Efficacy of an Electronic System to Support Clinical Decisions in Adults With Type 2 Diabetes Mellitus. (OSI-DM)
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|ClinicalTrials.gov Identifier: NCT03160196|
Recruitment Status : Not yet recruiting
First Posted : May 19, 2017
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Other: Clinical Decision Support System Other: Usual care based on clinical practice guideline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1768 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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: Clinical and Cluster-randomized Controlled Trial.|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Experimental practices
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.
Other: Clinical Decision Support System
It is about a Clinical Decision Support System based on a diabetes mellitus clinical practice guideline.
Active Comparator: Control practices
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.
Other: Usual care based on clinical practice guideline
It is about usual care aligned with the diabetes guideline.
- Proportions of participants with normal Hb1Ac [ Time Frame: 6 months and a year of enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160196
|Contact: Abel González, PhDfirstname.lastname@example.org|