Open doors by fair means: Study protocol for a 3-year prospective controlled study with a quasi-experimental design towards (or to implement) an open Ward policy in acute care units.

Background: Acute psychiatric wards in Germany are often locked due to the assumption that opening could endanger patients and society. On the contrary, some findings suggest that aversive events such as absconding and attempted suicides do not occur more often on wards with an open-door policy. However, these data are probably biased with regard to differing patient populations on open and locked wards. To our best knowledge, the present study is the first prospective controlled study with a quasi-experimental design dealing with this issue. Methods: This study investigates whether indicators of an open-door policy, as measured by a priori determined outcomes, can be improved by a defined complex intervention on two intervention wards in two psychiatric hospitals, compared to two control wards with otherwise very similar conditions. Both hospitals contain two wards identical in structure and patient admittance policies, so that a similar study protocol can be followed with similar patient populations. Both hospitals have a defined catchment area and receive voluntary and involuntary admissions. In a baseline phase, wards will be opened facultatively (i.e., if it seems possible to staff). In the following intervention period, one ward per hospital will establish an enhanced open-door policy by applying additional strategic and personnel support. As a control group, the control ward will continue to be opened facultatively. After one year, control wards will be opened according to the open-door policy as well. Interventions will include the continuous identification of patients at risk as well as the development of individual care concepts and additional staffing. For this purpose, nursing and medical staff will be methodically supported on an ongoing basis by study staff. Outcomes variables will be the percentage of door opening on each ward between 8 a.m. and 8 p.m., the percentage of all treatment days with the door opened and the number of involuntary treatment days with open doors. Data on frequencies of aggressive incidents, absconding, police searches, and seclusion or restraint will be used as control variables. Additional costs will be calculated. Discussion: Treating mentally ill patients on locked wards is a highly relevant and critically discussed topic. In particular, it is controversially discussed whether changes in door policy can be established without increasing risks to patients and others. This study aims to gain robust data on this issue, going beyond beliefs and questionable retrospective observational studies. Trial registration: Our trial "Open Doors By Fair Means" is retrospectively registered with DRKS (DRKS00015154) on Sept. 10th 2018 and displayed on the public web site. It is searchable via its Meta-registry (http://apps.who.int/trialsearch/). [ABSTRACT FROM AUTHOR]