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

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

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.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Behavioral: UNDERPIN-ICU program

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.

• Study Type: Interventional
• Enrollment (Actual): 1750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Den Haag, Netherlands
    • Haaglanden Medical Center location Westeinde
  • Ede, Netherlands
    • Hospital Gelderse Vallei
  • Enschede, Netherlands
    • Medical spectrum Twente
  • Harderwijk, Netherlands
    • Hospital St. Jansdal
  • Leeuwarden, Netherlands
    • Medical Center Leeuwarden
  • Tilburg, Netherlands
    • Hospital ETZ location Elisabeth
  • Tilburg, Netherlands
    • Hospital ETZ location Tweesteden
  • Uden, Netherlands
    • Bernhoven Hospital
  • Veldhoven, Netherlands
    • Maxima Medical Center
  • Zwolle, Netherlands
    • Isala Clinics
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of delirium-coma-free 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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium incidence	One or more episodes of positive delirium screening after ICU admission.	28 days
The number of days of survival	The number of days survived since ICU admission.	28 days
The number of days of survival	The number of days survived since ICU admission.	90 days
Duration of mechanical ventilation	The number of days a patient was mechanically ventilated.	28 days
Incidence of re-intubation	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.	28 days
Incidence of ICU re-admission	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.	28 days
Incidence of unplanned removal of tubes/catheters	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.	28 days
Incidence of physical restraints	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.	28 days
ICU length of stay	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.	365 days
Hospital length of stay	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.	365 days
Health related quality of Life (HRQoL)		90 days after ICU admission
Health related quality of Life (HRQoL)		365 days after ICU admission
Post-hoc analysis		During admission
Cost-effectiveness		During ICU admission

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Mark van den Boogaard, PhD, Radboud University Medical Center

Publications and helpful links

General Publications

• Wassenaar A, Rood P, Schoonhoven L, Teerenstra S, Zegers M, Pickkers P, van den Boogaard M. The impact of nUrsiNg DEliRium Preventive INnterventions in the Intensive Care Unit (UNDERPIN-ICU): A study protocol for a multi-centre, stepped wedge randomized controlled trial. Int J Nurs Stud. 2017 Mar;68:1-8. doi: 10.1016/j.ijnurstu.2016.11.018. Epub 2016 Dec 8.
• Rood PJT, Zegers M, Ramnarain D, Koopmans M, Klarenbeek T, Ewalds E, van der Steen MS, Oldenbeuving AW, Kuiper MA, Teerenstra S, Adang E, van Loon LM, Wassenaar A, Vermeulen H, Pickkers P, van den Boogaard M; UNDERPIN-ICU Study Investigators. The Impact of Nursing Delirium Preventive Interventions in the ICU: A Multicenter Cluster-randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2021 Sep 15;204(6):682-691. doi: 10.1164/rccm.202101-0082OC.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2016
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: November 25, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Nurse; Prevention; RCT; Critical care; Delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: UNDERPIN-ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided