaults per bed and months differed significantly between the 27 intervention wards and the 27 control wards in the final 3 months of the intervention period. The median number of coercive measures used decreased by 45% (median 0.96 (IQR 1.34)-0.53 (IQR 0.59) from baseline until the end of the intervention period on the intervention wards and by 28% (median 0.98 (IQR 1.71)-0.71 (IQR 1.08) on waiting list wards. The PreVCo Rating Tool showed a significant improvement in intervention wards compared to control wards, indicating a successful implementation. Interpretation: The study demonstrated that guideline adherence could be significantly improved by the intervention. However, there was no evidence for an effect on the frequency or duration of coercive measures used. Spill-over effects and the impact of the COVID-19 pandemic on in-patient care might have limited the effect of the intervention. Further research from robust randomised controlled trials are necessary to identify effective interventions to reduce the use of coercion in psychiatric hospitals. Funding: The study was funded by the German