Cross Infection Clinical Trial
Official title:
Improving Empirical Antibiotic Treatment Using TREAT,a Computerized Decision Support System. Cluster Randomized Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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