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The Impact of Nursing Delirium Preventive Interventions in the Intensive Care Unit (UNDERPIN-ICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03002701
Recruitment Status : Active, not recruiting
First Posted : December 26, 2016
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment Phase
Delirium Behavioral: UNDERPIN-ICU program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1750 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A Multi-centre, Stepped Wedge Randomized Controlled Trial
Actual Study Start Date : December 31, 2016
Actual Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma Delirium

Arm Intervention/treatment
No Intervention: Control - standard care
Prior to implementation of the intervention package the current standard of care will be maintained.
Active Comparator: Intervention group
After implementation the intervention package will be implemented as standard care.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03002701


Locations
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Netherlands
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6500HB
Haaglanden Medical Center location Westeinde
Den Haag, Netherlands
Hospital Gelderse Vallei
Ede, Netherlands
Medical Spectrum Twente
Enschede, Netherlands
Hospital St. Jansdal
Harderwijk, Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands
Hospital ETZ location Elisabeth
Tilburg, Netherlands
Hospital ETZ location Tweesteden
Tilburg, Netherlands
Bernhoven Hospital
Uden, Netherlands
Maxima Medical Center
Veldhoven, Netherlands
ISALA clinics
Zwolle, Netherlands
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Mark van den Boogaard, PhD Radboud University
Additional Information:
Publications of Results:
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03002701    
Other Study ID Numbers: UNDERPIN-ICU
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Radboud University:
Prevention
Critical care
Delirium
Nurse
RCT
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders