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

Primary Purpose

Acute Respiratory Infection

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated clinical prediction rule (iCPR) system (iCPR)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Respiratory Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Health
  • University of Utah School of Medicine
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

iCPR group

Control no intervention group

Arm Description

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.

standard care will continue as usual.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
January 9, 2020
Last Updated
October 12, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT04255303
Brief Title
Decreasing Antibiotic Prescribing in Acute Respiratory Infections Through Nurse Driven Clinical Decision Support
Official Title
Decreasing Antibiotic Prescribing in Acute Respiratory Infections Through Implementation of Nurse Driven Clinical Decision Support
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infection

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iCPR group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control no intervention group
Arm Type
No Intervention
Arm Description
standard care will continue as usual.
Intervention Type
Other
Intervention Name(s)
Integrated clinical prediction rule (iCPR) system (iCPR)
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants Who Perceive the iCPR Tool as Useful.
Description
Participants will be interviewed to measure the usefulness of the iCPR tool in prescribing appropriate antibiotics.
Time Frame
Month 6
Title
Change in number of Acute Respiratory Infection(ARI) encounters
Description
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
Time Frame
Baseline, Month 36
Secondary Outcome Measure Information:
Title
Change in Job Satisfaction of RNs and physicians
Description
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
Time Frame
Baseline, Month 6, Month 12
Title
Number of nurse triage encounters completed
Description
Adoption of using iCPR tool will be measured by the number of nurse triage encounters completed through extracted EHR data.
Time Frame
Week 2
Title
Number of patients requiring repeat healthcare visits
Description
Adoption of using iCPR tool will be measured by the number of patients requiring repeat healthcare visits through extracted EHR data.
Time Frame
week 2

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devin Mann, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing 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.

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

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