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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: The EBMeDS system; Other: Evidence Linker

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Katholieke Universiteit Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EBMeDS group; The regular Evidence Linker and the EBMeDS system will be available in this group.	Behavioral: The EBMeDS system; 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.; Other: Evidence Linker; 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.
Other: Control group; The regular Evidence Linker will be available in this group.	Other: Evidence Linker; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actual use of the EBMeDS system	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.	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

Collaborators and Investigators

• Sponsor: KU Leuven

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (Estimate): April 12, 2013

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Family Practice; Decision Support Systems, Clinical; Evidence-Based practice
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: S55183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No