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Background: Physical restraints remain to be commonly used in agitated intensive care unit (ICU) patients worldwide, despite a lack of evidence on efficacy and safety and reports of detrimental short and long-term consequences, such as prolonged delirium and a longer ICU length of stay. Physical restraint minimization approaches have focused mainly on educational strategies and other non-pharmacological interventions. Combining these interventions with goal-directed light sedation therapy if needed may play an important contributory role in further reducing the use of physical restraints. The aim of the study is to determine the effectiveness of a multicomponent intervention (MCI) program, combining person-centered non-pharmacological interventions with goal-directed light sedation, compared to physical restraints. Methods: A multicenter stepped-wedge cluster randomized controlled trial will be conducted in six Dutch ICUs. A power calculation based total of 480 (expected to become) agitated adult patients will be included in 26 months with a subsequent 2-year follow-up. Patients included in the control period will receive standard care with the current agitation management protocol including physical restraints. Patients included in the intervention period will be treated with the MCI program, consisting of four components, without physical restraints: education of ICU professionals, identification of patients at risk for agitation, formulation of a multidisciplinary person-centered care plan including non-pharmacological and medical interventions, and protocolized goal-directed light sedation using dexmedetomidine. Primary outcome is the number of days alive and outside of the ICU within 28 days after ICU admission. Secondary outcomes include length of hospital stay; 3-, 12-, and 24-month post-ICU quality of life; physical (fatigue, frailty, new physical problems), mental (anxiety, depression, and post-traumatic stress disorder), and cognitive health; and 1-year cost-effectiveness. A process evaluation will be conducted. Discussion: This will be the first multicenter randomized controlled trial determining the effect of a combination of non-pharmacological interventions and light sedation using dexmedetomidine compared to physical restraints in agitated ICU patients. The results of this study, including long-term patient-centered outcomes, will provide relevant insights to aid ICU professionals in the management of agitated patients. Trial registration: NCT05783505, registration date 23 March 2023. [ABSTRACT FROM AUTHOR]

Background: General practitioners (GPs) are advised to offer advance care planning (ACP) to people with dementia (PWD). In a randomized controlled trial, an educational intervention for GPs aimed at initiating and optimizing ACP proved to be effective. During the intervention most GPs were accompanied by their practice nurse (PN). To provide insights into the intervention's successful components and what could be improved, we conducted a process evaluation and explored implementation, mechanisms of impact and contextual factors. Methods: We used the Medical Research Council guidance for process evaluations. Implementation was explored identifying reach and acceptability. We performed descriptive analyses of participants' characteristics; selection, inclusion and intervention attendance; a GP post-intervention survey on initiating ACP; a post intervention focus group with trainers of the intervention. Mechanisms of impact were explored identifying adoption and appropriateness. We used: participants' intervention ratings; a GP post-intervention survey on conducting ACP; ACP documentation in PWD's medical files; post-intervention interviews with PWD/FC dyads. All data was used to identify contextual factors. Results: The intervention was implemented by a small percentage of the total Dutch GP population invited, who mostly included motivated PWD/FC dyads with relatively little burden, and PWD with limited cognitive decline. The mechanisms of impact for GPs were: interactively learning to initiate ACP with training actors with a heterogeneous group of GPs and PNs. For PWD/FCs dyads, discussing non-medical preferences was most essential regarding their SDM experience and QoL. Some dyads however found ACP stressful and not feasible. Younger female GPs more often initiated ACP. Male PWD and those with mild dementia more often had had ACP. These characteristics and the safe and intimate training setting, were important contextual facilitators. Conclusion: We recommend Interventions aimed at improving ACP initiation with PWD by GPs to include interactive components and discussion of non-medical preferences. A safe environment and a heterogeneous group of participants facilitates such interventions. However, in practice not all FC/PWD dyads will be ready to start. Therefore, it is necessary to check their willingness when ACP is offered. [ABSTRACT FROM AUTHOR]