|- candidate number||14190|
|- NTR Number||NTR3787|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-jan-2013|
|- Secondary IDs||2012.20 METC of Albert Schweitzer Hospital, Dordrecht|
|- Public Title||The effect of early identification of and response to clinically deteriorating patients on the surgical ward by using automated continuous patientmonitoring on patientrelated outcomes.|
|- Scientific Title||The effect of early identification of and response to clinically deteriorating patients on the surgical ward by using automated continuous patientmonitoring on patientrelated outcomes.|
|- hypothesis||Is automated continuous monitoring of vital signs of patients on the surgical ward more effective than standard practice (= intermittent monitoring)?|
|- Healt Condition(s) or Problem(s) studied||Monitoring vital signs, Deteriorating patient|
|- Inclusion criteria||1. Adult patients (18 years and older);|
2. Able to consent.
|- Exclusion criteria||1. Patients younger than 18 years;|
2. Unable to consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||18-jun-2012|
|- planned closingdate||17-jun-2013|
|- Target number of participants||1700|
|- Interventions||1. Automated continuous patientmonitoring;|
2. Intermittent patientmonitoring.
|- Primary outcome||Number of unplanned ICU admissions per 1000 admissions.|
|- Secondary outcome||1. Number cardiac arrests on the ward per 1000 admissions;|
2. Mortality rate on the ward per 1000 admissions;
3. Number of MET (medical emergency Team) calls per 1000 admissions;
4. Assessment safety culture (% of respondents reporting a good safety climate).
|- Timepoints||T=0 months; start of inclusions;|
T=12 months; end of inclusions.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| K.L. So|
|- CONTACT for SCIENTIFIC QUERIES|| K.L. So|
|- Sponsor/Initiator ||Albert Schweitzer Ziekenhuis |
(Source(s) of Monetary or Material Support)
|Albert Schweitzer Ziekenhuis, Dordrecht , Early Sense Company, Israel|
|- Brief summary||Many hospitals introduced rapid response teams (RRT) to provide appropriate care to patients with deteriorating vital functions. Still the number of deteriorating patients, and accompanying healthcare costs, are high and can possibly be reduced by improving the process of early detection. According to care professionals, early detection is crucial to provide timely care. The objective of this single-centre randomised pilot study is to improve early detection of deteriorating patients and investigate the (cost)effectiveness od automated continuous monitoring of patients in hospital wards compared to usual intermittent nurse monitoring. The intervention is the EverOn system. 850 patients in 1 intervention ward and 850 patients in 1 control ward will be monitored. The primary outcome measure is unplanned ICU transfers, secondary outcome measures are cardiac arrests on the ward, patient mortality on the ward, number and intensity of RRT calls and perceived safety culture. An economic evaluation will provide insight into cost effectiveness of continuous automated monitoring compared to usual intermittent nurse monitoring. |
|- Main changes (audit trail)|
|- RECORD||10-jan-2013 - 20-jan-2013|