Evidence-based Laboratory Test Order Sets in Primary Care

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950142
• Other study ID #: S59472
• Secondary ID: CB1611
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: January 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: August 1, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Anemia
• Cardiovascular Diseases
• Chronic Kidney Diseases
• Diabetes Mellitus
• Diarrhea
• Embolism
• Fatigue
• General Check-up
• Gout
• Hypertension
• Kidney Diseases
• Liver Diseases
• Lung Embolism
• Medication Monitoring
• Obesity
• Renal Insufficiency, Chronic
• Rheumatoid Arthritis
• Sexually Transmitted Diseases
• Thyroid Diseases

Intervention

Other:
• CPOE with order sets for lab testing
CPOE including series of recommended tests ordered per indication
• CPOE without order sets for lab testing
CPOE only

Locations

Country	Name	City	State
Belgium	Academic Centre for General Practice	Leuven

Sponsors (5)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	KU Leuven, Norwegian Institute of Public Health, Sciensano, University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Downstream or cascade clinical activities	All downstream or cascade clinical activities as a result of abnormal test result	1 year
Primary	Appropriateness	number of appropriate tests for 17 study indications	3 months
Secondary	Missed or delayed diagnoses	Incidence of missed or delayed diagnoses after laboratory test	1 year
Secondary	Laboratory test volume	Total volume of ordered laboratory tests	1 year