Impact of a Computerized Guidelines on the Management of Hypertension and Diabetes

Hypertension Clinical Trial

— ASTI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398944
• Other study ID #: SFTG1968A
• Status: Completed
• Phase: N/A
• First received: November 13, 2006
• Last updated: July 26, 2010
• Start date: November 2006
• Est. completion date: May 2008

Study information

• Verified date: November 2006
• Source: Société de Formation Thérapeutique du Généraliste
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical 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.

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 :

1. to design a guideline-based decision support system for diabetic and/or hypertensive patients, to help general practitioners :

1. 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

2. 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.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2715
• Est. completion date: May 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

• Hypertension

• Mellitus diabetes

• Follow-up by GP's

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension

Intervention

Device:
• Evaluation of the impact of a guideline based computerized decision support system.

Locations

Country	Name	City	State
France	SFTG	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Société de Formation Thérapeutique du Généraliste

Country where clinical trial is conducted

France, 

References & Publications (1)

Séroussi B, Bouaud J, Dréau 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients who underwent the recommended procedures during the last 12 months		16 months	No