- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02950142
Evidence-based Laboratory Test Order Sets in Primary Care
The Effect of Evidence-based Order Sets Within a CPOE System on the Quantity and Quality of Laboratory Test Ordering in Family Practice: a Cluster Randomised Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Leuven, Belgium, B-3000
- Academic Centre for General Practice
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CPOE with order sets
Physicians who use CPOE including order sets for large range of indications.
|
CPOE including series of recommended tests ordered per indication
Other Names:
|
Active Comparator: CPOE without order sets
Physicians who use CPOE without order sets.
|
CPOE only
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appropriateness
Time Frame: 3 months
|
number of appropriate tests for 17 study indications
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Missed or delayed diagnoses
Time Frame: 1 year
|
Incidence of missed or delayed diagnoses after laboratory test
|
1 year
|
Laboratory test volume
Time Frame: 1 year
|
Total volume of ordered laboratory tests
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Downstream or cascade clinical activities
Time Frame: 1 year
|
All downstream or cascade clinical activities as a result of abnormal test result
|
1 year
|
Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Vascular Diseases
- Infections
- Communicable Diseases
- Urologic Diseases
- Endocrine System Diseases
- Disease Attributes
- Signs and Symptoms, Digestive
- Renal Insufficiency
- Embolism and Thrombosis
- Liver Diseases
- Cardiovascular Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Embolism
- Diarrhea
- Thyroid Diseases
- Acute Coronary Syndrome
- Sexually Transmitted Diseases
Other Study ID Numbers
- S59472
- CB1611 (Other Identifier: Belgian Health Care Knowledge Centre)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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