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

Delirium Clinical Trial

— UNDERPIN-ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002701
• Other study ID #: UNDERPIN-ICU
• Status: Completed
• Phase: N/A
• Start date: December 31, 2016
• Est. completion date: May 31, 2020

Study information

• Verified date: October 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1750
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Intervention

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.

Locations

Country	Name	City	State
Netherlands	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	Radboud University Medical Center	Nijmegen	Gelderland
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

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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 c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Delirium incidence	One or more episodes of positive delirium screening after ICU admission.	28 days
Secondary	The number of days of survival	The number of days survived since ICU admission.	28 days
Secondary	The number of days of survival	The number of days survived since ICU admission.	90 days
Secondary	Duration of mechanical ventilation	The number of days a patient was mechanically ventilated.	28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Health related quality of Life (HRQoL)		90 days after ICU admission
Secondary	Health related quality of Life (HRQoL)		365 days after ICU admission
Secondary	Post-hoc analysis		During admission
Secondary	Cost-effectiveness		During ICU admission

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