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

Sponsor
NYU Langone Health (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04255303
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Integrated clinical prediction rule (iCPR) system (iCPR)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Decreasing Antibiotic Prescribing in Acute Respiratory Infections Through Implementation of Nurse Driven Clinical Decision Support
Actual Study Start Date :
Feb 23, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: iCPR group

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)
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

No Intervention: Control no intervention group

standard care will continue as usual.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants Who Perceive the iCPR Tool as Useful. [Month 6]

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

  2. Change in number of Acute Respiratory Infection(ARI) encounters [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 Outcome Measures

  1. Change in Job Satisfaction of RNs and physicians [Baseline, 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

  2. Number of nurse triage encounters completed [Week 2]

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

  3. Number of patients requiring repeat healthcare visits [week 2]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwell Health Feinstein Institute Great Neck New York United States 11021
2 NYU Langone Health New York New York United States 10016
3 University of Utah School of Medicine Salt Lake City Utah United States 84112
4 University of Wisconsin Madison Wisconsin United States 53705

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Devin Mann, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04255303
Other Study ID Numbers:
  • 19-01222
  • 2R01AI108680-07A1
First Posted:
Feb 5, 2020
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2022