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Completed

NCT Number: NCT02950142

Evidence-based Laboratory Test Order Sets in Primary Care

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.

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Key information

Conditions

Diabetes Mellitus Acute Coronary Syndrome Anemia Arthritis Arthritis, Rheumatoid Autoimmune Diseases Body Weight Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Crystal Arthropathies Diarrhea Digestive System Diseases Disease Attributes Embolism Embolism and Thrombosis Endocrine System Diseases Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications General Check-up Genetic Diseases, Inborn Genital Diseases Glucose Metabolism Disorders Gout Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypertension Immune System Diseases Infections Joint Diseases Kidney Diseases Liver Diseases Lung Diseases Lung Embolism Male Urogenital Diseases Medication Monitoring Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Myocardial Ischemia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Purine-Pyrimidine Metabolism, Inborn Errors Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Rheumatic Diseases Rheumatoid Arthritis Sexually Transmitted Diseases Signs and Symptoms Signs and Symptoms, Digestive Skin and Connective Tissue Diseases Thyroid Diseases Urogenital Diseases Urologic Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Centre for General Practice

Leuven, B-3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPOE with order sets for lab testing

Other

CPOE including series of recommended tests ordered per indication

Other names: CPOE with order sets for laboratory testing

CPOE without order sets for lab testing

Other

CPOE only

Other names: CPOE without order sets for laboratory testing

Primary outcomes

  1. Appropriateness

    Time frame: 3 months

    number of appropriate tests for 17 study indications

Secondary outcomes

  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 outcomes

  1. Downstream or cascade clinical activities

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven
  • Norwegian Institute of Public Health
  • Sciensano
  • University Ghent

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 31, 2016
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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