Evidence-based Laboratory Test Order Sets in Primary Care

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Completed

CT.gov ID

NCT02950142

Collaborator

KU Leuven (Other), University Ghent (Other), Norwegian Institute of Public Health (Other), Sciensano (Other)

288

Enrollment

Location

Arms

Actual Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: CPOE with order sets for lab testing Other: CPOE without order sets for lab testing	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

288 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Dec 1, 2017

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPOE with order sets Physicians who use CPOE including order sets for large range of indications.	Other: CPOE with order sets for lab testing CPOE including series of recommended tests ordered per indication Other Names: CPOE with order sets for laboratory testing
Active Comparator: CPOE without order sets Physicians who use CPOE without order sets.	Other: CPOE without order sets for lab testing CPOE only Other Names: CPOE without order sets for laboratory testing

Arm

Intervention/Treatment

Experimental: CPOE with order sets

Physicians who use CPOE including order sets for large range of indications.

Other: CPOE with order sets for lab testing

CPOE including series of recommended tests ordered per indication

Other Names:

CPOE with order sets for laboratory testing

Active Comparator: CPOE without order sets

Physicians who use CPOE without order sets.

Other: CPOE without order sets for lab testing

CPOE only

Other Names:

CPOE without order sets for laboratory testing

Outcome Measures

Primary Outcome Measures

Appropriateness [3 months]
number of appropriate tests for 17 study indications

Secondary Outcome Measures

Missed or delayed diagnoses [1 year]
Incidence of missed or delayed diagnoses after laboratory test
Laboratory test volume [1 year]
Total volume of ordered laboratory tests

Other Outcome Measures

Downstream or cascade clinical activities [1 year]
All downstream or cascade clinical activities as a result of abnormal test result

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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