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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical Decision Support System
Usual care based on clinical practice guideline
Sponsored by
Sanitas University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Hemoglobin A, Glycosylated

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental practices

    Control practices

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Proportions of participants with normal Hb1Ac

    Secondary Outcome Measures

    Full Information

    First Posted
    May 17, 2017
    Last Updated
    May 18, 2017
    Sponsor
    Sanitas University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03160196
    Brief Title
    Efficacy of an Electronic System to Support Clinical Decisions in Adults With Type 2 Diabetes Mellitus.
    Acronym
    OSI-DM
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    September 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sanitas University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Diabetes Mellitus, Type 2, Hemoglobin A, Glycosylated

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    1768 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental practices
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Control practices
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Clinical Decision Support System
    Intervention Description
    It is about a Clinical Decision Support System based on a diabetes mellitus clinical practice guideline.
    Intervention Type
    Other
    Intervention Name(s)
    Usual care based on clinical practice guideline
    Intervention Description
    It is about usual care aligned with the diabetes guideline.
    Primary Outcome Measure Information:
    Title
    Proportions of participants with normal Hb1Ac
    Time Frame
    6 months and a year of enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abel González, PhD
    Phone
    +573132578216
    Email
    abegonzalez@colsanitas.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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