- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04255303
Decreasing Antibiotic Prescribing in Acute Respiratory Infections Through Nurse Driven Clinical Decision Support
December 30, 2025 updated by: NYU Langone Health
Decreasing Antibiotic Prescribing in Acute Respiratory Infections Through Implementation of Nurse Driven Clinical Decision Support
This study evaluates the effects of a novel integrated clinical prediction tool on antibiotic prescription patterns of nurses for acute respiratory infections (ARIs).
The intervention is an EHR-integrated risk calculator and order set to help guide appropriate, evidence-based antibiotic prescriptions for patients presenting with ARI symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The proposed project will fill a critical gap in the evidence base and answer the important question: can pivoting ARI CDS tools towards nurses overcome established implementation barriers to reducing antibiotic use?
The proposal is highly innovative in three ways: It uses CDS tools to embed evidence-based risk stratification to enable nurse-led ARI management.
It creates a nurse training program to support this nurse-led ARI treatment pathway.
It will be evaluated and optimized using evidence-based implementation frameworks that will guide assessment of the fidelity, acceptability, adoption, cost, and sustainability of the tool.
This will provide comprehensive implementation measures, formative and summative, and enable a rigorous understanding of barriers and facilitators to implementing nurse-led CDS tools for reducing antibiotic overprescribing.
This study will provide much needed guidance on how to implement CDS-enabled, nurse-led ARI assessment and treatment to reduce antibiotic overprescribing.
Study Type
Interventional
Enrollment (Actual)
347
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10016
- NYU Langone Health
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Utah
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Salt Lake City, Utah, United States, 84112
- University of Utah School of Medicine
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Clinics:
- must be primary care and/or urgent care clinics
- should have a minimum of one registered nurse (RN) full time equivalents (FTE)
Nurses :
- be licensed to see patients and prescribed and/or recommend prescriptions for patients
- work a minimum of 0.5 FTE to ensure that they are seeing sufficient numbers of patients to maintain competency
- have access to the clinic EHR system, and use regularly as part of patient care
Patients:
- patients must have been seen at a participating clinic with a complaint of cough or sore throat.
- Ages 3-70 will be included for sore throat and ages 18-70 for cough
Exclusion Criteria:
- are unable or unwilling to provide informed consent
- are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia)
- clinics will be excluded if phone call triage of patients with sore throat and cough is not performed by RNs
- Nurses will be excluded if they do not work with the clinic EHR as part of their workflow
- Patients with a history of chronic lung disease or immunosuppression will be excluded since the CPRs were not validated in these groups
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: iCPR group
Clinic personnel (Providers and Nurses) will receive online training that includes: 1) an overview of the project; 2) iCPR workflows including triage; 3) CPR component review and risk categories; 4) history and physical examination components of the CPRs.
The online training will be followed by in-person training to reinforce the online training and teach additional skills.
In-person training sessions led by study team will last approximately 60 minutes, and consist of four basic components: 1) a review of the iCPR ARI protocol and tools; 2) on-screen walk-throughs of common scenarios employing the new tools; 3) physical examination technique practice with simulated patients; A 60-minute in-person follow-up nurse training will take place 4-6 weeks after implementation of the intervention.
|
The iCPR tool consists of an electronic calculator that can be used to determine whether the patient is at low, intermediate or high risk for having the diagnosis and a bundled order set (called a "Smartset").
The iCPR tool will be made available directly within the Electronic Health Record (EHR) for Registered Nurses (RNs) who are seeing patients fall into the study categories.
The iCPR tool through the use of order sets will guide the RN in the patient's care.
The order set for patients at low risk for these diseases will recommend supportive care including over the counter cold remedies and pain relievers.
The order set for patients at intermediate or high risk of these disease will recommend diagnostic tests (rapid strep antigen or CXR) to help determine if they have the disease.
Based on the results of the diagnostic tests new order sets will recommend antibiotics or supportive care
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No Intervention: Control no intervention group
standard care will continue as usual.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants Who Perceive the iCPR Tool as Useful.
Time Frame: Month 6
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Participants will be interviewed to measure the usefulness of the iCPR tool in prescribing appropriate antibiotics.
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Month 6
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Change in proportion of Acute Respiratory Infection (ARI) encounters with inappropriate antibiotic prescribing
Time Frame: Baseline, Month 36
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The number of Acute Respiratory Infection (ARI) encounters with inappropriate antibiotic prescription will be measured pre and post-intervention using EHR reports assessing ordering of antibiotics
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Baseline, Month 36
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of nurse triage encounters completed
Time Frame: Week 2
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Adoption of using iCPR tool will be measured by the number of nurse triage encounters completed through extracted EHR data.
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Week 2
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Number of patients requiring repeat healthcare visits
Time Frame: week 2
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Adoption of using iCPR tool will be measured by the number of patients requiring repeat healthcare visits through extracted EHR data.
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week 2
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Change in Job Satisfaction of RNs and physicians
Time Frame: Baseline, Month 6
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Job satisfaction/ burnout of the RNs and physicians in enrolled clinics will be measured qualitatively with interviews at baseline, 6, and 12 months after implementation
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Baseline, Month 6
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Change in Job Satisfaction of RNs and physicians
Time Frame: Month 6, Month 12
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Job satisfaction/ burnout of the RNs and physicians in enrolled clinics will be measured qualitatively with interviews at baseline, 6, and 12 months after implementation
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Month 6, Month 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Devin Mann, MD, NYU Langone Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stevens ER, Xu L, Kwon J, Tasneem S, Henning N, Feldthouse D, Kim EJ, Hess R, Dauber-Decker KL, Smith PD, Halm W, Gautam-Goyal P, Feldstein DA, Mann DM. Barriers to Implementing Registered Nurse-Driven Clinical Decision Support for Antibiotic Stewardship: Retrospective Case Study. JMIR Form Res. 2024 May 23;8:e54996. doi: 10.2196/54996.
- Stevens ER, Agbakoba R, Mann DM, Hess R, Richardson SI, McGinn T, Smith PD, Halm W, Mundt MP, Dauber-Decker KL, Jones SA, Feldthouse DM, Kim EJ, Feldstein DA. Reducing prescribing of antibiotics for acute respiratory infections using a frontline nurse-led EHR-Integrated clinical decision support tool: protocol for a stepped wedge randomized control trial. BMC Med Inform Decis Mak. 2023 Nov 14;23(1):260. doi: 10.1186/s12911-023-02368-0.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 23, 2022
Primary Completion (Actual)
June 15, 2025
Study Completion (Actual)
December 15, 2025
Study Registration Dates
First Submitted
January 9, 2020
First Submitted That Met QC Criteria
February 3, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Estimated)
January 2, 2026
Last Update Submitted That Met QC Criteria
December 30, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-01222
- 2R01AI108680-07A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
Upon reasonable request.
Requests should be directed to devin.mann@nyulangone.org.
To gain access, data requestors will need to sign a data access agreement.
The investigator who proposed to use the data.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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