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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: The EBMeDS system; Other: Evidence Linker

• Registration Number: NCT01830569
• Lead Sponsor: KU Leuven

Brief 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.

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 Timeline

• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-12
• Study Start: 2017-03-29
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBMeDS group	Evidence Linker	The regular Evidence Linker and the EBMeDS system will be available in this group.
EBMeDS group	The EBMeDS system	The regular Evidence Linker and the EBMeDS system will be available in this group.
Control group	Evidence Linker	The regular Evidence Linker will be available in this group.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 a composite patient score.	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	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.
Pre- to post-implementation change in a composite process score.	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	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.

Trial Locations

Locations (1)

Katholieke Universiteit Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium