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

NCT03397433 | Completed DMC

• 1 other identifier: EH13-368
• Study Type: interventional
• Target: 9,673
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Infections

Keywords

Antibiotic Stewardship; Information Technology; Healthcare Outcomes; Antibiotic Resistance; Bacterial Infection

Outcome Measures

Primary Outcomes (10)

• Changes in length of stay

  Changes in length of hospital stay (in days) between intervention and control groups

  36 months

• Rapid response to initial therapy

  Duration of treatment (in days) between intervention and control groups

  36 Months

• Reduced cost of ancillary testing

  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

  36 months

• Lower mortality

  Rate of inpatient mortality between intervention and control groups

  36 months

• Reduced adverse events

  Rate of adverse events from antibacterial therapy between intervention and control groups

  36 months

• Improved response to Infectious Disease therapy

  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

  36 months

• Reduced occurrence of infection recurrence

  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

  36 months (the total time frame of the crossover study)

• Fewer unintended consequences of antibiotic use

  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

  36 months

• Reduced therapy cost

  Antimicrobial drug cost between intervention and control groups

  36 months

• Less antimicrobial resistance

  Antimicrobial resistance rates between intervention and control groups

  36 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Information Technology physician assist OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any person without the 4 studied infections

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem Research Institute

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• Lance R Peterson, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 12, 2018
• Study Start: June 15, 2015
• Primary Completion: July 31, 2018
• Study Completion: June 30, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

US (1)