Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00214344
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 5, 2015
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Critically Ill Behavioral: family preparation for withdrawing life support Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluating the Usefulness of Preparing Families For Withdrawal of Mechanical Ventilation From Their Family Member: A Pilot Study
Study Start Date : October 2003
Actual Study Completion Date : February 2007

Primary Outcome Measures :
  1. Are the families who received education/counseling better prepared for the experience of the dying patient

Secondary Outcome Measures :
  1. This is a feasibility Pilot Study

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00214344

Layout table for location information
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Layout table for investigator information
Principal Investigator: Karin T Kirchhoff University of Wisconsin, Madison

Layout table for additonal information
Responsible Party: University of Wisconsin, Madison Identifier: NCT00214344     History of Changes
Other Study ID Numbers: M-2003-0040
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: September 2005
Keywords provided by University of Wisconsin, Madison:
Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Disease Attributes
Pathologic Processes