Bacterial InfectionsNCT02837081
Preauthorization Versus Prospective Audit in Antimicrobial Stewardship Program
A study testing Prospective audit strategy of antimicrobial stewardship and preauthorization strategy of antimicrobial stewardship in people with Bacterial Infections, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Antimicrobial stewardship program (ASP) is recommended to improve appropriate antimicrobial use, reduce bacterial resistance, unnecessary drug costs and enhance patient health outcomes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Prospective audit strategy of antimicrobial stewardship and preauthorization strategy of antimicrobial stewardship
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,060 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In-hospital patients, aged 20 and above, with request from managing physicians for use of restricted antimicrobials.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
Susan Shin-Jung Lee, M.D., M.Sc., +886-968971300, ssjlee28@yahoo.com.tw
Kelly Yen-Yun Ni, R.N., +886-73422121 ext. 2029, ni0630b@yahoo.com.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Bacterial Infections
- Being tested
- Prospective audit strategy of antimicrobial stewardship, preauthorization strategy of antimicrobial stewardship
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective audit strategy of antimicrobial stewardshipOther
Also called prospective audit
applying prospective audit as a different strategy of antimicrobial stewardship
preauthorization strategy of antimicrobial stewardshipOther
Also called preauthorization
applying preauthorization as one strategy of antimicrobial stewardship
| Study group | Role | What they receive |
|---|---|---|
| Preauthorization group | Active comparator | Strategy 1 of antimicrobial stewardship: Prescriptions of antimicrobial agents are done real-time by infectious diseases physician consultant. Use restricted without real-time authorization. Receives: Other: preauthorization strategy of antimicrobial stewardship |
| Prospective audit | Experimental | 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. Receives: Other: Prospective audit strategy of antimicrobial stewardship |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial utilization using defined daily dose (DDD)
Defined daily dose (DDD),
Measured: 4 weeks
Antimicrobial utilization using defined daily dose per 1000 patient days (DID)
Defined daily dose per 1000 patient days
Measured: 4 weeks
Secondary outcomes (2)
Appropriateness of antimicrobial prescription by susceptibility of culture
cultures shows susceptibility to antimicrobial prescribed
Measured: 4 weeks
Rate of acceptance to use antimicrobial agents recommended by infectious disease physicians
choice of antimicrobial agents used matches recommendation by infectious diseases physician
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Shin-Jung Lee, Kaohsiung Veterans General Hospital.
- Investigators
- Susan Shin-Jung Lee, M.D., Ph.D., Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837081
- Sponsor's protocol ID
- VGHKS15-CT12-05
- Status last verified
- Jul 2016
- First submitted
- 1 Dec 2015
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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 Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society (PIDS). Infect Control Hosp Epidemiol. 2012 Apr;33(4):322-7. doi: 10.1086/665010.
PubMed 22418625W.H.O. (2011) WHO Global Strategy for Containment of Antimicrobial Resistance.
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. Epub 2012 Apr 5.
PubMed 22483434Dellit 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. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007 Jan 15;44(2):159-77. doi: 10.1086/510393. Epub 2006 Dec 13. No abstract available.
PubMed 17173212Chung 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.
PubMed 23302793Lin 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.2013.04.004. Epub 2013 Jul 17.
PubMed 23870295Teng 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 Singap. 2015 Jan;44(1):19-25.
PubMed 25703493Reed 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.
PubMed 23154323Mehta 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 antimicrobial stewardship. Infect Control Hosp Epidemiol. 2014 Sep;35(9):1092-9. doi: 10.1086/677624. Epub 2014 Jul 23.
PubMed 25111916Charlson 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. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716W.H.O. Defined Daily Dose (DDD). 2015 [cited 2015 May 24]; Available from: http://www.whocc.no/ddd/definition_and_general_considera/.
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.
PubMed 25266285
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preauthorization Compared to Prospective Audit on Outcome Indicators as Core Strategies of Antimicrobial Stewardship Program
- ClinicalTrials.gov ID
- NCT02837081
- Acronym / sponsor ID
- VGHKS15-CT12-05
- Conditions
- Bacterial Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,060 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preauthorization group | Active comparator | Other: preauthorization strategy of antimicrobial stewardshipStrategy 1 of antimicrobial stewardship: Prescriptions of antimicrobial agents are done real-time by infectious diseases physician consultant. Use restricted without real-time authorization. |
| Prospective audit | Experimental | Other: Prospective audit strategy of antimicrobial stewardshipStrategy 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In-hospital patients, aged 20 and above, with request from managing physicians for use of restricted antimicrobials.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective audit strategy of antimicrobial stewardshipAlso: prospective auditapplying prospective audit as a different strategy of antimicrobial stewardship | Other | Prospective audit |
| preauthorization strategy of antimicrobial stewardshipAlso: preauthorizationapplying preauthorization as one strategy of antimicrobial stewardship | Other | Preauthorization group |
Primary outcome
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
2 secondary outcomes
Appropriateness of antimicrobial prescription by susceptibility of culture
Time frame: 4 weeks
Rate of acceptance to use antimicrobial agents recommended by infectious disease physicians
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Results publication: PubMed 22418625Society 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 Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society (PIDS). Infect Control Hosp Epidemiol. 2012 Apr;33(4):322-7. doi: 10.1086/665010.
- Results publicationW.H.O. (2011) WHO Global Strategy for Containment of Antimicrobial Resistance.
- Results publication: PubMed 22483434Tseng 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. Epub 2012 Apr 5.
- Results publication: PubMed 17173212Dellit 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. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007 Jan 15;44(2):159-77. doi: 10.1086/510393. Epub 2006 Dec 13. No abstract available.
- Results publication: PubMed 23302793Chung 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.
- Results publication: PubMed 23870295Lin 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.2013.04.004. Epub 2013 Jul 17.
- Results publication: PubMed 25703493Teng 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 Singap. 2015 Jan;44(1):19-25.
- Results publication: PubMed 23154323Reed 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.
- Results publication: PubMed 25111916Mehta 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 antimicrobial stewardship. Infect Control Hosp Epidemiol. 2014 Sep;35(9):1092-9. doi: 10.1086/677624. Epub 2014 Jul 23.
- Results publication: PubMed 3558716Charlson 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. doi: 10.1016/0021-9681(87)90171-8.
- Results publicationW.H.O. Defined Daily Dose (DDD). 2015 [cited 2015 May 24]; Available from: http://www.whocc.no/ddd/definition_and_general_considera/.
- Results publication: PubMed 25266285van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Shin-Jung Lee, M.D., Ph.D. principal investigator
Kaohsiung Veterans General Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prospective audit strategy of antimicrobial stewardship and preauthorization strategy of antimicrobial stewardship in people with Bacterial Infections, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan Shin-Jung Lee, M.D., Ph.D. (+886-7-342-2121 ext. 2029, ssjlee28@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial utilization using defined daily dose (DDD) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837081, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.