Efficacy of an Electronic System to Support Clinical Decisions in Adults With Type 2 Diabetes Mellitus.
OSI-DM
interventional
1,768
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jan 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMay 19, 2017
May 1, 2017
1.7 years
May 17, 2017
May 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportions of participants with normal Hb1Ac
6 months and a year of enrollment
Study Arms (2)
Experimental practices
EXPERIMENTALThe 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
ACTIVE COMPARATORControl 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.
Interventions
It is about a Clinical Decision Support System based on a diabetes mellitus clinical practice guideline.
It is about usual care aligned with the diabetes guideline.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Terminally ill
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 17, 2017
First Posted
May 19, 2017
Study Start
January 1, 2018
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
May 19, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share