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Effective Antimicrobial StewaRdship StrategIES (ARIES)

Effective Antimicrobial StewaRdship StrategIES (ARIES): Cluster-randomized Trial of a Computerized Decision Support System Versus Antibiotic Prospective Review and Feedback in Antimicrobial Stewardship

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04011657
Acronym
ARIES
Enrollment
1257
Registered
2019-07-08
Start date
2017-03-01
Completion date
2018-02-28
Last updated
2019-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Bacterial

Keywords

computerized decision support, prospective review and feedback, antimicrobial stewardship

Brief summary

Background Prospective review and feedback (PRF) of antibiotic prescriptions is a labor-intensive core strategy of antimicrobial stewardship (AMS). The investigators hypothesized that a computerized decision support system (CDSS) providing recommendations for antibiotics, investigations and referrals would reduce the requirement for PRF without causing harm. Methods A parallel-group, 1:1 block-cluster randomized, cross-over study was conducted in 32 medical and surgical wards from March to August 2017. The intervention arm comprised voluntary use of CDSS at first prescription of piperacillin-tazobactam or a carbapenem, while the control arm was compulsory CDSS. PRF was continued for both arms. Primary outcome was 30-day mortality.

Detailed description

Increasing antimicrobial resistance due to inappropriate antimicrobial use is a global concern. Multi-disciplinary antimicrobial stewardship teams have become an integral part of the response to this issue. Through prospective review of antibiotic prescriptions and feedback (PRF) to healthcare providers, antimicrobial stewardship has been shown to improve clinical response, reduce adverse effects and mortality. However, this strategy is labor-intensive to implement and skilled healthcare workers are an expensive and scarce resource. Antibiotic computerized decision support systems (CDSS) have been used to facilitate these processes and may circumvent the limitations of lack of manpower. In previous studies, CDSS led to increased susceptibility of Pseudomonas aeruginosa to imipenem and Enterobacteriaceae to gentamicin and ciprofloxacin, and an overall reduction in broad-spectrum antibiotic use. CDSS could improve clinical outcomes. Currently, there are limited studies comparing the combined effects of these two strategies. At Tan Tock Seng Hospital, a university teaching hospital in Singapore, antimicrobial stewardship has focused on PRF by a multi-disciplinary team since 2009. This team reviews piperacillin-tazobactam and carbapenem orders against hospital antibiotic guidelines from day two of antibiotic prescription. In March 2010, we implemented CDSS triggered at the point of antibiotic ordering and compulsory for the prescriber to review. Prescribers are free to accept or reject the CDSS recommendations. While PRF and CDSS are performed following the same institutional guidelines, there may be differences in physicians' acceptance of recommendations and the accessibility to recommendations between these two interventions. In previous studies, PRF recommendations had an acceptance of 60-70% while compulsory CDSS was 40%. The investigators hypothesized that compulsory CDSS and PRF would improve clinical outcomes compared with voluntary CDSS and PRF, and compulsory CDSS would improve appropriate antibiotic practice and reduce the requirement for subsequent PRF.

Interventions

OTHERCompulsory CDSS

Compulsory CDSS use with prospective review feedback in patients prescribed with piperacillin tazobactam or carbapenems

Sponsors

Tan Tock Seng Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

A parallel-group, 1:1 block-cluster randomized, cross-over study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who are started on the 1st episode of piperacillin-tazobactam or carbapenem during the study period. * Medical and surgical wards

Exclusion criteria

* Intensive care unit (ICU), high dependency and step-down care wards

Design outcomes

Primary

MeasureTime frameDescription
30-day mortalityFollow-up up to 30 days from the start date of the first episode of piperacillin-tazobactam or carbapenem useDeath at 30 days

Secondary

MeasureTime frameDescription
30-day re-infectionRe-start of piperacilin-tazobactam or carbapenem 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem useRe-start of piperacilin-tazobactam or carbapenem 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use
30-day readmissionReadmissions 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem useReadmission after the cessation of first episode of piperacillin-tazobactam or carbapenem use
length of stayIt is assessed from the date of admission till the date of discharge or up to 6 monthsDuration of admission
6-months incidence of multi-drug resistant organismsup to 6 months (Clinical cultures only)MRSA, VRE, ESBL, MDR-A. baumannii, XDR- A baumannii, MDR- P. aeruginosa, XDR-P aeruginosa, C difficile , Carbapenem resistant enterobacterales
7-day clinical responseFollow-up up to 7 days from the date of the first episode of piperacillin-tazobactam or carbapenem useresolution of systemic inflammatory response syndrome
Appropriateness of antibioticsIt is assessed only once at the point of the first episode of piperacillin-tazobactam or carbapenem use in the index admission. It is only assessed once till discharge or up to 6 monthsfirst episode of piperacillin-tazobactam or carbapenem use according to hospital guidelines. Appropriateness will be described as yes or no.
Index antibiotic days of therapy,From the start date of the first episode of piperacillin-tazobactam or carbapenem use to the end date of this antibiotic which is followed up till discharge or up to 6 months.Duration of the first episode of piperacillin-tazobactam or carbapenem use
Gross hospitalization costsGross hospitalization costs incured from date of admission till date of discharge or up to 6 monthsGross hospitalization costs
Diarrhea this admissionFrom the start date from the first episode of piperacillin-tazobactam or carbapenem use until the discharge date or up to 6 months whichever occurred earlierIncidence of diarrhea from start of first episode of piperacillin-tazobactam or carbapenem use till discharge

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026