|- candidate number||13206|
|- NTR Number||NTR3570|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-aug-2012|
|- Secondary IDs||W11_151# 11.17.0990 / IJ.154.001; METC / AMR|
|- Public Title||Improving stroke prevention in atrial fibrillation.|
|- Scientific Title||Decision-Support for improving adherence to Dutch general practitioner guidelines for stroke prevention in atrial fibrillation.|
|- hypothesis||The use of a decision support system will increase adherence to the GP guideline for atrial fibrillation in terms of accurate antithrombotic treatment for stroke prevention.|
General Practitioners have informal reasons for not prescribing indicated oral anricoagulation.
|- Healt Condition(s) or Problem(s) studied||Atrial Fibrillation, Prevention, Stroke, Coumarin|
|- Inclusion criteria||Patients: All patients with atrial fibrillation enlisted in general practitice.
Physicians: All primary care physicians in the GAZO centers and other GPs, consenting in participation.
|- Exclusion criteria||N/A|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-okt-2012|
|- planned closingdate||31-dec-2013|
|- Target number of participants||500|
|- Interventions||Decision support messages that alert the physician about issues with the antithrombotic treatment used for their current patient (active on screen). Positive feedback when current treatment is according to the Dutch NHG guideline.
The system will show messages which are generated on a remote server using information that is available about the on-screen patient. The system will show a small message, which can be expanded to a larger report which includes the detailed advice and reasons for the advice.
We will use the three arms:
1. Arm 1 will be the control group and will receive no messages;
2. Arm 2 receives messages but will not be obliged to answer and can ignore messages without giving an explanation;
3. Arm 3 will be able to ignore messages but when GPs do they will be required to provide a reason. They cannot continue with other patients before they provide a reason. This way we hope to gather data on reasons GPs have to deviate from the guideline.
|- Primary outcome||The proportion of patients with non-valvular atrial fibrillation whose anti-thrombotic treatment prescription is in accordance with the Dutch NHG guideline.|
|- Secondary outcome||Reasons GPs report to deviate from the given advice (/guideline).|
|- Timepoints||Measurements are automatically made at each trigger moment. We will measure adherence at end of study.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Diederick L. Arts|
|- CONTACT for SCIENTIFIC QUERIES|| Diederick L. Arts|
|- Sponsor/Initiator ||Academic Medical Center (AMC)|
(Source(s) of Monetary or Material Support)
|- Brief summary||A decision support system will be implemented in the general practitioners EMR. This system will alert the GP about the antithrombotic treatment used as stroke prevention for patients with atrial fibrillation. The system will evaluate several parameters using the Dutch GP guideline for atrial fibrillation. Advice will be presented as a small message that can be expanded to a complete report. GPs may choose to ignore the message. We will use three arms in our study, the first arm receives no messages, the second will receive messages which can be ignored immediately, the third will be required to provide explanation when the message is ignored.
Our main outcomes will be the percentage of anti-thrombotic prescriptions in patients with atrial fibrillation according to the Dutch guideline and reasons GPs give to deviate from the guideline.
|- Main changes (audit trail)|
|- RECORD||7-aug-2012 - 3-sep-2012|