Prevention of physical restraints in the acute care setting (PROTECT): study protocol for a cluster-randomised controlled pilot study

INTRODUCTION: Physical restraints (PR) are regularly used in acute care settings, although evidence for their effectiveness and safety (eg, for prevention of falls) is lacking. Their use is associated with adverse events, such as decreased mobility and injuries for patients. We developed a complex intervention to prevent PR in acute care settings according to the UK Medical Research Council Framework, and investigated the feasibility. The intervention comprised the qualification of key nurses as multipliers and a short interprofessional information session. The intervention has proven to be feasible. It also became apparent that further development of the intervention and the study procedures is necessary. Therefore, this study aims to refine and pilot the complex intervention. Furthermore, the objective of this pilot study is to improve study procedures. METHODS AND ANALYSIS: In a preparatory phase, we will conduct focus groups and individual interviews with the target groups to explore the possibilities for adaption of the intervention and implementation strategies. Subsequently, a cluster-randomised controlled trial with a 6-month follow-up period will be conducted. It is planned to recruit eight general hospitals in Germany (area of Halle (Saale) and Leipzig) with 28 wards and 924 patients per observation period (2772 overall). Primary outcome is the proportion of patients with at least one PR after 6 months. Data will be collected by direct observation over a period of seven consecutive days and three times a day. Secondary outcomes are falls, interruptions in therapy and prescription of psychotropic medication. A comprehensive process evaluation will accompany the study. ETHICS AND DISSEMINATION: The Ethics committee of the Medical Faculty of the University of Halle (Saale) approved the study protocol. Results will be published in a peer-reviewed journal and presented at conferences. Study information and additional material will be freely available on an already existing website. TRIAL REGISTRATION NUMBER: DRKS00027989.