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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how to better manage antibiotics for patients discharged after treatment for pneumonia or a urinary tract infection (UTI). It compares a new strategy, the ROAD Home Intervention, which customizes antibiotic plans for each hospital, to the usual antibiotic management. The goal is to determine if this new approach can reduce unnecessary antibiotic use. Suitable participants have been hospitalized for pneumonia or a UTI, received antibiotics during their stay, and do not have other infections or conditions affecting their immunity. As an unphased trial, this study allows patients to contribute to innovative strategies that could enhance antibiotic management for future patients.

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 prior data suggests that the ROAD Home Intervention is safe for reducing antibiotic overuse at discharge?

Research has shown that programs like the ROAD Home Intervention can help reduce the overuse of antibiotics. These programs shorten the duration of unnecessary antibiotic use, leading to better health outcomes for patients.

The ROAD Home Intervention creates customized antibiotic use plans for each hospital. This personalized approach has been linked to fewer days of unnecessary antibiotic use. Evidence suggests that hospitals using similar programs have reduced antibiotic overuse without major safety concerns, indicating the intervention is generally safe.

Overall, while specific reports of negative effects are absent, the available data supports the safety and effectiveness of this type of program in reducing antibiotic overuse. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ROAD Home Intervention because it offers a new approach to antibiotic stewardship at hospital discharge for pneumonia patients. Unlike the standard care, which involves routine stewardship practices, this intervention provides hospitals with tailored strategies based on their specific needs and context. The ROAD Home framework includes external facilitation and adaptable tools that help hospitals implement evidence-based practices effectively. This personalized support could lead to more efficient and safer use of antibiotics, potentially reducing resistance and improving patient outcomes.

What evidence suggests that the ROAD Home Intervention is effective for reducing antibiotic overuse at discharge in patients with CAP and UTI?

Research has shown that the ROAD Home Intervention, which participants in this trial may receive, can help reduce unnecessary antibiotic use when patients leave the hospital. One study found that hospitals using this method had fewer days of unnecessary antibiotic use compared to those that did not. The program tailors antibiotic plans to fit each hospital's needs, helping to manage and reduce unnecessary use. Evidence suggests that organized antibiotic strategies, like those in the ROAD Home framework, lead to better results in reducing overuse. This approach provides tools and support to help hospitals make informed decisions about when and how to use antibiotics. ^{2 4 6 7 8}

Who Is on the Research Team?

Valerie M Vaughn, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10910678/

Protocol for a parallel cluster randomized trial ... The objective of this study is to evaluate the effectiveness of the Reducing Overuse of Antibiotics at Discharge Home multicomponent ...

2. withpower.com withpower.com/trial/phase-pneumonia-10-2023-06a1d

Antibiotic Stewardship at Discharge for Pneumonia (ROAD ... The ROAD Home Intervention treatment is supported by evidence showing that structured antibiotic stewardship programs, like the Reducing Overuse of Antibiotics ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9390953/

Antibiotic Stewardship Strategies and Their Association ... Association of ROAD Home Tiers With Antibiotic Overuse at Discharge. When weighted by ROAD Home Tier, having more weighted stewardship interventions was ...

4. academic.oup.com academic.oup.com/cid/article/78/6/1412/7459856

Excellence in Antibiotic Stewardship: A Mixed-Methods Study ... Antibiotic stewardship interventions as described in the ROAD Home model where Tier 1 is critical infrastructure (eg, dedicated stewardship ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2804780

Implementation of an Antibiotic Stewardship Initiative in a ... This study's findings suggest that a multifaceted antibiotic stewardship initiative was associated with reduced antibiotic prescribing for UC respiratory ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9427146/

A Statewide Collaborative Quality Initiative to Improve ... Several studies have demonstrated that antibiotic stewardship interventions can decrease excessive-duration antibiotic therapy for CAP, but data from large ...

7. academic.oup.com academic.oup.com/cid/article/75/6/1063/6526415

Antibiotic Stewardship Strategies and Their Association With ... When weighted by ROAD Home Tier, having more weighted stewardship interventions was associated with fewer days of antibiotic overuse at ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1198743X21003037

Are antimicrobial stewardship interventions effective and ... Outcomes assessed were antimicrobial consumption and appropriateness, infections, hospital admissions and mortality. Available data were pooled in a meta- ...