The impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit: A study protocol for a multi-centre, stepped wedge randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24866

Enrollment

1750

Registered

2016-11-25

Start date

2016-12-31

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Interventions

The UNDERPIN-ICU program consists of interventions tailored for ICU patients focusing on the modifiable delirium risk factors: visual and hearing impairment, to prevent or treat sensory deprivation an

sleep deprivation, to minimize/avoid sleep deprivation

cognitive impairment to (re)orientate patients with regard to time, place and person to prevent or minimize decline

and immobility, to improve patients¡¯ functional mobility in the ICU and to stimulate patients¡¯ cognition.

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The number of delirium-coma-free days in 28 days	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactPaul Rood

paul.rood@radboudumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)