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Trial record 2 of 850 for:    Recruiting, Not yet recruiting, Available Studies | "Diabetes Mellitus, Type 2"

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
Sponsor:
Information provided by (Responsible Party):
Abel Ernesto González Vélez, 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Proportions of participants with normal Hb1Ac [ Time Frame: 6 months and a year of enrollment ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Abel González, PhD +573132578216 abegonzalez@colsanitas.com

Sponsors and Collaborators
Sanitas University

Responsible Party: Abel Ernesto González Vélez, Principal Investigator, Sanitas University
ClinicalTrials.gov Identifier: NCT03160196     History of Changes
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abel Ernesto González Vélez, Sanitas University:
Diabetes Mellitus, Type 2
Hemoglobin A, Glycosylated

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases