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Clinical Trials/NCT01830569
NCT01830569CompletedNot Applicable

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

KU Leuven2 sites in 1 country45 target enrollmentStarted: March 29, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
KU Leuven
Enrollment
45
Locations
2
Primary Endpoint
Pre- to post-implementation change in HbA1c.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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

  • 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)
  • 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)

Investigators

Sponsor
KU Leuven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bert Aertgeerts

Prof. Dr.

KU Leuven

Study Sites (2)

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