NCT00331877

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2005

Shorter than P25 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
Last Updated

May 31, 2006

Status Verified

May 1, 2006

First QC Date

May 30, 2006

Last Update Submit

May 30, 2006

Conditions

Family of Dying Patient in the ICU

Keywords

familyend-of-lifeintensive care unit

Outcome Measures

Primary Outcomes (1)

  • symptoms related to posttraumatic stress disorder

Secondary Outcomes (1)

  • symptoms of anxiety and depression

Interventions

family conference with bereavement information leafletPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • family of dying patient

You may not qualify if:

  • family having no enough knowledge of French to respond to telephone interview
  • patient alive on day 90

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 35802350DERIVED

  • 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.

    PMID: 17267907DERIVED

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elie Azoulay, Md, PhD

    Famirea Study Group

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 30, 2006

First Posted

May 31, 2006

Study Start

May 1, 2005

Study Completion

January 1, 2006

Last Updated

May 31, 2006

Record last verified: 2006-05