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The impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A study protocol for a multi-centre, stepped wedge randomized controlled trial

The impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A study protocol for a multi-centre, stepped wedge randomized controlled trial
The impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A study protocol for a multi-centre, stepped wedge randomized controlled trial
Background: 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.

Discussion: For every intervention the balance between putative benefit and potential unwanted side effects needs to be considered. In non-ICU patients, it has been shown that a similar program resulted in a significant reduction of delirium incidence and duration. Recent small studies using multi component interventions to prevent delirium in ICU patients have also shown beneficial effect, without unwanted side effects. We therefore feel that the proportionality of potential positive effects of the UNDERPIN-ICU program, weighed against potential unwanted side effects is favourable. Since this has not been rigorously proven in ICU patients, we will study the effects of this program in ICU patients using a stepped wedge design.

Trial registration: Intended registry: https://clinicaltrials.gov/. This will be done when the final version of this manuscript is accepted.

Reporting method: Standard Protocol Items: Recommendations for Interventional Trails (SPIRIT).
0020-7489
1-45
Wassenaar, Annelies
4a047852-d9cb-4760-879d-af4ec237204e
Rood, Paul
8431dbaa-aa36-459b-be3a-680f11904346
Schoonhoven, Lisette
46a2705b-c657-409b-b9da-329d5b1b02de
Teerenstra, Steven
c0e47f7c-40b4-478d-8a4a-88b9a8e19318
Zegers, Marieke
ac163919-9e64-45c0-8ca5-e8c89cff2fed
Pickkers, Peter
516df191-7ae2-457e-a7f7-abd6ca935687
van den Boogard, Mark
9151cea1-82a4-4bcb-be41-722fb31a939f
Wassenaar, Annelies
4a047852-d9cb-4760-879d-af4ec237204e
Rood, Paul
8431dbaa-aa36-459b-be3a-680f11904346
Schoonhoven, Lisette
46a2705b-c657-409b-b9da-329d5b1b02de
Teerenstra, Steven
c0e47f7c-40b4-478d-8a4a-88b9a8e19318
Zegers, Marieke
ac163919-9e64-45c0-8ca5-e8c89cff2fed
Pickkers, Peter
516df191-7ae2-457e-a7f7-abd6ca935687
van den Boogard, Mark
9151cea1-82a4-4bcb-be41-722fb31a939f

Wassenaar, Annelies, Rood, Paul, Schoonhoven, Lisette, Teerenstra, Steven, Zegers, Marieke, Pickkers, Peter and van den Boogard, Mark (2016) The impact of nUrsiNg DEliRium Preventive INterventions in the Intensive Care Unit (UNDERPIN-ICU): A study protocol for a multi-centre, stepped wedge randomized controlled trial. International Journal of Nursing Studies, 1-45. (doi:10.1016/j.ijnurstu.2016.11.018).

Record type: Article

Abstract

Background: 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.

Discussion: For every intervention the balance between putative benefit and potential unwanted side effects needs to be considered. In non-ICU patients, it has been shown that a similar program resulted in a significant reduction of delirium incidence and duration. Recent small studies using multi component interventions to prevent delirium in ICU patients have also shown beneficial effect, without unwanted side effects. We therefore feel that the proportionality of potential positive effects of the UNDERPIN-ICU program, weighed against potential unwanted side effects is favourable. Since this has not been rigorously proven in ICU patients, we will study the effects of this program in ICU patients using a stepped wedge design.

Trial registration: Intended registry: https://clinicaltrials.gov/. This will be done when the final version of this manuscript is accepted.

Reporting method: Standard Protocol Items: Recommendations for Interventional Trails (SPIRIT).

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Accepted/In Press date: 29 November 2016
e-pub ahead of print date: 8 December 2016
Organisations: Faculty of Health Sciences

Identifiers

Local EPrints ID: 403802
URI: http://eprints.soton.ac.uk/id/eprint/403802
ISSN: 0020-7489
PURE UUID: 7f245b1f-de1c-4a18-b579-4ccf12a5af88
ORCID for Lisette Schoonhoven: ORCID iD orcid.org/0000-0002-7129-3766

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Date deposited: 13 Dec 2016 09:17
Last modified: 16 Mar 2024 04:09

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Contributors

Author: Annelies Wassenaar
Author: Paul Rood
Author: Steven Teerenstra
Author: Marieke Zegers
Author: Peter Pickkers
Author: Mark van den Boogard

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