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

Acute Respiratory Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04255303
• Other study ID #: 19-01222
• Secondary ID: 2R01AI108680-07A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 presenting with ARI symptoms.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: August 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Communicable Diseases
• Infections
• Respiratory Tract Infections

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin
United States	NYU Langone Health	New York	New York
United States	University of Utah School of Medicine	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in number of Acute Respiratory Infection(ARI) encounters	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	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	Baseline, Month 6, Month 12
Secondary	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.	Week 2
Secondary	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.	week 2