Perspectives on Prophylactic Antibiotic Use in Dermatologic Surgery

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150523
• Other study ID #: 833873
• Status: Completed
• Start date: October 15, 2019
• Est. completion date: August 25, 2021

Study information

• Verified date: August 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: August 25, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Other:
• Survey
The study will involve a 22 question online survey, administered through the online survey platform conjoint.ly. Conjoint.ly is a web-based survey tool used to conduct survey research, evaluations and other data collection activities. Participants will complete a conjoint.ly survey and choose between treatment (antibiotic vs no antibiotic) scenarios.

Locations

Country	Name	City	State
United States	University of Missouri Health Care	Columbia	Missouri
United States	The Ohio State University	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	University of California, Davis	Davis	California
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Indiana University	Indianapolis	Indiana
United States	University of Minnesota	Minneapolis	Minnesota
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Pechère JC. Parameters important in short antibiotic courses. J Int Med Res. 2000;28 Suppl 1:3A-12A. Review. — View Citation

Pechère JC. Patients' interviews and misuse of antibiotics. Clin Infect Dis. 2001 Sep 15;33 Suppl 3:S170-3. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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