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| ID | Type | Description | Link |
|---|---|---|---|
| CB1611 | Other Identifier | Belgian Health Care Knowledge Centre |
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| Name | Class |
|---|---|
| KU Leuven | OTHER |
| University Ghent | OTHER |
| Norwegian Institute of Public Health | OTHER_GOV |
| Sciensano |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPOE with order sets | Experimental | Physicians who use CPOE including order sets for large range of indications. |
|
| CPOE without order sets | Active Comparator | Physicians who use CPOE without order sets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPOE with order sets for lab testing | Other | CPOE including series of recommended tests ordered per indication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Appropriateness | number of appropriate tests for 17 study indications | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Missed or delayed diagnoses | Incidence of missed or delayed diagnoses after laboratory test | 1 year |
| Laboratory test volume | Total volume of ordered laboratory tests |
| Measure | Description | Time Frame |
|---|---|---|
| Downstream or cascade clinical activities | All downstream or cascade clinical activities as a result of abnormal test result | 1 year |
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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Centre for General Practice | Leuven | B-3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29212546 | Background | 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. | |
| 35379642 | Derived |
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IPD sharing plan not yet decided. Decision will be made upon start of trial.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Full protocol | Aug 7, 2017 | Jan 13, 2020 |
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| OTHER_GOV |
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| CPOE without order sets for lab testing | Other | CPOE only |
|
|
| 1 year |
| 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. |
| 33148311 | Derived | 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. |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2019 | Jan 13, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| D005221 | Fatigue |
| D000740 | Anemia |
| D008107 | Liver Diseases |
| D006073 | Gout |
| D051436 | Renal Insufficiency, Chronic |
| D011655 | Pulmonary Embolism |
| D054058 | Acute Coronary Syndrome |
| D003967 | Diarrhea |
| D013959 | Thyroid Diseases |
| D012749 | Sexually Transmitted Diseases |
| D001172 | Arthritis, Rheumatoid |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D004066 | Digestive System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D050316 | Medical Order Entry Systems |
| ID | Term |
|---|---|
| D006751 | Hospital Information Systems |
| D006739 | Hospital Administration |
| D058016 | Health Facility Administration |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D008331 | Management Information Systems |
| D016347 | Medical Records Systems, Computerized |
| D008499 | Medical Records |
| D011996 | Records |
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