INSPIRE Stewardship Bundle for Skin and Soft Tissue Infections

Recruiting at 101 trial locations

Overseen By Shruti Gohil, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Pilgrim Health Care

Must be taking: Extended-spectrum antibiotics

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

102 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a computer system that helps doctors choose the right antibiotics for adults with skin infections by predicting if the infection will resist common treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the INSPIRE Stewardship Bundle for Skin and Soft Tissue Infections treatment?

Research shows that using electronic alerts and multifaceted interventions can improve how doctors treat skin and soft tissue infections by increasing the rate of cultures taken and reducing inappropriate antibiotic use. ^{1 2 3 4 5}

How is the INSPIRE Stewardship Bundle for Skin and Soft Tissue Infections treatment different from other treatments?

The INSPIRE Stewardship Bundle for Skin and Soft Tissue Infections is unique because it combines a smart prompt system with a comprehensive stewardship program to improve antibiotic use, focusing on reducing inappropriate antibiotic duration and enhancing adherence to guidelines, which is not typically emphasized in standard care. ^{1 3 5 6 7}

Research Team

Shruti Gohil, MD, MPH

Principal Investigator

UC Irvine Division of Infectious Diseases

Susan Huang, MD, MPH

Principal Investigator

UC Irvine Division of Infectious Diseases

Richard Platt, MD, MS

Principal Investigator

Harvard Pilgrim Health Care Institute/Harvard Medical School

Eligibility Criteria

The INSPIRE trial is for HCA Healthcare hospitals using MEDITECH electronic health records, admitting non-critically ill adults with skin and soft tissue infections. It's not about individual patients but the hospital practices.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of routine empiric antibiotic stewardship practices and CPOE smart prompts for the first 3 days of hospitalization

3 days

Hospital-based intervention

Follow-up

Monitoring of outcomes such as MDRO-positive cultures, antibiotic costs, and ICU transfers over a 12-month period

12 months

Treatment Details

Interventions

• INSPIRE CPOE Smart Prompt for Skin and Soft Tissue Infection
• INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection
• Routine Care

Trial Overview This study compares routine care against a new 'Stewardship Bundle' that uses smart software prompts to guide antibiotic use, aiming to improve treatment by predicting resistant infections in real-time.

Participant Groups

Group I: Arm 2: INSPIRE Stewardship Bundle Active Control 1 Intervention

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.

Group II: Arm 1: Routine Care Active Control 1 Intervention

Continuation of routine antibiotic stewardship strategies.

Who Is Running the Clinical Trial?

Harvard Pilgrim Health Care

Lead Sponsor

Trials

61

Recruited

27,990,000+

Hospital Corporation of America

Industry Sponsor

Trials

8

Recruited

3,433,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

HCA Healthcare, Inc

Collaborator

Trials

2

Recruited

200+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of an electronic alert on treatment of skin and soft tissue infections. [2015]

2. Egypt pubmed.ncbi.nlm.nih.gov

The use of an early alert system to improve compliance with sepsis bundles and to assess impact on mortality. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Inpatient Management of Uncomplicated Skin and Soft Tissue Infections in 34 Veterans Affairs Medical Centers: A Medication Use Evaluation. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Severe and complicated soft tissue infections: a single-centre case series. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A multifaceted intervention improves antibiotic stewardship for skin and soft tissues infections. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of Antimicrobial Stewardship Program Guidance on the Management of Uncomplicated Skin and Soft Tissue Infections in Hospitalized Adults. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Fast track SSTI management program based on a rapid molecular test (GeneXpert® MRSA/SA SSTI) and antimicrobial stewardship. [2020]