Decreasing Antibiotic Prescribing in Acute Respiratory Infections Through Nurse Driven Clinical Decision Support

NCT ID: NCT04255303

Last Updated: 2026-01-02

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

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2025-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Integrated clinical prediction rule (iCPR) system (iCPR)

Intervention Type OTHER

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

Control no intervention group

standard care will continue as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Integrated clinical prediction rule (iCPR) system (iCPR)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Devin Mann, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

University of Utah School of Medicine

Salt Lake City, Utah, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38781006 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37964232 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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2R01AI108680-07A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-01222

Identifier Type: -

Identifier Source: org_study_id

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