- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00331877
A Communication Strategy for Families of Patients Dying in the ICU
May 30, 2006 updated by: Famirea Study Group
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
136
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- family of dying patient
Exclusion Criteria:
- family having no enough knowledge of French to respond to telephone interview
- patient alive on day 90
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: ECT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
symptoms related to posttraumatic stress disorder
|
Secondary Outcome Measures
Outcome Measure |
---|
symptoms of anxiety and depression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Elie Azoulay, Md, PhD, Famirea Study Group
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Lautrette 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. Erratum In: N Engl J Med. 2007 Jul 12;357(2):203.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Study Completion
January 1, 2006
Study Registration Dates
First Submitted
May 30, 2006
First Submitted That Met QC Criteria
May 30, 2006
First Posted (ESTIMATE)
May 31, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
May 31, 2006
Last Update Submitted That Met QC Criteria
May 30, 2006
Last Verified
May 1, 2006
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- famirea VIII
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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