Smart Antibiotic Use Prompt for Pneumonia

Recruiting at 58 trial locations

Overseen By Shruti K Gohil, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Pilgrim Health Care

Must be taking: Extended-spectrum antibiotics

Disqualifiers: Prisoners

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 days

44780 Participants Needed

Trial Summary

What is the purpose of this trial?

The INSPIRE-ASP PNA trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with PNA is infected with a resistant pathogen. Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.

Research Team

Richard Platt, MD, MS

Principal Investigator

Harvard Pilgrim Health Care Institute

Susan Huang, MD, MPH

Principal Investigator

UC Irvine Div Infectious Diseases

Shruti Gohil, MD, MPH

Principal Investigator

UC Irvine Div Infectious Diseases

Eligibility Criteria

The INSPIRE-ASP PNA Trial is for HCA hospitals using MEDITECH electronic health records, admitting non-critically ill adults with pneumonia. It's not about individual patients but the facilities themselves.

Inclusion Criteria

The clinical trial is for adults with pneumonia who are admitted to HCA hospitals.

The medical facility uses MEDITECH as their electronic health record system.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Use of computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for PNA in non-ICU patients

3 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

Extended Monitoring

Monitoring of extended-spectrum antibacterial treatment and incidence of hospital-onset infections

15 months

Treatment Details

Interventions

• INSPIRE CPOE Smart Prompt
• Routine Care

Trial Overview This trial tests routine care against a smart system that tells doctors the chance of a pneumonia patient having a resistant infection. Hospitals are randomly chosen to use either standard methods or this new computer prompt.

Participant Groups

Group I: INSPIRE CPOE Smart Prompt Active Control 1 Intervention

Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for PNA in non-ICU patients in the first 3 days of hospitalization.

Group II: Routine Care Active Control 1 Intervention

Continued 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+

Hospital Corporation of America Healthcare (HCA)

Collaborator

Trials

2

Recruited

100,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+