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
1 other identifier
interventional
1,750
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2016
CompletedFirst Posted
Study publicly available on registry
December 26, 2016
CompletedStudy Start
First participant enrolled
December 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedOctober 9, 2020
October 1, 2020
2.4 years
November 25, 2016
October 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (14)
Delirium incidence
28 days
The number of days of survival
28 days
The number of days of survival
90 days
Duration of mechanical ventilation
28 days
Incidence of re-intubation
28 days
- +9 more secondary outcomes
Study Arms (2)
Control - standard care
NO INTERVENTIONPrior to implementation of the intervention package the current standard of care will be maintained.
Intervention group
ACTIVE COMPARATORAfter implementation the intervention package will be implemented as standard care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Radboud University Medical Center
Nijmegen, Gelderland, 6500HB, Netherlands
Hospital Gelderse Vallei
Ede, Netherlands
Medical Spectrum Twente
Enschede, Netherlands
Hospital St. Jansdal
Harderwijk, Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands
Haaglanden Medical Center location Westeinde
The Hague, 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
Related Publications (3)
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.
PMID: 28013104RESULTTilburgs B, Rood PJT, Zegers M, van den Boogaard M; UNDERPIN-ICU study group. The implementation of nUrsiNg DEliRium preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A qualitative evaluation. Int J Nurs Stud. 2023 Jan;137:104386. doi: 10.1016/j.ijnurstu.2022.104386. Epub 2022 Nov 8.
PMID: 36427481DERIVEDRood 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.
PMID: 34170798DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark van den Boogaard, PhD
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2016
First Posted
December 26, 2016
Study Start
December 31, 2016
Primary Completion
May 31, 2019
Study Completion
May 31, 2020
Last Updated
October 9, 2020
Record last verified: 2020-10