Clinical trial NCT02950142: Evidence-based Laboratory Test Order Sets in Primary Care
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: order sets
decision support
laboratory test
primary care
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: University Ghent
name: Norwegian Institute of Public Health
name: Sciensano
First posted: 2016-10-31
Enrollment: 288
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Appropriateness
timeFrame: 3 months
Secondary outcomes:
measure: Missed or delayed diagnoses
timeFrame: 1 year
measure: Laboratory test volume
timeFrame: 1 year
Other outcomes:
measure: Downstream or cascade clinical activities
timeFrame: 1 year
Locations:
city: Leuven
country: Belgium
facility: Academic Centre for General Practice
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.