Antibiotic Adherence Practices in Dermatologic Surgery

NCT ID: NCT04117724

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 276 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2021-05-01

Brief Summary

This multi-center prospective observational cohort study will examine the prevalence of non-adherence along with analyze the risk factors of non-adherence for patients presenting to dermatologic surgery. Patients prescribed antibiotics will be invited to participate in the study and appropriate follow up to inquire about antibiotic usage will be conducted. All data will be collected and stored in a secured REDCap database managed by the Penn Dermatologic Surgery Clinical Research Team.

Detailed Description

This multi-center prospective observational cohort study will examine the prevalence of non-adherence and analyze the risk factors of non-adherence for patients presenting to dermatologic surgery. Patients prescribed antibiotics will be invited to participate in the study and appropriate follow up to inquire about antibiotic usage will be conducted. Inclusion criteria are 1) Patients with age greater than or equal to 18 who are capable of providing informed consent and 2) Patients who have been prescribed antibiotics following their visit with a dermatologic surgery department. We plan to examine patients who have presented to a dermatologic surgery clinic and were prescribed antibiotics from June 1, 2019 to June 1, 2021 at the University of Pennsylvania Health System and other Institutional Review Board (IRB) approved sites. After obtaining informed consent at their visit to enroll in the study, variables of interest will be collected from patients including name, date of birth (DOB), gender, visit date, contact information, antibiotic regimen, and 4 question survey assessing adherence. Follow up via patient's preferred method of contact will be conducted after the patient's intended antibiotic completion date and covariates for antibiotic regimens will be recorded including antibiotic type, number of doses, antibiotic duration, reason for non-adherence, pills remaining, and number of other medications. All data will be collected and stored in a secured REDCap database managed by the Penn Dermatologic Surgery Clinical Research Team.

Conditions

Medication Adherence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Survey

Patients will be asked to complete a 4 question survey assessing adherence. Follow up via patient's preferred method of contact will be conducted after the patient's intended antibiotic completion date and covariates for antibiotic regimens will be recorded including antibiotic type, number of doses, antibiotic duration, reason for non-adherence, pills remaining, and number of other medications.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age greater than equal to 18
• All patients presenting to one of the dermatologic surgery settings approved by the IRB who are prescribed a post-operative antibiotic regimen

Exclusion Criteria

• Patients who do not present to or are not prescribed post-operative antibiotics in a dermatologic surgery setting

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California, Davis

Davis, California, United States

Indiana University

Indianapolis, Indiana, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Missouri Health Care

Columbia, Missouri, United States

Washington University in St. Louis

St Louis, Missouri, United States

The Ohio State University

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23865410 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30825412 (View on PubMed)

Kardas P. Patient compliance with antibiotic treatment for respiratory tract infections. J Antimicrob Chemother. 2002 Jun;49(6):897-903. doi: 10.1093/jac/dkf046.

Reference Type: BACKGROUND

PMID: 12039881 (View on PubMed)

Pechere JC. Parameters important in short antibiotic courses. J Int Med Res. 2000;28 Suppl 1:3A-12A.

Reference Type: BACKGROUND

PMID: 11092225 (View on PubMed)

Pechere JC. Patients' interviews and misuse of antibiotics. Clin Infect Dis. 2001 Sep 15;33 Suppl 3:S170-3. doi: 10.1086/321844.

Reference Type: BACKGROUND

PMID: 11524715 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7866659 (View on PubMed)

Other Identifiers

833525

Identifier Type: -

Identifier Source: org_study_id