Clinical trial NCT01902277: ICU Delirium: a One-week Snapshot of Burden Across the Eastern UK Region
Official title: ICU Delirium: a One-week Snapshot of Burden Across the Eastern UK Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Delirium
Intensive Care Unit
Critical illness
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN)
First posted: 2013-07-18
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult critically ill patients across eastern UK region

Brief summary: ICU delirium negatively impacts on patient outcomes, as well as on resources and clinical workflow of the ICU. Effective healthcare resource planning requires reliable (i.e., multicentre) data that can inform on both of these.

The purpose of this study was to determine the impact of ICU delirium in terms of both patients and beds. The study was carried out prospectively, over a one-week period, at adult ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN).

Detailed description: Previous delirium prevalence research has been carried out at single sites and yielded highly variable results (between 3-87%). Reliable multisite data can be obtained cost-effectively using a point-prevalence ("snapshot") approach.

Purpose: to obtain reliable data informing on prevalence of ICU delirium, in terms of both patients and beds, across the eastern UK region.

Design and Setting: this one-week observational prospective cohort study was carried out between June 25, 2012 (start of ICU day shift) to July 01, 2012 (end of night shift). Nine ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN) took part. Cambridgeshire 2 Research Ethics Committee approved the study (REC reference: 10/H0308/116) and waived the need for informed consent.

Patients and procedure: All adults treated over the study week at participating ICUs were considered eligible for inclusion. Delirium screening was carried out by patients' direct care clinicians using the Confusion Assessment Method for the ICU (CAM-ICU). All sites used this tool as part of their routine clinical practice and had delirium management guidelines in place at the time of the study. Patients who screened positive for delirium were treated according to local hospital practice.

Eligibility criteria: Inclusion Criteria:

* Adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK

Exclusion Criteria:

-

Primary outcomes:
measure: Delirium prevalence
timeFrame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Secondary outcomes:
measure: Proportion of patient-days with delirium
timeFrame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
measure: Median delirium duration
timeFrame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
measure: Median days to transition to delirium
timeFrame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
measure: Patient age, by delirium status
timeFrame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
measure: Patient gender, by delirium status
timeFrame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
measure: Admission type, by delirium status
timeFrame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
measure: Admission reason, by delirium status
timeFrame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
measure: Organ support, by delirium status
timeFrame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
measure: Mobilisation therapy, by delirium status
timeFrame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
measure: Median ICU days, by delirium status
timeFrame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
measure: Delirium screening compliance
timeFrame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Alain Vuylsteke, MD
role: PRINCIPAL_INVESTIGATOR
References: