ClinicalTrials.gov

History of Changes for Study: NCT00331877
A Communication Strategy for Families of Patients Dying in the ICU
Latest version (submitted May 30, 2006) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 30, 2006 None (earliest Version on record)
Comparison Format:

Scroll up to access the controls

Study NCT00331877
Submitted Date:  May 30, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: famirea VIII
Brief Title: A Communication Strategy for Families of Patients Dying in the ICU
Official Title: A Proactive Communication Strategy for Family Members of Patients Dying in the ICU: A Multicenter Randomized Controlled Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2006
Overall Status: Terminated
Study Start: May 2005
Primary Completion:
Study Completion: January 2006
First Submitted: May 30, 2006
First Submitted that
Met QC Criteria:
May 30, 2006
First Posted: May 31, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 30, 2006
Last Update Posted: May 31, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Famirea Study Group
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Family of Dying Patient in the ICU
Keywords: family
end-of-life
intensive care unit
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Educational/Counseling/Training
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 136
Open or close this module Arms and Interventions
Intervention Details:
Procedure: family conference with bereavement information leaflet
Open or close this module Outcome Measures
Primary Outcome Measures:
1. symptoms related to posttraumatic stress disorder
Secondary Outcome Measures:
1. symptoms of anxiety and depression
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Study Officials: Elie Azoulay, Md, PhD
Study Director
Famirea Study Group
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services