Efficacy of an Electronic System to Support Clinical Decisions in Adults With Type 2 Diabetes Mellitus. (OSI-DM)

Sanitas University

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Clinical Decision Support System; Other: Usual care based on clinical practice guideline

Study type: Interventional

Funder types: Other

Identifier

NCT03160196

Details and patient eligibility

About

To assess the efficacy of an electronic system to support clinical decisions based on an evidence-based clinical practice guide for metabolic control of adults with Type 2 Diabetes Mellitus through Clinical and cluster-randomized controlled trial in a Colombian population.

Enrollment: 1,768 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No prior exposure to the tool (through development and beta testing)
• Access to an organized diabetes pathway consistent with the Sanitas EPS (Entidad Promotora de Salud) diabetes mellitus 2 guideline.

Exclusion criteria

• Terminally ill

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,768 participants in 2 patient groups

Experimental practices

Experimental group

Description:

The decision support tool is a Web-based software program accessed via a GP computer desktop icon. Clicking the icon opens a single page of tick boxes asking for relevant aspects of the presenting illness. Most fields for relevant medical history and patient demographics are automatically populated from data in the electronic health record. Depending on diagnosis and risk estimation, the tool recommends a guideline-based management strategy. Override options exist but require a justification from the GP. The tool also provides relevant prescriptions, radiology access, and referral forms, and a variety of patient information leaflets. GPs in practices randomized to the intervention group will have to initiate the tool but will not have to follow the tool's advice.

Treatment:

Other: Clinical Decision Support System

Control practices

Active Comparator group

Description:

Control practices will be aware of the tool but will be unable to access it and managed patients by usual care, which could include care aligned with the Guidelines. Prior to randomization, GPs from all participating practices (control and intervention) will attend a 1-hour face-to-face didactic education session on diabetes mellitus 2 management and the Colombia diabetes mellitus 2 Guidelines. The intervention pertains to the cluster level.

Treatment:

Other: Usual care based on clinical practice guideline