EHR Alert + Structured Communication for Pneumonia

(UP-CAPTAIn Trial)

No longer recruiting at 1 trial location

Overseen By Jonathan D Baghdadi, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonathan Baghdadi

Must be taking: Antibiotics

Disqualifiers: Immunosuppression, 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 explores ways to improve antibiotic use in patients hospitalized with suspected pneumonia. It tests an alert system within electronic health records to guide testing and treatment. Some patients will receive structured communication of test results to help reduce unnecessary antibiotics if their tests suggest a viral infection. This trial may suit those hospitalized with a suspected respiratory infection, already on antibiotics, but whose tests indicate a viral cause. As an unphased trial, it offers a unique opportunity to contribute to improving antibiotic practices in hospitals.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study focuses on antibiotic use, you may need to adjust your antibiotic treatment based on the trial's findings.

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 improving antibiotic use for pneumonia, so it's best to discuss your current medications with the trial team.

What prior data suggests that this protocol is safe for improving antibiotic use in pneumonia patients?

Research has shown that electronic alerts with clear communication can improve antibiotic use in hospitals. Studies have found that these systems reduce unnecessary antibiotic use by advising doctors when to stop or reduce the dose. Patients generally accept this approach because it changes how doctors receive information rather than introducing new medications or treatments.

In one study, a similar system shortened the time patients were on antibiotics without causing harm. The goal is to ensure antibiotics are used only when necessary, helping to prevent resistance and keep patients safe. Various hospitals have successfully used this type of system, proving it is generally safe and effective for managing infections like pneumonia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how electronic health record (EHR) alerts combined with structured communication can optimize pneumonia treatment. Traditional treatments often rely on the clinician’s discretion for interpreting test results and deciding on antibiotics. This trial introduces an EHR alert system that not only guides diagnostic testing but also communicates test results along with recommendations for when to consider adjusting antibiotic use. This approach aims to refine antibiotic usage, potentially reducing unnecessary prescriptions and combating antibiotic resistance. By enhancing communication and decision-making, the trial could lead to more effective and responsible pneumonia care.

What evidence suggests that this trial's treatments could be effective for pneumonia?

Studies have shown that electronic alerts can help hospitals use antibiotics more effectively. Research indicates that these alerts can shorten the duration of antibiotic use, preventing overuse. In this trial, one group will receive an electronic alert combined with structured communication of test results, which studies have shown helps doctors decide when to stop or change antibiotics for pneumonia patients. Another group will receive only the electronic alert without structured communication. Previous research suggests that combining alerts with advice from a team focused on smart antibiotic use can enhance decision-making about stopping or changing treatments. Therefore, using an alert system with clear communication might improve antibiotic use for patients suspected of having pneumonia. ^{1 3 6 7 8}

Who Is on the Research Team?

Daniel J. Morgan, MD, MS

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for adult patients at two Maryland medical centers who are hospitalized with suspected community-acquired respiratory infections and have test results that may indicate a viral infection. They must be on antibiotics and not just have cold symptoms.

Inclusion Criteria

I am an adult at UMMC or UMMC-Midtown prescribed antibiotics for a suspected lung infection.

Protocol-based diagnostic testing indicates a potential viral infection, confirmed by either a positive molecular test result or low procalcitonin value.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Randomization and Intervention

Patients with test results suggesting viral infection are randomized to receive either structured communication from the antimicrobial stewardship team or usual care.

3 days

In-hospital

Follow-up

Participants are monitored for safety outcomes including length of stay, readmissions, hospital-free days, and mortality.

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Electronic alert
• Structured communication of test results

Trial Overview The study tests if an electronic alert in the health record, advising doctors based on the likelihood of bacterial pneumonia, can improve antibiotic use. Patients flagged as likely having a virus will either get special advice to reduce antibiotics or continue with standard care.

How Is the Trial Designed?

Group I: Electronic alert plus structured communication of test results Experimental Treatment 2 Interventions

An electronic health record alert will guide diagnostic testing for pneumonia. For patients with low or moderate probability of bacterial pneumonia, test results will be communicated to the primary team with guidance to consider discontinuing or de-escalating antibiotics.

Group II: Electronic alert without structured communication of test results Active Control 1 Intervention

An electronic health record alert will guide diagnostic testing for pneumonia. The primary care team will access and interpret test results and decide upon composition and duration of antimicrobial without external guidance.

Who Is Running the Clinical Trial?

Jonathan Baghdadi

Lead Sponsor

Trials

1

Recruited

100+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Published Research Related to This Trial

The implementation of the Alert Notification of Critical Results (ANCR) system significantly reduced the proportion of critical radiology reports lacking documented communication between care providers, decreasing from 19% to 5% over four years (2009-2014).

There was no increase in the communication of non-critical results after the ANCR system was implemented, indicating that the system did not lead to overuse for non-critical findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an electronic alert notification system embedded in radiologists' workflow on closed-loop communication of critical results: a time series analysis. Lacson, R., O'Connor, SD., Sahni, VA., et al.[2018]

In a survey of 54 hospitalized patients receiving antimicrobial therapy, 83% were informed they were on antimicrobials, but only 18% were told about potential side effects and 36% knew the duration of treatment, indicating significant gaps in communication.

The study revealed that 62% of patients desired more information about their therapy, highlighting the need for improved communication strategies and quality improvement actions to enhance patient understanding and satisfaction regarding antimicrobial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing patient understanding of their antimicrobial treatment: How are we doing and how might we improve? Yeoh, K., George, C., Rajkhowa, A., et al.[2021]

A study of 28 primary care providers at a Veterans Affairs Medical Center revealed significant variability in how they manage electronic alerts for critical diagnostic test results, with nearly half not utilizing any alert-management features.

Providers with lower rates of timely follow-up often relied on manual scanning and clinical judgment rather than using available tools, suggesting that improving knowledge and standardizing alert-management strategies could enhance follow-up rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider management strategies of abnormal test result alerts: a cognitive task analysis. Hysong, SJ., Sawhney, MK., Wilson, L., et al.[2021]

The study aims to improve electronic communication in the Veterans Health Administration's EMR by analyzing how abnormal test results, referral requests, and prescriptions are communicated, highlighting the importance of effective communication beyond just information transfer.

Using a human factors engineering approach, the research will identify potential errors in electronic communication processes and gather insights from focus groups to redesign work systems for better healthcare outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving outpatient safety through effective electronic communication: a study protocol. Hysong, SJ., Sawhney, MK., Wilson, L., et al.[2021]

The implementation of 'stealth' alerts in electronic health records led to a significant increase in anticoagulation monitoring, with 39% of patients completing monitoring within 5 days after co-prescribing a medication that interacts with warfarin, compared to 34% before the alerts were introduced.

This innovative approach directs alerts to a specialized anticoagulation management service rather than the prescribing clinicians, reducing alert fatigue and improving patient safety through better monitoring of potential drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Stealth" alerts to improve warfarin monitoring when initiating interacting medications. Koplan, KE., Brush, AD., Packer, MS., et al.[2021]

The adaptation of an electronic referral application for antimicrobial stewardship significantly increased the completion rate of antimicrobial round reviews from 59% to 88% over 12 months, indicating improved efficiency in the referral process.

There was a notable reduction in the use of broad-spectrum antibiotics, such as piperacillin/tazobactam and fluoroquinolones, alongside a decrease in the proportion of ignored advice from 18% to 8.5%, demonstrating enhanced adherence to clinical recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of a hospital electronic referral system for antimicrobial stewardship prospective audit and feedback rounds. Rawlins, MDM., Raby, E., Sanfilippo, FM., et al.[2022]

Primary care practitioners (PCPs) received an average of 56.4 asynchronous electronic health record (EHR) alerts per day, which significantly contributes to their workload.

On average, PCPs spent about 49 minutes each day processing these alerts, highlighting the need for further investigation into the effectiveness and management of such alert systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Notifications received by primary care practitioners in electronic health records: a taxonomy and time analysis. Murphy, DR., Reis, B., Sittig, DF., et al.[2022]

The study involving 28 ED triage nurses and over 39,000 patients found that a passive EHR alert did not significantly increase the utilization of triage protocols for diagnostic testing in emergency settings.

Despite some increases in protocol implementation after the intervention, the overall benefits of using EHR alerts were minimal, suggesting that more rigorous studies are needed to optimize alert systems for improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic alerts for triage protocol compliance among emergency department triage nurses: a randomized controlled trial. Holmes, JF., Freilich, J., Taylor, SL., et al.[2018]

An active communication method using on-call pharmacy residents significantly reduced the time to optimal therapy for patients with positive blood cultures compared to a passive electronic notification system, with median times of 23.4 hours versus 42.2 hours and 45.9 hours, respectively.

The active approach also led to faster discontinuation of empiric antibiotics in cases of contamination, with an immediate response in the active group compared to 17.7 hours and 7.2 hours in the control and passive groups, highlighting its effectiveness in improving antibiotic stewardship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of active versus passive methods of responding to rapid diagnostic blood culture results. Chandler, EL., Wallace, KL., Palavecino, E., et al.[2022]

A computer-generated alert system for reviewing antibiotic prescriptions in hospitals led to a significant reduction in antibiotic use, with a 26.5% decrease in the number of days antibiotics were prescribed after intervention.

The alert prompted direct counselling for 51.7% of flagged prescriptions, resulting in modifications such as shortening treatment duration or withdrawing unnecessary antibiotics, and physicians complied with these recommendations 80% of the time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a computer-generated alert system prompting review of antibiotic use in hospitals. Lesprit, P., Duong, T., Girou, E., et al.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11777576/

P-663. Evaluating the Effectiveness of a Real-Time ... This study aims to assess the impact of a Real-Time Electronic Alert system designed to monitor the duration of antibiotic therapy in ...

2. journals.asm.org journals.asm.org/doi/10.1128/aac.01680-24

Impact of an electronic antibiotic time-out best practice alert on ... Provider-directed electronic antibiotic time-outs (ATOs) are a stewardship strategy capable of efficient and widespread impact with ...

3. academic.oup.com academic.oup.com/ofid/article/8/6/ofab291/6291361

Development of an Electronic Algorithm to Identify in Real ... Creating an electronic tool that effectively identifies CAP cases in real time is possible, but its accuracy is dependent on NLP-derived radiographic data.

4. researchgate.net researchgate.net/publication/366312636_905_Impact_of_a_Real-Time_Electronic_Alert_on_Antibiotic_Treatment_Duration_for_Pneumonia_in_Hospitalized_Patients

905. Impact of a Real-Time Electronic Alert on Antibiotic ... Up to two-thirds of patients receive excessive durations of therapy for pneumonia. This study evaluated the effect of a stewardship intervention ...

5. mdpi.com mdpi.com/2079-6382/10/9/1078

Effectiveness of an Electronic Automated Antibiotic Time ... Similar to other studies, we found that an automated ATO alert may not be as effective as the sole stewardship intervention. A passive ...

6. academic.oup.com academic.oup.com/ofid/article/9/7/ofac235/6582429

Impact of Clinical Decision Support System Implementation at ... Implementation of a CDSS within an established TASP at a community hospital resulted in decreased antimicrobial usage, higher rates of oral usage, faster TTOT,

7. dason.medicine.duke.edu dason.medicine.duke.edu/sites/default/files/media-file/dason-cdcfinalanalysistool-r11-21.pdf

Developing Patient Safety Outcome Measures and ... Each year in the United States, over 2 million people are infected with antibiotic resistant bacteria, and nearly 25,000 die from these infections.1 In ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1198743X17301258

A systematic review of clinical decision support systems for ... Clinical decision support systems (CDSS) for antimicrobial management can support clinicians to optimize antimicrobial therapy.