Purpose

The INSPIRE Skin and Soft Tissue Infection trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with skin and soft tissue infection is infected with a resistant pathogen. Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. HCA Healthcare hospitals admitting adults for skin and soft tissue infection 2. Facility use of MEDITECH as their electronic health record system Facility

Exclusion Criteria

  • Note: unit of randomization is the hospital, however the computerized physician order entry (CPOE) alert intervention will calculate risk estimates for adults age >=18 admitted to non-intensive care unit wards and who are ordered to receive extended-spectrum antibiotics for skin and soft tissue infection.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Cluster randomized controlled trial
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm 1: Routine Care
Continuation of routine antibiotic stewardship strategies.
  • Other: Arm 1: Routine Care
    Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards
Active Comparator
Arm 2: INSPIRE CPOE Smart Prompt
Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for skin and soft tissue infection in non-critically ill patients in the first 3 days of hospitalization.
  • Other: Arm 2: INSPIRE CPOE Smart Prompt for Skin and Soft Tissue Infection
    Quality improvement intervention: computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimate of having a skin and soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends appropriate antibiotic choice for non-critically ill patients in the first 3 days of hospitalization. Continuation of other antibiotic stewardship activities in accordance with national standards.

Recruiting Locations

Tulane Medical Center
New Orleans, Louisiana 70112

More Details

Status
Recruiting
Sponsor
Harvard Pilgrim Health Care

Study Contact

Micaela Coady, MS
617-867-4880
micaela_coady@harvardpilgrim.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.