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
  Purpose

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 Intervention Phase
Mechanical Ventilation
Critically Ill
Behavioral: family preparation for withdrawing life support
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Evaluating the Usefulness of Preparing Families For Withdrawal of Mechanical Ventilation From Their Family Member: A Pilot Study

Further study details as provided by University of Wisconsin, Madison:

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

Secondary Outcome Measures:
  • This is a feasibility Pilot Study

Estimated Enrollment: 20
Study Start Date: October 2003
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214344

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Karin T Kirchhoff University of Wisconsin, Madison
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00214344     History of Changes
Other Study ID Numbers: M-2003-0040
Study First Received: September 15, 2005
Last Updated: April 17, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
dying

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014