- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03160196
Efficacy of an Electronic System to Support Clinical Decisions in Adults With Type 2 Diabetes Mellitus. (OSI-DM)
May 18, 2017 updated by: Abel Ernesto González Vélez, Sanitas University
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.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1768
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Abel González, PhD
- Phone Number: +573132578216
- Email: abegonzalez@colsanitas.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
It is about usual care aligned with the diabetes guideline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportions of participants with normal Hb1Ac
Time Frame: 6 months and a year of enrollment
|
6 months and a year of enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2018
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
May 17, 2017
First Submitted That Met QC Criteria
May 18, 2017
First Posted (Actual)
May 19, 2017
Study Record Updates
Last Update Posted (Actual)
May 19, 2017
Last Update Submitted That Met QC Criteria
May 18, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
AstraZenecaRecruiting
Clinical Trials on Clinical Decision Support System
-
University of California, San FranciscoCompletedHypertension | Renal Insufficiency, ChronicUnited States
-
Aifred HealthMcGill UniversityCompletedDepressionUnited States, Canada
-
Hannover Medical SchoolTechnische Universitaet Braunschweig; Helmholtz Centre for Infection ResearchCompletedSepsis | SIRS | Pediatric SIRSGermany
-
University of Alabama at BirminghamCompletedObesity | Diabetes | OverweightUnited States
-
University Hospital, LilleRegional Agency of Sante Nord Pas-de-Calais; OméDIT (Observatory of Medicines...Not yet recruitingAcute Renal Failure | Patient Acceptance of Health Care
-
South London and Maudsley NHS Foundation TrustActive, not recruitingStroke | Atrial FibrillationUnited Kingdom
-
Peking University Third HospitalUnknown
-
Hospital Italiano de Buenos AiresDuke UniversityUnknown
-
Andrew Tomas ReisnerRecruitingWounds and InjuriesUnited States
-
University of PittsburghPatient-Centered Outcomes Research Institute; Northwell Health; University of...CompletedChild Abuse | Trauma | Child Maltreatment | Physical AbuseUnited States