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
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Infections||Other: Prospective audit strategy of antimicrobial stewardship Other: preauthorization strategy of antimicrobial stewardship||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||1060 participants|
|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|
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
- Antimicrobial utilization using defined daily dose (DDD) [ Time Frame: 4 weeks ]Defined daily dose (DDD),
- Antimicrobial utilization using defined daily dose per 1000 patient days (DID) [ Time Frame: 4 weeks ]Defined daily dose per 1000 patient days
- Appropriateness of antimicrobial prescription by susceptibility of culture [ Time Frame: 4 weeks ]cultures shows susceptibility to antimicrobial prescribed
- 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
- 30-day mortality [ Time Frame: 30 days post randomization ]mortality rate at 30-days post randomization
- 3-day defervescence rate [ Time Frame: 3 day post randomization ]Rate of defervescence on day 3 post randomization
- Rate of hospital associated bloodstream infections [ Time Frame: 12 months ]overall rate of bloodstream infection within the hospital during the study period
- 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
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
|Contact: Susan Shin-Jung Lee, M.D., Ph.D.||+886-7-342-2121 ext email@example.com|
|Kaohsiung Veterans General Hospital||Recruiting|
|Kaohsiung, Taiwan, 813|
|Contact: Susan Shin-Jung Lee, M.D., M.Sc. +886-968971300 firstname.lastname@example.org|
|Contact: Kelly Yen-Yun Ni, R.N. +886-73422121 ext 2029 email@example.com|
|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.|
|Principal Investigator:||Susan Shin-Jung Lee, M.D., Ph.D.||Kaohsiung Veterans General Hospital.|