KCE16011: The effect of evidence-based decision support for ordering laboratory tests in family practice: a cluster randomised trial - ELMO

Lay summary (French or Dutch)

General practitioners (GP’s) often order laboratory tests for their patients. They do this to find diseases, to evaluate (side-)effects of treatments or measure the progression of a condition. GP’s are confronted with more complex care decisions due to an increase in the amount of chronic illnesses, more frequent use of multiple drugs increasing the risk of interactions, and the increase in the amount of laboratory tests. This makes it more difficult to order the most appropriate tests for each patient. Sometimes unnecessary tests are ordered which can lead to results of unknown significance. This in turn can cause unnecessary anxiety and often leads to further testing and costs. On the other hand, some necessary tests may not be ordered, possibly delaying the diagnosis of important conditions or diseases. GP’s order laboratory tests by marking each desired test on a request form, quite often on paper. Based on the reason(s) why the GP orders laboratory tests (the disease to diagnose or follow-up) we will propose necessary tests within a computerised request form. We want to evaluate what influence this new way of ordering laboratory tests has on laboratory test ordering behaviour of GPs.

Trials description

The effect of evidence-based order sets within a CPOE (computerised physician order entry) system on the quantity and quality of laboratory test ordering in family practice: a cluster randomised trial (KCE-16011)

Participants (P)

Patients from primary care physicians (GPs) affiliated to one of three collaborating laboratories in the Leuven, Ghent or Antwerp regions

Intervention (I)

Evidence-based order sets for laboratory tests based on indication, implemented within a computerised physician order entry (CPOE) system

Control (C)

CPOE without evidence-based laboratory test order sets

Outcome (O)

Percentage of appropriate laboratory tests, volume of tests ordered, percentage of missed diagnoses.

Trial Design

Cluster randomised controlled trial

Sample Size

300 physicians randomized, data collected for 12 000 patients

Trial duration

2 years


1.8 million € (incl. VAT)


Closed - follow up complete


Trial team


UZ Leuven – KU Leuven

Chief Investigator

Prof Dr Bert Aertgeerts,
Academic Center for General Practice, KU Leuven

Trial coordinator

Dr Nicolas Delvaux,
Academic Center for General Practice, KU Leuven

External Partners

Prof Dr An De Sutter,
Department of Family Medicine and Primary Health Care,
Ghent University

Scientific Institute of Public Health

Laboratory Anacura, Evergem

Medisch Centrum Huisartsen (MCH), Leuven

Algemeen Medisch Labo (AML), Antwerpen

Protocol published
  Linkage of data methods
Report 30/03/2020

Summary results Results


Webpage: www.elmostudy.be

ClinicalTrials.gov: NCT02950142



Funding scheme

Commissioning workstream 2016

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