Impact of a Computerized Guidelines on the Management of Hypertension and Diabetes (ASTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398944
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : July 27, 2010
Information provided by:
Société de Formation Thérapeutique du Généraliste

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Hypertension Device: Evaluation of the impact of a guideline based computerized decision support system. Not Applicable

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 :

  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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2715 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : November 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : May 2008

Primary Outcome Measures :
  1. Patients who underwent the recommended procedures during the last 12 months [ Time Frame: 16 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hypertension
  • Mellitus diabetes
  • Follow-up by GP's

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00398944

Paris, France, 75013
Sponsors and Collaborators
Société de Formation Thérapeutique du Généraliste
Principal Investigator: Hector FALCOFF Société de Formation Thérapeutique du Généraliste

Responsible Party: Doctor Hector Falcoff, Société de Formation Thérapeutique du Généraliste Identifier: NCT00398944     History of Changes
Other Study ID Numbers: SFTG1968A
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: November 2006

Keywords provided by Société de Formation Thérapeutique du Généraliste:
Guideline based decision support system, Hypertension, Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases