The Impact of Nursing Delirium Preventive Interventions in the Intensive Care Unit
- Conditions
- Delirium
- Interventions
- Behavioral: UNDERPIN-ICU program
- Registration Number
- NCT03002701
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1750
- aged ≥ 18 years
- surgical, medical or trauma patients
- admitted to one of the participating ICUs
- at high risk for delirium (>35% determined with the E-PRE-DELIRIC prediction tool)
- delirious before ICU admission
- an ICU stay < one day
- reliable assessment for delirium is not possible due to: sustained coma; serious auditory or visual disorders; inability to understand Dutch; severely mentally disabled; serious receptive aphasia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention group UNDERPIN-ICU program After implementation the intervention package will be implemented as standard care.
- Primary Outcome Measures
Name Time Method The number of delirium-coma-free days 28 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.
- Secondary Outcome Measures
Name Time Method Incidence of physical restraints 28 days 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.
Health related quality of Life (HRQoL) 365 days after ICU admission ICU length of stay 365 days 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.
Hospital length of stay 365 days 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.
Post-hoc analysis During admission The number of days of survival 90 days The number of days survived since ICU admission.
Incidence of ICU re-admission 28 days 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.
Duration of mechanical ventilation 28 days The number of days a patient was mechanically ventilated.
Incidence of re-intubation 28 days 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.
Incidence of unplanned removal of tubes/catheters 28 days 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.
Delirium incidence 28 days One or more episodes of positive delirium screening after ICU admission.
Cost-effectiveness During ICU admission
Trial Locations
- Locations (11)
Medical Center Leeuwarden
🇳🇱Leeuwarden, Netherlands
Haaglanden Medical Center location Westeinde
🇳🇱Den Haag, Netherlands
Hospital Gelderse Vallei
🇳🇱Ede, Netherlands
Radboud University Medical Center
🇳🇱Nijmegen, Gelderland, Netherlands
Hospital ETZ location Tweesteden
🇳🇱Tilburg, Netherlands
Bernhoven Hospital
🇳🇱Uden, Netherlands
Hospital St. Jansdal
🇳🇱Harderwijk, Netherlands
Hospital ETZ location Elisabeth
🇳🇱Tilburg, Netherlands
Maxima Medical Center
🇳🇱Veldhoven, Netherlands
ISALA clinics
🇳🇱Zwolle, Netherlands
Medical Spectrum Twente
🇳🇱Enschede, Netherlands