A multicomponent intervention program to Prevent and Reduce AgItation and phySical rEstraint use in the ICU (PRAISE): study protocol for a multicenter, stepped-wedge, cluster randomized controlled trial.

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.

Differences in long-term outcomes between ICU patients with persistent delirium, non-persistent delirium and no delirium: A longitudinal cohort study.

PURPOSE: Determine differences in physical, mental and cognitive outcomes 1-year post-ICU between patients with persistent delirium (PD), non-persistent delirium (NPD) and no delirium (ND). MATERIALS AND METHODS: A longitudinal cohort study was performed in adult ICU patients of two hospitals admitted between July 2016-February 2020. Questionnaires on physical, mental and cognitive health, frailty and QoL were completed regarding patients' pre-ICU health status and 1-year post-ICU. Delirium data were from patients' total hospital stay. Patients were divided in PD (≥14 days delirium), NPD (<14 days delirium) or ND patients. RESULTS: 2400 patients completed both questionnaires, of whom 529 (22.0%) patients developed delirium; 35 (6.6%) patients had PD and 494 (93.4%) had NPD. Patients with delirium (PD or NPD) had worse outcomes in all domains compared to ND patients. Compared to NPD, more PD patients were frail (34.3% vs. 14.6%, p = 0.006) and fatigued (85.7% vs. 61.1%, p = 0.012). After adjustment, PD was significantly associated with long-term cognitive impairment only (aOR 3.90; 95%CI 1.31-11.63). CONCLUSIONS: Patients with PD had a higher likelihood to develop cognitive impairment 1-year post-ICU compared to NPD or ND. Patients with PD and NPD were more likely to experience impairment on all health domains (i.e. physical, mental and cognitive), compared to ND patients.

Factors associated with a persistent delirium in the intensive care unit: A retrospective cohort study.

PURPOSE: To explore differences between ICU patients with persistent delirium (PD), non-persistent delirium (NPD) and no delirium (ND), and to determine factors associated with PD. MATERIALS AND METHODS: Retrospective cohort study including all ICU adults admitted for ≥12 h (January 2015-February 2020), assessable for delirium and followed during their entire hospitalization. PD was defined as ≥14 days of delirium. Factors associated with PD were determined using multivariable logistic regression analysis. RESULTS: Out of 10,295 patients, 3138 (30.5%) had delirium, and 284 (2.8%) had PD. As compared to NPD (n = 2854, 27.7%) and ND (n = 7157, 69.5%), PD patients were older, sicker, more physically restrained, longer comatose and mechanically ventilated, had a longer ICU and hospital stay, more ICU readmissions and a higher mortality rate. Factors associated with PD were age (adjusted odds ratio [aOR] 1.03; 95% confidence interval [CI] 1.02-1.04); emergency surgical (aOR 1.84; 95%CI 1.26-2.68) and medical (aOR 1.57; 95%CI 1.12-2.21) referral, mean Sequential Organ Failure Assessment (SOFA) score before delirium onset (aOR 1.18; 95%CI 1.13-1.24) and use of physical restraints (aOR 5.02; 95%CI 3.09-8.15). CONCLUSIONS: Patients with persistent delirium differ in several characteristics and had worse short-term outcomes. Physical restraints were the most strongly associated with PD.