- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04117724
Antibiotic Adherence Practices in Dermatologic Surgery
August 25, 2021 updated by: University of Pennsylvania
Antibiotic Adherence Practices in Dermatologic Surgery: a Multicenter Prospective Cohort Study
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
276
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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
-
Saint Louis, Missouri, United States, 63130
- Washington University in St. Louis
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
We plan to examine patients who have presented to a dermatologic surgery clinic and were prescribed post-operative antibiotics from June 1, 2019 to June 1, 2021 at the University of Pennsylvania Health System and other IRB approved sites.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of antibiotic non-adherence
Time Frame: Oct 3 2019-July 1 2021
|
To analyze the prevalence of antibiotic non-adherence in the dermatologic surgery setting
|
Oct 3 2019-July 1 2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk factors for antibiotic non-adherence
Time Frame: Oct 3 2019-July 1 2021
|
To identify risk factors for antibiotic non-adherence
|
Oct 3 2019-July 1 2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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, 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.
- 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.
- 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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2019
Primary Completion (Actual)
May 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
October 3, 2019
First Submitted That Met QC Criteria
October 3, 2019
First Posted (Actual)
October 7, 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
- 833525
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Only the study team at the University of Pennsylvania will have access to study data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Medication Adherence
-
NYU Langone HealthRobert Wood Johnson Foundation; New York City Health and Hospitals CorporationCompletedMedication Adherence | Medication ErrorsUnited States
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingMedication Adherence | Medication ComplianceUnited States
-
Vanderbilt University Medical CenterCompletedAdherence, Medication | Nonadherence, MedicationUnited States
-
Universidad Autonoma de Baja CaliforniaCompletedMedication Adherence | Medication ComplianceMexico
-
Universiti Putra MalaysiaCompletedMedication Adherence | Adherence, TreatmentPakistan
-
University Hospital, Basel, SwitzerlandUniversity of BaselCompletedPolymedication-Check With Insight in Patients' Medication Organisation and Comprehension of GenericsMedication Adherence | Medication Therapy ManagementSwitzerland
-
Cliniques universitaires Saint-Luc- Université...RecruitingAdherence, MedicationBelgium
-
Northwell HealthNational Institute on Aging (NIA)RecruitingMedication AdherenceUnited States
-
Swedish Medical CenterNational Institute of Mental Health (NIMH); University of Washington; University...Recruiting
-
Northwell HealthToronto Dominion BankCompletedMedication AdherenceUnited States
Clinical Trials on Survey
-
Johns Hopkins Bloomberg School of Public HealthPontificia Universidad JaverianaCompletedNoncommunicable Diseases | Surveys and QuestionnairesColombia
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSarcoma | Breast Carcinoma | Head and Neck CarcinomaUnited States
-
Ohio State UniversityWithdrawnMedicare Part DUnited States
-
Johns Hopkins Bloomberg School of Public HealthIfakara Health InstituteCompletedNoncommunicable Diseases | Surveys and QuestionnairesTanzania
-
Memorial Sloan Kettering Cancer CenterCompletedInpatients With Limited English ProficiencyUnited States
-
Lawson Health Research InstituteCompletedEvaluation of an Introductory Videotape Intervention to Improve Cardiac Rehabilitation ParticipationMyocardial Infarction | Unstable Angina | Coronary Angioplasty | Coronary Artery Bypass SurgeryCanada
-
University GhentCompletedStroke | Upper Extremity Paresis | Survey
-
Assistance Publique - Hôpitaux de ParisUniversité de Cergy PontoiseCompleted
-
Weill Medical College of Cornell UniversityBoston Children's Hospital; Brigham and Women's Hospital; The Commonwealth FundCompletedPediatric ALLUnited States