Point-of-Care Ultrasound Educational Initiative for Insect Bites

NCT03619746 | Terminated DMC

• 1 other identifier: 2018-9176
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Cellulitis; Insect Bites; Insect Stings

Keywords

infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pre-Intervention

NO INTERVENTION

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

Post-Intervention

EXPERIMENTAL

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

Behavioral: POCUS Educational Intervention

Interventions

POCUS Educational Intervention BEHAVIORAL

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.

Post-Intervention

Eligibility Criteria

• Age: 3 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (20)

• 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.

  PMID: 19458526 BACKGROUND

• 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):21. doi: 10.3390/antibiotics6040021.

  PMID: 29023420 BACKGROUND

• 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. No abstract available.

  PMID: 25162160 BACKGROUND

• 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.

  PMID: 28807835 BACKGROUND

• 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.

  PMID: 19665335 BACKGROUND

• 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. doi: 10.1197/j.aem.2005.11.074. Epub 2006 Mar 10.

  PMID: 16531602 BACKGROUND

• 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.

  PMID: 27770490 BACKGROUND

• 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.

  PMID: 25154956 BACKGROUND

• 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. No abstract available.

  PMID: 19303521 BACKGROUND

• 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.

  PMID: 20974788 BACKGROUND

• 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.

  PMID: 23758300 BACKGROUND

• 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.

  PMID: 28012823 BACKGROUND

• 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.

  PMID: 26563535 BACKGROUND

• 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.

  PMID: 22100468 BACKGROUND

• 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.

  PMID: 21314777 BACKGROUND

• 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.

  PMID: 23517263 BACKGROUND

• 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.

  PMID: 24868305 BACKGROUND

• 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.

  PMID: 21277138 BACKGROUND

• 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.

  PMID: 29521429 BACKGROUND

• 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.

  PMID: 27139059 BACKGROUND

MeSH Terms

Conditions

Cellulitis; Insect Bites and Stings; Infections

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• James A Meltzer, MD, MS

  Jacobi Medical Center, Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: All participants in the study (i.e., patients and physicians) will be aware of what arm of the study they are in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 8, 2018
• Study Start: August 10, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)