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Antibiotic Adherence Practices in Dermatologic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117724
Recruitment Status : Suspended (Suspended due to COVID-19)
First Posted : October 7, 2019
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment
Medication Adherence Other: Survey

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.

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Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antibiotic Adherence Practices in Dermatologic Surgery: a Multicenter Prospective Cohort Study
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics


Intervention Details:
  • Other: 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.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Risk factors for antibiotic non-adherence [ Time Frame: Oct 3 2019-July 1 2021 ]
    To identify risk factors for antibiotic non-adherence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117724


Locations
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United States, California
University of California, Davis
Davis, California, United States, 95616
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65201
Washington University in St. Louis
Saint Louis, Missouri, United States, 63130
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43230
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Pennsylvania
Publications:
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04117724    
Other Study ID Numbers: 833525
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only the study team at the University of Pennsylvania will have access to study data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No