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ANti-infective Stewardship Using the Wisca Tool in the Electronic Medical Record (ANSWER)

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ClinicalTrials.gov Identifier: NCT03397433
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Lance Peterson, NorthShore University HealthSystem Research Institute

Brief Summary:
Beginning in the mid-to late 1980s and accelerating through the 1990s and 2000s the shield of antibiotic invincibility began to crack sufficiently so that it was apparent to everyone we faced a serious problem. The investigators will demonstrate and expand the use of information technology based on the ingenious weighted-incidence, syndromic, combination antibiogram (WISCA) tool for the widespread use of automated clinician prompts enhancing empiric antibiotic therapy as part of a comprehensive infection control stewardship program that reduces antibiotic resistance. This research program will demonstrate that use of such a tool lowers mortality, improves outcome, lowers antimicrobial resistance and reduces healthcare cost.

Condition or disease Intervention/treatment Phase
Bacterial Infections Other: Information Technology physician assist Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a prospective, pragmatic trial of initial antibiotic prescribing review by Infectious Disease Specialists. The study involves 4 hospitals, 2 of which are intervention and 2 control for 18 months, followed by switching the intervention and control hospitals in a crossover fashion for another 18 months. Medical and economic outcomes will be assessed and reported
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ANti-infective Stewardship Using the Wisca Tool in the Electronic Medical Record
Actual Study Start Date : June 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention

In this arm, an Information Technology physician assist tool will be used to predict best available therapy for patients coming to the hospital with either pneumonia, cellulitis, intraabdominal infection, or complicated urinary tract infection.

Intervention: After review of the information technology recommendation by a board certified Infectious Disease physician, the recommendation will be discussed with the primary care physician and treatment implemented.

Other: Information Technology physician assist
The intervention hospitals will have a progress note placed in the electronic health record by a reviewing Infectious Disease specialist that comments on the initial antibiotic choice. The comment is based on an electronic prediction tool (Information Technology physician assist) as to what the best therapy is for the individual patient whose health record is reviewed.

No Intervention: Control
In the two control hospitals there will be no use of the information technology tool for implementation of initial treatment (No intervention). No notes will be placed in the electronic health record and no contact as a result of this research will be made with the medical care team.



Primary Outcome Measures :
  1. Changes in length of stay [ Time Frame: 36 months ]
    Changes in length of hospital stay (in days) between intervention and control groups

  2. Rapid response to initial therapy [ Time Frame: 36 Months ]
    Duration of treatment (in days) between intervention and control groups

  3. Reduced cost of ancillary testing [ Time Frame: 36 months ]
    Rate of use of therapeutic drug monitoring between intervention and control groups - ancillary testing such as therapeutic drug monitoring adds to cost of anti-infective therapy and use of fewer antibiotics when they are not needed is expected to reduce this cost

  4. Lower mortality [ Time Frame: 36 months ]
    Rate of inpatient mortality between intervention and control groups

  5. Reduced adverse events [ Time Frame: 36 months ]
    Rate of adverse events from antibacterial therapy between intervention and control groups

  6. Improved response to Infectious Disease therapy [ Time Frame: 36 months ]
    Rate of change between admission and discharge location (with the goal being fewer persons needing skilled care after discharge than is now required) between intervention and control groups - improved therapy is expected to give a better response and permit patients to return home rather than needing to go to a skilled nursing facility following their inpatient therapy

  7. Reduced occurrence of infection recurrence [ Time Frame: 36 months (the total time frame of the crossover study) ]
    30 day readmission rates (for repeated infection therapy) between intervention and control groups is a measure that is expected to differentiate between patients who receive optimal therapy that avoids recurrence of infection from those who do not

  8. Fewer unintended consequences of antibiotic use [ Time Frame: 36 months ]
    Rates of Clostridium difficile infection between intervention and control groups - antibiotic use is the main cause of the unintended consequence of Clostridium difficile infection and less antibiotic use is expected to have a lower rate of Clostridium difficile infection in the intervention group

  9. Reduced therapy cost [ Time Frame: 36 months ]
    Antimicrobial drug cost between intervention and control groups

  10. Less antimicrobial resistance [ Time Frame: 36 months ]
    Antimicrobial resistance rates between intervention and control groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any person admitted to the hospital with pneumonia, cellulitis, intraabdominal infection, or urinary tract infection

Exclusion Criteria:

  • Any person without the 4 studied infections

Information from the National Library of Medicine

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): NCT03397433


Contacts
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Contact: Lance R Peter, MD 8475701637 lance1@uchicago.edu
Contact: Susan Boehm, RN 9475702420 sboehm@northshore.org

Locations
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United States, Illinois
NorthShore University HealthSystem Research Institute Recruiting
Evanston, Illinois, United States, 60201
Contact: Lance R Peterson, MD    847-570-2420    lance1@uchicago.edu   
Contact: Parul Patel, MT(ASCP)    847-926-5860    ppatel@northshore.org   
Principal Investigator: Lance R Peterson, MD         
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
Investigators
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Principal Investigator: Lance R Peterson, MD NorthShore University HealthSystem

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Responsible Party: Lance Peterson, Principal Investigator, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT03397433     History of Changes
Other Study ID Numbers: EH13-368
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Keywords provided by Lance Peterson, NorthShore University HealthSystem Research Institute:
Antibiotic Stewardship
Information Technology
Healthcare Outcomes
Antibiotic Resistance
Bacterial Infection

Additional relevant MeSH terms:
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Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents