Viewing Study NCT00214344



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Last Modification Date: 2024-10-26 @ 9:18 AM
Study NCT ID: NCT00214344
Status: COMPLETED
Last Update Posted: 2015-10-05
First Post: 2005-09-15

Brief Title: Family Preparation Study For Withdrawal of Mechanical Ventilation From Their Family Member
Sponsor: University of Wisconsin Madison
Organization: University of Wisconsin Madison

Study Overview

Official Title: Evaluating the Usefulness of Preparing Families For Withdrawal of Mechanical Ventilation From Their Family Member A Pilot Study
Status: COMPLETED
Status Verified Date: 2005-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 familys 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 himher about the study and inquire about hisher 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None