Computerized Decision Support System for Antibiotic Treatment

NCT ID: NCT00233376

Last Updated: 2006-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2004-11-30

Brief Summary

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.

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.

Conditions

Community-Acquired Infection; Cross Infection

Keywords

Decision support system; Causal probabilistic network; Antibiotics; Antibiotic resistance; Community-acquired infections; Cross-infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Access to an antibiotic decision support system

Intervention Type: PROCEDURE

Distribution of local antibiotic guidelines

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eu Fifth Framework IST

UNKNOWN

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Leonard Leibovici, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center, Beilinson Campus

Steen Andreassen, PhD

Role: STUDY_CHAIR

Center for Model-based Medical Decision Support, Aalborg University

Locations

Department of Clinical Microbiology and Hospital Hygeine, Freiburg University Hospital

Freiburg im Breisgau, , Germany

Rabin Medical Center; Beilinson Campus

Petah Tikva, , Israel

Department of Infectious Diseases, Gemelli Hospital in Rome

Rome, , Italy

Countries

Germany; Israel; Italy

Related Links

http://www.treat.dk

Project web site

Other Identifiers

Fifth framework IST-1999-11459

Identifier Type: -

Identifier Source: secondary_id

IST-1999-11459

Identifier Type: -

Identifier Source: org_study_id