NCT04117724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

October 3, 2019

Last Update Submit

August 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of antibiotic non-adherence

    To analyze the prevalence of antibiotic non-adherence in the dermatologic surgery setting

    Oct 3 2019-July 1 2021

Secondary Outcomes (1)

  • Risk factors for antibiotic non-adherence

    Oct 3 2019-July 1 2021

Interventions

SurveyOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of California, Davis

Davis, California, 95616, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65201, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

The Ohio State University

Columbus, Ohio, 43230, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related 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.

    PMID: 23865410BACKGROUND
  • 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.

    PMID: 30825412BACKGROUND
  • 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.

    PMID: 12039881BACKGROUND
  • Pechere JC. Parameters important in short antibiotic courses. J Int Med Res. 2000;28 Suppl 1:3A-12A.

    PMID: 11092225BACKGROUND
  • Pechere JC. Patients' interviews and misuse of antibiotics. Clin Infect Dis. 2001 Sep 15;33 Suppl 3:S170-3. doi: 10.1086/321844.

    PMID: 11524715BACKGROUND
  • 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.

    PMID: 7866659BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 7, 2019

Study Start

October 10, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Only the study team at the University of Pennsylvania will have access to study data.

Locations