ICU Delirium: a One-week Snapshot of Burden Across the Eastern UK Region

Delirium Clinical Trial

Official title:

ICU Delirium: a One-week Snapshot of Burden Across the Eastern UK Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902277
• Other study ID #: P01535
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: July 17, 2013
• Start date: June 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2013
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital NHS Foundation Trust	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium prevalence	Number of patients with at least one recorded delirium-positive result, over total number of patients recorded over study time frame. Delirium screening will be carried out using the CAM-ICU by local direct care clinicians in accordance with region-wide clinical delirium-screening guidelines.	June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No
Secondary	Proportion of patient-days with delirium	Number of patient-days with at least one recorded delirium-positive result over total patient-days recorded.	June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No
Secondary	Median delirium duration	In delirium patients: median number of days recorded with delirium over study time frame.	June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No
Secondary	Median days to transition to delirium	In delirium patients admitted during study time frame: median number of days from ICU admission to first recorded delirium day.	June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No
Secondary	Patient age, by delirium status	In delirium patients versus patients with no recorded delirium-positive result over study time frame: median age.	June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No
Secondary	Patient gender, by delirium status	In delirium patients versus patients with no recorded delirium-positive result over study time frame: number of males over total patients in each group.	June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No
Secondary	Admission type, by delirium status	In delirium patients versus patients with no recorded delirium-positive result over study time frame: number of (1) urgent/emergency and (2) elective admissions, over total patients in each group.	June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No
Secondary	Admission reason, by delirium status	In delirium patients versus patients with no recorded delirium-positive result over study time frame: number of (1) medical and (2) surgical admissions, over total patients in each group.	June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No
Secondary	Organ support, by delirium status	In delirium patients versus patients with no recorded delirium-positive result over study time frame: number receiving advanced and basic respiratory, advanced and basic cardiovascular, and renal support since ICU admission to end of study time frame, over total patients in each group.	June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No
Secondary	Mobilisation therapy, by delirium status	In delirium patients versus patients with no recorded delirium-positive result over study time frame: number receiving mobilisation therapy over study time frame, over total patients in each group.	June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No
Secondary	Median ICU days, by delirium status	In delirium patients versus patients with no recorded delirium-positive result over study time frame: median number of patient-days in ICU per patient, since admission to end of study time frame.	June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No
Secondary	Delirium screening compliance	Number of patient-days CAM-ICU administered (1) once or more and (2) twice or more, over total number of patient-days recorded over study time frame.	June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)	No