|- candidate number||8970|
|- NTR Number||NTR2706|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-jan-2011|
|- Secondary IDs||W11_008 METC|
|- Public Title||The analysis of Medical Emergency Teams in the Netherlands, a multi center approach. The COMET study.|
|- Scientific Title||Analysis of effectiveness and associated costs of implementing a Rapid Response System (RRS).|
|- ACRONYM||COMET, Cost and Outcomes analysis of Medical Emergency Teams|
|- hypothesis||Early recognition of deteriorating patients is key to possible effectiveness of an RRS. Therefore, phased introduction of the afferent limb (aimed at detection) followed up by the implementation of the efferent limb (the Medical Emergency Team) will enable to analysis the additive effect of an RRT compared to earlier detection at the bedside. |
|- Healt Condition(s) or Problem(s) studied||Deteriorating patient, Medical Emergency Team, Rapid Response System, Modified Early Warning Score (MEWS), Situation-Background-Assessment-Recommendation (SBAR)|
|- Inclusion criteria||All adult patients admitted to the study wards and all primary outcomes are included if transpired on nursing wards.|
|- Exclusion criteria||Outcomes on higher care wards like Medium Care, Intensive Care etc. are excluded from analysis.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-apr-2009|
|- planned closingdate||30-nov-2011|
|- Target number of participants||27720|
|- Interventions||Following a baseline measurements phase of five months, the MEWS and SBAR instruments are implemented and primary endpoints are measured for seven months. Measurements of vital parameters is protocolized using the Modified Early Warning Score (MEWS) which is based on a sum score for the vital parameters. On the basis of the degree of derangement from normality, points are scored for each included parameter and at a threshold set at three for the sum score, action towards the physician is compulsory. Measurement of the MEWS is left ‘on clinical grounds’ and is thus measured whenever one or more points are scored at either regular rounds or whenever a nurse ‘feels worried’ about the clinical condition of the patient. |
After which a score of three is found, communication of the information with the physician is structured using the Situation-Background-Assessment-Recommendation (SBAR) tool.
Following these seven months, a Rapid Response Team (RRT) is implemented which can be called to the patient bedside by either the physician or nurse according to an activation protocol. The RRT consists out of an ICU clinician (intensivist/fellow at least ACLS certified) and an ICU nurse. The team is available 24/7 and responds within 10 minutes to the patient. Following initial contact by the nurse, the (attending) physician has 30 minutes to evaluate and initiate a treatment plan for the patient. In the following 60 minutes, the patient’s clinical condition should improve or otherwise the RRT has to be notified. If the physician is not able to keep to these timeframes and protocol, mandatory activation of the RRT by the nurse is clearly stated. This phase takes 17 months which includes the after measurement phase which is five months.
|- Primary outcome||1. Cardiac arrest rate;|
2. Unplanned ICU admission rate (following the NICE registry);
3. Unexpected death rate.
These endpoints will be analyzed as a composite endpoint and as separate outcomes.
Rate is defined as number of outcomes per 1000 admitted patients.
|- Secondary outcome||1. Total mortality (irrespective of code);|
2. Hospital Length of Stay (LOS);
3. ICU length of stay;
4. Number of RRT calls per 1000 admitted;
5. Costs from a hospital perspective.
|- Timepoints||The comet study is set-up as a before after trial (5 months before and 5 months after comparison) with the direct ability to perform a generalized estimating equations analysis to analyze for trends.
This successive implementation of the components that build up an RRS, enables differentiated analysis of the additive effect of an RRT compared to the effectiveness of sole implementation of the MEWS/SBAR instruments. Also this study incorporates ample time for sufficient implementation compared to previous studies which analyzed complex interventions.
|- Trial web site||www.comet-studie.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Jeroen Ludikhuize|
|- CONTACT for SCIENTIFIC QUERIES|| Jeroen Ludikhuize|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||In this multicenter trial, the effectiveness of an RRS is analyzed using a before after design incorporating a generalized estimating equations analysis to analyze for trends and study the associated costs of implementating an RRS. Through phased introduction of the RRS components, it can be hypothesized as to were the possible effectiveness may reside ie early detection or assistance of a specialized ICU team. Effectiveness will be analyzed by the composite and separate outcomes including cardiac arrest rate, unplanned ICU admission rate and unexpected death rate.|
|- Main changes (audit trail)|
|- RECORD||19-jan-2011 - 8-feb-2011|