INSPIRE Trial for Skin and Soft Tissue Infections

Summary

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.

Conditions

• Skin and Soft Tissue (SST) Infection

Interventions

OTHER

Arm 1: Routine Care

Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.

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.

Sponsors & Collaborators

• Hospital Corporation of America

  collaborator INDUSTRY

• University of California, Irvine

  collaborator OTHER

• University of Massachusetts, Amherst

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Rush University

  collaborator OTHER

• Harvard Pilgrim Health Care

  lead OTHER

Principal Investigators

• Shruti Gohil, MD, MPH · UC Irvine Division of Infectious Diseases

• Susan Huang, MD, MPH · UC Irvine Division of Infectious Diseases

• Richard Platt, MD, MS · Harvard Pilgrim Health Care Institute/Harvard Medical School

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2024-05-09

Completion

2024-05-09

Countries

• United States

Study Locations