|- candidate number||13248|
|- NTR Number||NTR3589|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-aug-2012|
|- Secondary IDs||W12_178 METC AMC|
|- Public Title||CONSULT study.|
|- Scientific Title||Mortality prediction in the intensive care: The impact of prognostic information on perceptions of mortality risks and clinical decision-making.|
|- hypothesis||We hypothesize that providing additional objective prognostic information regarding a patient's chance of survival based on a mathematical prognostic model will influence the physician's perception of mortality risk and their (un)certainty about the decision they make to withdraw ICU treatment.|
|- Healt Condition(s) or Problem(s) studied||Prognostic models, Mortality|
|- Inclusion criteria||Patients who died during ICU stay after withdrawal of ICU treatment.|
|- Exclusion criteria||N/A|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2012|
|- planned closingdate||31-dec-2012|
|- Target number of participants||25|
|- Interventions||The attending physicians of patients who died after withdrawal of ICU treatment receive a questionnaire in which questions are asked regarding:|
1. Their perception of mortality risk (if treatment had been continued);
2. Their (un)certainty about their decision.
Next a survival chance will be provided based on an objective prognostic model. The same set of questions will be asked again to measure the effect of the model on the physicians' perception of mortality risk and (un)certainty about their decision.
|- Primary outcome||1. Perception of mortality risk;|
2. (Un)certainty about the decision to withdraw treatment.
|- Secondary outcome||1. Perceived usefulness of the prognostic information provided by the model;|
2. Percentage of planned versus unplanned deaths in the ICU.
|- Timepoints||Daily (in case of a death after withdrawal of ICU treatment).|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Lilian Minne|
|- CONTACT for SCIENTIFIC QUERIES|| Dave Dongelmans|
|- Sponsor/Initiator ||Academic Medical Center (AMC, Amsterdam)|
(Source(s) of Monetary or Material Support)
|Afdeling Klinische Informatiekunde, Academisch Medisch Centrum, Amsterdam|
|- Brief summary||Aim: |
To assess the impact of prognostic information provision on their perceptions of individual mortality risks and their decisions regarding provision of life support to these patients.
Due to ethical considerations this study only concerns non-survivors and is conducted in only one centre, which allows us to control the study in a small, in-house environment.
For a period of at least four weeks, one of our intensivists will daily check which patients died in the last 24 hours, whether treatment was withdrawn in this patient and who were the attending physicians. For each patient in whom treatment is withdrawn, one of our researchers will calculate his/her survival chance based on an earlier developed prognostic model. The attending team will then receive a link to an online questionnaire prepared by this researcher which contains: 1) A set of demographical questions, 2) A set of 3 questions concerning the physicians’ perception of mortality risk in this patient and his/her certainty about the decision they made, 3) the survival chance of this patient together with a confidence interval, and 4) a repetition of the same 3 questions described in point 2. The questionnaire will not contain any patient information to guarantee the patients’ privacy. All observed patients will be followed until death or hospital discharge.
The main research question is:
Does prognostic information regarding a patient’s probability of survival influence:
1. Clinicians’ perceptions of mortality risks?
2. Clinicians’ uncertainty regarding their decision?
|- Main changes (audit trail)|
|- RECORD||21-aug-2012 - 12-sep-2012|