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Evidence-based Laboratory Test Order Sets in Primary Care

Primary Purpose

Diabetes Mellitus, Hypertension, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CPOE with order sets for lab testing
CPOE without order sets for lab testing
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus focused on measuring order sets, decision support, laboratory test, primary care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Academic Centre for General Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CPOE with order sets

CPOE without order sets

Arm Description

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

Physicians who use CPOE without order sets.

Outcomes

Primary Outcome Measures

Appropriateness
number of appropriate tests for 17 study indications

Secondary Outcome Measures

Missed or delayed diagnoses
Incidence of missed or delayed diagnoses after laboratory test
Laboratory test volume
Total volume of ordered laboratory tests

Full Information

First Posted
October 25, 2016
Last Updated
January 17, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, University Ghent, Norwegian Institute of Public Health, Sciensano
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1. Study Identification

Unique Protocol Identification Number
NCT02950142
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, University Ghent, Norwegian Institute of Public Health, Sciensano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPOE with order sets
Arm Type
Experimental
Arm Description
Physicians who use CPOE including order sets for large range of indications.
Arm Title
CPOE without order sets
Arm Type
Active Comparator
Arm Description
Physicians who use CPOE without order sets.
Intervention Type
Other
Intervention Name(s)
CPOE with order sets for lab testing
Other Intervention Name(s)
CPOE with order sets for laboratory testing
Intervention Description
CPOE including series of recommended tests ordered per indication
Intervention Type
Other
Intervention Name(s)
CPOE without order sets for lab testing
Other Intervention Name(s)
CPOE without order sets for laboratory testing
Intervention Description
CPOE only
Primary Outcome Measure Information:
Title
Appropriateness
Description
number of appropriate tests for 17 study indications
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Missed or delayed diagnoses
Description
Incidence of missed or delayed diagnoses after laboratory test
Time Frame
1 year
Title
Laboratory test volume
Description
Total volume of ordered laboratory tests
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Downstream or cascade clinical activities
Description
All downstream or cascade clinical activities as a result of abnormal test result
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Academic Centre for General Practice
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD sharing plan not yet decided. Decision will be made upon start of trial.
Citations:
PubMed Identifier
29212546
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.
Results Reference
background
PubMed Identifier
35379642
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.
Results Reference
derived
PubMed Identifier
33148311
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.
Results Reference
derived

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Evidence-based Laboratory Test Order Sets in Primary Care

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