The impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit: A study protocol for a multi-centre, stepped wedge randomized controlled trial
- Conditions
- Delirium
- Registration Number
- NL-OMON24866
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1750
Inclusion Criteria
Adult (¡Ý 18 years); surgical, medical or trauma patients; admitted to one of the participating ICUs and at high risk for delirium (>35% determined with the E-PRE-DELIRIC prediction tool)
Exclusion Criteria
delirious before ICU admission; have an ICU stay < one day; if reliable assessment for delirium is not possible due to: sustained coma during complete ICU stay; serious auditory or visual disorders; inability to understand Dutch; severely mentally disabled; serious receptive aphasia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of delirium-coma-free days in 28 days
- Secondary Outcome Measures
Name Time Method delirium incidence; the number of days of survival in 28 and 90 days; delirium-related outcomes including: duration of mechanical ventilation, incidence of re-intubation, or restart of mechanical ventilation in case of tracheostomy patients, incidence of ICU re-admission, unplanned removal of tubes/catheters, and the use of physical restraints; ICU and hospital length of stay; QoL and cognitive function of ICU patients at ICU admission (baseline), and three and twelve months after ICU discharge; an exploratory subgroup analyses (e.g. based on admission type, predicted delirium risk); a process evaluation to explain the effects based on adherence to the interventions; and a cost-effectiveness analysis which will include an economic evaluation.