<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/NCT03815500</url>
  </required_header>
  <id_info>
    <org_study_id>18-008124</org_study_id>
    <nct_id>NCT03815500</nct_id>
  </id_info>
  <brief_title>Patient Education at Dismissal After Surgical Procedure</brief_title>
  <official_title>Patient Education at Dismissal After Surgical Procedure: Clinical Outcome Implications and Improvement Strategies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Can improvements in patient dismissal education materials reduce incidence of wound&#xD;
      non-healing and infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators seek to address the specific educational needs of patients and caregivers&#xD;
      with low-literacy, dyslexia and related learning disabilities in the context of properly&#xD;
      performing wound care for patients with surgical wounds. Specific aims include both improving&#xD;
      care by decreasing wound complications and improving patient satisfaction by using techniques&#xD;
      designed for this population. Objectives include utilizing surveys to determine the incidence&#xD;
      of dyslexia among the patients' and caregivers' within the general surgery service as well as&#xD;
      the perception of our current educational offerings, to design a new dismissal package with&#xD;
      enhanced educational offerings, to re-measure this effect on the patient experience with&#xD;
      survey data, and to compare wound infection rates before and after implementing the new&#xD;
      curriculum. Dyslexia and associated learning disabilities are common and likely impact the&#xD;
      health literacy among this population due to the ubiquitous literacy-based documentation of&#xD;
      hospital course and dismissal instructions. Adults with dyslexia may be reluctant to disclose&#xD;
      any inability to understand written instructions. There is currently no mechanism within the&#xD;
      dismissal system to specifically identify and address the unique needs of this population.&#xD;
      The impact on clinical outcomes of proper wound packing is substantial, and if performed&#xD;
      incorrectly can lead to slow wound healing and infections that often require readmission,&#xD;
      multiple courses of antibiotics, and reoperation. In severe cases, improper wound care can&#xD;
      lead to severe infection, sepsis, and death. By enhancing the educational offerings of proper&#xD;
      wound care to this population, the investigators hope to reduce these complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI no longer with the organization, no subjects enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Utilization of education curriculum designed for learners with low literacy, dyslexia and associate learning disorders</measure>
    <time_frame>6 months</time_frame>
    <description>Nursing surveys answering the question, &quot;Have you been trained to teach wound care to patients with dyslexia or learning disabilities?&quot; Were answered &quot;No,&quot; by 43/46 (93%) respondents. We seek to have a 90% rate of affirmative (&quot;Yes&quot;) answers to this survey after implementation of our curriculum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with wound education</measure>
    <time_frame>6 months</time_frame>
    <description>Survey of patients' wound education experiences should indicate that they are being offered curriculum suitable for learners with low literacy, dyslexia and associated learning disorders. We will utilize a scale of &quot;Definitely satisfied, somewhat satisfied, somewhat dissatisfied, definitely dissatisfied&quot; as our measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>shorter time to wound healing</measure>
    <time_frame>1 year</time_frame>
    <description>After implementation of new curriculum, it is anticipated that wound complication rates and time to wound healing would decrease. We will calculate the &quot;time&quot; based on the date of wound creation to their final clinic appointment indicated the wound is satisfactorily healed with &quot;days&quot; as our unit of measure.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Wound Infection Post-Traumatic</condition>
  <condition>Wound Infection</condition>
  <condition>Wound Complication</condition>
  <condition>Wound Breakdown</condition>
  <condition>Wound Open</condition>
  <arm_group>
    <arm_group_label>Patients with open surgical wounds</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with open surgical wounds will undergo enhanced packing education with curriculum designed for learners with low literacy, dyslexia or associated learning disorders.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Education</intervention_name>
    <description>Enhanced educational curriculum will involve learning modalities including 3D modeling, video, and visual-aid enhanced text for references to improve caregiver and patient understanding of wound packing techniques.</description>
    <arm_group_label>Patients with open surgical wounds</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients on the general surgery service with open wounds requiring packing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with wound vacs&#xD;
&#xD;
          -  Patients receiving exclusively professional wound care or home health services&#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>Martin D Zielinski</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>August 12, 2022</last_update_submitted>
  <last_update_submitted_qc>August 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Dehiscence</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT03815500
org study id: 18-008124
nct id: NCT03815500
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Can improvements in patient dismissal education materials reduce incidence of wound
      non-healing and infection.
The investigators seek to address the specific educational needs of patients and caregivers
      with low-literacy, dyslexia and related learning disabilities in the context of properly
      performing wound care for patients with surgical wounds. Specific aims include both improving
      care by decreasing wound complications and improving patient satisfaction by using techniques
      designed for this population. Objectives include utilizing surveys to determine the incidence
      of dyslexia among the patients' and caregivers' within the general surgery service as well as
      the perception of our current educational offerings, to design a new dismissal package with
      enhanced educational offerings, to re-measure this effect on the patient experience with
      survey data, and to compare wound infection rates before and after implementing the new
      curriculum. Dyslexia and associated learning disabilities are common and likely impact the
      health literacy among this population due to the ubiquitous literacy-based documentation of
      hospital course and dismissal instructions. Adults with dyslexia may be reluctant to disclose
      any inability to understand written instructions. There is currently no mechanism within the
      dismissal system to specifically identify and address the unique needs of this population.
      The impact on clinical outcomes of proper wound packing is substantial, and if performed
      incorrectly can lead to slow wound healing and infections that often require readmission,
      multiple courses of antibiotics, and reoperation. In severe cases, improper wound care can
      lead to severe infection, sepsis, and death. By enhancing the educational offerings of proper
      wound care to this population, the investigators hope to reduce these complications.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Utilization of education curriculum designed for learners with low literacy, dyslexia and associate learning disorders
time frame: 6 months
description: Nursing surveys answering the question, "Have you been trained to teach wound care to patients with dyslexia or learning disabilities?" Were answered "No," by 43/46 (93%) respondents. We seek to have a 90% rate of affirmative ("Yes") answers to this survey after implementation of our curriculum.
measure: Patient satisfaction with wound education
time frame: 6 months
description: Survey of patients' wound education experiences should indicate that they are being offered curriculum suitable for learners with low literacy, dyslexia and associated learning disorders. We will utilize a scale of "Definitely satisfied, somewhat satisfied, somewhat dissatisfied, definitely dissatisfied" as our measure.
measure: shorter time to wound healing
time frame: 1 year
description: After implementation of new curriculum, it is anticipated that wound complication rates and time to wound healing would decrease. We will calculate the "time" based on the date of wound creation to their final clinic appointment indicated the wound is satisfactorily healed with "days" as our unit of measure.
arm group label: Patients with open surgical wounds
arm group type: Experimental
description: Patients with open surgical wounds will undergo enhanced packing education with curriculum designed for learners with low literacy, dyslexia or associated learning disorders.
intervention type: Behavioral
intervention name: Enhanced Education
description: Enhanced educational curriculum will involve learning modalities including 3D modeling, video, and visual-aid enhanced text for references to improve caregiver and patient understanding of wound packing techniques.
arm group label: Patients with open surgical wounds
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin D Zielinski
role: Principal Investigator
affiliation: Mayo Clinic
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Wound Infection
mesh term: Surgical Wound Dehiscence
mesh term: Wounds and Injuries