Antimicrobial Prescribing PracticesNCT00552838
The Impact of an Antimicrobial Utilization Program on Antimicrobial Use
A study testing Academic Detailing by the Antimicrobial Utilization Team (AUT) in people with Antimicrobial Prescribing Practices, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Multidisciplinary antimicrobial utilization teams (AUT) have been proposed as an effective mechanism for improving antimicrobial use, but data on their efficacy remain limited. The researchers postulated that a multi-disciplinary AUT would improve antimicrobial use in a teaching hospital when compared to the standard… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Antimicrobial Prescribing Practices
- What is being tested?
- Academic Detailing by the Antimicrobial Utilization Team (AUT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 785 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Aug 2003
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients prescribed vancomycin, piperacillin-tazobactam, or levofloxacin during the time period of the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of an Antimicrobial Utilization Program on Antimicrobial Use in a Large Public Hospital: A Randomized Controlled Trial
Multidisciplinary antimicrobial utilization teams (AUT) have been proposed as an effective mechanism for improving antimicrobial use, but data on their efficacy remain limited. The researchers postulated that a multi-disciplinary AUT would improve antimicrobial use in a teaching hospital when compared to the standard of care (no AUT intervention).
Design: Randomized-controlled intervention trial. Setting: A 953-bed urban teaching hospital.
Read more
Patients: Patients admitted to internal medicine ward teams who were prescribed selected antimicrobial agents (piperacillin-tazobactam, levofloxacin, or vancomycin) during the 10month study period.
Intervention: Eight internal medicine ward teams were randomized monthly to academic detailing by the AUT while 8 internal medicine ward teams were randomized indication-based prescription of broad spectrum antimicrobials.
Measurements: Proportion of appropriate empiric, definitive, and end antimicrobial usage (antimicrobial use from the initiation of therapy until definitive therapy is prescribed).
Read the detailed description
This study was conducted when Bernard C Camins, MD (BCC), one of the investigators, was still employed at Emory University. The principal investigator is no longer at Emory University. This trial is being registered by one of the investigators, BCC, so we can submit the manuscript for publication. BCC is now at Washington University and this study was conducted while he was at Emory University.
- Conditions
- Antimicrobial Prescribing Practices
- Being tested
- Academic Detailing by the Antimicrobial Utilization Team (AUT)
- Keywords
- Antimicrobial prescribing, Antimicrobial utilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic Detailing by the Antimicrobial Utilization Team (AUT)Behavioural
Physicians caring for patients who were prescribed one of three antimicrobials were randomly assigned to academic detailing by the AUT. The AUT would review the antimicrobial prescription and provide consultation to the ordering physician if the prescription is appropriate and provide feedback on a better alternative if inappropriate.
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Physicians in this arm did not have any intervention with the AUT. Antimicrobial prescriptions were based on hospital guidelines or on the physician's medical knowledge. Receives: Behavioral: Academic Detailing by the Antimicrobial Utilization Team (AUT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Appropriateness of Antimicrobial Prescriptions in each group.
Measured: 10-month period
Secondary outcomes (1)
Clinical Cure Rate, Mortality Rate between the two groups
Measured: 10-month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startOct 2002
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial Prescribing PracticesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 785 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Investigators
- Mark D King, MD, MSCR, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552838
- Sponsor's protocol ID
- 579-2002 Emory IRB
- Status last verified
- Sep 2007
- First submitted
- 29 Oct 2007
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Camins BC, King MD, Wells JB, Googe HL, Patel M, Kourbatova EV, Blumberg HM. Impact of an antimicrobial utilization program on antimicrobial use at a large teaching hospital: a randomized controlled trial. Infect Control Hosp Epidemiol. 2009 Oct;30(10):931-8. doi: 10.1086/605924.
PubMed 19712032
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Antimicrobial Utilization Program on Antimicrobial Use in a Large Public Hospital: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00552838
- Acronym / sponsor ID
- 579-2002 Emory IRB
- Conditions
- Antimicrobial Prescribing Practices
- Keywords
- Antimicrobial prescribing, Antimicrobial utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 785 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- Oct 2002
- Study completion
- Aug 2003 (actual)
- First posted
- 2 Nov 2007 (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.
Multidisciplinary antimicrobial utilization teams (AUT) have been proposed as an effective mechanism for improving antimicrobial use, but data on their efficacy remain limited. The researchers postulated that a multi-disciplinary AUT would improve antimicrobial use in a teaching hospital when compared to the standard of care (no AUT intervention).
Design: Randomized-controlled intervention trial. Setting: A 953-bed urban teaching hospital.
Patients: Patients admitted to internal medicine ward teams who were prescribed selected antimicrobial agents (piperacillin-tazobactam, levofloxacin, or vancomycin) during the 10month study period.
Intervention: Eight internal medicine ward teams were randomized monthly to academic detailing by the AUT while 8 internal medicine ward teams were randomized indication-based prescription of broad spectrum antimicrobials.
Measurements: Proportion of appropriate empiric, definitive, and end antimicrobial usage (antimicrobial use from the initiation of therapy until definitive therapy is prescribed).
Detailed description
This study was conducted when Bernard C Camins, MD (BCC), one of the investigators, was still employed at Emory University. The principal investigator is no longer at Emory University. This trial is being registered by one of the investigators, BCC, so we can submit the manuscript for publication. BCC is now at Washington University and this study was conducted while he was at Emory University.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | Behavioral: Academic Detailing by the Antimicrobial Utilization Team (AUT)Physicians in this arm did not have any intervention with the AUT. Antimicrobial prescriptions were based on hospital guidelines or on the physician's medical knowledge. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients prescribed vancomycin, piperacillin-tazobactam, or levofloxacin during the time period of the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Academic Detailing by the Antimicrobial Utilization Team (AUT)Physicians caring for patients who were prescribed one of three antimicrobials were randomly assigned to academic detailing by the AUT. The AUT would review the antimicrobial prescription and provide consultation to the ordering physician if the prescription is appropriate and provide feedback on a better alternative if inappropriate. | Behavioural | A |
Primary outcome
Proportion of Appropriateness of Antimicrobial Prescriptions in each group.
Time frame: 10-month period
1 secondary outcome
Clinical Cure Rate, Mortality Rate between the two groups
Time frame: 10-month period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
- Derived from this study: PubMed 19712032Camins BC, King MD, Wells JB, Googe HL, Patel M, Kourbatova EV, Blumberg HM. Impact of an antimicrobial utilization program on antimicrobial use at a large teaching hospital: a randomized controlled trial. Infect Control Hosp Epidemiol. 2009 Oct;30(10):931-8. doi: 10.1086/605924.
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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.
Mark D King, MD, MSCR principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Academic Detailing by the Antimicrobial Utilization Team (AUT) in people with Antimicrobial Prescribing Practices, run by Washington University School of Medicine at 1 site in United States.
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 0 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: finished, as of the sponsor's last update on 2 Nov 2007. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Appropriateness of Antimicrobial Prescriptions in each group. (time frame: 10-month period). 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 NCT00552838, which also lists 1 linked publication.
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 2 Nov 2007.