Diabetes MellitusNCT02950142
Evidence-based Laboratory Test Order Sets in Primary Care
A study testing CPOE with order sets for lab testing and CPOE without order sets for lab testing in people with Diabetes Mellitus and Hypertension, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Cardiovascular Diseases
- What is being tested?
- CPOE with order sets for lab testing and CPOE without order sets for lab testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2017to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Primary care practices where one or more physicians refuse to be enrolled will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Hypertension, Cardiovascular Diseases, Fatigue, Anemia, Liver Diseases
- Being tested
- CPOE with order sets for lab testing, CPOE without order sets for lab testing
- Keywords
- order sets, decision support, laboratory test, primary care
- Medical subject headings
- Diabetes Mellitus, Hypertension, Cardiovascular Diseases, Fatigue, Anemia, Liver Diseases, Gout, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPOE with order sets for lab testingOther
Also called CPOE with order sets for laboratory testing
CPOE including series of recommended tests ordered per indication
CPOE without order sets for lab testingOther
Also called CPOE without order sets for laboratory testing
CPOE only
| Study group | Role | What they receive |
|---|---|---|
| CPOE with order sets | Experimental | Physicians who use CPOE including order sets for large range of indications. Receives: Other: CPOE with order sets for lab testing |
| CPOE without order sets | Active comparator | Physicians who use CPOE without order sets. Receives: Other: CPOE without order sets for lab testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriateness
number of appropriate tests for 17 study indications
Measured: 3 months
Secondary outcomes (2)
Missed or delayed diagnoses
Incidence of missed or delayed diagnoses after laboratory test
Measured: 1 year
Laboratory test volume
Total volume of ordered laboratory tests
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start1 Dec 2017
- Primary completion1 Jun 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, University Ghent, Norwegian Institute of Public Health, Sciensano
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950142
- Sponsor's protocol ID
- S59472
- Other IDs
- CB1611
- Status last verified
- Jan 2020
- First submitted
- 25 Oct 2016
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing plan not yet decided. Decision will be made upon start of trial.
Publications
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.
PubMed 29212546Piessens 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.
PubMed 35379642Delvaux 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.
PubMed 33148311
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02950142
- Acronym / sponsor ID
- S59472
- Conditions
- Diabetes Mellitus, Hypertension, Cardiovascular Diseases, Fatigue, Anemia, Liver Diseases
- Keywords
- order sets, decision support, laboratory test, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven, University Ghent, Norwegian Institute of Public Health, Sciensano
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPOE with order sets | Experimental | Other: CPOE with order sets for lab testingPhysicians who use CPOE including order sets for large range of indications. |
| CPOE without order sets | Active comparator | Other: CPOE without order sets for lab testingPhysicians who use CPOE without order sets. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (1 listed)
- Primary care practices where one or more physicians refuse to be enrolled will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPOE with order sets for lab testingAlso: CPOE with order sets for laboratory testingCPOE including series of recommended tests ordered per indication | Other | CPOE with order sets |
| CPOE without order sets for lab testingAlso: CPOE without order sets for laboratory testingCPOE only | Other | CPOE without order sets |
Primary outcome
Appropriateness
Time frame: 3 months
number of appropriate tests for 17 study indications
2 secondary outcomes
Missed or delayed diagnoses
Time frame: 1 year
Laboratory test volume
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Background: PubMed 29212546Delvaux 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.
- Derived from this study: PubMed 35379642Piessens 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.
- Derived from this study: PubMed 33148311Delvaux 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.
- Individual participant dataSharing planned: No. IPD sharing plan not yet decided. Decision will be made upon start of trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPOE with order sets for lab testing and CPOE without order sets for lab testing in people with Diabetes Mellitus and Hypertension, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriateness (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02950142, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.