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Completed

NCT Number: NCT01956045

Critically Ill Patient's 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.

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Key information

Conditions

Decision Making Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Patient's capacity

Other

Primary outcomes

  1. correlation between the decision-making capacity and the decision-making capacity assessed by standardized methods

    Time frame: 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 outcomes

  1. 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

    Time frame: 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

  2. association between burnout in evaluators and consistency of their decision-making capacity assessments

    Time frame: at day 1

  3. 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

    Time frame: at day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: Capacity

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2013
Registry last updated
Jul 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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