Effective Antimicrobial StewaRdship StrategIES (ARIES) (ARIES)

November 12, 2019 updated by: Tan Tock Seng Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1257

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Voluntary CDSS
Voluntary use of computerized decision support with prospective review and feedback
Other: Compulsory CDSS
Compulsory CDSS use with prospective review feedback in patients prescribed with piperacillin tazobactam or carbapenems
NO_INTERVENTION: Compulsory CDSS
Compulsory use of computerized decision support with prospective review and feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: Follow-up up to 30 days from the start date of the first episode of piperacillin-tazobactam or carbapenem use
Death at 30 days
Follow-up up to 30 days from the start date of the first episode of piperacillin-tazobactam or carbapenem use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day clinical response
Time Frame: Follow-up up to 7 days from the date of the first episode of piperacillin-tazobactam or carbapenem use
resolution of systemic inflammatory response syndrome
Follow-up up to 7 days from the date of the first episode of piperacillin-tazobactam or carbapenem use
30-day re-infection
Time Frame: Re-start of piperacilin-tazobactam or carbapenem 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use
Re-start of piperacilin-tazobactam or carbapenem 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use
Re-start of piperacilin-tazobactam or carbapenem 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use
30-day readmission
Time Frame: Readmissions 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use
Readmission after the cessation of first episode of piperacillin-tazobactam or carbapenem use
Readmissions 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use
length of stay
Time Frame: It is assessed from the date of admission till the date of discharge or up to 6 months
Duration of admission
It is assessed from the date of admission till the date of discharge or up to 6 months
6-months incidence of multi-drug resistant organisms
Time Frame: up 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
up to 6 months (Clinical cultures only)
Diarrhea this admission
Time Frame: From the start date from the first episode of piperacillin-tazobactam or carbapenem use until the discharge date or up to 6 months whichever occurred earlier
Incidence of diarrhea from start of first episode of piperacillin-tazobactam or carbapenem use till discharge
From the start date from the first episode of piperacillin-tazobactam or carbapenem use until the discharge date or up to 6 months whichever occurred earlier
Appropriateness of antibiotics
Time Frame: It 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 months
first episode of piperacillin-tazobactam or carbapenem use according to hospital guidelines. Appropriateness will be described as "yes" or "no".
It 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 months
Index antibiotic days of therapy,
Time Frame: 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
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.
Gross hospitalization costs
Time Frame: Gross hospitalization costs incured from date of admission till date of discharge or up to 6 months
Gross hospitalization costs
Gross hospitalization costs incured from date of admission till date of discharge or up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ACTUAL)

September 30, 2017

Study Completion (ACTUAL)

February 28, 2018

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 4, 2019

First Posted (ACTUAL)

July 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/00671

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data can be made available only after project agreement is made

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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