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INSPIRE Trial for Skin and Soft Tissue Infections

Harvard Pilgrim Health Care logo

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)

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

Trial contacts and locations

102

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Central trial contact

Micaela Coady, MS; Shruti Gohil, MD, MPH

Data sourced from clinicaltrials.gov

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