Evidence-based Laboratory Test Order Sets in Primary Care

January 17, 2020 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, B-3000
        • Academic Centre for General Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriateness
Time Frame: 3 months
number of appropriate tests for 17 study indications
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Missed or delayed diagnoses
Time Frame: 1 year
Incidence of missed or delayed diagnoses after laboratory test
1 year
Laboratory test volume
Time Frame: 1 year
Total volume of ordered laboratory tests
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Downstream or cascade clinical activities
Time Frame: 1 year
All downstream or cascade clinical activities as a result of abnormal test result
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Norwegian Institute of Public Health
KU Leuven
University Ghent
Sciensano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S59472
  • CB1611 (Other Identifier: Belgian Health Care Knowledge Centre)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD sharing plan not yet decided. Decision will be made upon start of trial.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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