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Completed

NCT Number: NCT03002701

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Medical Center, Nijmegen, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UNDERPIN-ICU program

Behavioral

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.

Primary outcomes

  1. 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

  1. Delirium incidence

    Time frame: 28 days

    One or more episodes of positive delirium screening after ICU admission.

  2. The number of days of survival

    Time frame: 28 days

    The number of days survived since ICU admission.

  3. The number of days of survival

    Time frame: 90 days

    The number of days survived since ICU admission.

  4. Duration of mechanical ventilation

    Time frame: 28 days

    The number of days a patient was mechanically ventilated.

  5. Incidence of re-intubation

    Time frame: 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.

  6. Incidence of ICU re-admission

    Time frame: 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.

  7. Incidence of unplanned removal of tubes/catheters

    Time frame: 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.

  8. Incidence of physical restraints

    Time frame: 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.

  9. ICU length of stay

    Time frame: 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.

  10. Hospital length of stay

    Time frame: 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.

  11. Health related quality of Life (HRQoL)

    Time frame: 90 days after ICU admission

  12. Health related quality of Life (HRQoL)

    Time frame: 365 days after ICU admission

  13. Post-hoc analysis

    Time frame: During admission

  14. Cost-effectiveness

    Time frame: During ICU admission

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: UNDERPIN-ICU

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Dec 26, 2016
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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