The Impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A Multi-centre, Stepped Wedge Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Delirium
- Sponsor
- Radboud University Medical Center
- Enrollment
- 1750
- Locations
- 11
- Primary Endpoint
- The number of delirium-coma-free days
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The number of delirium-coma-free days
Time Frame: 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 Outcomes
- Incidence of physical restraints(28 days)
- Health related quality of Life (HRQoL)(365 days after ICU admission)
- ICU length of stay(365 days)
- Hospital length of stay(365 days)
- Post-hoc analysis(During admission)
- Duration of mechanical ventilation(28 days)
- Incidence of re-intubation(28 days)
- Incidence of unplanned removal of tubes/catheters(28 days)
- Delirium incidence(28 days)
- The number of days of survival(90 days)
- Incidence of ICU re-admission(28 days)
- Cost-effectiveness(During ICU admission)