Preauthorization Versus Prospective Audit in Antimicrobial Stewardship Program

Bacterial Infections Clinical Trial

Official title:

The Impact of Preauthorization Compared to Prospective Audit on Outcome Indicators as Core Strategies of Antimicrobial Stewardship Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02837081
• Other study ID #: VGHKS15-CT12-05
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2015
• Last updated: July 14, 2016
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: July 2016
• Source: Kaohsiung Veterans General Hospital.
• Contact: Susan Shin-Jung Lee, M.D., Ph.D.
• Phone: +886-7-342-2121
• Email: ssjlee28[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Antimicrobial stewardship program (ASP) is recommended to improve appropriate antimicrobial use, reduce bacterial resistance, unnecessary drug costs and enhance patient health outcomes. Two core strategies of ASP recommended as effective in guidelines are formulary restriction with drug preauthorization and prospective audit with feedback. Investigators will evaluate the effectiveness of the 2 strategies using antimicrobial utilization and patient outcomes.

Description:

Background: Antimicrobial stewardship program (ASP) is recommended to improve appropriate antimicrobial use, reduce bacterial resistance, unnecessary drug costs and enhance patient health outcomes. Two core strategies of ASP recommended as effective in guidelines are formulary restriction with drug preauthorization and prospective audit with feedback. Preauthorization is the current strategy used in our hospital, while most other hospitals in Taiwan and worldwide uses prospective audit with feedback. Preauthorization requires intensive manpower to maintain timeliness of antimicrobial use. This study will evaluate a policy change in strategy used for antimicrobial stewardship. Investigators will evaluate the effectiveness of the 2 strategies using antimicrobial utilization and patient outcomes.

Methods: During a stepwise change in the policy of the antimicrobial stewardship program in this hospital, the study will observe the differences between two standardized core strategies (preauthorization vs prospective audit) of ASP. Hospitalized patients aged 20 and above, requiring use of restricted antimicrobials will be recruited into the study. Signing of consent forms are waived since both strategies are already proven to be effective and are widely implemented in Taiwan and worldwide. Also, the evaluation of such policy changes will not impact on patient safety or patient rights. The conduction of the study will not require contacting patients and no clinical samples will be collected. All data required for analysis will be collected via a computerized patient care system. Patient data will be protected via de-linking. Patients will be excluded if admitted at or entered the intensive care unit within 48 hours of entry, and if infectious diseases consultation had been requested. Eligible patients will be randomized to either preauthorization, which is the current practice in the hospital; or prospective audit, that will be done at 48-72 hours after prescription, as is the current practice in other hospitals in Taiwan and worldwide. Managing physicians are not obligated to follow our advice and the investigators will not intervene in their management decisions. Primary outcomes include antimicrobial utilization, drug costs and patient outcomes such as length of stay and clinical improvement. The time spent on implementing these two strategies will be compared.

The study hypothesis is that the preauthorization group will impact on a reduction in antimicrobial cost and utilization, especially in the first 72 hours, when compared to prospective audit. However, patient outcomes will likely be similar. Antimicrobial stewardship programs using preauthorization as a core strategy compared to prospective audit with feedback have similar patient outcomes, but may reduce antimicrobial utilization.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1060
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• In-hospital patients, aged 20 and above, with request from managing physicians for use of restricted antimicrobials.

Exclusion Criteria:

• Patients admitted to the intensive care unit at evaluation or within 48 hours of entry into the study.

• Patients with antimicrobial prescriptions prescribed during after-hours, including weekends and public holidays.

• Formal infectious disease consultations requested prior to randomization.

• Patients in the emergency department and outpatient department.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Other:
• Prospective audit strategy of antimicrobial stewardship
applying prospective audit as a different strategy of antimicrobial stewardship
• preauthorization strategy of antimicrobial stewardship
applying preauthorization as one strategy of antimicrobial stewardship

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (12)

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. — View Citation

Chung GW, Wu JE, Yeo CL, Chan D, Hsu LY. Antimicrobial stewardship: a review of prospective audit and feedback systems and an objective evaluation of outcomes. Virulence. 2013 Feb 15;4(2):151-7. doi: 10.4161/viru.21626. Epub 2013 Jan 9. Review. — View Citation

Dellit TH, Owens RC, McGowan JE Jr, Gerding DN, Weinstein RA, Burke JP, Huskins WC, Paterson DL, Fishman NO, Carpenter CF, Brennan PJ, Billeter M, Hooton TM; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America. Infectiou — View Citation

Lin YS, Lin IF, Yen YF, Lin PC, Shiu YC, Hu HY, Yang YP. Impact of an antimicrobial stewardship program with multidisciplinary cooperation in a community public teaching hospital in Taiwan. Am J Infect Control. 2013 Nov;41(11):1069-72. doi: 10.1016/j.ajic — View Citation

Mehta JM, Haynes K, Wileyto EP, Gerber JS, Timko DR, Morgan SC, Binkley S, Fishman NO, Lautenbach E, Zaoutis T; Centers for Disease Control and Prevention Epicenter Program. Comparison of prior authorization and prospective audit with feedback for antimic — View Citation

Reed EE, Stevenson KB, West JE, Bauer KA, Goff DA. Impact of formulary restriction with prior authorization by an antimicrobial stewardship program. Virulence. 2013 Feb 15;4(2):158-62. doi: 10.4161/viru.21657. Epub 2012 Nov 15. Review. — View Citation

Society for Healthcare Epidemiology of America; Infectious Diseases Society of America; Pediatric Infectious Diseases Society. Policy statement on antimicrobial stewardship by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Disea — View Citation

Teng CB, Ng TM, Tan MW, Tan SH, Tay M, Lim SF, Ling LM, Ang BS, Lye DC. Safety and effectiveness of improving carbapenem use via prospective review and feedback in a multidisciplinary antimicrobial stewardship programme. Ann Acad Med Singapore. 2015 Jan;4 — View Citation

Tseng SH, Lee CM, Lin TY, Chang SC, Chuang YC, Yen MY, Hwang KP, Leu HS, Yen CC, Chang FY. Combating antimicrobial resistance: antimicrobial stewardship program in Taiwan. J Microbiol Immunol Infect. 2012 Apr;45(2):79-89. doi: 10.1016/j.jmii.2012.03.007. — View Citation

van den Bosch CM, Geerlings SE, Natsch S, Prins JM, Hulscher ME. Quality indicators to measure appropriate antibiotic use in hospitalized adults. Clin Infect Dis. 2015 Jan 15;60(2):281-91. doi: 10.1093/cid/ciu747. Epub 2014 Sep 28. — View Citation

W.H.O. (2011) WHO Global Strategy for Containment of Antimicrobial Resistance.

W.H.O. Defined Daily Dose (DDD). 2015 [cited 2015 May 24]; Available from: http://www.whocc.no/ddd/definition_and_general_considera/.

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30-day mortality	mortality rate at 30-days post randomization	30 days post randomization	Yes
Other	3-day defervescence rate	Rate of defervescence on day 3 post randomization	3 day post randomization	Yes
Other	Rate of hospital associated bloodstream infections	overall rate of bloodstream infection within the hospital during the study period	12 months	No
Other	Rates of multidrug resistant organisms within the hospital	Rates of carbapenem-resistant Acinetobacter baumanii (CRAB), vancomycin resistant Enterococcus (VRE), Clostridium difficile	12 months	No
Primary	Antimicrobial utilization using defined daily dose (DDD)	Defined daily dose (DDD),	4 weeks	No
Primary	Antimicrobial utilization using defined daily dose per 1000 patient days (DID)	Defined daily dose per 1000 patient days	4 weeks	No
Secondary	Appropriateness of antimicrobial prescription by susceptibility of culture	cultures shows susceptibility to antimicrobial prescribed	4 weeks	No
Secondary	Rate of acceptance to use antimicrobial agents recommended by infectious disease physicians	choice of antimicrobial agents used matches recommendation by infectious diseases physician	4 weeks	No