Perspectives on Prophylactic Antibiotic Use in Dermatologic Surgery

Perspectives on Prophylactic Antibiotic Use in Dermatologic Surgery: a Prospective Multi-center Cohort Study

This is a prospective, multi-center observational survey study to uncover how antibiotic differences can influence utilization decisions. The purpose is to assess the trade-offs between drug side effects and infection prevention that patients are willing to make when taking prophylactic antibiotics. Misuse of antibiotics or non-adherence to prescribed regimens is a public health issue that may be due to a variety of reasons including unclear instructions, symptom improvement and adverse events Subjects will be healthcare providers (physician or nurse) and individuals 18+ years of age in the dermatologic surgery waiting area (including patients and accompanying individuals). Participants will complete a conjoint.ly survey and choose between treatment (antibiotic vs no antibiotic) scenarios.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Other: Survey

Detailed Description

This is a prospective, multi-center observational survey study to uncover how antibiotic differences can influence utilization decisions. The purpose is to assess the trade-offs between drug side effects and infection prevention that patients are willing to make when taking prophylactic antibiotics. Misuse of antibiotics or non-adherence to prescribed regimens is a public health issue that may be due to a variety of reasons including unclear instructions, symptom improvement and adverse events Subjects will be healthcare providers (physician or nurse) and individuals 18+ years of age in the dermatologic surgery waiting area (including patients and accompanying individuals). Participants will complete a conjoint.ly survey and choose between treatment (antibiotic vs no antibiotic) scenarios.

Adults in the dermatologic surgery department waiting room with age greater than or equal to 18 years (this includes both patients and accompanying individuals (family members, friends, caregivers)) and healthcare providers in dermatologic surgery. A member of the study team will approach patients in the Perelman Dermatology Clinic to determine if they meet inclusion criteria and educate them about the study using the verbal script. If interested, patients will receive a link to the online survey, which will contain an informed consent page. Dermatology healthcare providers will be identified in clinic or from academic center staff directories. Individuals meeting inclusion criteria will also be recruited from the dermatologic surgery waiting rooms of other collaborating institutions (Penn State Health, University of Missouri Health Care, Indiana University Health, University of Minnesota, Oregon Health & Science University, Washington University in St. Louis, UT Southwestern, UC Davis and Ohio State University) once approved by their IRB.

All data will be collected and stored in a secured password-protected conjoint.ly account managed by the Penn Dermatologic Surgery Clinical Research Team. Collaborating institutions will not have access to the survey responses. Data analysis: Multivariate random parameters logit will be used to estimate preference weights for each attribute level. These preference weights will be used to estimate the maximum acceptable risk of various side effects that subjects would be willing to accept in exchange for infection prevention. Collaborating researchers from other institutions will not be involved in data analysis.

• Study Type: Observational
• Enrollment (Actual): 338

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • University of California, Davis
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • Columbia, Missouri, United States, 65201
      • University of Missouri Health Care
  • Ohio
    • Columbus, Ohio, United States, 43230
      • The Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • UT southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults in the dermatologic surgery department waiting room with age greater than or equal to 18 years (this includes both patients and accompanying individuals (family members, friends, caregivers)) and healthcare providers in dermatologic surgery. A member of the study team will approach patients in the Perelman Dermatology Clinic to determine if they meet inclusion criteria and educate them about the study using the verbal script. If interested, patients will receive a link to the online survey, which will contain an informed consent page. Dermatology healthcare providers will be identified in clinic or from academic center staff directories.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Individual in the dermatologic surgery waiting room: patient, caregiver, family member or accompanying individual to patient receiving dermatologic surgery service, or dermatology healthcare provider

Exclusion Criteria:

• Age less than 18 years.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trade-offs	Determine the trade-offs between surgical site infection prophylaxis and antibiotic-associated adverse effects that patients, healthcare providers and caregivers are willing to make	Oct 3 2019-July 1 2021

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Publications and helpful links

General Publications

• Bae-Harboe YS, Liang CA. Perioperative antibiotic use of dermatologic surgeons in 2012. Dermatol Surg. 2013 Nov;39(11):1592-601. doi: 10.1111/dsu.12272. Epub 2013 Jul 18.
• Barbieri JS, Bhate K, Hartnett KP, Fleming-Dutra KE, Margolis DJ. Trends in Oral Antibiotic Prescription in Dermatology, 2008 to 2016. JAMA Dermatol. 2019 Mar 1;155(3):290-297. doi: 10.1001/jamadermatol.2018.4944.
• Barbieri JS, Etzkorn JR, Margolis DJ. Use of Antibiotics for Dermatologic Procedures From 2008 to 2016. JAMA Dermatol. 2019 Apr 1;155(4):465-470. doi: 10.1001/jamadermatol.2019.0152.
• Pechere JC. Parameters important in short antibiotic courses. J Int Med Res. 2000;28 Suppl 1:3A-12A.
• Pechere JC. Patients' interviews and misuse of antibiotics. Clin Infect Dis. 2001 Sep 15;33 Suppl 3:S170-3. doi: 10.1086/321844.
• Sclar DA, Tartaglione TA, Fine MJ. Overview of issues related to medical compliance with implications for the outpatient management of infectious diseases. Infect Agents Dis. 1994 Oct;3(5):266-73.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2019
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): August 25, 2021

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (ACTUAL): November 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 833873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No