|- candidate number||21117|
|- NTR Number||NTR5002|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-dec-2014|
|- Secondary IDs||N/A |
|- Public Title||Improving antithrombotic treatment in atrial fibrillation|
|- Scientific Title||Clinical Decision Support System for improving adherence to ESC guidelines for antithrombotic treatment in atrial fibrillation|
|- hypothesis||The use of a clinical decision support system will increase adherence to the ESC guideline for atrial fibrillation in terms of calculation of CHA2DS2-VASc score and HAS-BLED score, and the resulting accurate antithrombotic treatment.
|- Healt Condition(s) or Problem(s) studied||Atrial Fibrillation, Prevention, Ischemic stroke|
|- Inclusion criteria||Patients: All patients with atrial fibrillation visisting one of the three selected hospitals in the Netherlands.
Physicians: All cardiologists working in one of the three selected hospitals in the Netherlands (Franciscus Ziekenhuis Roosendaal, Lievensberg Ziekenhuis Bergen op Zoom, and Beatrixziekenhuis Gornichem). |
|- Exclusion criteria||N/A|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2015|
|- planned closingdate||1-jul-2015|
|- Target number of participants||0|
|- Interventions||A clinical decision support system integrated in the electronic health record (EHR) of the patient, that calculates the CHA2DS2-VASc score and HAS-BLED score based on the patient information stored in the EHR, and advises the physician regarding the antithrombotic treatment strategy to be followed, based on the ESC guidelines for atrial fibrillation.
Two study arms will be used: An intervention group which received the clinical decision support system, integrated in the EHR, and a control group using the same EHR but without the clinical decision support system. |
|- Primary outcome||The proportion of patients with non-valvular atrial fibrillation whose anti-thrombotic treatment prescription is in accordance with the ESC guideline for atrial fibrillation.|
|- Secondary outcome||N/A|
|- Timepoints||Adherence will be measured at the end of the study. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| R.J. van Brummelen|
|- CONTACT for SCIENTIFIC QUERIES|| R.J. van Brummelen|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||A clinical decision support system will be implemented in three hospitals in the Netherlands, integrated in the electronic health record. This system will alert the cardiologist about the CHA2DS2-VASc score and HAS-BLED score of a patient with atrial fibrillation, and suggests antithrombotic treatment based don the ESC guideline for atrial fibrillation.
Two study arms will be used: an intervention arm using the EHR with the clinical decision support system, the control group with the same EHR, but without the clinical decision support system.
The main outcomes will be the percentage of anti-thrombotic prescriptions in patients with atrial fibrillation according to the Dutch guideline.|
|- Main changes (audit trail)|
|- RECORD||5-dec-2014 - 3-apr-2015|