Clinical trial NCT03002701: The Impact of Nursing Delirium Preventive Interventions in the Intensive Care Unit
Official title: The Impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A Multi-centre, Stepped Wedge Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: Prevention
Critical care
Delirium
Nurse
RCT
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2016-12-26
Enrollment: 1750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: The number of delirium-coma-free days
timeFrame: 28 days
Secondary outcomes:
measure: Delirium incidence
timeFrame: 28 days
measure: The number of days of survival
timeFrame: 28 days
measure: The number of days of survival
timeFrame: 90 days
measure: Duration of mechanical ventilation
timeFrame: 28 days
measure: Incidence of re-intubation
timeFrame: 28 days
measure: Incidence of ICU re-admission
timeFrame: 28 days
measure: Incidence of unplanned removal of tubes/catheters
timeFrame: 28 days
measure: Incidence of physical restraints
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 365 days
measure: Hospital length of stay
timeFrame: 365 days
measure: Health related quality of Life (HRQoL)
timeFrame: 90 days after ICU admission
measure: Health related quality of Life (HRQoL)
timeFrame: 365 days after ICU admission
measure: Post-hoc analysis
timeFrame: During admission
measure: Cost-effectiveness
timeFrame: During ICU admission
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
city: Den Haag
country: Netherlands
facility: Haaglanden Medical Center location Westeinde
city: Ede
country: Netherlands
facility: Hospital Gelderse Vallei
city: Enschede
country: Netherlands
facility: Medical Spectrum Twente
city: Harderwijk
country: Netherlands
facility: Hospital St. Jansdal
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
city: Tilburg
country: Netherlands
facility: Hospital ETZ location Elisabeth
city: Tilburg
country: Netherlands
facility: Hospital ETZ location Tweesteden
city: Uden
country: Netherlands
facility: Bernhoven Hospital
city: Veldhoven
country: Netherlands
facility: Maxima Medical Center
city: Zwolle
country: Netherlands
facility: ISALA clinics
Study officials:
affiliation: Radboud University Medical Center
name: Mark van den Boogaard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.