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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02950142
Other study ID # S59472
Secondary ID CB1611
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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