Clinical Trials Directory

Trials / Completed

CompletedNCT00214344

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
20 (planned)
Sponsor
University of Wisconsin, Madison · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALfamily preparation for withdrawing life support

Timeline

Start date
2003-10-01
Completion
2007-02-01
First posted
2005-09-21
Last updated
2015-10-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00214344. Inclusion in this directory is not an endorsement.