Clinical trial NCT01830569: Impact of an Evidence-based Electronic Decision Support System on Diabetes Care
Official title: Feasibility and Impact of an Evidence-based Electronic Decision Support System on Diabetes Care in Family Medicine: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Decision Support Systems, Clinical
Evidence-Based practice
Family Practice
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2013-04-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

Eligibility criteria: 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

Primary outcomes:
measure: Pre- to post-implementation change in HbA1c.
timeFrame: 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:
measure: Pre- to post-implementation change in cholesterol levels.
timeFrame: 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
measure: Pre- to post-implementation change in blood pressure measurements.
timeFrame: 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
measure: Pre- to post-implementation change in a composite patient score.
timeFrame: 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
measure: Pre- to post-implementation change in a composite process score.
timeFrame: 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:
measure: Actual use of the EBMeDS system
timeFrame: 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
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
state: Vlaams-Brabant
Study officials:
References:
citation: 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.
citation: 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.