Electronic Laboratory Medicine ordering with evidence-based Order sets in primary care (ELMO study): protocol for a cluster randomised trial

Nicolas Delvaux, An De Sutter, Stijn Van de Velde, Dirk Ramaekers, Steffen Fieuws, Bert Aertgeerts, Nicolas Delvaux, An De Sutter, Stijn Van de Velde, Dirk Ramaekers, Steffen Fieuws, Bert Aertgeerts

Abstract

Background: Laboratory testing is an important clinical act with a valuable role in screening, diagnosis, management and monitoring of diseases or therapies. However, inappropriate laboratory test ordering is frequent, burdening health care spending and negatively influencing quality of care. Inappropriate tests may also result in false-positive results and potentially cause excessive downstream activities. Clinical decision support systems (CDSSs) have shown promising results to influence the test-ordering behaviour of physicians and to improve appropriateness. Order sets, a form of CDSS where a limited set of evidence-based tests are proposed for a series of indications, integrated in a computerised physician order entry (CPOE) have been shown to be effective in reducing the volume of ordered laboratory tests but convincing evidence that they influence appropriateness is lacking. The aim of this study is to evaluate the effect of order sets on the quality and quantity of laboratory test orders by physicians. We also aim to evaluate the effect of order sets on diagnostic error and explore the effect on downstream or cascade activities.

Methods: We will conduct a cluster randomised controlled trial in Belgian primary care practices. The study is powered to measure two outcomes. We will primarily measure the influence of our CDSS on the appropriateness of laboratory test ordering. Additionally, we will also measure the influence on diagnostic error. We will also explore the effects of our intervention on cascade activities due to altered results of inappropriate tests.

Discussion: We have designed a study that should be able to demonstrate whether the CDSS aimed at diagnostic testing is not only able to influence appropriateness but also safe with respect to diagnostic error. These findings will influence a lager, nationwide implementation of this CDSS.

Trial registration: ClinicalTrials.gov, NCT02950142 .

Conflict of interest statement

Ethics approval and consent to participate

Before the start of the study, we will propose a research agreement to the physicians that stipulates the trial objectives and the formalities on data collection. Study physicians will seek informed consent from all patients for whom laboratory tests are ordered for one or more of the 17 study indications. Only data from patients who consent to the terms of the informed consent form will be included in the study.

Ethics committee approval for this study was obtained from the University Hospital Leuven Medical Ethics Committee on 26 July 2017. Additional authorisation for the use of medical and personal data was requested from the Commission for the Protection of Privacy Sector Committee Health.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow of the study including data collection points, assessments and reports. EHR: electronic health record

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Source: PubMed

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