INSPIRE Trial for Skin and Soft Tissue Infections

  • STATUS
    Recruiting
  • End date
    Dec 18, 2028
  • participants needed
    102
  • sponsor
    Harvard Pilgrim Health Care
Updated on 7 October 2022

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.

Details
Condition Skin and Soft Tissue (SST) Infection
Treatment Arm 1: Routine care, Arm 2: INSPIRE CPOE Smart Prompt for Skin and Soft Tissue Infection
Clinical Study IdentifierNCT05423756
SponsorHarvard Pilgrim Health Care
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

HCA Healthcare hospitals admitting adults for skin and soft tissue infection
Facility use of MEDITECH as their electronic health record system

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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