<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/NCT02970435</url>
  </required_header>
  <id_info>
    <org_study_id>CASE1616</org_study_id>
    <nct_id>NCT02970435</nct_id>
  </id_info>
  <brief_title>Evaluating the Impact of Video Discharge Instructions for Mohs Surgery Post-Operative Care</brief_title>
  <official_title>Evaluating the Impact of Video Discharge Instructions for Mohs Surgery Post-Operative Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to look at how educational videos provided by doctors might&#xD;
      affect patients knowledge, satisfaction, confidence, and anxiety with post-operative Mohs&#xD;
      surgery care. Patients will be randomized to either: 1) a group that receives educational&#xD;
      videos in addition to standard-of-care written and verbal instructions or 2) a group that&#xD;
      receives only standard-of-care written and verbal instructions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Primary Objective of this study is to determine if video discharge instructions, when&#xD;
      added to standard of care written and verbal instructions, lead to a decrease in unnecessary&#xD;
      phone calls from patients in a Mohs dermatology clinic.&#xD;
&#xD;
      The Secondary Objectives of this study are to determine if video discharge instructions, when&#xD;
      added to standard of care written and verbal instructions, help to improve patients'&#xD;
      satisfaction with education materials provided by the clinic, improve patients' knowledge of&#xD;
      post-operative management, improve patients' confidence in taking care of their suture site&#xD;
      post-operatively, and reduce post-operative anxiety about their suture site.&#xD;
&#xD;
      This study will be a randomized controlled trial in which the impact of video discharge&#xD;
      instructions on patient calls, anxiety, and confidence will be evaluated. Patients will be&#xD;
      randomized using a permuted block model generated through SAS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual&#xD;
  </why_stopped>
  <start_date type="Actual">July 12, 2017</start_date>
  <completion_date type="Actual">June 21, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ratio of patients in the intervention group who call the clinic compared to percentage of patients in the control group who call the clinic</measure>
    <time_frame>Up to 8 weeks after discharge</time_frame>
    <description>Researchers will record when each participant calls the clinic. The number of people who call in the intervention group will be compared to the number of people who call in the control group. This will give an efficacy measure of the video discharge instructions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in knowledge of discharge instructions in intervention group versus control group</measure>
    <time_frame>Up to 8 weeks after discharge</time_frame>
    <description>Answers to survey questions investigating knowledge of discharge instruction will be compared between the control and intervention groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in confidence in intervention group versus control group</measure>
    <time_frame>Up to 8 weeks after discharge</time_frame>
    <description>A survey investigating confidence about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in satisfaction in intervention group versus control group</measure>
    <time_frame>Up to 8 weeks after discharge</time_frame>
    <description>A survey investigating patient satisfaction about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in self reported anxiety levels in intervention group versus control group</measure>
    <time_frame>Up to 8 weeks after discharge</time_frame>
    <description>A survey investigating anxiety about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Linear Closure</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Video Discharge Instructions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These videos contain the same instructions that a patient receives via the standard-of-care verbal and written discharge instructions. These instructions will be delivered by the same nursing and medical staff that also regularly provides verbal and written discharge instructions to patients. There will be no difference in the content between the standard-of-care verbal and written instructions and the video discharge instructions. Patients in this group will receive telecommunication reminders on how to access discharge videos.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Verbal and Written Discharge Instructions</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nursing and medical staff will provide verbal and written discharge instructions as is standard of care post surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video Discharge Instructions</intervention_name>
    <description>The video discharge instructions, will be provided to the patient at the time of surgical procedure.</description>
    <arm_group_label>Video Discharge Instructions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telecommunication Reminders</intervention_name>
    <description>Telecommunication reminders including text messages, email, or phone calls to remind participants how to access the video discharge instruction up to three times before follow-up</description>
    <arm_group_label>Video Discharge Instructions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of Care: verbal and written discharge instructions for patients after surgery</description>
    <arm_group_label>Verbal and Written Discharge Instructions</arm_group_label>
    <arm_group_label>Video Discharge Instructions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent a linear closure on the face at UH Mohs clinic&#xD;
&#xD;
          -  Fluent English speakers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        ● Non-fluent English speakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy Bordeaux, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals at Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106-5065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>January 21, 2021</last_update_submitted>
  <last_update_submitted_qc>January 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>surgery</keyword>
  <keyword>video discharge instructions</keyword>
  <!-- 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/NCT02970435
org study id: CASE1616
nct id: NCT02970435
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research is to look at how educational videos provided by doctors might
      affect patients knowledge, satisfaction, confidence, and anxiety with post-operative Mohs
      surgery care. Patients will be randomized to either: 1) a group that receives educational
      videos in addition to standard-of-care written and verbal instructions or 2) a group that
      receives only standard-of-care written and verbal instructions.
The Primary Objective of this study is to determine if video discharge instructions, when
      added to standard of care written and verbal instructions, lead to a decrease in unnecessary
      phone calls from patients in a Mohs dermatology clinic.

      The Secondary Objectives of this study are to determine if video discharge instructions, when
      added to standard of care written and verbal instructions, help to improve patients'
      satisfaction with education materials provided by the clinic, improve patients' knowledge of
      post-operative management, improve patients' confidence in taking care of their suture site
      post-operatively, and reduce post-operative anxiety about their suture site.

      This study will be a randomized controlled trial in which the impact of video discharge
      instructions on patient calls, anxiety, and confidence will be evaluated. Patients will be
      randomized using a permuted block model generated through SAS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Ratio of patients in the intervention group who call the clinic compared to percentage of patients in the control group who call the clinic
time frame: Up to 8 weeks after discharge
description: Researchers will record when each participant calls the clinic. The number of people who call in the intervention group will be compared to the number of people who call in the control group. This will give an efficacy measure of the video discharge instructions
measure: Difference in knowledge of discharge instructions in intervention group versus control group
time frame: Up to 8 weeks after discharge
description: Answers to survey questions investigating knowledge of discharge instruction will be compared between the control and intervention groups.
measure: Difference in confidence in intervention group versus control group
time frame: Up to 8 weeks after discharge
description: A survey investigating confidence about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.
measure: Difference in satisfaction in intervention group versus control group
time frame: Up to 8 weeks after discharge
description: A survey investigating patient satisfaction about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.
measure: Difference in self reported anxiety levels in intervention group versus control group
time frame: Up to 8 weeks after discharge
description: A survey investigating anxiety about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.
arm group label: Video Discharge Instructions
arm group type: Experimental
description: These videos contain the same instructions that a patient receives via the standard-of-care verbal and written discharge instructions. These instructions will be delivered by the same nursing and medical staff that also regularly provides verbal and written discharge instructions to patients. There will be no difference in the content between the standard-of-care verbal and written instructions and the video discharge instructions. Patients in this group will receive telecommunication reminders on how to access discharge videos.
arm group label: Verbal and Written Discharge Instructions
arm group type: Active Comparator
description: Nursing and medical staff will provide verbal and written discharge instructions as is standard of care post surgery
intervention type: Behavioral
intervention name: Video Discharge Instructions
description: The video discharge instructions, will be provided to the patient at the time of surgical procedure.
arm group label: Video Discharge Instructions
intervention type: Behavioral
intervention name: Telecommunication Reminders
description: Telecommunication reminders including text messages, email, or phone calls to remind participants how to access the video discharge instruction up to three times before follow-up
arm group label: Video Discharge Instructions
intervention type: Behavioral
intervention name: Standard of Care
description: Standard of Care: verbal and written discharge instructions for patients after surgery
arm group label: Verbal and Written Discharge Instructions
arm group label: Video Discharge Instructions
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeremy Bordeaux, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor