<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03036358</url>
  </required_header>
  <id_info>
    <org_study_id>2015H0134</org_study_id>
    <nct_id>NCT03036358</nct_id>
  </id_info>
  <brief_title>Effect of Teledermatology on Length of Hospital Admission, Length of Stay, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic ED Setting</brief_title>
  <official_title>The Effect of Teledermatology on Length of Hospital Admission, Length of Stay, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic Emergency Department Setting.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of teledermatology on length of hospital admission, length of stay, 30 day&#xD;
      readmission rate, and antibiotic use in patients presenting with cellulitis vs&#xD;
      pseudocellulitis in an academic emergency department setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Investigator hope to determine if the implementation of teledermatology in the emergency&#xD;
      department (ED) at The Ohio State University Wexner Medical Center is beneficial in&#xD;
      diagnosing cases of cellulitis and pseudocellulitis conditions. Prior studies have indicated&#xD;
      that misdiagnosis may occur in up to 28% of patients in the ED with these conditions.&#xD;
      Additionally, dermatological consults have been shown to change diagnosis or management of&#xD;
      these conditions in more than 60% of the patients examined. Without the use of&#xD;
      teledermatology, however, a dermatological consult would be prohibitively expensive and take&#xD;
      time to obtain. The investigator proposes that by utilizing teledermatology in emergency&#xD;
      rooms, the investigator can make faster, yet just as accurate, dermatological diagnoses in&#xD;
      patients presenting with cellulitis-like symptoms. Subsequently, by reducing the number of&#xD;
      misdiagnoses, unnecessary use of antibiotics and hospitalizations will also decrease,&#xD;
      lowering health care costs and simultaneously providing patients with faster treatment of the&#xD;
      actual dermatologic condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Admission to the hospital</measure>
    <time_frame>30 days</time_frame>
    <description>To determine the benefit of teledermatology to differentiate cellulitis from pseudocellulitis in emergency departments through the analysis of time spent in the emergency department (ED), admission to the inpatient hospital, antibiotic use, time to improvement, We anticipate a high rate of pseudocellulitis, and this aim will determine if there is a difference in patient admissions among those who receive a dermatologic assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay in the hospital</measure>
    <time_frame>30 days post admission</time_frame>
    <description>Will assess time spent in the hospital for those that were admitted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 day readmission rate</measure>
    <time_frame>30 days post admission</time_frame>
    <description>Will assess hospitalization/emergency department readmission in the following 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibiotic use</measure>
    <time_frame>30 days post admission</time_frame>
    <description>Will assess the frequency of antibiotic use between groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Cellulitis</condition>
  <arm_group>
    <arm_group_label>Teledermatology consult</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>To determine the benefit of teledermatology to differentiate cellulitis from pseudocellulitis in emergency departments through the analysis of time spent in the emergency department (ED), admission to the inpatient hospital, antibiotic use, time to improvement, and 30-day remission rate. This arm will undergo imaging, a dermatologic assessment will be performed, AND this assessment will be entered into the patients chart.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>To determine the benefit of teledermatology to differentiate cellulitis from pseudocellulitis in emergency departments through the analysis of time spent in the emergency department (ED), admission to the inpatient hospital, antibiotic use, time to improvement, and 30-day remission rate. This arm will undergo imaging, a dermatologic assessment will be performed, AND this assessment WILL NOT be entered into the patients chart</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>teledermatology consult</intervention_name>
    <description>Information from the dermatologic assessment will be entered into the patients chart.</description>
    <arm_group_label>Teledermatology consult</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine Care</intervention_name>
    <description>The dermatologic assessment will occur but not added to the patients medical record. Dermatology may still be consulted but will be at the prerogative of the treating hospitalist.</description>
    <arm_group_label>Routine Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18&#xD;
&#xD;
          -  Present to the ED with cellulitis-like symptoms, including but not limited to the&#xD;
             following: tenderness, redness, swelling, expansive lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  prisoner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin H Kaffenberger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OSU Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>June 4, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Benjamin Kaffenberger</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cellulitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036358
org study id: 2015H0134
nct id: NCT03036358
lead sponsor: 
has dmc: No
The effect of teledermatology on length of hospital admission, length of stay, 30 day
      readmission rate, and antibiotic use in patients presenting with cellulitis vs
      pseudocellulitis in an academic emergency department setting.
The Investigator hope to determine if the implementation of teledermatology in the emergency
      department (ED) at The Ohio State University Wexner Medical Center is beneficial in
      diagnosing cases of cellulitis and pseudocellulitis conditions. Prior studies have indicated
      that misdiagnosis may occur in up to 28% of patients in the ED with these conditions.
      Additionally, dermatological consults have been shown to change diagnosis or management of
      these conditions in more than 60% of the patients examined. Without the use of
      teledermatology, however, a dermatological consult would be prohibitively expensive and take
      time to obtain. The investigator proposes that by utilizing teledermatology in emergency
      rooms, the investigator can make faster, yet just as accurate, dermatological diagnoses in
      patients presenting with cellulitis-like symptoms. Subsequently, by reducing the number of
      misdiagnoses, unnecessary use of antibiotics and hospitalizations will also decrease,
      lowering health care costs and simultaneously providing patients with faster treatment of the
      actual dermatologic condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Admission to the hospital
time frame: 30 days
description: To determine the benefit of teledermatology to differentiate cellulitis from pseudocellulitis in emergency departments through the analysis of time spent in the emergency department (ED), admission to the inpatient hospital, antibiotic use, time to improvement, We anticipate a high rate of pseudocellulitis, and this aim will determine if there is a difference in patient admissions among those who receive a dermatologic assessment
measure: Length of stay in the hospital
time frame: 30 days post admission
description: Will assess time spent in the hospital for those that were admitted
measure: 30 day readmission rate
time frame: 30 days post admission
description: Will assess hospitalization/emergency department readmission in the following 30 days
measure: Antibiotic use
time frame: 30 days post admission
description: Will assess the frequency of antibiotic use between groups
arm group label: Teledermatology consult
arm group type: Other
description: To determine the benefit of teledermatology to differentiate cellulitis from pseudocellulitis in emergency departments through the analysis of time spent in the emergency department (ED), admission to the inpatient hospital, antibiotic use, time to improvement, and 30-day remission rate. This arm will undergo imaging, a dermatologic assessment will be performed, AND this assessment will be entered into the patients chart.
arm group label: Routine Care
arm group type: Other
description: To determine the benefit of teledermatology to differentiate cellulitis from pseudocellulitis in emergency departments through the analysis of time spent in the emergency department (ED), admission to the inpatient hospital, antibiotic use, time to improvement, and 30-day remission rate. This arm will undergo imaging, a dermatologic assessment will be performed, AND this assessment WILL NOT be entered into the patients chart
intervention type: Other
intervention name: teledermatology consult
description: Information from the dermatologic assessment will be entered into the patients chart.
arm group label: Teledermatology consult
intervention type: Other
intervention name: Routine Care
description: The dermatologic assessment will occur but not added to the patients medical record. Dermatology may still be consulted but will be at the prerogative of the treating hospitalist.
arm group label: Routine Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Benjamin H Kaffenberger, MD
role: Principal Investigator
affiliation: OSU Dermatology
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Benjamin Kaffenberger
investigator title: Assistant Professor
mesh term: Cellulitis
sharing ipd: Yes