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Completed

NCT Number: NCT01549197

Quality of Dying in the Intensive Care Unit: 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)).

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Réanimation médicale Centre hospitalier Pays d'Aix, Aix-en-Provence, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. CAESAR score

    Time frame: Within 3 weeks after patient's death

    Score on the 32-item CAESAR scale assessing quality of end-of-life process

Secondary outcomes

  1. Job strain of the physicians and nurses in charge of the patient

    Time frame: within 3 weeks following patient's death

    Score on the Job strain, a validated scale assessing stress in work environment

  2. Anxiety and depression

    Time frame: 3 months after patient's death

    Anxiety and depression of the relative, assessed by the Hospital Anxiety and Depression Scale (HADS)

  3. Post Traumatic Stress Disorder

    Time frame: 3 months after patient's death

    PTSD of relatives assessed by Inventory of Event Scale revised (IES-R)

  4. Complicated Grief

    Time frame: 6 months after patients' death

    Complicated grief assessed by the Inventory of Complicated Grief (ICG) scale

  5. PTSD

    Time frame: 6 months after patient's death

    PTSD assessed by IES-R

  6. PTSD

    Time frame: 12 months after patient's death

    PTSD assessed by IES-R

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: CAESAR

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 9, 2012
Registry last updated
Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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