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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03619746
Recruitment Status : Terminated (Lack of accrual. We were unable to enroll enough participants to have meaningful results.)
First Posted : August 8, 2018
Last Update Posted : October 28, 2020
Information provided by (Responsible Party):
James Meltzer, Jacobi Medical Center

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.

Condition or disease Intervention/treatment Phase
Cellulitis Insect Bites Insect Stings Behavioral: POCUS Educational Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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.
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 10, 2018
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Pre-Intervention
Current practice (unchanged). This arm of patients will cared for by physicians who have NOT received the POCUS Educational Intervention.
Experimental: Post-Intervention
This arm of patients will cared for by physicians who have received the POCUS Educational Intervention.
Behavioral: POCUS Educational Intervention
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 Measures :
  1. Antibiotic Prescription [ Time Frame: index visit to the emergency department ]
    - 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03619746

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United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
New York City Health and Hospitals Corporation
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Principal Investigator: James A Meltzer, MD, MS Jacobi Medical Center, Albert Einstein College of Medicine

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Responsible Party: James Meltzer, Associate Professor, Pediatrics, Jacobi Medical Center Identifier: NCT03619746    
Other Study ID Numbers: 2018-9176
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Meltzer, Jacobi Medical Center:
Additional relevant MeSH terms:
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Insect Bites and Stings
Bites and Stings
Chemically-Induced Disorders
Wounds and Injuries
Skin Diseases, Infectious
Connective Tissue Diseases
Pathologic Processes