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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 Stewardship Bundle 		Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.
  • Other: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection
    Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.

More Details

Status
Active, not recruiting
Sponsor
Harvard Pilgrim Health Care

Study Contact

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.