<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/NCT04401891</url>
  </required_header>
  <id_info>
    <org_study_id>201911175</org_study_id>
    <nct_id>NCT04401891</nct_id>
  </id_info>
  <brief_title>Formal Pre-Operative Education</brief_title>
  <official_title>The Benefit of Formal Pre-operative Education to Patient Satisfaction, Pain and Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators want to determine if delivering formal preoperative education to patients&#xD;
      helps the patients with post operative pain, function and overall satisfaction. Education&#xD;
      would cover surgery, post operative activities of daily living, pain and edema management,&#xD;
      duration of recovery and any expected therapy they might need. All participants will receive&#xD;
      a pre and post operative questionnaire to determine level of understanding of anticipated&#xD;
      needs and barriers due to surgery. Group one will receive formal education from an&#xD;
      occupational therapist or physical therapist while Group two will receive only standard&#xD;
      education in the MD clinic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 5, 2020</start_date>
  <completion_date type="Anticipated">February 5, 2025</completion_date>
  <primary_completion_date type="Anticipated">February 5, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function Subtest -- change is being assessed</measure>
    <time_frame>prior to surgery and two weeks post surgery</time_frame>
    <description>Bell curve scale for scoring: A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety subtest -- change is being assessed</measure>
    <time_frame>prior to surgery and two weeks post surgery</time_frame>
    <description>Bell Curve scale for scoring:A score of 50 is the average amount of anxiety in the general public. A score above 60 the patient has significant anxiety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS (Patient-Reported Outcomes Measurement Information System) Depression subtest -- change is being assessed</measure>
    <time_frame>prior to surgery and two weeks post surgery</time_frame>
    <description>Bell shape curve scoring: A score of 50 is the average amount for depression in the general public. A score above 60 corresponds to a score of 10 on the Patient Health Questionnaire (PHQ)-9 scale, which is the cutoff with the highest sensitivity and specificity to detect a diagnosis of moderately severe major depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference subtest -- change is being assessed</measure>
    <time_frame>prior to surgery and two weeks post surgery</time_frame>
    <description>Bell shape curve scoring: The higher the score above 50 the more the pain the lower the score below 50 the less the pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS (Patient-Reported Outcomes Measurement Information System)Upper Extremity Function subtest -- change is being assessed</measure>
    <time_frame>prior to surgery and two weeks post surgery</time_frame>
    <description>Bell shape curve scoring:A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) Pre-Operative</measure>
    <time_frame>prior to surgery</time_frame>
    <description>1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) post operative</measure>
    <time_frame>2 weeks post surgery</time_frame>
    <description>1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Scale</measure>
    <time_frame>prior to surgery and 2 weeks post surgery</time_frame>
    <description>0 to 10 likert scale. 0 being no pain and 10 being worst pain possible</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Upper Extremity Orthopedic Surgery Patients</condition>
  <arm_group>
    <arm_group_label>Routine Pre-Operative Education in MD office prior to surgery</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Formal Pre-operative education/therapy prior to surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Formal pre-operative education</intervention_name>
    <description>One group of patients will receive formal pre-operative education prior to surgery from an occupational or physical therapists while the other group of patients will only receive routine education in the MD office.</description>
    <arm_group_label>Formal Pre-operative education/therapy prior to surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older,&#xD;
&#xD;
          -  English as Primary language,&#xD;
&#xD;
          -  scheduled to have orthopedic upper extremity surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 18 years&#xD;
&#xD;
          -  Conservative management or non operative management of orthopedic upper extremity&#xD;
             surgery&#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>Logan Berlet, OTD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University in Saint Louis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Logan Berlet, OTD</last_name>
    <phone>314-286-1669</phone>
    <email>lberlet@wustl.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Washington University in Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63130</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Logan Berlet, OTD</last_name>
      <phone>614-202-5333</phone>
      <email>lberlet@wustl.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04401891
org study id: 201911175
nct id: NCT04401891
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators want to determine if delivering formal preoperative education to patients
      helps the patients with post operative pain, function and overall satisfaction. Education
      would cover surgery, post operative activities of daily living, pain and edema management,
      duration of recovery and any expected therapy they might need. All participants will receive
      a pre and post operative questionnaire to determine level of understanding of anticipated
      needs and barriers due to surgery. Group one will receive formal education from an
      occupational therapist or physical therapist while Group two will receive only standard
      education in the MD clinic.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function Subtest -- change is being assessed
time frame: prior to surgery and two weeks post surgery
description: Bell curve scale for scoring: A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety subtest -- change is being assessed
time frame: prior to surgery and two weeks post surgery
description: Bell Curve scale for scoring:A score of 50 is the average amount of anxiety in the general public. A score above 60 the patient has significant anxiety
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Depression subtest -- change is being assessed
time frame: prior to surgery and two weeks post surgery
description: Bell shape curve scoring: A score of 50 is the average amount for depression in the general public. A score above 60 corresponds to a score of 10 on the Patient Health Questionnaire (PHQ)-9 scale, which is the cutoff with the highest sensitivity and specificity to detect a diagnosis of moderately severe major depression.
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference subtest -- change is being assessed
time frame: prior to surgery and two weeks post surgery
description: Bell shape curve scoring: The higher the score above 50 the more the pain the lower the score below 50 the less the pain
measure: PROMIS (Patient-Reported Outcomes Measurement Information System)Upper Extremity Function subtest -- change is being assessed
time frame: prior to surgery and two weeks post surgery
description: Bell shape curve scoring:A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.
measure: MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) Pre-Operative
time frame: prior to surgery
description: 1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable
measure: MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) post operative
time frame: 2 weeks post surgery
description: 1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable
measure: Pain Scale
time frame: prior to surgery and 2 weeks post surgery
description: 0 to 10 likert scale. 0 being no pain and 10 being worst pain possible
arm group label: Routine Pre-Operative Education in MD office prior to surgery
arm group type: No Intervention
arm group label: Formal Pre-operative education/therapy prior to surgery
arm group type: Experimental
intervention type: Behavioral
intervention name: Formal pre-operative education
description: One group of patients will receive formal pre-operative education prior to surgery from an occupational or physical therapists while the other group of patients will only receive routine education in the MD office.
arm group label: Formal Pre-operative education/therapy prior to surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Logan Berlet, OTD
role: Principal Investigator
affiliation: Washington University in Saint Louis
last name: Logan Berlet, OTD
phone: 314-286-1669
email: lberlet@wustl.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
sharing ipd: No