Effective Antimicrobial StewaRdship StrategIES (ARIES)

Infection, Bacterial Clinical Trial

— ARIES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011657
• Other study ID #: 2015/00671
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: November 2019
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1257
• Est. completion date: February 28, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial

Intervention

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

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (8)

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. — View Citation

Chow 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. — View Citation

Davey 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:CD003543. doi: 10.1002/14651858.CD003543.pub4. Review. — View Citation

Leibovici 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. — View Citation

Lew 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. — View Citation

Schuts 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. Review. Erratum in: Lancet Infect Dis. 2016 Jul;16(7):768. — View Citation

Thursky K. Use of computerized decision support systems to improve antibiotic prescribing. Expert Rev Anti Infect Ther. 2006 Jun;4(3):491-507. Review. — View Citation

Yong 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	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	7-day clinical response	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
Secondary	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	Re-start of piperacilin-tazobactam or carbapenem 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use
Secondary	30-day readmission	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
Secondary	length of stay	Duration of admission	It is assessed from the date of admission till the date of discharge or up to 6 months
Secondary	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	up to 6 months (Clinical cultures only)
Secondary	Diarrhea this admission	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
Secondary	Appropriateness of antibiotics	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
Secondary	Index antibiotic days of therapy,	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.
Secondary	Gross hospitalization costs	Gross hospitalization costs	Gross hospitalization costs incured from date of admission till date of discharge or up to 6 months