ANti-infective Stewardship Using the Wisca Tool in the Electronic Medical Record (ANSWER)
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|ClinicalTrials.gov Identifier: NCT03397433|
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : July 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Infections||Other: Information Technology physician assist||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9673 participants|
|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)|
|Official Title:||ANti-infective Stewardship Using the Wisca Tool in the Electronic Medical Record|
|Actual Study Start Date :||June 15, 2015|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||June 30, 2019|
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.
- Changes in length of stay [ Time Frame: 36 months ]Changes in length of hospital stay (in days) between intervention and control groups
- Rapid response to initial therapy [ Time Frame: 36 Months ]Duration of treatment (in days) between intervention and control groups
- 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
- Lower mortality [ Time Frame: 36 months ]Rate of inpatient mortality between intervention and control groups
- Reduced adverse events [ Time Frame: 36 months ]Rate of adverse events from antibacterial therapy between intervention and control groups
- 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
- 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
- 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
- Reduced therapy cost [ Time Frame: 36 months ]Antimicrobial drug cost between intervention and control groups
- Less antimicrobial resistance [ Time Frame: 36 months ]Antimicrobial resistance rates between intervention and control groups
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
|United States, Illinois|
|NorthShore University HealthSystem Research Institute|
|Evanston, Illinois, United States, 60201|
|Principal Investigator:||Lance R Peterson, MD||NorthShore University HealthSystem|