Critically Ill Patient's Capacity (Capacity)

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Decision Making
• Intervention / Treatment: Other: Patient's capacity

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 Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

critically-ill patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Decision making	Other: Patient's capacity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between the decision-making capacity and the decision-making capacity assessed by standardized methods	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.	at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	at day 1
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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Alexandre Lautrette, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: July 16, 2013
• First Submitted That Met QC Criteria: September 30, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): July 4, 2014
• Last Update Submitted That Met QC Criteria: July 3, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Disability Evaluation; Intensive Care Units; Autonomy; Judgment
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: CHU-0164; 2011-A01492-39