Back to resultsImpact of an Evidence-based Electronic Decision Support System on Diabetes Care
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
The EBMeDS system
Evidence Linker
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Decision Support Systems, Clinical, Evidence-Based practice, Family Practice
Eligibility Criteria
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
Sites / Locations
- Katholieke Universiteit Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
EBMeDS group
Control group
Arm Description
The regular Evidence Linker and the EBMeDS system will be available in this group.
The regular Evidence Linker will be available in this group.
Outcomes
Primary Outcome Measures
Pre- to post-implementation change in HbA1c.
Secondary Outcome Measures
Pre- to post-implementation change in cholesterol levels.
Pre- to post-implementation change in blood pressure measurements.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01830569
Brief Title
Impact of an Evidence-based Electronic Decision Support System on Diabetes Care
Official Title
Feasibility and Impact of an Evidence-based Electronic Decision Support System on Diabetes Care in Family Medicine: a Cluster Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Decision Support Systems, Clinical, Evidence-Based practice, Family Practice
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EBMeDS group
Arm Type
Experimental
Arm Description
The regular Evidence Linker and the EBMeDS system will be available in this group.
Arm Title
Control group
Arm Type
Other
Arm Description
The regular Evidence Linker will be available in this group.
Intervention Type
Behavioral
Intervention Name(s)
The EBMeDS system
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Evidence Linker
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Pre- to post-implementation change in a composite patient score.
Description
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.
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
Title
Pre- to post-implementation change in a composite process score.
Description
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.
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
Other Pre-specified Outcome Measures:
Title
Actual use of the EBMeDS system
Description
Scripts are automatically triggered, users can see that a script is available from their main screen but have to click before seeing the script content. As such, click events can give an indication of physicians' interest to use the system. Following data of actual use are collected in the log file: the percentage of triggered scripts that are opened, the type of scripts that are opened (reminder, interaction, contraindication, drugs to avoid, indication or GuidelineLink), the number of requests to open the details of the script or the script information.
Time Frame
Outcomes 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Katholieke Universiteit Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
31910877
Citation
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.
Results Reference
derived
PubMed Identifier
23915250
Citation
Heselmans 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.
Results Reference
derived
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Impact of an Evidence-based Electronic Decision Support System on Diabetes Care
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