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Acute Respiratory InfectionNCT04255303

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

A study testing Integrated clinical prediction rule (iCPR) system (iCPR) in people with Acute Respiratory Infection, run by NYU Langone Health at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Infection
What is being tested?
Integrated clinical prediction rule (iCPR) system (iCPR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
347 participants
Where
3 sitesUnited States
Study dates
23 Feb 2022to 15 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • NYU Langone Health

    New York, New York, 10016

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Integrated clinical prediction rule (iCPR) system (iCPR)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT04255303
Study groupRoleWhat they receive
iCPR groupExperimentalClinic 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.
Receives: Other: Integrated clinical prediction rule (iCPR) system (iCPR)
Control no intervention groupNo interventionstandard care will continue as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Month 6

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

    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

    Measured: Baseline, Month 36

Secondary outcomes (4)

  1. Change in Job Satisfaction of RNs and physicians

    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

    Measured: Baseline, Month 6

  2. Change in Job Satisfaction of RNs and physicians

    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

    Measured: Month 6, Month 12

  3. Number of nurse triage encounters completed

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

    Measured: Week 2

  4. Number of patients requiring repeat healthcare visits

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

    Measured: week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start23 Feb 2022
  3. Primary completion15 Jun 2025
  4. Study completion15 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
347 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04255303
Sponsor's protocol ID
19-01222
Other IDs
2R01AI108680-07A1
Status last verified
Dec 2025
First submitted
9 Jan 2020
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Publications

  • Dauber-Decker KL, Feldstein D, Hess R, Mann D, Kim EJ, Gautam-Goyal P, Solomon J, Khan S, Malik F, Xu L, Huffman A, Smith PD, Halm W, Yuroff A, Richardson S. Snowball Group Usability Testing for Rapid and Iterative Multisite Tool Development: Method Development Study. JMIR Form Res. 2025 Feb 18;9:e55316. doi: 10.2196/55316.

    PubMed 39964400

  • 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.

    PubMed 38781006

  • 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.

    PubMed 37964232

Questions about this trial

What is this clinical trial studying?

A study testing Integrated clinical prediction rule (iCPR) system (iCPR) in people with Acute Respiratory Infection, run by NYU Langone Health at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Perceive the iCPR Tool as Useful. (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04255303, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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