NCT03002701

The Impact of Nursing Delirium Preventive Interventions in the Intensive Care Unit

The Impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A Multi-centre, Stepped Wedge Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,750 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Delirium

Interventions

Type	Name	Description
BEHAVIORAL	UNDERPIN-ICU program	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.

Timeline

• Start date: 2016-12-31
• Primary completion: 2019-05-31
• Completion: 2020-05-31
• First posted: 2016-12-26
• Last updated: 2020-10-09

Locations

11 sites across 1 country: Netherlands