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Sponsors and Collaborators: |
Rabin Medical Center Eu Fifth Framework IST |
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Information provided by: | Rabin Medical Center |
ClinicalTrials.gov Identifier: | NCT00233376 |
We developed a computerized decision support system for prescription of antibiotics to inpatients. The purpose of the study is to assess the performance of the system in different wards, in three different hospitals, in three countries.
Condition | Intervention | Phase |
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Community-Acquired Infection Cross Infection |
Procedure: Access to an antibiotic decision support system Behavioral: Distribution of local antibiotic guidelines |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Improving Empirical Antibiotic Treatment Using TREAT,a Computerized Decision Support System. Cluster Randomized Trial |
Estimated Enrollment: | 1500 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | November 2004 |
Antibiotic treatment for suspected moderate to severe bacterial infections is usually initiated empirically, prior to identification of the causative pathogen. Appropriate treatment, that is matching in-vitro susceptibilities of subsequently isolated pathogens, reduces the overall fatality rate of severe infections with adjusted odds ratios varying between 1.6 and 6.9. In the same studies, 20-50% of patients were given inappropriate empirical antibiotic treatment.
We developed a computerized decision support system (TREAT) based on a causal probabilistic network to improve antibiotic treatment of inpatients. The aims of the system were to improve the rate of appropriate antibiotic treatment, thereby reducing mortality, and to route antibiotic use towards ecologically economical antibiotics as determined by local resistance profiles. The system can be calibrated to different locations.
The TREAT system was tested in a multi-center observational cohort study. The study proved the system safe and effective. TREAT prescribed appropriate antibiotic treatment to 70% of patients, 58% of whom were treated appropriately by physicians. TREAT used a narrow antibiotic formulary and at lower costs, mainly lowering costs assigned by the model to future resistance. The system performed well in three different countries (Israel, Italy and Germany).
We then proceeded to assess the effect of TREAT on the management of inpatients in these sites in a cluster randomized controlled trial. We used wards as the unit of randomization to avoid contamination through education of users by the system, and to benefit from the interaction of TREAT with the ward as a whole.
Comparison: the TREAT system was installed in intervention wards and its use was offered to physicians at the time of empirical antibiotic treatment. Physicians were asked to inspect TREAT’s result interface. The final choice of antibiotic treatment was theirs. Control wards had no access to the system. We assessed outcomes in intervention vs. control wards with regard to patient outcomes, appropriateness of antibiotic treatment and antibiotic costs.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Department of Clinical Microbiology and Hospital Hygeine, Freiburg University Hospital | |
Freiburg, Germany | |
Israel | |
Rabin Medical Center; Beilinson Campus | |
Petah Tikva, Israel, 49100 | |
Italy | |
Department of Infectious Diseases, Gemelli Hospital in Rome | |
Rome, Italy |
Principal Investigator: | Leonard Leibovici, M.D. | Rabin Medical Center, Beilinson Campus |
Study Chair: | Steen Andreassen, PhD | Center for Model-based Medical Decision Support, Aalborg University |
Study ID Numbers: | IST-1999-11459, Fifth framework IST-1999-11459 |
Study First Received: | October 4, 2005 |
Last Updated: | July 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00233376 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Decision support system Causal probabilistic network Antibiotics |
Antibiotic resistance Community-acquired infections Cross-infections |
Community-Acquired Infections Cross Infection |
Communicable Diseases Infection |