Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-05-31

Brief Summary

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The goal of this prospective randomized study is to improve antibiotic use among hospitalized patients with suspected pneumonia. An alert was built into the electronic health record to guide use of diagnostic testing based on probability of bacterial pneumonia. Patients with test results suggesting viral infection will be randomized to either: (1) receive a structured communication from the antimicrobial stewardship team to de-escalate antibiotics or (2) usual care.

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Detailed Description

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Low-risk patients with viral pneumonia do not benefit from and may be harmed by antibiotic therapy. In this study, an alert will appear in the electronic health record of patients undergoing molecular diagnostic testing for respiratory symptoms that provides options for diagnostic testing based on pre-test probability of bacterial infection. Patients with test results suggesting possible viral infection will be randomized to either usual care or to receive test results along with structured guidance from antimicrobial stewardship to consider discontinuing or de-escalating antibiotics. This guidance, which will include an explicit calculation of the post-test probability of bacterial infection based on considering risk factors, vital signs, symptoms, and available imaging, will be communicated to the primary care team via direct electronic message and a summary note in the patient's chart. The final decision on whether to continue antibiotic therapy will be up to the primary team. The primary outcome of interest will be in-hospital antibiotic use. Safety outcomes will include length of stay, readmissions, hospital-free days, and mortality.

Conditions

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Pneumonia Pneumonia, Viral Pneumonia, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study involves a randomized trial embedded within a quasi-experiment. During the 1-year study period, we anticipate that 1,500 patients will be exposed to the electronic health record modification performed as part of the quasi-experiment. Regarding the randomized trial, if 100 patients are enrolled during the 1-year study period, including 50 in intervention patients and 50 controls, we anticipate that we will have sufficient precision to estimate the difference in binary outcomes (e.g., antibiotic discontinuation within 5 days) between the two groups with a margin of error of approximately 15% based on a 95% confidence interval.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Electronic alert plus structured communication of test results

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 Type EXPERIMENTAL

Electronic alert

Intervention Type BEHAVIORAL

An alert will appear in the electronic health record that provides options for diagnostic testing based on low, medium, or high probability of bacterial pneumonia.

Structured communication of test results

Intervention Type BEHAVIORAL

A clinical research team member will send an electronic message to the primary care team on behalf of the antimicrobial stewardship program with structured guidance to stop or de-escalate antibiotics and document these recommendations in the patient's chart.

Electronic alert without structured communication of test results

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.

Group Type ACTIVE_COMPARATOR

Electronic alert

Intervention Type BEHAVIORAL

An alert will appear in the electronic health record that provides options for diagnostic testing based on low, medium, or high probability of bacterial pneumonia.

Interventions

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Electronic alert

An alert will appear in the electronic health record that provides options for diagnostic testing based on low, medium, or high probability of bacterial pneumonia.

Intervention Type BEHAVIORAL

Structured communication of test results

A clinical research team member will send an electronic message to the primary care team on behalf of the antimicrobial stewardship program with structured guidance to stop or de-escalate antibiotics and document these recommendations in the patient's chart.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adult patients admitted to the University of Maryland Medical Center or University of Maryland Medical Center-Midtown Campus who are prescribed antibiotics for suspected community-acquired respiratory infection.
* Protocol-based diagnostic testing supports possible viral infection, either by positive molecular test or low procalcitonin value.

Exclusion Criteria

* Hospitalization for \>72 hours prior to protocol-based diagnostic testing.
* Previous molecular testing for viral infection during the same hospital encounter.
* Severely immunosuppressed, defined as having hematologic malignancy, solid organ tumor on chemotherapy, or solid organ transplant on immunosuppression

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No