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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00214344
Enrollment
20
Registered
2005-09-21
Start date
2003-10-31
Completion date
2007-02-28
Last updated
2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill, Mechanical Ventilation

Keywords

dying

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.

Interventions

BEHAVIORALfamily preparation for withdrawing life support

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Are the families who received education/counseling better prepared for the experience of the dying patient

Secondary

MeasureTime frame
This is a feasibility Pilot Study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026