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
About this trial
This is an interventional supportive care trial for Cellulitis focused on measuring infection
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
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
NCT ID
NCT03619746
First Posted
August 3, 2018
Last Updated
October 26, 2020
Sponsor
New York City Health and Hospitals Corporation
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:
PubMed Identifier
19458526
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.
Results Reference
background
PubMed Identifier
29023420
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):21. doi: 10.3390/antibiotics6040021.
Results Reference
background
PubMed Identifier
25162160
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. No abstract available.
Results Reference
background
PubMed Identifier
28807835
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.
Results Reference
background
PubMed Identifier
19665335
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.
Results Reference
background
PubMed Identifier
16531602
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. doi: 10.1197/j.aem.2005.11.074. Epub 2006 Mar 10.
Results Reference
background
PubMed Identifier
27770490
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.
Results Reference
background
PubMed Identifier
25154956
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.
Results Reference
background
PubMed Identifier
19303521
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. No abstract available.
Results Reference
background
PubMed Identifier
20974788
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.
Results Reference
background
PubMed Identifier
23758300
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.
Results Reference
background
PubMed Identifier
28012823
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.
Results Reference
background
PubMed Identifier
26563535
Citation
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.
Results Reference
background
PubMed Identifier
22100468
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.
Results Reference
background
PubMed Identifier
21314777
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.
Results Reference
background
PubMed Identifier
23517263
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.
Results Reference
background
PubMed Identifier
24868305
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.
Results Reference
background
PubMed Identifier
21277138
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.
Results Reference
background
PubMed Identifier
29521429
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.
Results Reference
background
PubMed Identifier
27139059
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.
Results Reference
background
Learn more about this trial
Point-of-Care Ultrasound Educational Initiative for Insect Bites
We'll reach out to this number within 24 hrs