NCT02950142

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

October 25, 2016

Last Update Submit

January 17, 2020

Conditions

Diabetes MellitusHypertensionCardiovascular DiseasesFatigueAnemiaLiver DiseasesMedication MonitoringGoutChronic Kidney DiseasesLung EmbolismAcute Coronary SyndromeDiarrheaThyroid DiseasesSexually Transmitted DiseasesRheumatoid ArthritisObesityGeneral Check-up

Keywords

order setsdecision supportlaboratory testprimary care

Outcome Measures

Primary Outcomes (1)

  • Appropriateness

    number of appropriate tests for 17 study indications

    3 months

Secondary Outcomes (2)

  • Missed or delayed diagnoses

    1 year

  • Laboratory test volume

    1 year

Other Outcomes (1)

  • Downstream or cascade clinical activities

    1 year

Study Arms (2)

CPOE with order sets

EXPERIMENTAL

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

Other: CPOE with order sets for lab testing

CPOE without order sets

ACTIVE COMPARATOR

Physicians who use CPOE without order sets.

Other: CPOE without order sets for lab testing

Interventions

CPOE with order sets for lab testingOTHER

CPOE including series of recommended tests ordered per indication

Also known as: CPOE with order sets for laboratory testing
CPOE with order sets
CPOE without order sets for lab testingOTHER

CPOE only

Also known as: CPOE without order sets for laboratory testing
CPOE without order sets

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Centre for General Practice

Leuven, B-3000, Belgium

Location

Related Publications (3)

  • 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.

    PMID: 29212546BACKGROUND

  • 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.

    PMID: 35379642DERIVED

  • 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.

    PMID: 33148311DERIVED

MeSH Terms

Conditions

Diabetes MellitusHypertensionCardiovascular DiseasesFatigueAnemiaLiver DiseasesGoutRenal Insufficiency, ChronicPulmonary EmbolismAcute Coronary SyndromeDiarrheaThyroid DiseasesSexually Transmitted DiseasesArthritis, RheumatoidObesity

Interventions

Medical Order Entry Systems

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic DiseasesDigestive System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisMyocardial IschemiaHeart DiseasesSigns and Symptoms, DigestiveCommunicable DiseasesInfectionsGenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesOverweightOvernutritionNutrition DisordersBody Weight

Intervention Hierarchy (Ancestors)

Hospital Information SystemsHospital AdministrationHealth Facility AdministrationOrganization and AdministrationHealth Services AdministrationManagement Information SystemsMedical Records Systems, ComputerizedMedical RecordsRecords

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 31, 2016

Study Start

December 1, 2017

Primary Completion

June 1, 2018

Study Completion

August 1, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

IPD sharing plan not yet decided. Decision will be made upon start of trial.

Locations

BE(1)