INSPIRE Stewardship Bundle for Abdominal Infections

No longer recruiting at 104 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve antibiotic use in hospitals for non-critically ill adults with abdominal infections. It compares the usual method of selecting antibiotics with a new system, the INSPIRE CPOE Smart Prompt for Abdominal Infection, which provides real-time advice through smart prompts. This guidance helps doctors choose the best antibiotics based on the likelihood of antibiotic resistance. The trial focuses on adults admitted to HCA Healthcare hospitals who have been prescribed extended-spectrum antibiotics for abdominal infections. Participants are from hospitals using a specific electronic health record system called MEDITECH. As an unphased trial, this study allows participants to contribute to innovative research that could enhance antibiotic use and patient care in hospitals.

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

Research has shown that computerized tools, like the smart prompts in the INSPIRE Stewardship Bundle, can help doctors choose better antibiotics for abdominal infections. These smart prompts are digital aids, not medications or physical treatments, that assist doctors in selecting the most effective antibiotics.

Studies comparing these smart prompts to usual practices focused more on effectiveness than safety, as the prompts themselves don't directly affect health. No reports of negative effects from using these prompts have emerged. Instead, these tools help in selecting the right antibiotics, indirectly enhancing patient safety by reducing the risk of antibiotic resistance.

While specific safety data for the smart prompts themselves is lacking, they are considered a safe addition to current methods for treating abdominal infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the INSPIRE Stewardship Bundle for abdominal infections because it introduces a smart, tech-driven approach to guide antibiotic use. Unlike standard antibiotic stewardship methods, which typically rely on clinician judgment and existing protocols, this bundle uses computerized physician order entry (CPOE) smart prompts to support decision-making right from the start of hospitalization. This method aims to enhance the accuracy and speed of empiric antibiotic choices, potentially improving patient outcomes and reducing antibiotic resistance. The integration of clinician feedback and educational activities further supports the adoption of these smart prompts, making it a comprehensive strategy to tackle abdominal infections effectively.

What evidence suggests that the INSPIRE Stewardship Bundle and CPOE Smart Prompt could be effective for abdominal infections?

In this trial, participants will be assigned to one of two treatment arms. Research has shown that the INSPIRE Stewardship Bundle for Abdominal Infection, one of the treatment arms, uses smart prompts through a computer system to improve antibiotic use. In earlier studies, hospitals using this system made better antibiotic choices for abdominal infections. These smart prompts assist doctors in selecting the right antibiotics by providing real-time advice. This method has led to reduced use of broad-spectrum antibiotics, helping to prevent antibiotic resistance. Overall, the INSPIRE system has proven effective in aiding doctors to make better antibiotic choices, thereby improving treatment for patients with abdominal infections. ^{1 2 3 4 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?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05423743

NCT05423743 | INSPIRE Trial for Abdominal Infections The INSPIRE Abdominal Infection Trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40208583/

The INSPIRE 4 Cluster Randomized Clinical Trial - PubMed This 92-hospital cluster randomized clinical trial assessed the effect of an antibiotic stewardship bundle with CPOE prompts vs routine stewardship on ...

3. 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 ...

4. ucihealth.org ucihealth.org/-/media/files/pdf/inspire-clinical-trial/2024-jama-surgery-improving-empiric-antibiotic-selection-for-patients-hospitalized-with-abdominal-in.pdf

Improving Empiric Antibiotic Selection for Patients ... ... (INSPIRE) for Abdominal Infection Routine. Stewardship vs Computerized Provider Order Entry (CPOE) Bundle on Trial Effectiveness and Safety Outcomes. 4. 2. 1.

5. cidrap.umn.edu cidrap.umn.edu/antimicrobial-stewardship/computerized-stewardship-alert-tied-improved-antibiotic-prescribing-skin

Computerized stewardship alert tied to improved antibiotic ... In two INSPIRE trials published in April 2024, the same team reported similar reductions in extended-spectrum antibiotic prescribing for ...

6. academic.oup.com academic.oup.com/ofid/article/12/Supplement_1/ofae631.150/7987553

444. SHEA FEATURED ORAL ABSTRACT: INSPIRE Trial: A ... This 92-hospital cluster-randomized trial compared CPOE prompts providing patient-specific absolute risk estimates for MDRO abdominal infection ...