AnxietyCAESARNCT01549197
Quality of Dying in the Intensive Care Unit: Validation of the CAESAR Scale
An observational study of Anxiety and Depression, run by Assistance Publique - Hôpitaux de Paris at 47 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Posttraumatic Stress Disorder
- How many people
- 475 participants
- Where
- 47 sitesFrance
- Study dates
- Aug 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Physicians and nurses in charged of ICU deceased patients Bereaved relatives of ICU patients
Who may be able to join
- Adult patients Deceased in the ICU after at least 48 hours of ICU stay
- At least one visit of a relative in the ICU
Who cannot join
- no French-speaking relative
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
France47 sites
Réanimation médicale Centre hospitalier Pays d'Aix
Aix-en-Provence, 13616
Réanimation Polyvalente Centre Hospitalier Victor Dupouy
Argenteuil, 95107
Réanimation médicale Hôpital Saint André
Bordeaux, 33000
Réanimation médicale CHU de la Cavale Blanche
Brest, 29609
Réanimation Chirurgicale
Caen, 14033
Réanimation Médicale Hôpital de Caen
Caen, 14033
Réanimation Médico-Chirugicale CH Chambéry
Chambéry, 73011
Réanimation CHU ESTAING
Clermont-Ferrand, 63000
Réanimation polyvalente CH de Dieppe
Dieppe, 76202
Réanimation polyvalente CH Sud Francilien
Évry, 91014
Réanimation Polyvalente Centre Hospitalier de Gonesse
Gonesse, 95503
Réanimation polyvalente Hôpital Les Oudairies
La Roche-sur-Yon, 85925
Réanimation polyvalente Centre hospitalier de Versailles
Le Chesnay, 78157
Réanimation médicale Hôpital Calmette
Lille, 59037
Réanimation polyvalente Hôpital Roger Salengro
Lille, 59037
Réanimation polyvalente CH Bretagne Sud
Lorient, 56322
Réanimation médicale Hôpital de La Croix Rousse
Lyon, 69317
Réanimation Médicale Groupement Hospitalier Edouard Herriot
Lyon, 69437
Réanimation polyvalente GH Edouard Herriot
Lyon, 69437
Service de réanimation Institut Paoli Calmettes
Marseille, 13009
Service d'anesthésie et de réanimation Chu Timone
Marseille, 13385
Service d'anesthésie et de réanimation Hôpital Nord
Marseille, 13915
Service de réanimation, détresses respiratoires et infections sévères Hôpital Nord
Marseille, 13915
Réanimation Centre hospitalier Marc Jacquet
Melun, 77011
Réanimation Anesthésie CHU Saint Eloi
Montpellier, 34295
Réanimation Centre Hospitalier Intercommunal André Grégoire
Montreuil, 93105
Réanimation médicale CHU de Nancy- Hôpital central
Nancy, 54035
Anesthésie-Réanimation CHU de Nantes- Hôtel Dieu
Nantes, 44093
réanimation chirurgicale Groupe Hospitalier Universitaire Carémeau
Nîmes, 30029
Service de réanimation polyvalente CHR - Hôpital de la Source
Orléans, 45067
Reanimation medicale, Hôpital Saint Louis
Paris, 75010
Neuro-réanimation chirurgicale Groupe hospitalier Pitié-Salpêtrière
Paris, 75013
Service de réanimation Hôpital Saint Joseph
Paris, 75014
Réanimation chirurgicale Hôpital Saint-Louis
Paris, 75475
Service de réanimation médicale et toxicologique CHU Lariboisière
Paris, 75475
Réanimation médicale Hôpital Cochin
Paris, 75679
Réanimation polyvalente au CH d'Annecy
Pringy, 74374
Réanimation médico-chirurgicale CH de Roanne
Roanne, 42300
Service de réanimation médicale Hôpital Victor Provo
Roubaix, 59100
Service de réanimation médicale CHU CH Nicolle
Rouen, 76031
Service de réanimation polyvalente CH de Saint Lô
Saint-Lô, 50009
Réanimation polyvalente Centre hospitalier d'Angoulême
Saint-Michel, 16470
Réanimation Hôpital Font-Pré
Toulon, 83056
Réanimation médicale Hôpital Chatilliez
Tourcoing, 59208
Service de réanimation polyvalente CH de Valenciennes
Valenciennes, 59322
Réanimation Polyvalente CH Bretagne Atlantique
Vannes, 56017
Service de réanimation médico-chirurgicale Institut Gustave Roussy
Villejuif, 94805
About this study
Official 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
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)).
Read the detailed description
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).
- Conditions
- Anxiety, Depression, Posttraumatic Stress Disorder
- Keywords
- PTSD
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU staff and relatives | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAESAR score
Score on the 32-item CAESAR scale assessing quality of end-of-life process
Measured: Within 3 weeks after patient's death
Secondary outcomes (6)
Job strain of the physicians and nurses in charge of the patient
Score on the Job strain, a validated scale assessing stress in work environment
Measured: within 3 weeks following patient's death
Anxiety and depression
Anxiety and depression of the relative, assessed by the Hospital Anxiety and Depression Scale (HADS)
Measured: 3 months after patient's death
Post Traumatic Stress Disorder
PTSD of relatives assessed by Inventory of Event Scale revised (IES-R)
Measured: 3 months after patient's death
Complicated Grief
Complicated grief assessed by the Inventory of Complicated Grief (ICG) scale
Measured: 6 months after patients' death
PTSD
PTSD assessed by IES-R
Measured: 6 months after patient's death
PTSD
PTSD assessed by IES-R
Measured: 12 months after patient's death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Kentish-Barnes, PhD, Principal investigator, Reanimation Médicale, Hôpital Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549197
- Sponsor's protocol ID
- AOM10104
- Acronym
- CAESAR
- Status last verified
- Nov 2012
- First submitted
- 6 Mar 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01549197
- Acronym / sponsor ID
- CAESAR / AOM10104
- Conditions
- Anxiety, Depression, Posttraumatic Stress Disorder
- Keywords
- PTSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU staff and relatives | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians and nurses in charged of ICU deceased patients Bereaved relatives of ICU patients
Key inclusion criteria (2 listed)
- Adult patients Deceased in the ICU after at least 48 hours of ICU stay
- At least one visit of a relative in the ICU
Key exclusion criteria (1 listed)
- no French-speaking relative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Job strain of the physicians and nurses in charge of the patient
Time frame: within 3 weeks following patient's death
Anxiety and depression
Time frame: 3 months after patient's death
Post Traumatic Stress Disorder
Time frame: 3 months after patient's death
Complicated Grief
Time frame: 6 months after patients' death
PTSD
Time frame: 6 months after patient's death
PTSD
Time frame: 12 months after patient's death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Kentish-Barnes, PhD principal investigator
Reanimation Médicale, Hôpital Saint Louis
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression, run by Assistance Publique - Hôpitaux de Paris at 47 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAESAR score (time frame: Within 3 weeks after patient's death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.