Preauthorization Versus Prospective Audit in Antimicrobial Stewardship Program

July 14, 2016 updated by: Susan Shin-Jung Lee, Kaohsiung Veterans General Hospital.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1060

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 Contact

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Recruiting
        • Kaohsiung Veterans General Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Pi-Han Hung, M.D.

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • prospective audit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antimicrobial utilization using defined daily dose (DDD)
Time Frame: 4 weeks
Defined daily dose (DDD),
4 weeks
Antimicrobial utilization using defined daily dose per 1000 patient days (DID)
Time Frame: 4 weeks
Defined daily dose per 1000 patient days
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriateness of antimicrobial prescription by susceptibility of culture
Time Frame: 4 weeks
cultures shows susceptibility to antimicrobial prescribed
4 weeks
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
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality
Time Frame: 30 days post randomization
mortality rate at 30-days post randomization
30 days post randomization
3-day defervescence rate
Time Frame: 3 day post randomization
Rate of defervescence on day 3 post randomization
3 day post randomization
Rate of hospital associated bloodstream infections
Time Frame: 12 months
overall rate of bloodstream infection within the hospital during the study period
12 months
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
12 months

Collaborators and Investigators

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

Sponsor

Kaohsiung Veterans General 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

December 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 19, 2016

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS15-CT12-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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