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Family Preparation Study For Withdrawal of Mechanical Ventilation From Their Family Member

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214344
First received: September 15, 2005
Last updated: April 17, 2007
Last verified: September 2005

September 15, 2005
April 17, 2007
October 2003
Not Provided
Are the families who received education/counseling better prepared for the experience of the dying patient
Are the families who received education/couseling better prepared for the experience of the dying patient
Complete list of historical versions of study NCT00214344 on ClinicalTrials.gov Archive Site
This is a feasibility Pilot Study
Same as current
Not Provided
Not Provided
 
Family Preparation Study For Withdrawal of Mechanical Ventilation From Their Family Member
Evaluating the Usefulness of Preparing Families For Withdrawal of Mechanical Ventilation From Their Family Member: A Pilot Study

Using the self-regulation theory, an intervention to prepare families for that experience was developed. This study will assess the impact of the intervention on a family’s evaluation of their preparation and their short-term coping. The site used for this study will be the Trauma and Life Support Center (TLC), University of Wisconsin (UW) Hospital. After a decision has been made to withdraw life support, a member of the TLC staff will approach the next of kin of the patient to inform him/her about the study and inquire about his/her interest to participate. Using an experimental design, 10 family members will be assigned to the control group and 10 to the intervention group. Upon agreement, a research nurse will use a “coin toss method” for group assignment of the subjects until there are ten in each group. Experimental group subjects will receive the intervention after the family meeting. Demographics of the next of kin will be collected at this time. Patient information such as demographics, diagnosis, and time of withdrawal and death will be collected too. Two to four weeks after death, a telephone interview will be conducted with the next of kin using the “Evaluation of the Experience of Withdrawal” questionnaire and the Profile of Mood State - shortened version.

Potential benefits are that the families will be prepared for the experience of the dying patient, which will help them cope better during withdrawal and after their loss. There are no major risks to the subjects but there might be an increase in psychological distress.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
  • Mechanical Ventilation
  • Critically Ill
Behavioral: family preparation for withdrawing life support
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2007
Not Provided

Inclusion Criteria:

  • Next of kin of a patient who will have withdrawal of life support
  • Participant must be 18 years of age or older and read, write, and speak English

Exclusion Criteria:

  • Family is unusually highly emotional
  • Patient will be a living donor
  • Patient is conscious
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214344
M-2003-0040
Not Provided
Not Provided
University of Wisconsin, Madison
Not Provided
Principal Investigator: Karin T Kirchhoff University of Wisconsin, Madison
University of Wisconsin, Madison
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP