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

Sponsor
KU Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT01830569
Collaborator
(none)
45
1
2
25.1
1.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The EBMeDS system
  • Other: Evidence Linker
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Feasibility and Impact of an Evidence-based Electronic Decision Support System on Diabetes Care in Family Medicine: a Cluster Randomized Controlled Trial
Actual Study Start Date :
Mar 29, 2017
Actual Primary Completion Date :
May 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

  2. 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]

  3. 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.

  4. 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.

Other Outcome Measures

  1. Actual use of the EBMeDS system [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Katholieke Universiteit Leuven Leuven Vlaams-Brabant Belgium 3000

Sponsors and Collaborators

  • KU Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bert Aertgeerts, Prof. Dr., KU Leuven
ClinicalTrials.gov Identifier:
NCT01830569
Other Study ID Numbers:
  • S55183
First Posted:
Apr 12, 2013
Last Update Posted:
Jul 16, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bert Aertgeerts, Prof. Dr., KU Leuven
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 16, 2019