Infection, BacterialARIESNCT04011657
Effective Antimicrobial StewaRdship StrategIES (ARIES)
A study testing Compulsory CDSS in people with Infection, Bacterial, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- Compulsory CDSS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,257 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are started on the 1st episode of piperacillin-tazobactam or carbapenem during the study period.
- Medical and surgical wards
Who cannot join
- Intensive care unit (ICU), high dependency and step-down care wards
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Infection, Bacterial
- Being tested
- Compulsory CDSS
- Keywords
- computerized decision support, prospective review and feedback, antimicrobial stewardship
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compulsory CDSSOther
Compulsory CDSS use with prospective review feedback in patients prescribed with piperacillin tazobactam or carbapenems
| Study group | Role | What they receive |
|---|---|---|
| Voluntary CDSS | Experimental | Voluntary use of computerized decision support with prospective review and feedback Receives: Other: Compulsory CDSS |
| Compulsory CDSS | No intervention | Compulsory use of computerized decision support with prospective review and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Death at 30 days
Measured: Follow-up up to 30 days from the start date of the first episode of piperacillin-tazobactam or carbapenem use
Secondary outcomes (9)
7-day clinical response
resolution of systemic inflammatory response syndrome
Measured: Follow-up up to 7 days from the date of the first episode of piperacillin-tazobactam or carbapenem use
30-day re-infection
Re-start of piperacilin-tazobactam or carbapenem 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use
Measured: Re-start of piperacilin-tazobactam or carbapenem 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use
30-day readmission
Readmission after the cessation of first episode of piperacillin-tazobactam or carbapenem use
Measured: Readmissions 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use
length of stay
Duration of admission
Measured: 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
MRSA, VRE, ESBL, MDR-A. baumannii, XDR- A baumannii, MDR- P. aeruginosa, XDR-P aeruginosa, C difficile , Carbapenem resistant enterobacterales
Measured: up to 6 months (Clinical cultures only)
Diarrhea this admission
Incidence of diarrhea from start of first episode of piperacillin-tazobactam or carbapenem use till discharge
Measured: 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
first episode of piperacillin-tazobactam or carbapenem use according to hospital guidelines. Appropriateness will be described as "yes" or "no".
Measured: 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,
Duration of the first episode of piperacillin-tazobactam or carbapenem use
Measured: 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
Gross hospitalization costs
Measured: Gross hospitalization costs incured from date of admission till date of discharge or up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Mar 2017
- Primary completion30 Sep 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011657
- Sponsor's protocol ID
- 2015/00671
- Other IDs
- 2015
- Acronym
- ARIES
- Status last verified
- Nov 2019
- First submitted
- 1 Jul 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data can be made available only after project agreement is made
Publications
Barlam TF, Cosgrove SE, Abbo LM, MacDougall C, Schuetz AN, Septimus EJ, Srinivasan A, Dellit TH, Falck-Ytter YT, Fishman NO, Hamilton CW, Jenkins TC, Lipsett PA, Malani PN, May LS, Moran GJ, Neuhauser MM, Newland JG, Ohl CA, Samore MH, Seo SK, Trivedi KK. Implementing an Antibiotic Stewardship Program: Guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clin Infect Dis. 2016 May 15;62(10):e51-77. doi: 10.1093/cid/ciw118. Epub 2016 Apr 13.
PubMed 27080992Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD003543. doi: 10.1002/14651858.CD003543.pub4.
PubMed 28178770Lew KY, Ng TM, Tan M, Tan SH, Lew EL, Ling LM, Ang B, Lye D, Teng CB. Safety and clinical outcomes of carbapenem de-escalation as part of an antimicrobial stewardship programme in an ESBL-endemic setting. J Antimicrob Chemother. 2015 Apr;70(4):1219-25. doi: 10.1093/jac/dku479. Epub 2014 Dec 3.
PubMed 25473028Schuts EC, Hulscher MEJL, Mouton JW, Verduin CM, Stuart JWTC, Overdiek HWPM, van der Linden PD, Natsch S, Hertogh CMPM, Wolfs TFW, Schouten JA, Kullberg BJ, Prins JM. Current evidence on hospital antimicrobial stewardship objectives: a systematic review and meta-analysis. Lancet Infect Dis. 2016 Jul;16(7):847-856. doi: 10.1016/S1473-3099(16)00065-7. Epub 2016 Mar 3.
PubMed 26947617Yong MK, Buising KL, Cheng AC, Thursky KA. Improved susceptibility of Gram-negative bacteria in an intensive care unit following implementation of a computerized antibiotic decision support system. J Antimicrob Chemother. 2010 May;65(5):1062-9. doi: 10.1093/jac/dkq058. Epub 2010 Mar 9.
PubMed 20215130Thursky K. Use of computerized decision support systems to improve antibiotic prescribing. Expert Rev Anti Infect Ther. 2006 Jun;4(3):491-507. doi: 10.1586/14787210.4.3.491.
PubMed 16771625Leibovici L, Kariv G, Paul M. Long-term survival in patients included in a randomized controlled trial of TREAT, a decision support system for antibiotic treatment. J Antimicrob Chemother. 2013 Nov;68(11):2664-6. doi: 10.1093/jac/dkt222. Epub 2013 Jun 5.
PubMed 23743088Chow AL, Lye DC, Arah OA. Mortality Benefits of Antibiotic Computerised Decision Support System: Modifying Effects of Age. Sci Rep. 2015 Nov 30;5:17346. doi: 10.1038/srep17346.
PubMed 26617195
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Antimicrobial StewaRdship StrategIES (ARIES): Cluster-randomized Trial of a Computerized Decision Support System Versus Antibiotic Prospective Review and Feedback in Antimicrobial Stewardship
- ClinicalTrials.gov ID
- NCT04011657
- Acronym / sponsor ID
- ARIES / 2015/00671
- Conditions
- Infection, Bacterial
- Keywords
- computerized decision support, prospective review and feedback, antimicrobial stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,257 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voluntary CDSS | Experimental | Other: Compulsory CDSSVoluntary use of computerized decision support with prospective review and feedback |
| Compulsory CDSS | No intervention | –Compulsory use of computerized decision support with prospective review and feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are started on the 1st episode of piperacillin-tazobactam or carbapenem during the study period.
- Medical and surgical wards
Key exclusion criteria (1 listed)
- Intensive care unit (ICU), high dependency and step-down care wards
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compulsory CDSSCompulsory CDSS use with prospective review feedback in patients prescribed with piperacillin tazobactam or carbapenems | Other | Voluntary CDSS |
Primary outcome
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
9 secondary outcomes
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
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
30-day readmission
Time frame: 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
6-months incidence of multi-drug resistant organisms
Time frame: 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
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
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.
Gross hospitalization costs
Time frame: Gross hospitalization costs incured from date of admission till date of discharge or up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Background: PubMed 27080992Barlam TF, Cosgrove SE, Abbo LM, MacDougall C, Schuetz AN, Septimus EJ, Srinivasan A, Dellit TH, Falck-Ytter YT, Fishman NO, Hamilton CW, Jenkins TC, Lipsett PA, Malani PN, May LS, Moran GJ, Neuhauser MM, Newland JG, Ohl CA, Samore MH, Seo SK, Trivedi KK. Implementing an Antibiotic Stewardship Program: Guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clin Infect Dis. 2016 May 15;62(10):e51-77. doi: 10.1093/cid/ciw118. Epub 2016 Apr 13.
- Background: PubMed 28178770Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD003543. doi: 10.1002/14651858.CD003543.pub4.
- Background: PubMed 25473028Lew KY, Ng TM, Tan M, Tan SH, Lew EL, Ling LM, Ang B, Lye D, Teng CB. Safety and clinical outcomes of carbapenem de-escalation as part of an antimicrobial stewardship programme in an ESBL-endemic setting. J Antimicrob Chemother. 2015 Apr;70(4):1219-25. doi: 10.1093/jac/dku479. Epub 2014 Dec 3.
- Background: PubMed 26947617Schuts EC, Hulscher MEJL, Mouton JW, Verduin CM, Stuart JWTC, Overdiek HWPM, van der Linden PD, Natsch S, Hertogh CMPM, Wolfs TFW, Schouten JA, Kullberg BJ, Prins JM. Current evidence on hospital antimicrobial stewardship objectives: a systematic review and meta-analysis. Lancet Infect Dis. 2016 Jul;16(7):847-856. doi: 10.1016/S1473-3099(16)00065-7. Epub 2016 Mar 3.
- Background: PubMed 20215130Yong MK, Buising KL, Cheng AC, Thursky KA. Improved susceptibility of Gram-negative bacteria in an intensive care unit following implementation of a computerized antibiotic decision support system. J Antimicrob Chemother. 2010 May;65(5):1062-9. doi: 10.1093/jac/dkq058. Epub 2010 Mar 9.
- Background: PubMed 16771625Thursky K. Use of computerized decision support systems to improve antibiotic prescribing. Expert Rev Anti Infect Ther. 2006 Jun;4(3):491-507. doi: 10.1586/14787210.4.3.491.
- Background: PubMed 23743088Leibovici L, Kariv G, Paul M. Long-term survival in patients included in a randomized controlled trial of TREAT, a decision support system for antibiotic treatment. J Antimicrob Chemother. 2013 Nov;68(11):2664-6. doi: 10.1093/jac/dkt222. Epub 2013 Jun 5.
- Background: PubMed 26617195Chow AL, Lye DC, Arah OA. Mortality Benefits of Antibiotic Computerised Decision Support System: Modifying Effects of Age. Sci Rep. 2015 Nov 30;5:17346. doi: 10.1038/srep17346.
- Individual participant dataSharing planned: Yes. Anonymized data can be made available only after project agreement is made
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compulsory CDSS in people with Infection, Bacterial, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011657, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.