<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/NCT03834818</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00094157</org_study_id>
    <nct_id>NCT03834818</nct_id>
  </id_info>
  <brief_title>Collecting Outcomes and Managing Pain After Surgery</brief_title>
  <acronym>COMPAS</acronym>
  <official_title>COMPAS Trial. Collecting Outcomes and Managing Pain After Surgery: Predicting Patients at High Risk for Chronic Opioid Use and Creating Algorithms to Responsibly Tailor Opioid Prescribing and Weaning After Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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 primary aim of this study is to measure pain and psychosocial patient reported outcomes,&#xD;
      objective functionality, and actual daily at home opioid usage in orthopedic patients. The&#xD;
      study's goal following the data collection is to predict which patients are at high risk for&#xD;
      chronic opioid use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Administrative hold&#xD;
  </why_stopped>
  <start_date type="Actual">May 3, 2021</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Anticipated">April 2025</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>
    <intervention_model_description>Patients undergoing orthopedic surgery at Duke Health will be eligible for enrollment. Additionally, all potential participants must be an adult at least 18 years of age, speak and read English, own a smartphone they are willing to use for the study, and live in the United States of America. All study assessments will take place on the app and other than baseline screening all assessments will take place after surgery until the patient stops taking opioids. Patients will be approached in the orthopedic clinic up to the day of surgery and asked if they are willing to be screened for inclusion. If they accept the screening request a link will be emailed to them or a QR code supplied that permits them to download the study app on their phone. Screening, consent, and all study data collection will occur from the app launch. All data will be collected after enrollment and consent through the Medable Research Application.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reported Pain of Participants measured via PROMIS-29</measure>
    <time_frame>6 Months</time_frame>
    <description>28 Questions regarding pain are ranked on a 5-point Likert Scale with 1 meaning &quot;not at all&quot; and 5 meaning &quot;very much&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reported Pain of Participants measured via PROMIS-29</measure>
    <time_frame>6 Months</time_frame>
    <description>One question on an 11-point rating scale for pain intensity, with 0 meaning &quot;no pain&quot; and 10 meaning &quot;worst imaginable pain&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reported Pain of Participants measured via Pain Catastrophizing pain scale.</measure>
    <time_frame>6 Months</time_frame>
    <description>Statements regarding pain are rated on a scale from 0 to 4 with 0 meaning &quot;not at all&quot; and 4 meaning &quot;all the time&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Opioid Use of Participants</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of patients with self reported use of opioids.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Practicality of Mobile Application</measure>
    <time_frame>6 Months</time_frame>
    <description>How long participants actively use the app to track their opined use and pain.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>COMPAS Participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patents between the ages of 18 and 90 who are undergoing orthopedic surgery at Duke Health will be eligible for enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>COMPAS Participants</intervention_name>
    <description>The schedule of events for this study are as follows:&#xD;
Day 1 Pre-Surgery:&#xD;
Download the Medable App&#xD;
Register to the study&#xD;
Validated Questionnaires&#xD;
Active Task&#xD;
Every Day&#xD;
9:00 a.m. Daily Questions&#xD;
9:00 p.m. Daily Questions&#xD;
Outcome Surveys and Active Task:&#xD;
Day 1 Pre-Surgery&#xD;
1-Week Post Operation&#xD;
2-Weeks Post Operation&#xD;
1-Month Post Operation&#xD;
3-Months Post Operation&#xD;
6-Months Post Operation</description>
    <arm_group_label>COMPAS Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18-90 years old who are undergoing elective orthopedic surgery at Duke Health.&#xD;
&#xD;
          -  Patients must have their own smartphone IOS or Android device.&#xD;
&#xD;
          -  Patients must be able to read English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lacking capacity to provide consent.&#xD;
&#xD;
          -  Cannot read English&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Older than 90 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil D Ray, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>neil.d.ray@duke.edu</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Orthopaedics</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>opioid use</keyword>
  <keyword>pain</keyword>
  <keyword>surgery</keyword>
  <keyword>orthopedic surgery</keyword>
  <keyword>orthopedic</keyword>
  <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/NCT03834818
org study id: Pro00094157
nct id: NCT03834818
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to measure pain and psychosocial patient reported outcomes,
      objective functionality, and actual daily at home opioid usage in orthopedic patients. The
      study's goal following the data collection is to predict which patients are at high risk for
      chronic opioid use.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients undergoing orthopedic surgery at Duke Health will be eligible for enrollment. Additionally, all potential participants must be an adult at least 18 years of age, speak and read English, own a smartphone they are willing to use for the study, and live in the United States of America. All study assessments will take place on the app and other than baseline screening all assessments will take place after surgery until the patient stops taking opioids. Patients will be approached in the orthopedic clinic up to the day of surgery and asked if they are willing to be screened for inclusion. If they accept the screening request a link will be emailed to them or a QR code supplied that permits them to download the study app on their phone. Screening, consent, and all study data collection will occur from the app launch. All data will be collected after enrollment and consent through the Medable Research Application.
primary purpose: Prevention
masking: None (Open Label)
measure: Reported Pain of Participants measured via PROMIS-29
time frame: 6 Months
description: 28 Questions regarding pain are ranked on a 5-point Likert Scale with 1 meaning "not at all" and 5 meaning "very much".
measure: Reported Pain of Participants measured via PROMIS-29
time frame: 6 Months
description: One question on an 11-point rating scale for pain intensity, with 0 meaning "no pain" and 10 meaning "worst imaginable pain".
measure: Reported Pain of Participants measured via Pain Catastrophizing pain scale.
time frame: 6 Months
description: Statements regarding pain are rated on a scale from 0 to 4 with 0 meaning "not at all" and 4 meaning "all the time"
measure: Opioid Use of Participants
time frame: 6 months
description: Total number of patients with self reported use of opioids.
measure: Practicality of Mobile Application
time frame: 6 Months
description: How long participants actively use the app to track their opined use and pain.
arm group label: COMPAS Participants
arm group type: Experimental
description: Patents between the ages of 18 and 90 who are undergoing orthopedic surgery at Duke Health will be eligible for enrollment.
intervention type: Behavioral
intervention name: COMPAS Participants
description: The schedule of events for this study are as follows:
Day 1 Pre-Surgery:
Download the Medable App
Register to the study
Validated Questionnaires
Active Task
Every Day
9:00 a.m. Daily Questions
9:00 p.m. Daily Questions
Outcome Surveys and Active Task:
Day 1 Pre-Surgery
1-Week Post Operation
2-Weeks Post Operation
1-Month Post Operation
3-Months Post Operation
6-Months Post Operation
arm group label: COMPAS Participants
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Neil D Ray, MD
role: Principal Investigator
affiliation: neil.d.ray@duke.edu
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No