Evidence-based Laboratory Test Order Sets in Primary Care

NCT ID: NCT02950142

Last Updated: 2020-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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CPOE with order sets

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

Group Type EXPERIMENTAL

CPOE with order sets for lab testing

Intervention Type OTHER

CPOE including series of recommended tests ordered per indication

CPOE without order sets

Physicians who use CPOE without order sets.

Group Type ACTIVE_COMPARATOR

CPOE without order sets for lab testing

Intervention Type OTHER

CPOE only

Interventions

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CPOE with order sets for lab testing

CPOE including series of recommended tests ordered per indication

Intervention Type OTHER

CPOE without order sets for lab testing

CPOE only

Intervention Type OTHER

Other Intervention Names

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CPOE with order sets for laboratory testing CPOE without order sets for laboratory testing

Eligibility Criteria

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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

* Primary care practices where one or more physicians refuse to be enrolled will be excluded
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

Sciensano

OTHER_GOV

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Academic Centre for General Practice

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 29212546 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35379642 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33148311 (View on PubMed)

Provided Documents

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Document Type: Study Protocol: Full protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CB1611

Identifier Type: OTHER

Identifier Source: secondary_id

S59472

Identifier Type: -

Identifier Source: org_study_id

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