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

NCT00214344 | Completed Phase 2

• 1 other identifier: M-2003-0040
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Critically Ill

Keywords

dying

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• This is a feasibility Pilot Study

Interventions

family preparation for withdrawing life support BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Family is unusually highly emotional
• Patient will be a living donor
• Patient is conscious

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karin T Kirchhoff

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2003
• Study Completion: February 1, 2007
• Last Updated: October 5, 2015

Record last verified: 2005-09

Locations

US (1)