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Completed

NCT Number: NCT01830569

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Katholieke Universiteit Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The EBMeDS system

Behavioral

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 Linker

Other

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 outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

    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.

  4. 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

    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.

Other outcomes

  1. Actual use of the EBMeDS system

    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

    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.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 12, 2013
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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