Smart Antibiotic Use Prompt for Pneumonia

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help doctors select the best antibiotics for adults hospitalized with pneumonia. It compares standard antibiotic practices with the INSPIRE CPOE Smart Prompt, a smart computer prompt that provides real-time advice on the likelihood of a difficult-to-treat infection. The trial takes place in hospitals using a specific electronic record system and focuses on patients not in intensive care. Patients with pneumonia treated in these hospitals might find this trial suitable. As an unphased trial, it offers the chance to contribute to innovative research that could enhance pneumonia treatment strategies.

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

The trial information does not specify whether you need to stop taking your current medications. It focuses on hospitals using a computerized system to guide antibiotic use for pneumonia.

What prior data suggests that this protocol is safe for pneumonia patients?

Research shows that the INSPIRE CPOE Smart Prompt is generally safe for assisting doctors in selecting antibiotics for pneumonia in non-ICU patients. This digital tool helps by indicating the likelihood of a resistant infection. Studies have demonstrated that similar smart prompts improve antibiotic selection without adding risks to patients. Available data report no safety concerns from these prompts. Since this trial phase is labeled as "not applicable," it focuses on the tool's effectiveness rather than testing a new drug's safety, indicating that the smart prompt is already considered safe for this purpose. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the INSPIRE CPOE Smart Prompt because it offers a new way to guide doctors in choosing antibiotics for pneumonia in non-ICU patients. Unlike standard care, which relies on general antibiotic stewardship strategies, this computerized system provides timely, evidence-based alerts directly to physicians. This approach aims to optimize antibiotic selection early in the hospital stay, potentially improving patient outcomes and reducing antibiotic resistance.

What evidence suggests that the INSPIRE CPOE Smart Prompt is effective for pneumonia?

In this trial, participants will be assigned to one of two groups. Research has shown that the INSPIRE CPOE Smart Prompt, which some participants will use, can help doctors select better antibiotics for pneumonia patients. Studies have found that similar smart prompts improved antibiotic choices for other infections, such as those in the abdomen and skin. Although the length of hospital stays and ICU transfers showed little change, the prompt improved the accuracy of antibiotic selection. This improvement could help reduce unnecessary antibiotic use, which is crucial for combating antibiotic resistance. Overall, the smart prompt is designed to assist doctors in making better treatment decisions in real-time. ^{1 3 4 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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.

I'm sorry, but the criterion "Facility" is too general to be rewritten in simpler language. Could you please provide more context or details so that I can assist you more effectively?

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11185977/

Stewardship Prompts to Improve Antibiotic Selection for ...

Primary, Secondary, and Safety Outcomes in the INSPIRE Pneumonia Trial. Effectiveness outcomes, CPOE bundle, Routine stewardship, Overall rate ...

2.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/70/NCT03697070/SAP_001.pdf

INSPIRE-ASP Pneumonia Trial Statistical Analysis Plan

Trial outcomes evaluating intervention effectiveness are found in Table 1 below and trial safety outcomes are found in Table 2 below. Table 1: ...

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.

cidrap.umn.edu

cidrap.umn.edu/antimicrobial-stewardship/computerized-stewardship-prompt-linked-improved-antibiotic-prescribing-2

Computerized stewardship prompt linked to improved ...

In INSPIRE Pneumonia, mean days to ICU transfer (6.5 vs 7.1 days) and length of hospital stay (6.8 vs 7.1 days) were not significantly different ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11185978/

Stewardship Prompts to Improve Antibiotic Selection for ...

This study evaluated the effect of the INSPIRE antibiotic stewardship bundle, consisting of education, feedback, and computerized provider order ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03697070

Study Details | NCT03697070 | The INSPIRE-ASP PNA Trial

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 ...

7.

academic.oup.com

academic.oup.com/ofid/article/12/Supplement_1/ofae631.059/7987333

179. INSPIRE Trial: A 92-Hospital Cluster Randomized Trial of ...

This 92-hospital cluster-randomized trial compared CPOE prompts providing patient-specific absolute risk estimates for MDRO SST infection and ...