Diabetes Mellitus, Type 2NCT01830569
Impact of an Evidence-based Electronic Decision Support System on Diabetes Care
A study testing The EBMeDS system and Evidence Linker in people with Diabetes Mellitus, Type 2, run by KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the feasibility of the use of an evidence-based decision support system (EBMeDS) in daily Belgian family medicine and to study the effectiveness of EBMeDS use on improving diabetes care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- The EBMeDS system and Evidence Linker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Mar 2017to 1 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are 18 years or older.
- Patients have their electronic medical records registered by one of the included family physicians. Medical records are not centralized in Belgium. Patients are free to choose any physician, and can even see several physicians at the same time. To encourage a patient to have their medical records held by a single physician, 'Global Medical Records' werr introduced a decade ago. In return for a registration fee, patients can choose a main general practitioner who keeps their central medical records. This registration is a requirement for patient inclusion in the trial. Patients with 'Global Medical Records' are reimbursed a larger proportion of the consultation fees by the health insurance fund.
- Patients have an established diagnosis of diabetes at the baseline time point of the study (identified as having (1) an ICPC (International Classification of Primary Care) code of diabetes or (2) a prescription for a diabetes-specific or (3) the necessary labo results to confirm diabetes)
Who cannot join
- Pregnancy
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Impact of an Evidence-based Electronic Decision Support System on Diabetes Care in Family Medicine: a Cluster Randomized Controlled Trial
The purpose of this study is to assess the feasibility of the use of an evidence-based decision support system (EBMeDS) in daily Belgian family medicine and to study the effectiveness of EBMeDS use on improving diabetes care.
Read the detailed description
The purpose of this study is to assess the feasibility of the use of an evidence-based decision support system (EBMeDS) in daily Belgian family medicine and to study the effectiveness of EBMeDS use on improving diabetes care.
Specific research questions are:
- Does family physicians use the EBMeDS system in daily practice?
- Does the use of the EBMeDS system by family physicians leads to an improvement in diabetes control compared to the control group?
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- The EBMeDS system, Evidence Linker
- Keywords
- Decision Support Systems, Clinical, Evidence-Based practice, Family Practice
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The EBMeDS systemBehavioural
The EBMeDS system receives structured patient data from the electronic medical records in HealthOne and returns reminders, therapeutic suggestions and diagnosis-specific links to guidelines. Electronic forms and calculators (e.g. a calculator for glomerular filtration) are integrated in the system.
The original EBMeDS system was developed by Duodecim in Finland and covers a full spectrum of all clinical areas. Relevant reminders in all clinical areas are shown to the physicians in the intervention group.
Evidence LinkerOther
The Evidence Linker is already integrated in Belgian routine practice since 2012 and could be considered as part of the usual care process. When entering a diagnosis coded in ICPC, relevant clinical practice guidelines are retrieved by the Evidence Linker and could by consulted on the initiative of the family physician.
| Study group | Role | What they receive |
|---|---|---|
| EBMeDS group | Experimental | The regular Evidence Linker and the EBMeDS system will be available in this group. Receives: Behavioral: The EBMeDS system; Other: Evidence Linker |
| Control group | Other | The regular Evidence Linker will be available in this group. Receives: Other: Evidence Linker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- to post-implementation change in HbA1c.
Measured: Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months
Secondary outcomes (4)
Pre- to post-implementation change in cholesterol levels.
Measured: Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months
Pre- to post-implementation change in blood pressure measurements.
Measured: Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months
Pre- to post-implementation change in a composite patient score.
The composite patient score consists of reaching the evidence-based targets for glycated hemoglobin, blood pressure (systolic and diastolic) and cholesterol. Differences between pre- and post-implementation will be forming the outcomes scores.
Measured: Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months
Pre- to post-implementation change in a composite process score.
The process composite score consists of meeting the evidence-based targets of the number of blood pressure measurements, the number of laboratory results of HbA1c, cholesterol and micro-albuminuria, a prescription of statin (yes/no), if high cardiovascular risk a prescription of aspirin/clopidogrel (yes/no), if hypertension or nephropathy ACE inhibition/sartan (yes/no). Differences between pre- and post-implementation will be forming the outcomes scores.
Measured: Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study start29 Mar 2017
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bert Aertgeerts, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830569
- Sponsor's protocol ID
- S55183
- Status last verified
- Jul 2019
- First submitted
- 10 Apr 2013
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Heselmans A, Delvaux N, Laenen A, Van de Velde S, Ramaekers D, Kunnamo I, Aertgeerts B. Computerized clinical decision support system for diabetes in primary care does not improve quality of care: a cluster-randomized controlled trial. Implement Sci. 2020 Jan 7;15(1):5. doi: 10.1186/s13012-019-0955-6.
PubMed 31910877Heselmans A, Van de Velde S, Ramaekers D, Vander Stichele R, Aertgeerts B. Feasibility and impact of an evidence-based electronic decision support system for diabetes care in family medicine: protocol for a cluster randomized controlled trial. Implement Sci. 2013 Aug 5;8:83. doi: 10.1186/1748-5908-8-83.
PubMed 23915250
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Impact of an Evidence-based Electronic Decision Support System on Diabetes Care in Family Medicine: a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01830569
- Acronym / sponsor ID
- S55183
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Decision Support Systems, Clinical, Evidence-Based practice, Family Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 12 Apr 2013 (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.
The purpose of this study is to assess the feasibility of the use of an evidence-based decision support system (EBMeDS) in daily Belgian family medicine and to study the effectiveness of EBMeDS use on improving diabetes care.
Detailed description
The purpose of this study is to assess the feasibility of the use of an evidence-based decision support system (EBMeDS) in daily Belgian family medicine and to study the effectiveness of EBMeDS use on improving diabetes care.
Specific research questions are:
- Does family physicians use the EBMeDS system in daily practice?
- Does the use of the EBMeDS system by family physicians leads to an improvement in diabetes control compared to the control group?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBMeDS group | Experimental | Behavioral: The EBMeDS system, Other: Evidence LinkerThe regular Evidence Linker and the EBMeDS system will be available in this group. |
| Control group | Other | Other: Evidence LinkerThe regular Evidence Linker will be available in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients are 18 years or older.
- Patients have their electronic medical records registered by one of the included family physicians. Medical records are not centralized in Belgium. Patients are free to choose any physician, and can even see several physicians at the same time. To encourage a patient to have their medical records held by a single physician, 'Global Medical Records' werr introduced a decade ago. In return for a registration fee, patients can choose a main general practitioner who keeps their central medical records. This registration is a requirement for patient inclusion in the trial. Patients with 'Global Medical Records' are reimbursed a larger proportion of the consultation fees by the health insurance fund.
- Patients have an established diagnosis of diabetes at the baseline time point of the study (identified as having (1) an ICPC (International Classification of Primary Care) code of diabetes or (2) a prescription for a diabetes-specific or (3) the necessary labo results to confirm diabetes)
Key exclusion criteria (2 listed)
- Pregnancy
- Cognitive impairment
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 |
|---|---|---|
| The EBMeDS systemThe EBMeDS system receives structured patient data from the electronic medical records in HealthOne and returns reminders, therapeutic suggestions and diagnosis-specific links to guidelines. Electronic forms and calculators (e.g. a calculator for glomerular filtration) are integrated in the system. The original EBMeDS system was developed by Duodecim in Finland and covers a full spectrum of all clinical areas. Relevant reminders in all clinical areas are shown to the physicians in the intervention group. | Behavioural | EBMeDS group |
| Evidence LinkerThe Evidence Linker is already integrated in Belgian routine practice since 2012 and could be considered as part of the usual care process. When entering a diagnosis coded in ICPC, relevant clinical practice guidelines are retrieved by the Evidence Linker and could by consulted on the initiative of the family physician. | Other | Control group, EBMeDS group |
Primary outcome
Pre- to post-implementation change in HbA1c.
Time frame: Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months
4 secondary outcomes
Pre- to post-implementation change in cholesterol levels.
Time frame: Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months
Pre- to post-implementation change in blood pressure measurements.
Time frame: Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months
Pre- to post-implementation change in a composite patient score.
Time frame: Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months
Pre- to post-implementation change in a composite process score.
Time frame: Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 months
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 16 Jul 2019.
- Derived from this study: PubMed 31910877Heselmans A, Delvaux N, Laenen A, Van de Velde S, Ramaekers D, Kunnamo I, Aertgeerts B. Computerized clinical decision support system for diabetes in primary care does not improve quality of care: a cluster-randomized controlled trial. Implement Sci. 2020 Jan 7;15(1):5. doi: 10.1186/s13012-019-0955-6.
- Derived from this study: PubMed 23915250Heselmans A, Van de Velde S, Ramaekers D, Vander Stichele R, Aertgeerts B. Feasibility and impact of an evidence-based electronic decision support system for diabetes care in family medicine: protocol for a cluster randomized controlled trial. Implement Sci. 2013 Aug 5;8:83. doi: 10.1186/1748-5908-8-83.
- Individual participant dataSharing planned: Yes
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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 The EBMeDS system and Evidence Linker in people with Diabetes Mellitus, Type 2, run by 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 3 inclusion and 2 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 16 Jul 2019. 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?
Pre- to post-implementation change in HbA1c. (time frame: Outcome will be collected at five points in time: before the start of the study, at 3 months, at 6 months, at 9 months and at 12 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 NCT01830569, which also lists 2 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 16 Jul 2019.