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Perspectives on Prophylactic Antibiotic Use 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: NCT04150523
Recruitment Status : Suspended (Suspended due to COVID-19)
First Posted : November 4, 2019
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment
Medication Adherence Other: Survey

Detailed Description:

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.

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. Individuals meeting inclusion criteria will also be recruited from the dermatologic surgery waiting rooms of other collaborating institutions (Penn State Health, University of Missouri Health Care, Indiana University Health, University of Minnesota, Oregon Health & Science University, Washington University in St. Louis, UT Southwestern, UC Davis and Ohio State University) once approved by their IRB.

All data will be collected and stored in a secured password-protected conjoint.ly account managed by the Penn Dermatologic Surgery Clinical Research Team. Collaborating institutions will not have access to the survey responses. Data analysis: Multivariate random parameters logit will be used to estimate preference weights for each attribute level. These preference weights will be used to estimate the maximum acceptable risk of various side effects that subjects would be willing to accept in exchange for infection prevention. Collaborating researchers from other institutions will not be involved in data analysis.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Perspectives on Prophylactic Antibiotic Use in Dermatologic Surgery: a Prospective Multi-center Cohort Study
Actual Study Start Date : October 15, 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
    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.


Primary Outcome Measures :
  1. Trade-offs [ Time Frame: Oct 3 2019-July 1 2021 ]
    Determine the trade-offs between surgical site infection prophylaxis and antibiotic-associated adverse effects that patients, healthcare providers and caregivers are willing to make



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
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age less than 18 years.

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): NCT04150523


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
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: NCT04150523    
Other Study ID Numbers: 833873
First Posted: November 4, 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

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