Implementation of Guidelines on Prevention of Coercion and Violence (Prevco) in Psychiatry: Results of a Randomised Controlled Trial on 54 Psychiatric Wards

Abstract

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 effectiveness 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 was determined. Secondary outcomes were the cumulative duration of coercive measures used per bed and months and assaults per bed and month. Control variables were the number of admissions, the number of occupied beds, and the number of involuntarily admitted cases, main diagnoses, and staffing levels. 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 test for paired data and conducted sensitivity analyses for different periods of observation.

Results: 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 number of coercive measures used decreased significantly from baseline until the end of the intervention period on the intervention wards and waiting list wards, as well. The PreVCo Rating Tool showed a significant improvement in intervention wards compared to control wards, indicating a successful implementation.

Conclusions: 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 effectiveness 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.

Trial Registration: The trial was registered in the Clinical Trial Registration (www.isrctn.com) with the identifier ISRCTN 71467851.

Funding: The study was funded by the German Innovationsfonds beim Gemeinsamen Bundesausschuss (project no. 01VSF19037).

Declaration of Interest: No conflict of interest.

Ethical Approval: Ethical approval has been given by the ethics committee of Ulm University (55/19).

Keywords: coercion, seclusion, restraint, implementation, guidelines, randomised controlled trial