Antibiotic Stewardship at Discharge for Pneumonia

(ROAD Home Trial)

Overseen By Andrea T White, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Pregnant, Hospice, Spinal cord injury, others

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on antibiotic use at discharge for pneumonia and urinary tract infections.

What data supports the effectiveness of the ROAD Home Intervention treatment for pneumonia?

The ROAD Home Intervention treatment is supported by evidence showing that structured antibiotic stewardship programs, like the Reducing Overuse of Antibiotics at Discharge Home Framework, can improve antibiotic prescribing at hospital discharge. These programs help reduce unnecessary antibiotic use, which is a key component of effective pneumonia management. ^{1 2 3 4 5}

Is the ROAD Home Intervention for antibiotic stewardship safe for humans?

The ROAD Home Intervention, which focuses on improving antibiotic use at hospital discharge, is part of broader antibiotic stewardship efforts that aim to ensure safe and effective antibiotic prescribing. These programs are designed to reduce unnecessary antibiotic use, which can prevent harmful side effects and antibiotic resistance, indicating a focus on patient safety. ^{1 4 6 7 8}

What makes the ROAD Home Intervention treatment unique for pneumonia?

The ROAD Home Intervention is unique because it focuses on improving antibiotic prescribing at hospital discharge, aiming to reduce unnecessary antibiotic use and improve patient outcomes by addressing common issues like excess duration and inappropriate antibiotic choices. ^{1 2 3 4 8}

What is the purpose of this trial?

The goal of this two-arm parallel cluster-randomized trial of 40 hospitals is to test the effectiveness of the ROAD Home Intervention on days of antibiotic overuse at discharge in patients hospitalized with community-acquired pneumonia (CAP) or urinary tract infection (UTI). The main question it aims to answer is: Does an antibiotic stewardship approach that is customized to the needs, goals, and resources of a hospital (i.e., the ROAD Home Intervention) compared to standard stewardship approaches reduce antibiotic overuse at discharge in hospitalized patients with CAP and UTI? The investigators will randomize 20 hospitals in the Michigan Hospital Medicine Safety Consortium (HMS) to the intervention group and 20 HMS hospitals to the "usual care" control group. During the study the investigators will: (a) assess baseline performance, existing stewardship strategies, hospital priorities, and resources; (b) develop a customized discharge stewardship "suite" for each intervention hospital based on the findings of the baseline assessment and informed by the ROAD Home Framework; and (c) support hospitals in selecting strategies and creating an implementation blueprint to be implemented over 12 to 15 months. After the intervention period, the investigators will compare days of antibiotic overuse at discharge and patient outcomes between intervention and "usual care" hospitals. It is hypothesized that hospitals randomized to the ROAD Home Intervention will have fewer days of antibiotic overuse at discharge compared to "stewardship as usual" control hospitals.

Research Team

Valerie M Vaughn, MD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for adult patients hospitalized with pneumonia or a urinary tract infection (UTI) who have normal urinary anatomy, are generally healthy immune-wise, and are admitted to general care. They must not be on antibiotics for other infections and should have received certain antibiotics during their hospital stay.

Inclusion Criteria

You have a positive result on your urine test indicating the presence of bacteria.

My urinary system is normal.

I am currently admitted to a general care unit at a hospital.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Hospitals implement the ROAD Home Intervention, which includes external facilitation and customized antibiotic stewardship strategies

12-15 months

Post-intervention Follow-up

Investigators conduct a mixed-methods process evaluation to assess barriers, facilitators, and implementation outcomes

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 30-day post-discharge outcomes

30 days

Treatment Details

Interventions

• ROAD Home Intervention

Trial Overview The ROAD Home Intervention aims to reduce antibiotic overuse when patients with community-acquired pneumonia or UTI leave the hospital. It compares customized stewardship plans in some hospitals against standard practices in others, measuring antibiotic use after discharge.

Participant Groups

Group I: ROAD Home Intervention Experimental Treatment 1 Intervention

Hospitals randomized to receive the ROAD Home Intervention will receive an implementation intervention that includes external facilitation to support them in selecting and implementing evidence-based antibiotic stewardship strategies based on local context and the ROAD Home framework (https://academic.oup.com/cid/article/74/9/1696/6374407).

Group II: Stewardship as Usual Active Control 1 Intervention

Hospitals randomized to the control group will continue usual antibiotic stewardship activities. Although control hospitals are part of the HMS collaborative, during the intervention period they will not receive any of the ROAD Home Intervention components including analysis of their baseline data or needs assessment, customized suite of stewardship strategies, supported decision-making in selecting ROAD Home strategies to implement, an implementation blueprint, adaptable stewardship tools, or external facilitation from study investigators.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

References

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

Antibiotic Overuse and Stewardship at Hospital Discharge: The Reducing Overuse of Antibiotics at Discharge Home Framework. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[Antibiotic Stewardship in Community-Acquired Pneumonia]. [2020]

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

Sustained Reductions in Overall and Unnecessary Antibiotic Prescribing at Primary Care Clinics in a Veterans Affairs Healthcare System Following a Multifaceted Stewardship Intervention. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Improving antibiotic utilization through an outpatient stewardship initiative. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

It's about the patients: Practical antibiotic stewardship in outpatient settings in the United States. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A framework for implementing antibiotic stewardship in ambulatory care: Lessons learned from the Agency for Healthcare Research and Quality Safety Program for Improving Antibiotic Use. [2022]

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

Next Steps in Ambulatory Stewardship. [2023]

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

Core Elements of Outpatient Antibiotic Stewardship. [2022]