Point-of-Care Ultrasound Educational Initiative for Insect Bites

Cellulitis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03619746
• Other study ID #: 2018-9176
• Status: Terminated
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2020
• Source: New York City Health and Hospitals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Cellulitis
• Insect Bites
• Insect Bites and Stings
• Insect Stings

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.

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York City Health and Hospitals Corporation

Country where clinical trial is conducted

United States, 

References & Publications (20)

Adams CM, Neuman MI, Levy JA. Point-of-Care Ultrasonography for the Diagnosis of Pediatric Soft Tissue Infection. J Pediatr. 2016 Feb;169:122-7.e1. doi: 10.1016/j.jpeds.2015.10.026. Epub 2015 Nov 10. — View Citation

American College of Emergency Physicians. Emergency ultrasound guidelines. Ann Emerg Med. 2009 Apr;53(4):550-70. doi: 10.1016/j.annemergmed.2008.12.013. — View Citation

Araujo da Silva AR, Albernaz de Almeida Dias DC, Marques AF, Biscaia di Biase C, Murni IK, Dramowski A, Sharland M, Huebner J, Zingg W. Role of antimicrobial stewardship programmes in children: a systematic review. J Hosp Infect. 2018 Jun;99(2):117-123. doi: 10.1016/j.jhin.2017.08.003. Epub 2017 Aug 12. Review. — View Citation

Blaabjerg S, Artzi DM, Aabenhus R. Probiotics for the Prevention of Antibiotic-Associated Diarrhea in Outpatients-A Systematic Review and Meta-Analysis. Antibiotics (Basel). 2017 Oct 12;6(4). pii: E21. doi: 10.3390/antibiotics6040021. Review. — View Citation

Fleming-Dutra KE, Hersh AL, Shapiro DJ, Bartoces M, Enns EA, File TM Jr, Finkelstein JA, Gerber JS, Hyun DY, Linder JA, Lynfield R, Margolis DJ, May LS, Merenstein D, Metlay JP, Newland JG, Piccirillo JF, Roberts RM, Sanchez GV, Suda KJ, Thomas A, Woo TM, Zetts RM, Hicks LA. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016 May 3;315(17):1864-73. doi: 10.1001/jama.2016.4151. — View Citation

Greenlund LJS, Merry SP, Thacher TD, Ward WJ. Primary Care Management of Skin Abscesses Guided by Ultrasound. Am J Med. 2017 May;130(5):e191-e193. doi: 10.1016/j.amjmed.2016.11.040. Epub 2016 Dec 22. — View Citation

Haynes D, Lasarev M, Keller J. Systemic antibiotic use for nonbacterial dermatological conditions among referring providers. Int J Dermatol. 2018 May;57(5):566-571. doi: 10.1111/ijd.13962. Epub 2018 Mar 9. — View Citation

Iverson K, Haritos D, Thomas R, Kannikeswaran N. The effect of bedside ultrasound on diagnosis and management of soft tissue infections in a pediatric ED. Am J Emerg Med. 2012 Oct;30(8):1347-51. doi: 10.1016/j.ajem.2011.09.020. Epub 2011 Nov 17. — View Citation

Marin JR, Alpern ER, Panebianco NL, Dean AJ. Assessment of a training curriculum for emergency ultrasound for pediatric soft tissue infections. Acad Emerg Med. 2011 Feb;18(2):174-82. doi: 10.1111/j.1553-2712.2010.00990.x. — View Citation

Marin JR, Bilker W, Lautenbach E, Alpern ER. Reliability of clinical examinations for pediatric skin and soft-tissue infections. Pediatrics. 2010 Nov;126(5):925-30. doi: 10.1542/peds.2010-1039. Epub 2010 Oct 25. — View Citation

Marin JR, Dean AJ, Bilker WB, Panebianco NL, Brown NJ, Alpern ER. Emergency ultrasound-assisted examination of skin and soft tissue infections in the pediatric emergency department. Acad Emerg Med. 2013 Jun;20(6):545-53. doi: 10.1111/acem.12148. — View Citation

May L, Harter K, Yadav K, Strauss R, Abualenain J, Keim A, Schmitz G. Practice patterns and management strategies for purulent skin and soft-tissue infections in an urban academic ED. Am J Emerg Med. 2012 Feb;30(2):302-10. doi: 10.1016/j.ajem.2010.11.033. Epub 2011 Jan 28. — View Citation

Pallin DJ, Camargo CA Jr, Schuur JD. Skin infections and antibiotic stewardship: analysis of emergency department prescribing practices, 2007-2010. West J Emerg Med. 2014 May;15(3):282-9. doi: 10.5811/westjem.2013.8.18040. Epub 2014 Jan 6. — View Citation

Severino M, Bonadonna P, Passalacqua G. Large local reactions from stinging insects: from epidemiology to management. Curr Opin Allergy Clin Immunol. 2009 Aug;9(4):334-7. doi: 10.1097/ACI.0b013e32832d0668. Review. — View Citation

Sivitz AB, Lam SH, Ramirez-Schrempp D, Valente JH, Nagdev AD. Effect of bedside ultrasound on management of pediatric soft-tissue infection. J Emerg Med. 2010 Nov;39(5):637-43. doi: 10.1016/j.jemermed.2009.05.013. Epub 2009 Aug 8. — View Citation

Solomon SL, Oliver KB. Antibiotic resistance threats in the United States: stepping back from the brink. Am Fam Physician. 2014 Jun 15;89(12):938-41. — View Citation

Subramaniam S, Bober J, Chao J, Zehtabchi S. Point-of-care Ultrasound for Diagnosis of Abscess in Skin and Soft Tissue Infections. Acad Emerg Med. 2016 Nov;23(11):1298-1306. doi: 10.1111/acem.13049. Epub 2016 Nov 1. Review. — View Citation

Tay ET, Tsung JW. Sonographic appearance of angioedema in local allergic reactions to insect bites and stings. J Ultrasound Med. 2014 Sep;33(9):1705-10. doi: 10.7863/ultra.33.9.1705. — View Citation

Tayal VS, Hasan N, Norton HJ, Tomaszewski CA. The effect of soft-tissue ultrasound on the management of cellulitis in the emergency department. Acad Emerg Med. 2006 Apr;13(4):384-8. Epub 2006 Mar 10. — View Citation

Vieira RL, Hsu D, Nagler J, Chen L, Gallagher R, Levy JA; American Academy of Pediatrics. Pediatric emergency medicine fellow training in ultrasound: consensus educational guidelines. Acad Emerg Med. 2013 Mar;20(3):300-6. doi: 10.1111/acem.12087. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	index visit to the emergency department