The impact of nUrsiNg DEliRium Preventive INnterventions in the Intensive Care Unit (UNDERPIN-ICU): A study protocol for a multi-centre, stepped wedge randomized controlled trial☆
Introduction
Delirium is defined as an acute disturbance in level of awareness, attention and cognition, with a fluctuating course, caused by a direct physical condition, and occurs over a short period of time (APA, 2013). Delirium is a serious disorder in critically ill patients in the Intensive Care Unit (ICU). The overall incidence of delirium in ICU patients is approximately 30% (Salluh et al., 2015, van den Boogaard et al., 2012a), and even higher in patients admitted to the ICU for two days or longer (van den Boogaard et al., 2012c). It has serious short- and long-term consequences for ICU patients. Delirium is associated with prolonged duration of mechanical ventilation, length of stay in the ICU, and length of stay in the hospital (Salluh et al., 2015, van den Boogaard et al., 2012c). During their ICU stay patients who suffer from delirium are more likely to involuntarily remove tubes and catheters compared to non-delirious patients, and the incidence of re-intubations and ICU readmissions is significantly higher than those without delirium. In addition, delirium leads to long-term cognitive problems, is associated with higher mortality rates and can influence long-term quality of life (van den Boogaard et al., 2012c, van den Boogaard et al., 2012b, Girard et al., 2010, Ely et al., 2004, Van Rompaey et al., 2009). Moreover, delirium leads to a higher workload for ICU nurses (Pretto et al., 2009) and a higher financial burden due to increased costs for the ICU as well as the hospital (Milbrandt et al., 2004).
Considering the high incidence of delirium and these serious consequences, reducing burdening by delirium is imperative, comprising delirium prevention as well as reducing the duration of delirium. Important in effectively preventing delirium is the early identification of high-risk patients, as optimal use of preventive measures is warranted in these patients because of their vulnerability (Mistraletti et al., 2012). A validated prediction model (the Early PREdiction of DELIRium IC (E-PRE-DELIRIC) model) allows a reliable calculation of the chance that a patient will develop delirium and may facilitate early identification of high-risk patients (Wassenaar et al., 2015). With use of such a delirium prediction model it has been shown that prophylactic pharmacological treatment with haloperidol may have important beneficial effects in patients at high risk for delirium, including a significant decrease in delirium incidence and an increase in the number of delirium free days in 28 days (van den Boogaard et al., 2013). Despite the beneficial effects of haloperidol, the incidence of delirium remained rather high in high risk patients. Therefore, there is need to investigate alternative (non-pharmacological) interventions aimed at preventing delirium and its deleterious consequences.
Multiple risk factors are associated with delirium (Mehta et al., 2015, Zaal et al., 2015). Hence, a multi component intervention targeting several risk factors represents a promising strategy for delirium prevention (Reston and Schoelles, 2013). In non-ICU patients, it has been shown that a program with standardized interventions focusing on several modifiable delirium risk factors, including cognitive impairment, sleep deprivation, immobility, and visual and hearing impairment, resulted in a significant reduction of the delirium incidence and duration (Inouye et al., 1999, Zaubler et al., 2013). These interventions do not seem to be associated with significant harm for the patients (Reston and Schoelles, 2013). In ICU patients, data of such a program consisting of standardized interventions are lacking. However, in studies focusing on specific parts of the program beneficial effects have been reported (Needham et al., 2010, Schweickert et al., 2009, Taguchi et al., 2007, Colombo et al., 2012). Recent studies using a non-pharmacological multi component intervention program to prevent delirium in the ICU yielded insufficient proof regarding the efficacy of the program, as a consequence of the used study designs, the limited sample size and problems with data collection (Foster and Kelly, 2013, Rivosecchi et al., 2016, Moon and Lee, 2015). Therefore, further research using a more rigorous design and a larger sample size in multiple ICUs is needed, also including an estimation of the efficacy and cost-effectiveness of the program.
During this current study we will implement a multi component program including non-pharmacological nursing and physical therapy interventions aimed at delirium prevention in the ICU. This program, called UNDERPIN-ICU program (nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit), consists of standardized multi component interventions tailored to ICU patients (Wassenaar et al., 2016a, Wassenaar et al., 2016b) and focuses on delirium risk factors that can be influenced by nursing and physical therapy interventions: cognitive impairment, sleep deprivation, immobility, and visual and hearing impairment.
The primary objective of this study is to determine the effect of the UNDERPIN-ICU program on the number of delirium-coma-free days in 28 days.
The secondary objectives are threefold: to determine the effect of the UNDERPIN-ICU program on: delirium incidence; the number of days of survival in 28 and 90 days; delirium-related outcomes; ICU and hospital length of stay; Quality of Life (QoL) and cognitive function of ICU patients, to determine the effect of the UNDERPIN-ICU program in different subgroups: e.g. admission type, predicted delirium risk, and lastly to assess the cost-effectiveness of the UNDERPIN-ICU program.
Section snippets
Reporting method
Following the Standard Protocol Items: Recommendations for Interventional Trails (SPIRIT 2013) − checklist (Chan et al., 2013).
Study design and setting
This study will be conducted using a multicentre stepped wedge cluster randomized controlled trial (Brown and Lilford, 2006, Hussey and Hughes, 2007). Eight to ten Dutch ICUs from both academic and general hospitals are selected based on their membership of the Dutch ICU Delirium Consortium as well as their commitment to improve their quality of care regarding ICU
Discussion
Prevention of delirium in the ICU is very important as delirium is a common disorder in ICU patients, resulting in negative consequences (Salluh et al., 2015). Non-pharmacological multicomponent interventions targeting several modifiable delirium risk factors represent a promising prevention strategy (Reston and Schoelles, 2013, Rivosecchi et al., 2015). However, the effectiveness of a program consisting of such interventions is not yet rigorously studied in ICU patients (Foster and Kelly, 2013
Conflict of interests
The authors declare they have no competing interests.
Funding
‘Junior research round 2013′, XX. Role during study design and conducting the study: none.
Ethical approval
Medical research ethics committee (MREC) Arnhem-Nijmegen region (No. NL2013/173).
Anonymity
In view of the double blind review process the authors chose not to include author names in the paragraph ethics, the acknowledgements, funding and in reference number 26 and 27.
Acknowledgements
Prof. Dr. Theo van Achterberg, Dr. Bart Staal, Dr. Hub Wollersheim, and Prof. Dr. Ria Nijhuis-Van der Sanden are the investigators and assisted with the original protocol.
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2018, American Journal of Critical CareCitation Excerpt :This study was executed as extension of a earlier Delphi study20 in which the experts did not reach consensus on the cognitive training part of the MCI. Therefore, pilot testing the feasibility of cognitive training exercises in ICU patients was a necessary step to prepare for a future randomized, controlled, nonpharmacologic delirium prevention trial in which the effects of the MCI program on delirium will be assessed.19,41 Based on the results of this pilot study, we think a proper and well-substantiated decision about the feasibility of providing cognitive training exercises to ICU patients can be made, and these selected cognitive training exercises may now be included in the MCI program.19,20
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The UNDERPIN-ICU study is funded by ZonMw, the Netherlands Organisation for Health Research and Development (dossier number: 80-84300-98-71006)