INSPIRE Trial for Abdominal Infections

Harvard Pilgrim Health Care

Status: Completed

Conditions: Abdominal (ABD) Infection

Treatments: Other: Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection; Other: Arm 1: Routine Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05423743

PH000763B_ABD

Details and patient eligibility

About

The INSPIRE Abdominal 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 abdominal 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: 198,480 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 abdominal 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 abdominal infection.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198,480 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 abdominal infection in the first 3 days of hospitalization.

Treatment:

Other: Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection