The Impact of Nursing Delirium Preventive Interventions in the Intensive Care Unit
NCT ID: NCT03002701
Last Updated: 2020-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1750 participants
INTERVENTIONAL
2016-12-31
2020-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Control - standard care
Prior to implementation of the intervention package the current standard of care will be maintained.
No interventions assigned to this group
Intervention group
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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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Mark van den Boogaard, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud University Medical Center
Nijmegen, Gelderland, 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
Countries
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References
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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.
Tilburgs 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.
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.
Related Links
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Related Info
Other Identifiers
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UNDERPIN-ICU
Identifier Type: -
Identifier Source: org_study_id
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