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Point-of-Care Ultrasound Educational Initiative for Insect Bites (USED4BUGBITE)

Primary Purpose

Cellulitis, Insect Bites, Insect Stings

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
POCUS Educational Intervention
Sponsored by
New York City Health and Hospitals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cellulitis focused on measuring infection

Eligibility Criteria

3 Months - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Erythema or swelling surrounding an insect bite or sting for greater than 12 hours

Exclusion Criteria:

  • Patients with skin findings consistent with an abscess (ie. active drainage, fluctuance)
  • Patients who are relatively immunocompromised (e.g., patients with AIDS, diabetes mellitus, cancer)
  • Recent use of antibiotics within 1 week prior to symptoms
  • Pregnant
  • Altered mental status
  • Unable to provide a phone number for follow-up

Sites / Locations

  • Jacobi Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre-Intervention

Post-Intervention

Arm Description

Current practice (unchanged). This arm of patients will cared for by physicians who have NOT received the POCUS Educational Intervention.

This arm of patients will cared for by physicians who have received the POCUS Educational Intervention.

Outcomes

Primary Outcome Measures

Antibiotic Prescription
- whether or not the patient received a prescription for antibiotics prior to leaving the emergency department. This will be determined by review of the data collection instrument filled out by clinician at initial visit as well as review of the electronic medical record for that visit.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2018
Last Updated
October 26, 2020
Sponsor
New York City Health and Hospitals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03619746
Brief Title
Point-of-Care Ultrasound Educational Initiative for Insect Bites
Acronym
USED4BUGBITE
Official Title
The Utility of a Point-of-Care Ultrasound Educational Initiative in Decreasing Unnecessary Antibiotic Use in Children With Local Reactions From Insect Bites
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of accrual. We were unable to enroll enough participants to have meaningful results.
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York City Health and Hospitals Corporation

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 pre-post study, designed to decrease unnecessary antibiotic prescribing, will use a prospective cohort of patients presenting to the Pediatric Emergency Department (PED). Patients with local skin findings that the clinician believes are primarily due to an insect bite or sting will be approached for the study. The intervention will occur at the physician level. Midway through the study, physicians will receive an educational intervention describing how to differentiate cellulitis from allergic reaction using point-of-care bedside ultrasound. The main outcome observed will be whether or not the patient receives a prescription for antibiotics at the index visit.
Detailed Description
Thousands of children each year develop soft tissue swelling after an insect bite or sting and present shortly after to emergency departments (ED) across the United States. These wounds are particularly pruritic and can become self-inoculated with skin flora resulting in cellulitis. Clinicians who suspect cellulitis will typically prescribe oral antibiotics to treat this condition. Cellulitis, however, can be confused with a local allergic reaction to the insect bite because the physical examination findings are nearly identical. As such, the reliability of clinical examination in the diagnosis of pediatric skin and soft tissue infections is poor. Consequently, many patients with local allergic reactions are treated unnecessarily with antibiotics. Patients who take antibiotics may experience unintended and unpleasant side effects such as diarrhea and allergic reactions. Moreover, unnecessary antibiotic prescribing is an important factor in the development of antibiotic-resistant infections which are estimated to affect 2 million patients and result in 23 thousand deaths each year in the United States. The medical community has thus sought innovative approaches to reducing unnecessary antibiotic use. The goal of this study is to reduce unnecessary antibiotic prescriptions for children with insect bites that are not infected. This quality improvement initiative will focus on children with insect bites presenting to the Pediatric Emergency Department at Jacobi Medical Center (Bronx, NY). The pre-intervention phase will consist of patients enrolled prior to the physicians receiving a Point-of-Care Ultrasound (POCUS) Educational Intervention. The post-intervention phase will consist of patients enrolled after the physicians have received a POCUS Educational Intervention. In both phases, the physician will be able to care for the patient however he or she believes is appropriate. The POCUS Education Intervention will supplement the baseline knowledge of the Pediatric Emergency Medicine physician with regards to performing a soft-tissue examination using POCUS. A POCUS expert will train all clinicians how to properly perform a soft tissue examination using POCUS to differentiate between cellulitis and local reactions due to angioedema/allergic reaction. The education will include a formal lecture and practical clinical examination. The proportion of patients receiving antibiotics will be compared before and after the Educational Initiative had started. All patients will be contacted 3 to 5 days after their initial emergency department visit to determine if the patient's condition worsened, if the patient needed to return to a healthcare provider, and if the patient had taken any antibiotics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis, Insect Bites, Insect Stings
Keywords
infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Pre-Post Study Design with Non-Pharmacologic Intervention Patient in first arm of study will be treated by physicians who have not yet received educational training. Patients in the second arm of the study will be treated by physicians who went through the educational training.
Masking
None (Open Label)
Masking Description
All participants in the study (i.e., patients and physicians) will be aware of what arm of the study they are in.
Allocation
Non-Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Intervention
Arm Type
No Intervention
Arm Description
Current practice (unchanged). This arm of patients will cared for by physicians who have NOT received the POCUS Educational Intervention.
Arm Title
Post-Intervention
Arm Type
Experimental
Arm Description
This arm of patients will cared for by physicians who have received the POCUS Educational Intervention.
Intervention Type
Behavioral
Intervention Name(s)
POCUS Educational Intervention
Intervention Description
Midway through the study, all Pediatric Emergency Attendings and Fellows at Jacobi Medical Center will receive an educational session that describes how to properly perform a soft tissue examination using point-of-care ultrasound to differentiate between cellulitis and local allergic reaction.
Primary Outcome Measure Information:
Title
Antibiotic Prescription
Description
- whether or not the patient received a prescription for antibiotics prior to leaving the emergency department. This will be determined by review of the data collection instrument filled out by clinician at initial visit as well as review of the electronic medical record for that visit.
Time Frame
index visit to the emergency department

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Erythema or swelling surrounding an insect bite or sting for greater than 12 hours Exclusion Criteria: Patients with skin findings consistent with an abscess (ie. active drainage, fluctuance) Patients who are relatively immunocompromised (e.g., patients with AIDS, diabetes mellitus, cancer) Recent use of antibiotics within 1 week prior to symptoms Pregnant Altered mental status Unable to provide a phone number for follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Meltzer, MD, MS
Organizational Affiliation
Jacobi Medical Center, Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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19458526
Citation
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Point-of-Care Ultrasound Educational Initiative for Insect Bites

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