Diabetes MellitusASTINCT00398944
Impact of a Computerized Guidelines on the Management of Hypertension and Diabetes
A study testing Evaluation of the impact of a guideline based computerized decision support system. in people with Diabetes Mellitus and Hypertension, run by Société de Formation Thérapeutique du Généraliste at 1 site in France.
Trial summary
The purpose is to determine wether an electronic decision support system based on national guidelines is effective to improve the follow-up and the treatment of two conditions: hypertension and diabetes, in primary care practices. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypertension
- What is being tested?
- Evaluation of the impact of a guideline based computerized decision support system.
- Type of treatment
- Medical device
- How many people
- 2,715 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2006to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension
- Mellitus diabetes
- Follow-up by GP's
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Computerized Decision Support System, Based on EBM French Guidelines, on the Management of Hypertension and Diabetes: a Randomised Controlled Trial in Primary Care
The purpose is to determine wether an electronic decision support system based on national guidelines is effective to improve the follow-up and the treatment of two conditions: hypertension and diabetes, in primary care practices.
Read the detailed description
Existing computer-based ordering systems for physicians provide drug-centred checks but offer little assistance for optimizing the overall patient-centred treatment strategy.
The ASTI project aims :
- to design a guideline-based decision support system for diabetic and/or hypertensive patients, to help general practitioners :
- to carry out procedures (clinical and biological tests) according to guidelines (the recommended procedure at the recommended moment), and to get a synthetic view of all the elements they need to follow-up the patient
- to avoid prescription errors and to improve compliance with therapeutic guidelines. The " critic mode " operates as a background process and corrects the physician's prescription on the basis of automatically triggered elementary rules that account for isolated guideline recommendations. The " guided mode " directs the physician to the best treatment by browsing a comprehensive guideline knowledge base represented as a decision tree.
- To measure the impact of ASTI when it is implemented with an electronic medical record system. We adopt a randomized design, with the practice as the unit of randomization.
- Conditions
- Diabetes Mellitus, Hypertension
- Being tested
- Evaluation of the impact of a guideline based computerized decision support system.
- Keywords
- Guideline based decision support system, Hypertension, Diabetes
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the impact of a guideline based computerized decision support system.Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who underwent the recommended procedures during the last 12 months
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionJan 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société de Formation Thérapeutique du Généraliste
- Sponsor type
- University, hospital or other
- Investigators
- Hector FALCOFF, Principal investigator, Société de Formation Thérapeutique du Généraliste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398944
- Sponsor's protocol ID
- SFTG1968A
- Acronym
- ASTI
- Status last verified
- Nov 2006
- First submitted
- 13 Nov 2006
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Seroussi B, Bouaud J, Dreau H, Falcoff H, Riou C, Joubert M, Simon C, Simon G, Venot A. ASTI: a guideline-based drug-ordering system for primary care. Stud Health Technol Inform. 2001;84(Pt 1):528-32.
PubMed 11604796
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Computerized Decision Support System, Based on EBM French Guidelines, on the Management of Hypertension and Diabetes: a Randomised Controlled Trial in Primary Care
- ClinicalTrials.gov ID
- NCT00398944
- Acronym / sponsor ID
- ASTI / SFTG1968A
- Conditions
- Diabetes Mellitus, Hypertension
- Keywords
- Guideline based decision support system, Hypertension, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,715 participants (actual)
- Lead sponsor
- Société de Formation Thérapeutique du GénéralisteUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 14 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to determine wether an electronic decision support system based on national guidelines is effective to improve the follow-up and the treatment of two conditions: hypertension and diabetes, in primary care practices.
Detailed description
Existing computer-based ordering systems for physicians provide drug-centred checks but offer little assistance for optimizing the overall patient-centred treatment strategy.
The ASTI project aims :
- to design a guideline-based decision support system for diabetic and/or hypertensive patients, to help general practitioners :
- to carry out procedures (clinical and biological tests) according to guidelines (the recommended procedure at the recommended moment), and to get a synthetic view of all the elements they need to follow-up the patient
- to avoid prescription errors and to improve compliance with therapeutic guidelines. The " critic mode " operates as a background process and corrects the physician's prescription on the basis of automatically triggered elementary rules that account for isolated guideline recommendations. The " guided mode " directs the physician to the best treatment by browsing a comprehensive guideline knowledge base represented as a decision tree.
- To measure the impact of ASTI when it is implemented with an electronic medical record system. We adopt a randomized design, with the practice as the unit of randomization.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertension
- Mellitus diabetes
- Follow-up by GP's
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the impact of a guideline based computerized decision support system. | Device | – |
Primary outcome
Patients who underwent the recommended procedures during the last 12 months
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
- Background: PubMed 11604796Seroussi B, Bouaud J, Dreau H, Falcoff H, Riou C, Joubert M, Simon C, Simon G, Venot A. ASTI: a guideline-based drug-ordering system for primary care. Stud Health Technol Inform. 2001;84(Pt 1):528-32.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hector FALCOFF principal investigator
Société de Formation Thérapeutique du Généraliste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the impact of a guideline based computerized decision support system. in people with Diabetes Mellitus and Hypertension, run by Société de Formation Thérapeutique du Généraliste at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients who underwent the recommended procedures during the last 12 months (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00398944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2010.