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

NCT04255303 | Completed DMC

• 2 other identifiers: 19-012222R01AI108680-07A1
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 3

Brief 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 presenting with ARI symptoms.

Conditions

Acute Respiratory Infection

Outcome Measures

Primary Outcomes (2)

• 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.

  Month 6

• 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

  Baseline, Month 36

Secondary Outcomes (4)

• Change in Job Satisfaction of RNs and physicians

  Baseline, Month 6

• Change in Job Satisfaction of RNs and physicians

  Month 6, Month 12

• Number of nurse triage encounters completed

  Week 2

• Number of patients requiring repeat healthcare visits

  week 2

Study Arms (2)

iCPR group

EXPERIMENTAL

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.

Other: Integrated clinical prediction rule (iCPR) system (iCPR)

Control no intervention group

NO INTERVENTION

standard care will continue as usual.

Interventions

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

iCPR group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• NYU Langone Health: lead

Study Sites (3)

NYU Langone Health

New York, New York, 10016, United States

Location

University of Utah School of Medicine

Salt Lake City, Utah, 84112, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

• 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.

  PMID: 38781006 DERIVED

• 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.

  PMID: 37964232 DERIVED

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Devin Mann, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: February 5, 2020
• Study Start: February 23, 2022
• Primary Completion: June 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (3)