Effect of a Standardized Family Participation Program in the ICU: A Multicenter Stepped-Wedge Cluster Randomized Controlled Trial.

OBJECTIVES: To determine the effect of a standardized program for family participation in essential care activities in the ICU on symptoms of anxiety, depression, posttraumatic stress and satisfaction among relatives, and perceptions and experiences of ICU healthcare providers (HCPs). DESIGN: Multicenter stepped-wedge cluster randomized controlled trial. SETTING: Seven adult ICUs, one university, and six general teaching hospitals. PARTICIPANTS: Three hundred six relatives and 235 ICU HCPs. INTERVENTIONS: A standardized program to facilitate family participation inpatient communication, amusement/distraction, comfort, personal care, breathing, mobilization, and nutrition. MEASUREMENTS AND MAIN RESULTS: Data were collected through surveys among relatives and ICU HCPs. There were no significant differences in symptoms of anxiety in relatives in the intervention period compared with the control period (median Hospital Anxiety and Depression Scale [HADS] 5 [interquartile range (IQR) 2-10] vs 6 [IQR 3-9]; median ratio [MR] 0.72; 95% CI, 0.46-1.13; p = 0.15), depression (median HADS 4 [IQR 2-6] vs 3 [IQR 1-6]; MR 0.85; 95% CI, 0.55-1.32; p = 0.47) or posttraumatic stress (median Impact of Event Scale-Revised score 0.45 [IQR 0.27-0.82] vs 0.41 [IQR 0.14-1]; MR 0.94; 95% CI, 0.78-1.14; p = 0.54). Reported satisfaction was slightly lower in the intervention period (mean 8.90 [ sd 1.10] vs mean 9.06 [ sd 1.10], difference -0.60; 95% CI, -1.07 to -0.12; p = 0.01). ICU HCPs perceived that more relatives knew how to participate: 47% in the intervention period versus 22% in the control period (odds ratio [OR] 3.15; 95% CI, 1.64-6.05; p < 0.01). They also reported relatives having sufficient knowledge (41% vs 16%; OR 3.56; 95% CI, 1.75-7.25; p < 0.01) and skills (44% vs 25%; OR 2.38; 95% CI, 1.22-4.63; p = 0.01) to apply family participation. CONCLUSIONS: Application of a standardized program to facilitate family participation did not change mental health symptoms in relatives of ICU patients 3 months after discharge. ICU HCPs reported increased clarity, knowledge, and skills among relatives and ICU HCPs.

The Impact of Non-Pharmacological Interventions on Delirium in Neurological Intensive Care Unit Patients: A Single-Center Interrupted Time Series Trial.

Background: Delirium is a pathobiological brain process that is frequently observed in Intensive Care Unit (ICU) patients, and is associated with longer hospitalization as well as long-term cognitive impairment. In neurological ICU patients, delirium may be more treatment-resistant due to the initial brain injury. This study examined the effects of a multicomponent non-pharmacological nursing intervention program on delirium in neurological ICU patients. Methods: A single-center interrupted time series trial was conducted in adult neurological ICU patients at high risk for developing delirium who were non-delirious at admission. A multicomponent nursing intervention program focusing on modifiable risk factors for delirium, including the optimalization of vision, hearing, orientation and cognition, sleep and mobilization, was implemented as the standard of care, and its effects were studied. The primary outcome was the number of delirium-free and coma-free days alive at 28 days after ICU admission. The secondary outcomes included delirium incidence and duration, ICU and hospital length-of-stay and duration of mechanical ventilation. Results: Of 289 eligible patients admitted to the ICU, 130 patients were included, with a mean age of 68 ± 11 years, a mean APACHE-IV score of 79 ± 25 and a median predicted delirium risk (E-PRE-DELIRIC) score of 42 [IQR 38-50]). Of these, 73 were included in the intervention period and 57 in the control period. The median delirium- and coma-free days alive were 15 days [IQR 0-26] in the intervention group and 10 days [IQR 0-24] in the control group (level change -0.48 days, 95% confidence interval (95%CI) -7 to 6 days, p = 0.87; slope change -0.95 days, 95%CI -2.41 to 0.52 days, p = 0.18). Conclusions: In neurological ICU patients, our multicomponent non-pharmacological nursing intervention program did not change the number of delirium-free and coma-free days alive after 28 days.

The Delirium Interview as a new reference standard in studies on delirium assessment tools.

BACKGROUND: The reference standard in studies on delirium assessment tools is usually based on the clinical judgment of only one delirium expert and may be concise, unstandardized, or not specified at all. This multicenter study investigated the performance of the Delirium Interview, a new reference standard for studies on delirium assessment tools allowing classification of delirium based on written reports. METHODS: We tested the diagnostic accuracy of our standardized Delirium Interview by comparing delirium assessments of the reported results with live assessments. Our reference, the live assessment, was performed by two delirium experts and one well-trained researcher who registered the results. Their delirium assessment was compared to the majority vote of three other independent delirium experts who judged the rapportage of the Delirium Interview. Our total pool consisted of 13 delirium experts with an average of 13 ± 8 years of experience. RESULTS: We included 98 patients (62% male, mean age 69 ± 12 years), of whom 56 (57%) intensive care units (ICUs) patients, 22 (39%) patients with a Richmond Agitation Sedation Scale (RASS) < 0 and 26 (27%) non-verbal assessments. The overall prevalence of delirium was 28%. The Delirium Interview had a sensitivity of 89% (95% confidence interval [CI]: 71%-98%) and specificity of 82% (95% CI: 71%-90%), compared to the diagnosis of an independent panel of two delirium experts and one researcher who examined the patients themselves. Negative and positive predictive values were 95% (95% CI: 86%-0.99%), respectively, 66% (95% CI: 49%-80%). Stratification into ICU and non-ICU patients yielded similar results. CONCLUSION: The Delirium Interview is a feasible reference method for large study cohorts evaluating delirium assessment tools since experts could assess delirium with high accuracy without seeing the patient at the bedside.

The implementation of nUrsiNg DEliRium preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A qualitative evaluation.

BACKGROUND: Delirium frequently occurs in intensive care unit patients and is associated with worse outcomes. Recently, a multicomponent non-pharmacological nursing intervention program called UNDERPIN-ICU, was implemented in ten Dutch intensive care units. The program was aimed at delirium reduction by optimizing four modifiable risk factors: visual and hearing impairment, cognitive impairment, immobility, and sleep deprivation. Despite its scientific fundament and extensive implementation, this program showed no effect on delirium outcomes. OBJECTIVE: To explore factors that hindered or facilitated the application of the UNDERPIN-ICU delirium program in daily practice as experienced by healthcare professionals. METHODS: Semi-structured focus group interviews were conducted in all participating centers between April and June of 2019. Directed content and thematic analyses were applied. Interviews were coded. Codes were grouped into categories based on factors that hindered or facilitated program application. RESULTS: In total, 22 ICU nurses, 3 ICU physicians, 5 local delirium group members and one research manager participated in 10 focus group interviews. We found 41 factors that hindered or facilitated program application, grouped into five categories: interventions; individual healthcare professional; patient; implementation process; capacity for change, incentives and resources. Among the factors identified in this study, the facilitating factors included standardized interventions, a structured implementation, interactive educational meetings and, feedback and support. The hindering factors included doubts about usefulness, feasibility, the extensive number of program components, limited knowledge about the program and a focus on physical care. CONCLUSION: Factors that hindered program application may explain why the UNDERPIN-ICU program did not have positive effects on delirium outcomes. Factors that facilitated application should be strengthened in future non-pharmacological nursing interventions to prevent or reduce delirium in intensive care. REGISTRATION: ClinicalTrials.gov Identifier: NCT03002701; registration date December 26, 2016.

DeltaScan for the Assessment of Acute Encephalopathy and Delirium in ICU and non-ICU Patients, a Prospective Cross-Sectional Multicenter Validation Study.

OBJECTIVES: To measure the diagnostic accuracy of DeltaScan: a portable real-time brain state monitor for identifying delirium, a manifestation of acute encephalopathy (AE) detectable by polymorphic delta activity (PDA) in single-channel electroencephalograms (EEGs). DESIGN: Prospective cross-sectional study. SETTING: Six Intensive Care Units (ICU's) and 17 non-ICU departments, including a psychiatric department across 10 Dutch hospitals. PARTICIPANTS: 494 patients, median age 75 (IQR:64-87), 53% male, 46% in ICUs, 29% delirious. MEASUREMENTS: DeltaScan recorded 4-minute EEGs, using an algorithm to select the first 96 seconds of artifact-free data for PDA detection. This algorithm was trained and calibrated on two independent datasets. METHODS: Initial validation of the algorithm for AE involved comparing its output with an expert EEG panel's visual inspection. The primary objective was to assess DeltaScan's accuracy in identifying delirium against a delirium expert panel's consensus. RESULTS: DeltaScan had a 99% success rate, rejecting 6 of the 494 EEG's due to artifacts. Performance showed and an Area Under the Receiver Operating Characteristic Curve (AUC) of 0.86 (95% CI: 0.83-0.90) for AE (sensitivity: 0.75, 95%CI=0.68-0.81, specificity: 0.87 95%CI=0.83-0.91. The AUC was 0.71 for delirium (95%CI=0.66-0.75, sensitivity: 0.61 95%CI=0.52-0.69, specificity: 72, 95%CI=0.67-0.77). Our validation aim was an NPV for delirium above 0.80 which proved to be 0.82 (95%CI: 0.77-0.86). Among 84 non-delirious psychiatric patients, DeltaScan differentiated delirium from other disorders with a 94% (95%CI: 87-98%) specificity. CONCLUSIONS: DeltaScan can diagnose AE at bedside and shows a clear relationship with clinical delirium. Further research is required to explore its role in predicting delirium-related outcomes.

The updated national research agenda 2021-2026 for prehospital emergency medical services in the Netherlands: a Delphi study.

BACKGROUND: In 2015, a national research agenda was established for Dutch prehospital EMS to underpin the evidence base of care delivery and inform policymakers and funders. The continuously increasing demand for ambulance care and the reorientation towards the role of EMS in recent years may have changed research priorities. Therefore, this study aimed to update the Dutch national EMS research agenda. METHODS: A three-round online Delphi survey was used to explore and discuss different viewpoints and to reach consensus on research priorities (i.e., themes and special interest groups, e.g. patient types who require specific research attention). A multidisciplinary expert panel (n = 62) was recruited in the field of prehospital EMS and delegates of relevant professional organizations and stakeholders participated. In round one, fifty-nine research themes and six special interest groups (derived from several resources) were rated on importance on a 5-point scale by the panel members. In round two, the panel selected their priority themes and special interest groups (yes/no), and those with a positive difference score were further assessed in round three. In this final round, appropriateness of the remaining themes and agreement within the panel was taken into account, following the RAND/UCLA appropriateness method, which resulted in the final list of research priorities. RESULTS: The survey response per round varied between 94 and 100 percent. In round one, a reduction from 59 to 25 themes and the selection of three special interest groups was realized. Round two resulted in the prioritization of six themes and one special interest group ('Vulnerable elderly'). Round three showed an adequate level of agreement regarding all six themes: 'Registration and (digital) exchange of patient data in the chain of emergency care'; 'Mobile care consultation/Non conveyance'; 'Care coordination'; 'Cooperation with professional partners within the care domain'; 'Care differentiation' and 'Triage and urgency classification'. CONCLUSIONS: The updated Dutch national EMS research agenda builds further on the previous version and introduces new EMS research priorities that correspond with the future challenges prehospital EMS care is faced with. This agenda will guide researchers, policymakers and funding bodies in prioritizing future research projects.

The Impact of Nursing Delirium Preventive Interventions in the ICU: A Multicenter Cluster-randomized Controlled Clinical Trial.

Rationale: Delirium is common in critically ill patients and is associated with deleterious outcomes. Nonpharmacological interventions are recommended in current delirium guidelines, but their effects have not been unequivocally established. Objectives: To determine the effects of a multicomponent nursing intervention program on delirium in the ICU. Methods: A stepped-wedge cluster-randomized controlled trial was conducted in ICUs of 10 centers. Adult critically ill surgical, medical, or trauma patients at high risk of developing delirium were included. A multicomponent nursing intervention program focusing on modifiable risk factors was implemented as standard of care. The primary outcome was the number of delirium-free and coma-free days alive in 28 days after ICU admission. Measurements and Main Results: A total of 1,749 patients were included. Time spent on interventions per 8-hour shift was median (interquartile range) 38 (14-116) minutes in the intervention period and median 32 (13-73) minutes in the control period (P = 0.44). Patients in the intervention period had a median of 23 (4-27) delirium-free and coma-free days alive compared with a median of 23 (5-27) days for patients in the control group (mean difference, -1.21 days; 95% confidence interval, -2.84 to 0.42 d; P = 0.15). In addition, the number of delirium days was similar: median 2 (1-4) days (ratio of medians, 0.90; 95% confidence interval, 0.75 to 1.09; P = 0.27). Conclusions: In this large randomized controlled trial in adult ICU patients, a limited increase in the use of nursing interventions was achieved, and no change in the number of delirium-free and coma-free days alive in 28 days could be determined. Clinical trial registered with www.clinicaltrials.gov (NCT03002701).

Prophylactic Haloperidol Effects on Long-term Quality of Life in Critically Ill Patients at High Risk for Delirium: Results of the REDUCE Study.

BACKGROUND: Delirium incidence in intensive care unit patients is high and associated with impaired long-term outcomes. The use of prophylactic haloperidol did not improve short-term outcome among critically ill adults at high risk of delirium. This study evaluated the effects of prophylactic haloperidol use on long-term quality of life in this group of patients and explored which factors are associated with change in quality of life. METHODS: A preplanned secondary analysis of long-term outcomes of the pRophylactic haloperidol usE for DeliriUm in iCu patients at high risk for dElirium (REDUCE) study was conducted. In this multicenter randomized clinical trial, nondelirious intensive care unit patients were assigned to prophylactic haloperidol (1 or 2 mg) or placebo (0.9% sodium chloride). In all groups, patients finally received study medication for median duration of 3 days [interquartile range, 2 to 6] until onset of delirium or until intensive care unit discharge. Long-term outcomes were assessed using the Short Form-12 questionnaire at intensive care unit admission (baseline) and after 1 and 6 months. Quality of life was summarized in the physical component summary and mental component summary scores. Differences between the haloperidol and placebo group and factors associated with changes in quality of life were analyzed. RESULTS: Of 1,789 study patients, 1,245 intensive care unit patients were approached, of which 887 (71%) responded. Long-term quality of life did not differ between the haloperidol and placebo group (physical component summary mean score of 39 ± 11 and 39 ± 11, respectively, and P = 0.350; and mental component summary score of 50 ± 10 and 51 ± 10, respectively, and P = 0.678). Age, medical and trauma admission, quality of life score at baseline, risk for delirium (PRE-DELIRIC) score, and the number of sedation-induced coma days were significantly associated with a decline in long-term quality of life. CONCLUSIONS: Prophylactic haloperidol use does not affect long-term quality of life in critically ill patients at high risk for delirium. Several factors, including the modifiable factor number of sedation-induced coma days, are associated with decline in long-term outcomes.

Differences in 90-day mortality of delirium subtypes in the intensive care unit: A retrospective cohort study.

INTRODUCTION: Many intensive care unit (ICU) patients suffer from delirium which is associated with deleterious short-term and long-term effects, including mortality. We determined the association between different delirium subtypes and 90-day mortality. MATERIALS AND METHODS: Retrospective cohort study in ICU patients admitted in 2015-2017. Delirium, including its subtypes, was determined using the confusion assessment method-ICU (CAM-ICU) and Richmond agitation sedation scale (RASS). Exclusion criteria were insufficient assessments and persistent coma. Cox-regression analysis was used to determine associations of delirium subtypes with 90-day mortality, including relevant covariates (APACHE-IV, length of ICU stay and mechanical ventilation). RESULTS: 7362 ICU patients were eligible of whom 6323 (86%) were included. Delirium occurred in 1600 (25%) patients (stratified for delirium subtype: N = 571-36% mixed, N = 485-30% rapidly reversible, N = 433-27% hypoactive, N = 111-7% hyperactive). The crude hazard ratio (HR) for overall prevalent delirium with 90-day mortality was 2.84 (95%CI: 2.32-3.49), and the adjusted HR 1.29 (95%CI: 1.01-1.65). The adjusted HR for 90-day mortality was 1.57 (95%CI: 1.51-2.14) for the mixed subtype, 1.40 (95%CI: 0.71-2.73) for hyperactive, 1.31 (95%CI: 0.93-1.84) for hypoactive and 0.95 (95%CI: 0.64-1.42) for rapidly reversible delirium. CONCLUSION: After adjusting for covariates, including competing risk factors, only the mixed delirium subtype was significantly associated with 90-day mortality.

Recognition of Delirium in Postoperative Elderly Patients: A Multicenter Study.

OBJECTIVES: To evaluate to what extent delirium experts agree on the diagnosis of delirium when independently assessing exactly the same information and to evaluate the sensitivity of delirium screening tools in routine daily practice of clinical nurses. DESIGN: Prospective observational longitudinal study. SETTING: Three medical centers in the Netherlands. PARTICIPANTS: Elderly postoperative adults (n = 167). MEASUREMENTS: A researcher examined participants daily (Postoperative Day 1-3) for delirium using a standardized cognitive assessment and interview including the Delirium Rating Scale Revised-98 as global impression without any cut-off values that was recorded on video. Two delirium experts independently evaluated the videos and clinical information from the last 24 hours in the participants' record and classified each assessment as delirious, possibly delirious, or not delirious. Interrater agreement between the delirium experts was determined using weighted Cohen's kappa. When there was no consensus, a third expert was consulted. Final classification was based on median score and compared with the results of the Confusion Assessment Method for Intensive Care Unit and Delirium Observation Scale that clinical nurses administered. RESULTS: Four hundred twenty-four postoperative assessments of 167 participants were included. The overall kappa was 0.61 (95% confidence interval = 0.53-0.68). There was no agreement between the experts for 89 (21.0%) assessments and a third delirium expert was needed for the final classification. Delirium screening that nurses performed detected 32% of the assessments that the experts diagnosed as (possibly) delirious. CONCLUSION: There was considerable disagreement in classification of delirium by experts who independently assessed exactly the same information, showing the difficulty of delirium diagnosis. Furthermore, the sensitivity of daily delirium screening by clinical nurses was poor. Future research should focus on development of objective instruments to diagnose delirium.

Enemas, suppositories and rectal stimulation are not effective in accelerating enteral feeding or meconium evacuation in low-birthweight infants: a systematic review.

Early full enteral feeding in preterm infants decreases morbidity and mortality. Our systematic review covered the effectiveness of rectal stimulation, suppositories and enemas on stooling patterns and feeding tolerance in low-birthweight infants born at up to 32 weeks. It comprised seven studies published between 2007 and 2014 and covered 495 infants. CONCLUSION: Suppositories were ineffective in shortening the time to reach full enteral feeding, and the evidence on enemas was contradictory. Enemas and rectal stimulation did not shorten the time until complete meconium evacuation was reached. Further research into safe, effective interventions to accelerate meconium excretion is needed.