INSPIRE Stewardship Bundle for Skin and Soft Tissue Infections

No longer recruiting at 105 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to improve antibiotic prescribing for skin and soft tissue infections. It compares usual practices with the INSPIRE CPOE Smart Prompt for Skin and Soft Tissue Infection, which provides doctors with real-time advice on selecting the right antibiotics. This system aims to reduce the risk of ineffective antibiotic use due to resistant bacteria. Hospitals admitting adults with these infections and using a specific electronic health record system participate in the study. The trial targets non-critically ill adults prescribed extended-spectrum antibiotics for these infections in non-intensive care settings. As an unphased trial, it offers patients the chance to help improve antibiotic prescribing practices and combat antibiotic resistance.

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 prior data suggests that the INSPIRE CPOE Smart Prompt and Stewardship Bundle are safe for use in hospitals?

Research has shown that the INSPIRE Stewardship Bundle and CPOE Smart Prompt have been tested for safety in earlier studies. These studies evaluated key safety factors, such as the time it took for patients to be moved to the ICU and their total hospital stay. The results indicated that these treatments did not increase these safety concerns.

The CPOE Smart Prompt assists doctors in selecting the appropriate antibiotics, reducing the use of unnecessary broad-spectrum antibiotics and potentially leading to fewer side effects. The studies did not identify any major safety issues with using these prompts.

Overall, past studies have shown that the treatments tested in the trial are well-tolerated. No significant adverse events have been reported, suggesting they are generally safe for managing skin and soft tissue infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the INSPIRE Stewardship Bundle for skin and soft tissue infections because it integrates advanced technology to optimize antibiotic use. Unlike standard care, which relies on routine antibiotic stewardship strategies, this treatment uses a computerized physician order entry (CPOE) smart prompt system. This innovative approach provides real-time guidance, clinician feedback, and supports the adoption of CPOE workflows to improve the empiric choice of antibiotics in the crucial first days of hospitalization. By potentially reducing inappropriate antibiotic use, the INSPIRE Stewardship Bundle aims to enhance patient outcomes and combat antibiotic resistance.

What evidence suggests that the INSPIRE CPOE Smart Prompt and Stewardship Bundle are effective for skin and soft tissue infections?

Research shows that the INSPIRE Stewardship Bundle, which participants in this trial may receive, helps doctors choose the right antibiotics for skin and soft tissue infections. Studies have found that computerized prompts in hospitals reduce the use of broad-spectrum antibiotics. This enables doctors to select more specific treatments, which are often safer and more effective. The smart prompts provide real-time advice, aiding doctors in making better decisions quickly. This approach led to a 28% reduction in the use of extended-spectrum antibiotics. Overall, evidence suggests that this method improves antibiotic selection and patient outcomes. ^{1 2 3 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. contagionlive.com contagionlive.com/view/prompts-in-computerized-order-entry-improve-antimicrobial-treatment-for-skin-soft-tissue-infections

Prompts in Computerized Order Entry Improve ... The INSPIRE 3 trial demonstrates that computerized order entry recommendation prompts can reduce empiric use of broad-spectrum antibiotics in favor of targeted ...

2. ucihealth.org ucihealth.org/-/media/files/pdf/inspire-clinical-trial/2024-jama-im-improving-empiric-antibiotic-selection-for-patients-hospitalized-with-skin-and-softtiss.pdf

Improving Empiric Antibiotic Selection for Patients ... The INSPIRE 3 (Intelligent Stewardship Prompts to Improve. Real-Time Empiric Antibiotic Selection) Skin and Soft Tissue trial was a cluster- ...

3. dcricollab.dcri.duke.edu dcricollab.dcri.duke.edu/sites/NIHKR/KR/GR-Slides-05-31-24.pdf

INSPIRE Abdominal & Skin/Soft Tissue Infection Trials INSPIRE Skin & Soft Tissue Infection Trial Effectiveness Outcomes – As Randomized. CPOE Prompt Group. 28% reduction. Primary Outcome. Extended Spectrum. Days of ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40208610/

The INSPIRE 3 Skin and Soft Tissue Randomized Clinical Trial Data were collected from January 2019 to December 2023. Interventions: CPOE prompts recommending standard-spectrum antibiotics in patients ...

5. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/news/grand-rounds-may-31-2024-inspire-abdominal-skin-soft-tissue-infection-trials-intelligent-stewardship-prompts-to-improve-real-time-empiric-antibiotic-selection-for-patients-shruti-k-gohil-md-m/

INSPIRE Abdominal & Skin/Soft Tissue Infection Trials ... The INSPIRE trials demonstrated the effectiveness of real-time, individualized smart prompts. In both the abdominal infection trial and the ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/56/NCT05423756/SAP_001.pdf

time Empiric Antibiotic Selection for Patients) for Skin The INSPIRE Skin and Soft Tissue (SST) Infections Trial (INtelligent Stewardship. Prompts to Improve Real-time Empiric Antibiotic Selection ...