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Quality of Dying in the Intensive Care Unit: Validation of the CAESAR Scale

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01549197
First received: March 6, 2012
Last updated: November 19, 2012
Last verified: November 2012
History of Changes

March 6, 2012
November 19, 2012
August 2011
November 2012   (final data collection date for primary outcome measure)
CAESAR score [ Time Frame: Within 3 weeks after patient's death ] [ Designated as safety issue: No ]
Score on the 32-item CAESAR scale assessing quality of end-of-life process
Same as current
Complete list of historical versions of study NCT01549197 on ClinicalTrials.gov Archive Site
  • Job strain of the physicians and nurses in charge of the patient [ Time Frame: within 3 weeks following patient's death ] [ Designated as safety issue: No ]
    Score on the Job strain, a validated scale assessing stress in work environment
  • Anxiety and depression [ Time Frame: 3 months after patient's death ] [ Designated as safety issue: No ]
    Anxiety and depression of the relative, assessed by the Hospital Anxiety and Depression Scale (HADS)
  • Post Traumatic Stress Disorder [ Time Frame: 3 months after patient's death ] [ Designated as safety issue: No ]
    PTSD of relatives assessed by Inventory of Event Scale revised (IES-R)
  • Complicated Grief [ Time Frame: 6 months after patients' death ] [ Designated as safety issue: No ]
    Complicated grief assessed by the Inventory of Complicated Grief (ICG) scale
  • PTSD [ Time Frame: 6 months after patient's death ] [ Designated as safety issue: No ]
    PTSD assessed by IES-R
  • PTSD [ Time Frame: 12 months after patient's death ] [ Designated as safety issue: No ]
    PTSD assessed by IES-R
  • Job strain of the physicians and nurses in charge of the patient [ Time Frame: within 3 weeks following patient's death ] [ Designated as safety issue: No ]
    Score on the Job strain, a validated scale assessing stress in work environment
  • Anxiety and depression [ Time Frame: 3 months after patient's death ] [ Designated as safety issue: No ]
    Anixiety and depression of the relative, assessed by the Hospital Anxiety and Depression Scale (HADS)
  • Post Traumatic Stress Disorder [ Time Frame: 3 months after patient's death ] [ Designated as safety issue: No ]
    PTSD of relatives assessed by Inventory of Event Scale revised (IES-R)
  • Complicated Grief [ Time Frame: 6 months after patients' death ] [ Designated as safety issue: No ]
    Complicated grief assessed by the Inventory of Complicated Grief (ICG) scale
  • PTSD [ Time Frame: 6 months after patient's death ] [ Designated as safety issue: No ]
    PTSD assessed by IES-R
  • PTSD [ Time Frame: 12 months after patient's death ] [ Designated as safety issue: No ]
    PTSD assessed by IES-R
Not Provided
Not Provided
 
Quality of Dying in the Intensive Care Unit: Validation of the CAESAR Scale
End-of-life in French Intensive Care Units: Perception of the Quality of Dying and Experience of Physicians, Nurses and Relatives. Validation of the CAESAR Scale

The purpose of the study is to evaluate the quality of the dying process in french ICUs (assessed by the CAESAR scale) and to compare physicians', nurses' and relatives perceptions and experiences, with a one-year follow-up of bereaved relatives.

Our hypothesis is that perception of the quality of dying may impact on relatives' experience of bereavement (anxiety, depression, complicated grief, posttraumatic stress disorder (PTSD)).

Seventy percent of all deaths occur in the hospital environment, and amongst them 20% occur in intensive care units (ICU). In France, no studies have evaluated the quality of the end-of-life process from both the professional and the lay perspective.

The CAESAR scale has been developed from literature reviews and qualitative interviews with relatives, physicians and nurse to assess quality of dying in ICU. Our hypothesis is that perception of the quality of dying may impact on relatives' experience of bereavement (anxiety, depression, complicated grief, PTSD).
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Physicians and nurses in charged of ICU deceased patients Bereaved relatives of ICU patients
  • Anxiety
  • Depression
  • Posttraumatic Stress Disorder
Not Provided
ICU staff and relatives
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
475
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients Deceased in the ICU after at least 48 hours of ICU stay
  • At least one visit of a relative in the ICU

Exclusion Criteria:

  • no French-speaking relative
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01549197
AOM10104
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Nancy Kentish-Barnes, PhD Reanimation Médicale, Hôpital Saint Louis
Assistance Publique - Hôpitaux de Paris
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP