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CompletedNCT02950142Updated Jan 23, 2020

Evidence-based Laboratory Test Order Sets in Primary Care

An interventional study of CPOE with order sets for lab testing and CPOE without order sets for lab testing in Diabetes Mellitus, Hypertension and Cardiovascular Diseases, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
288
Allocation
Randomized
Sex
All
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Study summary

Cluster randomised controlled trial to evaluate what the effect is of evidence-based order sets aimed at five indications on the appropriateness of laboratory test ordering in primary care.

Read the detailed description

Cluster randomised controlled trial in Belgian primary care practices. Participants will be primary care physicians working in primary care practices affiliated to one of three collaborating laboratories in the Leuven, Ghent or Antwerp regions.

Primary care practices will be allocated and randomized to either the intervention or control group. Physicians in PCPs randomized to the intervention will be offered order sets based on indication when using the CPOE for ordering laboratory tests. The effect of order sets will be analyzed for 17 common indications for ordering laboratory tests in Belgian primary care: diabetes mellitus, hypertension, cardiovascular disease, general check-up, unexplained fatigue, anemia, liver pathology, medication monitoring, gout, chronic kidney disease, lung embolism, acute coronary syndrome, diarrhea, thyroid disease, sexually transmitted disease, rheumatoid arthritis and obesity.

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Conditions studied

  • Diabetes Mellitus
  • Hypertension
  • Cardiovascular Diseases
  • Fatigue
  • Anemia
  • Liver Diseases
  • Medication Monitoring
  • Gout
  • Chronic Kidney Diseases
  • Lung Embolism
  • Acute Coronary Syndrome
  • Diarrhea
  • Thyroid Diseases
  • Sexually Transmitted Diseases
  • Rheumatoid Arthritis
  • Obesity
  • General Check-up

Keywords

  • order sets
  • decision support
  • laboratory test
  • primary care
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In context

Sexually Transmitted Diseases

424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.

This study's enrollment of 288 is below the median of 470 across 346 interventional studies indexed under Sexually Transmitted Diseases.

Browse Sexually Transmitted Diseases studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Primary care practices will be considered eligible if all the physicians active in the practice agree to be involved in the study
  • All family physicians will be considered eligible if they:

    • Collaborate with either MCH, Anacura or AML for their laboratory test orders
    • Agree to use the online CPOE for their laboratory test orders
    • Use a computerized EHR for patient care
    • Agree to the terms in the informed consent

Exclusion criteria

Exclusion Criteria:

  • Primary care practices where one or more physicians refuse to be enrolled will be excluded
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
288 participants (actual)

Study arms

  • Experimental
    CPOE with order sets

    Physicians who use CPOE including order sets for large range of indications.

    Other: CPOE with order sets for lab testing

  • Active comparator
    CPOE without order sets

    Physicians who use CPOE without order sets.

    Other: CPOE without order sets for lab testing

Interventions

  • OtherCPOE with order sets for lab testing

    CPOE including series of recommended tests ordered per indication

    Also known as: CPOE with order sets for laboratory testing

  • OtherCPOE without order sets for lab testing

    CPOE only

    Also known as: CPOE without order sets for laboratory testing

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What researchers measure

Primary outcomes

  1. Appropriateness

    number of appropriate tests for 17 study indications

    Time frame: 3 months

Secondary outcomes

  1. Missed or delayed diagnoses

    Incidence of missed or delayed diagnoses after laboratory test

    Time frame: 1 year

  2. Laboratory test volume

    Total volume of ordered laboratory tests

    Time frame: 1 year

Other outcomes

  1. Downstream or cascade clinical activities

    All downstream or cascade clinical activities as a result of abnormal test result

    Time frame: 1 year

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Study locations

1 site
  • Academic Centre for General Practice
    Leuven, B-3000, Belgium
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References and documents

Publications

  • Delvaux N, De Sutter A, Van de Velde S, Ramaekers D, Fieuws S, Aertgeerts B. Electronic Laboratory Medicine ordering with evidence-based Order sets in primary care (ELMO study): protocol for a cluster randomised trial. Implement Sci. 2017 Dec 6;12(1):147. doi: 10.1186/s13012-017-0685-6. PubMed 29212546 ↗
  • Piessens V, Delvaux N, Heytens S, Aertgeerts B, De Sutter A. Downstream activities after laboratory testing in primary care: an exploratory outcome of the ELMO cluster randomised trial (Electronic Laboratory Medicine Ordering with evidence-based order sets in primary care). BMJ Open. 2022 Apr 4;12(4):e059261. doi: 10.1136/bmjopen-2021-059261. PubMed 35379642 ↗
  • Delvaux N, Piessens V, Burghgraeve T, Mamouris P, Vaes B, Stichele RV, Cloetens H, Thomas J, Ramaekers D, Sutter A, Aertgeerts B. Clinical decision support improves the appropriateness of laboratory test ordering in primary care without increasing diagnostic error: the ELMO cluster randomized trial. Implement Sci. 2020 Nov 4;15(1):100. doi: 10.1186/s13012-020-01059-y. PubMed 33148311 ↗

Study documents

  • Study protocol · Aug 7, 2017
  • Statistical analysis plan · Jul 18, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — IPD sharing plan not yet decided. Decision will be made upon start of trial.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02950142
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, University Ghent, Norwegian Institute of Public Health, Sciensano
Responsible party
Sponsor
First posted
Oct 31, 2016
Start date
Dec 1, 2017
Primary completion
Jun 1, 2018
Completion
Aug 1, 2019
Last update
Jan 23, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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