Impact of an Evidence-based Electronic Decision Support System on Diabetes Care

Study Overview
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Brief Summary
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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
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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?

Official Title
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Feasibility and Impact of an Evidence-based Electronic Decision Support System on Diabetes Care in Family Medicine: a Cluster Randomized Controlled Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: The EBMeDS system
* Other: Evidence Linker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Pregnancy Cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EBMeDS group<br>The regular Evidence Linker and the EBMeDS system will be available in this group. | Behavioral: The EBMeDS system<br>* 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.<br>Other: Evidence Linker<br>* 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.<br>|
| Other: Control group<br>The regular Evidence Linker will be available in this group. | Other: Evidence Linker<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre- to post-implementation change in HbA1c. |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre- to post-implementation change in cholesterol levels. |  | 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. |  | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision Support Systems, Clinical, Evidence-Based practice, Family Practice