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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00214344
Other study ID # M-2003-0040
Secondary ID
Status Completed
Phase Phase 2
First received September 15, 2005
Last updated October 1, 2015
Start date October 2003
Est. completion date February 2007

Study information

Verified date September 2005
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
family preparation for withdrawing life support


Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Are the families who received education/counseling better prepared for the experience of the dying patient
Secondary This is a feasibility Pilot Study
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