Antibiotic Resistant InfectionNCT01573195
Merck IISP Stewardship Grant for Antibiotic Best Practices
An observational study of Antibiotic Resistant Infection, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to pilot the use of best practices alerts to enhance an antimicrobial stewardship program using the electronic medical record, EPIC. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Resistant Infection
- How many people
- 1,285 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Apr 2012
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1285 consecutive patients issued BPA for de-escalation of antibiotics in EPIC
Who may be able to join
- Physicians with prescribing privileges at the UWHC
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Implementation of Antimicrobial Stewardship and Decision Support Into the EPIC Electronic Medical Record
The purpose of this study is to pilot the use of best practices alerts to enhance an antimicrobial stewardship program using the electronic medical record, EPIC.
Read the detailed description
The purpose of this study is to pilot the use of best practices to enhance an antimicrobial stewardship program using the electronic medical record, EPIC. Screening information technology tools via SETNET/Safety SUrveyor(Premier) and the electronic anti-infective order form would allow for sufficient medical record review to create best practices alerts for the purpose of appropriate de-escalation of anti-invectives.
- Conditions
- Antibiotic Resistant Infection
- Keywords
- deescalation, best practice alert, antimicrobial stewardship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All prescribing MDs at UWHC | Observational for accept, reject, or accept with modification of Best Practice Alers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of best practice alerts(BPA) that were completely accepted, partially accepted, or rejected within 72 hours of issuing the BPA
after issuing the BPA for deescalation, the responding healthcare provider will respond in one of the manners above
Measured: One Year
Secondary outcomes (1)
The number and type of antiinfectives that were administered before and after(11days) the best practice alert is issued.
The antiinfective use before and after the BPA will be analyzed in detail. The number of antibiotics, percentage decrease(or less likely increase) in antiinfectives in the 3 days before BPA , and 11 days after the BPA will be analyzed. A cost analysis will be performed. Patient outcomes will not be assessed.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionApr 2012
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 Antibiotic Resistant InfectionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 1,285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barry C Fox, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573195
- Sponsor's protocol ID
- 2012-0168 (MSN141105)
- Other IDs
- Merk Dr Fox
- Status last verified
- Dec 2014
- First submitted
- 4 May 2011
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Schulz L, Osterby K, Fox B. The use of best practice alerts with the development of an antimicrobial stewardship navigator to promote antibiotic de-escalation in the electronic medical record. Infect Control Hosp Epidemiol. 2013 Dec;34(12):1259-65. doi: 10.1086/673977. Epub 2013 Oct 28.
PubMed 24225610
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Antimicrobial Stewardship and Decision Support Into the EPIC Electronic Medical Record
- ClinicalTrials.gov ID
- NCT01573195
- Acronym / sponsor ID
- 2012-0168 (MSN141105)
- Conditions
- Antibiotic Resistant Infection
- Keywords
- deescalation, best practice alert, antimicrobial stewardship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,285 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Apr 2012 (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.
The purpose of this study is to pilot the use of best practices alerts to enhance an antimicrobial stewardship program using the electronic medical record, EPIC.
Detailed description
The purpose of this study is to pilot the use of best practices to enhance an antimicrobial stewardship program using the electronic medical record, EPIC. Screening information technology tools via SETNET/Safety SUrveyor(Premier) and the electronic anti-infective order form would allow for sufficient medical record review to create best practices alerts for the purpose of appropriate de-escalation of anti-invectives.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All prescribing MDs at UWHC | – | –Observational for accept, reject, or accept with modification of Best Practice Alers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1285 consecutive patients issued BPA for de-escalation of antibiotics in EPIC
Key inclusion criteria (1 listed)
- Physicians with prescribing privileges at the UWHC
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of best practice alerts(BPA) that were completely accepted, partially accepted, or rejected within 72 hours of issuing the BPA
Time frame: One Year
after issuing the BPA for deescalation, the responding healthcare provider will respond in one of the manners above
1 secondary outcome
The number and type of antiinfectives that were administered before and after(11days) the best practice alert is issued.
Time frame: One year
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 18 Dec 2014.
- Results publication: PubMed 24225610Schulz L, Osterby K, Fox B. The use of best practice alerts with the development of an antimicrobial stewardship navigator to promote antibiotic de-escalation in the electronic medical record. Infect Control Hosp Epidemiol. 2013 Dec;34(12):1259-65. doi: 10.1086/673977. Epub 2013 Oct 28.
- ICHE publicationLink provided by the sponsor.
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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.
Barry C Fox, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Resistant Infection, run by University of Wisconsin, Madison 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 1 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 18 Dec 2014. 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?
Percentage of best practice alerts(BPA) that were completely accepted, partially accepted, or rejected within 72 hours of issuing the BPA (time frame: One Year). 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 NCT01573195, 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 18 Dec 2014.