INSPIRE Trial for Skin and Soft Tissue Infections

Harvard Pilgrim Health Care

Status: Active, not recruiting

Conditions: Skin and Soft Tissue (SST) Infection

Treatments: Other: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection; Other: Arm 1: Routine Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05423756

PH000763B_SST

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Facility 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Arm 1: Routine Care

Active Comparator group

Description:

Continuation of routine antibiotic stewardship strategies.

Treatment:

Other: Arm 1: Routine Care

Arm 2: INSPIRE Stewardship Bundle

Active Comparator group

Description:

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.

Treatment:

Other: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection