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

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ClinicalTrials.gov Identifier: NCT01902277
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : July 18, 2013
Sponsor:
Collaborator:
Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN)
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

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).


Condition or disease
Delirium

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.


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Study Type : Observational
Actual Enrollment : 225 participants
Time Perspective: Prospective
Official Title: ICU Delirium: a One-week Snapshot of Burden Across the Eastern UK Region
Study Start Date : June 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort
Adult critically ill patients
All adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK



Primary Outcome Measures :
  1. Delirium prevalence [ Time Frame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    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.


Secondary Outcome Measures :
  1. Proportion of patient-days with delirium [ Time Frame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    Number of patient-days with at least one recorded delirium-positive result over total patient-days recorded.

  2. Median delirium duration [ Time Frame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    In delirium patients: median number of days recorded with delirium over study time frame.

  3. Median days to transition to delirium [ Time Frame: June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    In delirium patients admitted during study time frame: median number of days from ICU admission to first recorded delirium day.

  4. Patient age, by delirium status [ Time Frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    In delirium patients versus patients with no recorded delirium-positive result over study time frame: median age.

  5. Patient gender, by delirium status [ Time Frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    In delirium patients versus patients with no recorded delirium-positive result over study time frame: number of males over total patients in each group.

  6. Admission type, by delirium status [ Time Frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    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.

  7. Admission reason, by delirium status [ Time Frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    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.

  8. Organ support, by delirium status [ Time Frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    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.

  9. Mobilisation therapy, by delirium status [ Time Frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    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.

  10. Median ICU days, by delirium status [ Time Frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    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.

  11. Delirium screening compliance [ Time Frame: June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult critically ill patients across eastern UK region
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902277


Locations
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United Kingdom
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB23 5EF
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN)
Investigators
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Principal Investigator: Alain Vuylsteke, MD Papworth Hospital NHS Foundation Trust

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Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01902277     History of Changes
Other Study ID Numbers: P01535
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013

Keywords provided by Papworth Hospital NHS Foundation Trust:
Delirium
Intensive Care Unit
Critical illness

Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders