Computerized Decision Support System for Antibiotic Treatment

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.

Study Overview

• Status: Completed
• Conditions: Cross Infection; Community-Acquired Infection
• Intervention / Treatment: Procedure: Access to an antibiotic decision support system; Behavioral: Distribution of local antibiotic guidelines

Detailed Description

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.

• Study Type: Interventional
• Enrollment: 1500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany
    • Department of Clinical Microbiology and Hospital Hygeine, Freiburg University Hospital
• Israel
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center; Beilinson Campus
• Italy
  • Rome, Italy
    • Department of Infectious Diseases, Gemelli Hospital in Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients from whom blood cultures were drawn.
• Patients prescribed antibiotics (not for prophylaxis).
• Patients fulfilling sepsis diagnostic criteria.
• Patients with a focus of infection.
• Patients with shock compatible with septic shock.
• Patients with febrile neutropenia

Exclusion Criteria:

• HIV positive patients with a current (suspected or identified) opportunistic disease and/or AIDS defining illness currently or within the past six months
• Organ or bone marrow transplant recipients
• Children <18 years; suspected travel infections or tuberculosis
• Pregnant women
• Re-entries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Appropriate antibiotic treatment

Secondary Outcome Measures

Outcome Measure
Adverse events
Antibiotic use
Duration of hospital stay
Overall 30-day mortality
Durations of fever
Antibiotic costs

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Eu Fifth Framework IST
• Investigators: 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

Publications and helpful links

Helpful Links

• Project web site

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Study Completion: November 1, 2004

Study Registration Dates

• First Submitted: October 4, 2005
• First Submitted That Met QC Criteria: October 4, 2005
• First Posted (Estimate): October 5, 2005

Study Record Updates

• Last Update Posted (Estimate): July 18, 2006
• Last Update Submitted That Met QC Criteria: July 17, 2006
• Last Verified: October 1, 2005

More Information

Terms related to this study

• Keywords: Antibiotics; Antibiotic resistance; Decision support system; Community-acquired infections; Causal probabilistic network; Cross-infections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Cross Infection; Community-Acquired Infections; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: IST-1999-11459; Fifth framework IST-1999-11459