INSPIRE Stewardship Bundle for Abdominal Infections

Recruiting at 100 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

Disqualifiers: Under 18, Intensive care, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 days

102 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a computer system that helps doctors choose the best antibiotics for non-critically ill adults with abdominal infections. The system shows how likely it is that an infection is resistant to common antibiotics. This aims to improve treatment decisions and outcomes for these patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the INSPIRE Stewardship Bundle for Abdominal Infections treatment?

Research shows that using bundles, which are sets of best practices, can improve patient outcomes, such as reducing infections after surgery. Additionally, electronic alert systems have been effective in improving the timely administration of treatments, which can lead to better compliance and outcomes in managing conditions like sepsis. ^{1 2 3 4 5}

What makes the INSPIRE Stewardship Bundle for Abdominal Infections unique compared to other treatments?

The INSPIRE Stewardship Bundle for Abdominal Infections is unique because it uses a smart prompt system within a computerized order entry to ensure timely and consistent application of treatment guidelines, which can improve patient outcomes by enhancing compliance with recommended care practices. ^{1 5 6 7 8}

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

This trial is for HCA Healthcare hospitals that admit adults with abdominal infections and use MEDITECH electronic health record systems. It's not about individual patients, but the hospitals themselves are the 'subjects' being studied.

Inclusion Criteria

HCA Healthcare hospitals admitting adults for abdominal infection

Facility use of MEDITECH as their electronic health record system

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Routine empiric antibiotic stewardship practices compared with CPOE smart prompts for the first 3 days of hospitalization

3 days

In-hospital monitoring

Extended Treatment

Monitoring and treatment with extended-spectrum antibiotics from hospital days 4 to 14

11 days

In-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• INSPIRE CPOE Smart Prompt for Abdominal Infection
• INSPIRE Stewardship Bundle for Abdominal Infection
• Routine Care

Trial Overview The INSPIRE Trial compares usual antibiotic treatments in hospitals to a new method using computer prompts that help doctors guess if an infection is resistant to antibiotics. Hospitals are grouped and randomly assigned to one of these two approaches.

Participant Groups

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

Continuation of routine antibiotic stewardship strategies.

Group II: 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 abdominal infection in the first 3 days of hospitalization.

Who Is Running the Clinical Trial?

Harvard Pilgrim Health Care

Lead Sponsor

Trials

61

Recruited

27,990,000+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

Hospital Corporation of America

Industry Sponsor

Trials

8

Recruited

3,433,000+

HCA Healthcare, Inc

Collaborator

Trials

2

Recruited

200+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Findings from Research

A survey of 98 healthcare providers revealed that 69% approved of the electronic alert system for acute kidney injury (AKI), indicating a generally positive reception among physicians, pharmacists, and non-physician providers.

Approval of the alert system was strongly linked to the belief that it improved patient care, but notably, approval decreased by 20% for every additional 30 days of trial duration, highlighting the importance of perceived efficacy over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider acceptance of an automated electronic alert for acute kidney injury. Oh, J., Bia, JR., Ubaid-Ullah, M., et al.[2020]

References

1. 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]

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

A clinical trial comparing physician prompting with an unprompted automated electronic checklist to reduce empirical antibiotic utilization. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Provider acceptance of an automated electronic alert for acute kidney injury. [2020]

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

Early Identification of Severe Sepsis in Pediatric Patients Using an Electronic Alert System. [2023]

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

Using Bundled Interventions to Reduce Surgical Site Infection After Major Gynecologic Cancer Surgery. [2021]

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

The Impact of Care Bundles on the Incidence of Surgical Site Infections: A Systematic Review. [2023]

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

Bundled Care to Reduce Sepsis Mortality: The Improving Pediatric Sepsis Outcomes (IPSO) Collaborative. [2023]

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

Do surgical care bundles reduce the risk of surgical site infections in patients undergoing colorectal surgery? A systematic review and cohort meta-analysis of 8,515 patients. [2022]