Critically Ill Patient's Capacity

Completed

• Conditions: Decision Making; Critical Illness
• Interventions: Other: Patient's capacity

• Registration Number: NCT01956045
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

How to determine the decision-making capacity of critically-ill patients remain unclear. The investigator study the differences between standardised evaluation and subjective medical evaluation.

Detailed Description

After written information and consent, an independent, specially trained investigator interviews patients with a standardised test.

After written information and consent, an independent, specially trained investigator interviews residents, doctors and nurses in charge of the patient and ask them how they rates patients capacity.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-07-16
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted QC: 2013-09-30
• Study First Posted: 2013-10-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-03
• Last Update Posted: 2014-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

• Caregivers :

Doctors, hospital interns, nurses state of both sexes, aged 18 years or more working in Intensive Care, members of a social security system engaged in a clinic on the day of the assessment

• Patients :

Patients of both sexes, aged 18 years or more hospitalized in Intensive Care, members of a social security system

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Decision making	Patient's capacity	-

Primary Outcome Measures

Name	Time	Method
correlation between the decision-making capacity and the decision-making capacity assessed by standardized methods	at day 1	standardized methods (patient has decision-making capacity yes/no) as described by Sessums LL, Zembrzuska H, Jackson JL. Does this patient have medical decision-making capacity? JAMA. 2011;306(4):420-427. doi:10.1001/jama.2011.1023.

Secondary Outcome Measures

Name	Time	Method
correlation between the global decision-making capacity evaluated by the physician in charge of the patient and the specific decision-making capacity assessed by physician in charge of the patient	at day 1	Ability to designate a person of confidence, capacity to consent to inclusion in a research protocol, ability to participate in a discussion on the limitation therapy
association between burnout in evaluators and consistency of their decision-making capacity assessments	at day 1
Correlation between the decision-making capacity evaluated by the physician in charge of the patient, the nurse in charge of the patient and a physician not in charge of the patient	at day 1

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France