Family of Dying Patient in the ICUNCT00331877
A Communication Strategy for Families of Patients Dying in the ICU
A study testing family conference with bereavement information leaflet in people with Family of Dying Patient in the ICU, run by Famirea Study Group.
Trial summary
Decisions to limit life sustaining treatments are made for most patients dying in the ICU, usually with input from the family. The well-being of the family may be jeopardized by involvement in the decision-making process and bereavement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Family of Dying Patient in the ICU
- What is being tested?
- family conference with bereavement information leaflet
- Type of treatment
- Surgery or procedure
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jan 2006
- Phase
- Interventional
- 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
Who may be able to join
- family of dying patient
Who cannot join
- family having no enough knowledge of French to respond to telephone interview
- patient alive on day 90
About this study
Official title: A Proactive Communication Strategy for Family Members of Patients Dying in the ICU: A Multicenter Randomized Controlled Trial
Decisions to limit life sustaining treatments are made for most patients dying in the ICU, usually with input from the family. The well-being of the family may be jeopardized by involvement in the decision-making process and bereavement. We evaluated the ability of a proactive communication strategy (family conference and providing family members with a bereavement information leaflet) designed to improve family well-being.
- Conditions
- Family of Dying Patient in the ICU
- Being tested
- family conference with bereavement information leaflet
- Keywords
- family, end-of-life, intensive care unit
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family conference with bereavement information leafletProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms related to posttraumatic stress disorder
Secondary outcomes (1)
symptoms of anxiety and depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study startMay 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Family of Dying Patient in the ICUStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 136 participants
Sponsor and investigators
- Lead sponsor
- Famirea Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Elie Azoulay, Md, PhD, Study director, Famirea Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331877
- Sponsor's protocol ID
- famirea VIII
- Status last verified
- May 2006
- First submitted
- 30 May 2006
- Last updated
- 31 May 2006
- Results posted
- No
Publications
Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
PubMed 35802350Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446.
PubMed 17267907
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proactive Communication Strategy for Family Members of Patients Dying in the ICU: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00331877
- Acronym / sponsor ID
- famirea VIII
- Conditions
- Family of Dying Patient in the ICU
- Keywords
- family, end-of-life, intensive care unit
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 136 participants
- Lead sponsor
- Famirea Study GroupUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Jan 2006
- First posted
- 31 May 2006 (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.
Decisions to limit life sustaining treatments are made for most patients dying in the ICU, usually with input from the family. The well-being of the family may be jeopardized by involvement in the decision-making process and bereavement. We evaluated the ability of a proactive communication strategy (family conference and providing family members with a bereavement information leaflet) designed to improve family well-being.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- family of dying patient
Key exclusion criteria (2 listed)
- family having no enough knowledge of French to respond to telephone interview
- patient alive on day 90
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| family conference with bereavement information leaflet | Procedure or surgery | – |
Primary outcome
symptoms related to posttraumatic stress disorder
1 secondary outcome
symptoms of anxiety and depression
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2006.
- Derived from this study: PubMed 35802350Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
- Derived from this study: PubMed 17267907Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446.
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.
Elie Azoulay, Md, PhD study director
Famirea Study Group
Questions about this trial
What is this clinical trial studying?
A study testing family conference with bereavement information leaflet in people with Family of Dying Patient in the ICU, run by Famirea Study Group.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 31 May 2006. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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?
symptoms related to posttraumatic stress disorder. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00331877, which also lists 2 linked publications.
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 31 May 2006.