Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, and determines the effect of the program on the number of delirium-coma-free days in 28 days and several secondary outcomes in a multicenter randomized controlled trial.
Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences, including re-intubations, ICU readmissions, prolonged ICU and hospital stay, persistent cognitive problems, and higher mortality rates. Considering the high incidence of delirium and its consequences, prevention of delirium is imperative. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, called UNDERPIN-ICU (nUrsiNg DEliRium Preventive INterventions in the ICU). Objective: To determine the effect of the UNDERPIN-ICU program on the number of delirium-coma-free days in 28 days and several secondary outcomes, such as delirium incidence, the number of days of survival in 28 and 90 days and delirium-related outcomes. Design and Setting: A multicenter stepped wedge cluster randomized controlled trial. Methods: Eight to ten Dutch ICUs will implement the UNDERPIN-ICU program in a randomized order. Every two months the UNDERPIN-ICU program will be implemented in an additional ICU following a two months period of staff training. UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment. Participants: ICU patients aged ≥ 18 years (surgical, medical, or trauma) and at high risk for delirium, E-PRE-DELIRIC ≥35%, will be included, unless delirium was detected prior ICU admission, expected length of ICU stay is less then one day or when delirium assessment is not possible.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,750
UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Hospital Gelderse Vallei
Ede, Netherlands
Medical Spectrum Twente
Enschede, Netherlands
Hospital St. Jansdal
The number of delirium-coma-free days
The number of days a patient is not delirious and not in coma in 28 days starting from the day of inclusion in the study after ICU admission.
Time frame: 28 days
Delirium incidence
One or more episodes of positive delirium screening after ICU admission.
Time frame: 28 days
The number of days of survival
The number of days survived since ICU admission.
Time frame: 28 days
The number of days of survival
The number of days survived since ICU admission.
Time frame: 90 days
Duration of mechanical ventilation
The number of days a patient was mechanically ventilated.
Time frame: 28 days
Incidence of re-intubation
Patients who need to be intubated within 28 days after ICU admission, following a previous extubation, irrespectively the reason for re-intubation, will be counted as incident case for re-intubation.
Time frame: 28 days
Incidence of ICU re-admission
Patients who need to be readmitted to the ICU within 28 days, irrespectively the reason for readmission, will be counted as incident cases for ICU readmission.
Time frame: 28 days
Incidence of unplanned removal of tubes/catheters
Incidents in which patients remove their tube or catheter themselves will be counted as incident cases for unplanned removal. The period in which this is measured is during patients' ICU stay or during the period when the patient is delirious (in case a patient is discharged to the ward) with a maximum of 28 days.
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Harderwijk, Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands
Haaglanden Medical Center location Westeinde
The Hague, Netherlands
Hospital ETZ location Elisabeth
Tilburg, Netherlands
Hospital ETZ location Tweesteden
Tilburg, Netherlands
Bernhoven Hospital
Uden, Netherlands
Maxima Medical Center
Veldhoven, Netherlands
...and 1 more locations
Time frame: 28 days
Incidence of physical restraints
Patients who need physical restraints (fixation of their limbs to prevent them from removing tubes or lines) within 28 days, will be counted as incident cases for physical restraints.
Time frame: 28 days
ICU length of stay
This is defined as the number of days a patient is admitted to the ICU. Hospital length of stay is defined as number of days a patient is admitted to the hospital.
Time frame: 365 days
Hospital length of stay
This is defined as the number of days a patient is admitted to the ICU. Hospital length of stay is defined as number of days a patient is admitted to the hospital.
Time frame: 365 days
Health related quality of Life (HRQoL)
Time frame: 90 days after ICU admission
Health related quality of Life (HRQoL)
Time frame: 365 days after ICU admission
Post-hoc analysis
Time frame: During admission
Cost-effectiveness
Time frame: During ICU admission