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

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03002701

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

1,750

Enrollment

Locations

Arms

Actual Duration (Months)

159.1

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Dec 31, 2016

Actual Primary Completion Date :

May 31, 2019

Actual Study Completion Date :

May 31, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The number of delirium-coma-free days [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

Delirium incidence [28 days]
One or more episodes of positive delirium screening after ICU admission.
The number of days of survival [28 days]
The number of days survived since ICU admission.
The number of days of survival [90 days]
The number of days survived since ICU admission.
Duration of mechanical ventilation [28 days]
The number of days a patient was mechanically ventilated.
Incidence of re-intubation [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.
Incidence of ICU re-admission [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.
Incidence of unplanned removal of tubes/catheters [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.
Incidence of physical restraints [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.
ICU length of stay [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.
Hospital length of stay [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.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboud University Medical Center	Nijmegen	Gelderland	Netherlands	6500HB
2	Haaglanden Medical Center location Westeinde	Den Haag		Netherlands
3	Hospital Gelderse Vallei	Ede		Netherlands
4	Medical Spectrum Twente	Enschede		Netherlands
5	Hospital St. Jansdal	Harderwijk		Netherlands
6	Medical Center Leeuwarden	Leeuwarden		Netherlands
7	Hospital ETZ location Elisabeth	Tilburg		Netherlands
8	Hospital ETZ location Tweesteden	Tilburg		Netherlands
9	Bernhoven Hospital	Uden		Netherlands
10	Maxima Medical Center	Veldhoven		Netherlands
11	ISALA clinics	Zwolle		Netherlands