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Evidence-based Laboratory Test Order Sets in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02950142
Recruitment Status : Active, not recruiting
First Posted : October 31, 2016
Last Update Posted : October 11, 2018
KU Leuven
University Ghent
Norwegian Institute of Public Health
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
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 Other: CPOE with order sets for lab testing Other: CPOE without order sets for lab testing Not Applicable

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : June 1, 2018
Estimated Study Completion Date : October 1, 2020

Arm Intervention/treatment
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
CPOE including series of recommended tests ordered per indication
Other Name: CPOE with order sets for laboratory testing

Active Comparator: CPOE without order sets
Physicians who use CPOE without order sets.
Other: CPOE without order sets for lab testing
CPOE only
Other Name: CPOE without order sets for laboratory testing

Primary Outcome Measures :
  1. Appropriateness [ Time Frame: 3 months ]
    number of appropriate tests for 17 study indications

Secondary Outcome Measures :
  1. Missed or delayed diagnoses [ Time Frame: 1 year ]
    Incidence of missed or delayed diagnoses after laboratory test

  2. Laboratory test volume [ Time Frame: 1 year ]
    Total volume of ordered laboratory tests

Other Outcome Measures:
  1. Downstream or cascade clinical activities [ Time Frame: 1 year ]
    All downstream or cascade clinical activities as a result of abnormal test result

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02950142

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Academic Centre for General Practice
Leuven, Belgium, B-3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
University Ghent
Norwegian Institute of Public Health

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT02950142     History of Changes
Other Study ID Numbers: S59472
CB1611 ( Other Identifier: Belgian Health Care Knowledge Centre )
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD sharing plan not yet decided. Decision will be made upon start of trial.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
order sets
decision support
laboratory test
primary care
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Liver Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Acute Coronary Syndrome
Thyroid Diseases
Cardiovascular Diseases
Vascular Diseases
Urologic Diseases
Renal Insufficiency
Signs and Symptoms
Digestive System Diseases
Myocardial Ischemia
Heart Diseases
Signs and Symptoms, Digestive
Embolism and Thrombosis
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Endocrine System Diseases