Efficacy of an Electronic System to Support Clinical Decisions in Adults With Type 2 Diabetes Mellitus.

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Usual care based on clinical practice guideline; Other: Clinical Decision Support System

• Registration Number: NCT03160196
• Lead Sponsor: Sanitas University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-18
• Last Update Submitted: 2017-05-18
• Study First Posted: 2017-05-19
• Last Update Posted: 2017-05-19
• Study Start: 2018-01
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1768

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control practices	Usual care based on clinical practice guideline	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.
Experimental practices	Clinical Decision Support System	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.

Primary Outcome Measures

Name	Time	Method
Proportions of participants with normal Hb1Ac	6 months and a year of enrollment