Decision MakingCapacityNCT01956045
Critically Ill Patient's Capacity
An observational study of Decision Making and Critical Illness, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decision Making, Critical Illness
- What is being tested?
- Patient's capacity
- How many people
- 215 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically-ill patients
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Decision Making, Critical Illness
- Being tested
- Patient's capacity
- Keywords
- Intensive Care Units, Judgment, Disability Evaluation, Autonomy
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient's capacityOther
| Study group | Role | What they receive |
|---|---|---|
| Decision making | Not described Receives: Other: Patient's capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at day 1
Secondary outcomes (3)
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
Measured: at day 1
association between burnout in evaluators and consistency of their decision-making capacity assessments
Measured: 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
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startApr 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre LAUTRETTE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956045
- Sponsor's protocol ID
- CHU-0164
- Other IDs
- 2011-A01492-39
- Acronym
- Capacity
- Status last verified
- Jul 2014
- First submitted
- 16 Jul 2013
- Last updated
- 4 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critically Ill Patient's Capacity
- ClinicalTrials.gov ID
- NCT01956045
- Acronym / sponsor ID
- Capacity / CHU-0164
- Conditions
- Decision Making, Critical Illness
- Keywords
- Intensive Care Units, Judgment, Disability Evaluation, Autonomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision making | – | Other: Patient's capacity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically-ill patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient's capacity | Other | Decision making |
Primary outcome
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.
3 secondary outcomes
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
association between burnout in evaluators and consistency of their decision-making capacity assessments
Time frame: 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
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre LAUTRETTE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decision Making and Critical Illness, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between the decision-making capacity and the decision-making capacity assessed by standardized methods (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2014.