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

NCT01830569 | Completed

• 1 other identifier: S55183
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Decision Support Systems, Clinical; Evidence-Based practice; Family Practice

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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.

  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

Other Outcomes (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

Study Arms (2)

EBMeDS group

EXPERIMENTAL

The regular Evidence Linker and the EBMeDS system will be available in this group.

Behavioral: The EBMeDS system; Other: Evidence Linker

Control group

OTHER

The regular Evidence Linker will be available in this group.

Other: Evidence Linker

Interventions

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.

EBMeDS 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.

Control group; EBMeDS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are 18 years or older.
• 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)

You may not qualify if:

• Pregnancy
• Cognitive impairment

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Katholieke Universiteit Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 31910877 DERIVED

• 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.

  PMID: 23915250 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: April 12, 2013
• Study Start: March 29, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)