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Preauthorization Versus Prospective Audit in Antimicrobial Stewardship Program

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ClinicalTrials.gov Identifier: NCT02837081
Recruitment Status : Unknown
Verified July 2016 by Susan Shin-Jung Lee, Kaohsiung Veterans General Hospital..
Recruitment status was:  Recruiting
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Susan Shin-Jung Lee, Kaohsiung Veterans General Hospital.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Bacterial Infections Other: Prospective audit strategy of antimicrobial stewardship Other: preauthorization strategy of antimicrobial stewardship Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1060 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Impact of Preauthorization Compared to Prospective Audit on Outcome Indicators as Core Strategies of Antimicrobial Stewardship Program
Study Start Date : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Preauthorization group
Strategy 1 of antimicrobial stewardship: Prescriptions of antimicrobial agents are done real-time by infectious diseases physician consultant. Use restricted without real-time authorization.
 Other: preauthorization strategy of antimicrobial stewardship
applying preauthorization as one strategy of antimicrobial stewardship
Other Name: preauthorization
Experimental: Prospective audit
Strategy 2 of antimicrobial stewardship: Prescription of antimicrobial agents are audited 48-72 hours later by infectious diseases physician consultant. Use allowed without authorization for 72 hours.
 Other: Prospective audit strategy of antimicrobial stewardship
applying prospective audit as a different strategy of antimicrobial stewardship
Other Name: prospective audit


Outcome Measures
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Primary Outcome Measures :
  1. Antimicrobial utilization using defined daily dose (DDD) [ Time Frame: 4 weeks ]
    Defined daily dose (DDD),

  2. Antimicrobial utilization using defined daily dose per 1000 patient days (DID) [ Time Frame: 4 weeks ]
    Defined daily dose per 1000 patient days


Secondary Outcome Measures :
  1. Appropriateness of antimicrobial prescription by susceptibility of culture [ Time Frame: 4 weeks ]
    cultures shows susceptibility to antimicrobial prescribed

  2. Rate of acceptance to use antimicrobial agents recommended by infectious disease physicians [ Time Frame: 4 weeks ]
    choice of antimicrobial agents used matches recommendation by infectious diseases physician


Other Outcome Measures:
  1. 30-day mortality [ Time Frame: 30 days post randomization ]
    mortality rate at 30-days post randomization

  2. 3-day defervescence rate [ Time Frame: 3 day post randomization ]
    Rate of defervescence on day 3 post randomization

  3. Rate of hospital associated bloodstream infections [ Time Frame: 12 months ]
    overall rate of bloodstream infection within the hospital during the study period

  4. Rates of multidrug resistant organisms within the hospital [ Time Frame: 12 months ]
    Rates of carbapenem-resistant Acinetobacter baumanii (CRAB), vancomycin resistant Enterococcus (VRE), Clostridium difficile


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837081


Contacts
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Contact: Susan Shin-Jung Lee, M.D., Ph.D. +886-7-342-2121 ext 2029 ssjlee28@yahoo.com.tw

Locations
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Taiwan
Kaohsiung Veterans General Hospital Recruiting
Kaohsiung, Taiwan, 813
Contact: Susan Shin-Jung Lee, M.D., M.Sc.    +886-968971300    ssjlee28@yahoo.com.tw   
Contact: Kelly Yen-Yun Ni, R.N.    +886-73422121 ext 2029    ni0630b@yahoo.com.tw   
Principal Investigator: Susan Shin-Jung Lee, M.D., Ph.D.         
Sub-Investigator: Yao-Shen Chen, M.D.         
Sub-Investigator: Hung-Chin Tsai, M.D., Ph.D.         
Sub-Investigator: Jui-Kuang Chen, M.D.         
Sub-Investigator: Cheng-Len Sy, M.D., BSMT         
Sub-Investigator: Kuan-Sheng Wu, M.D.         
Sub-Investigator: Yu-Ting Tseng, M.D.         
Sub-Investigator: Pi-Han Hung, M.D.         
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Principal Investigator: Susan Shin-Jung Lee, M.D., Ph.D. Kaohsiung Veterans General Hospital.
More Information
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Publications of Results:
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/.

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Responsible Party: Susan Shin-Jung Lee, Attending physician, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02837081    
Other Study ID Numbers: VGHKS15-CT12-05
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents