Background:Physical and pharmacological restraints are frequently applied in intensive care patients to prevent accidental removal of devices. However, due to their contradictory benefits and ethical considerations, legal and health care institutions recommended a reduction of restraint use. Despite the awareness of this topic in the practice, change processes towards a reduced use of pharmacological and physical restraints remain challenging.Objectives:1) To develop an interprofessional, multidimensional intervention package and implementation strategy to improve the management of and reduce the incidence of restraint use in ICUs,2) to implement the intervention on selected ICUs, and3) to evaluate the intervention package with reference to selected outcomes and the implementation/change process regarding acceptability, feasibility, fidelity and influencing factors.Methods:The study will follow a synergistic, partnership based, iterative mixed methods design to embrace the complexity of the context. Qualitative and quantitative methods will be mixed on various stages of the project. The “Theory of change” of this project will be compiled in collaboration with stakeholders and researchers and serve as blueprint for the intervention development and monitoring of the implementation process. To evaluate the effectiveness of the developed intervention package quantitative outcome data such as incidence rate of restraint use, and adverse events will be extracted from patient charts. Qualitative data from physicians and nurses in focus group interviews will illuminate the dynamics of the change process and the appropriateness of the implementation strategy. Integrating the results of both methods will give a deeper and more comprehensive understanding of the change processes and the work environment of the ICUs.Expected results and relevance:We assume that with the developed measures fostering a cultural change on ICUs towards a patient/family needs based and caring environment the incidence rate of restraint use can be effectively reduced, and patient safety coevally maintained. Furthermore, the gained contextual knowledge might help us to adapt and transfer the intervention package to other ICUs and settings.(Akronym: p149-FEM)