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Completed

NCT Number: NCT04255303

Decreasing Antibiotic Prescribing in Acute Respiratory Infections Through 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.

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Key information

Conditions

Acute Respiratory Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated clinical prediction rule (iCPR) system (iCPR)

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

Primary outcomes

  1. Number of Participants Who Perceive the iCPR Tool as Useful.

    Time frame: Month 6

    Participants will be interviewed to measure the usefulness of the iCPR tool in prescribing appropriate antibiotics.

  2. Change in proportion of Acute Respiratory Infection (ARI) encounters with inappropriate antibiotic prescribing

    Time frame: Baseline, Month 36

    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

Secondary outcomes

  1. Change in Job Satisfaction of RNs and physicians

    Time frame: Baseline, Month 6

    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

  2. Change in Job Satisfaction of RNs and physicians

    Time frame: Month 6, Month 12

    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

  3. Number of nurse triage encounters completed

    Time frame: Week 2

    Adoption of using iCPR tool will be measured by the number of nurse triage encounters completed through extracted EHR data.

  4. Number of patients requiring repeat healthcare visits

    Time frame: week 2

    Adoption of using iCPR tool will be measured by the number of patients requiring repeat healthcare visits through extracted EHR data.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2020
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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