NCT04150523

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
338

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

8 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

Study Start

First participant enrolled

October 15, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

October 31, 2019

Last Update Submit

August 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

SurveyOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • Age less than 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

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

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, 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.

    PMID: 30649187BACKGROUND
  • 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
  • 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
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

October 15, 2019

Primary Completion

June 1, 2021

Study Completion

August 25, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations