<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/NCT02195063</url>
  </required_header>
  <id_info>
    <org_study_id>RAHM 1001</org_study_id>
    <nct_id>NCT02195063</nct_id>
  </id_info>
  <brief_title>Survey Study for Pain Management, Wound Care, Scar Care or UDT</brief_title>
  <official_title>Survey of Patients Who Have Been Prescribed a Topical Compound for Pain Management, Wound Care or Scar Care or to Patients Who Have Been Requested to do a Urinary Drug Test (UDT) by Their Provider.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rahm Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Datum Research, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rahm Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a survey study that will be given to patients who have been prescribed a topical&#xD;
      compound for pain management, wound care or scar care or to patients who have been requested&#xD;
      to do a urinary drug test (UDT) by their provider.&#xD;
&#xD;
      The initial survey for pain management, wound care, scar care or UDT will be given to the&#xD;
      patient by their providers during their office visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We have designed a survey study that will be given to patients who have been prescribed a&#xD;
      topical compound for pain management, wound care or scar care or to patients who have been&#xD;
      requested to do a urinary drug test (UDT) by their provider.&#xD;
&#xD;
      The initial survey for pain management, wound care, scar care or UDT will be given to the&#xD;
      patient by their providers during their office visit.&#xD;
&#xD;
      Follow-up surveys will be given at 30, 60, and 90 days. These surveys will be collected by&#xD;
      e-mail or follow-up calls from Datum Research, LLC, contract research organization.&#xD;
&#xD;
      Data collection for this study will be derived through the 4 patient surveys (initial, 30&#xD;
      day, 60 day, and 90 day) and the prescription written by the provider.&#xD;
&#xD;
      The survey study will enroll patients until December 31, 2014, or until sufficient numbers&#xD;
      have been achieved.&#xD;
&#xD;
      Rahm Foundation will continue the study until:&#xD;
&#xD;
        -  Sufficient information has accumulated to meet the scientific objectives of the Study&#xD;
           (i.e. numeric targets or effect size)&#xD;
&#xD;
        -  The feasibility of collecting sufficient information diminishes to unacceptable levels,&#xD;
           poor enrollment, loss to follow-up and/or&#xD;
&#xD;
        -  Other methods of gathering appropriate information become achievable or are deemed&#xD;
           preferable.&#xD;
&#xD;
      Datum Research will need to have access to the prescription to see what compound was&#xD;
      prescribed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2013</start_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain survey results from baseline at 30 days</measure>
    <time_frame>baseline and 30 days</time_frame>
    <description>Survey on pain management</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pain survey results from baseline at 60 days</measure>
    <time_frame>baseline and 60 days</time_frame>
    <description>Survey on pain management</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pain survey results from baseline at 90 days</measure>
    <time_frame>baseline and 90 days</time_frame>
    <description>Survey on pain management</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in scar care survey results from baseline at 30 days</measure>
    <time_frame>baseline and 30 days</time_frame>
    <description>Survey on scar care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in scar care survey results from baseline at 60 days</measure>
    <time_frame>baseline and 60 days</time_frame>
    <description>Survey on scar care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in scar care survey results from baseline at 90 days</measure>
    <time_frame>baseline and 90 days</time_frame>
    <description>Survey on scar care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in wound care survey results from baseline at 30 days</measure>
    <time_frame>baseline and 30 days</time_frame>
    <description>Survey on wound care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in wound care survey results from baseline at 60 days</measure>
    <time_frame>baseline and 60 days</time_frame>
    <description>Survey on wound care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in wound care survey results from baseline at 90 days</measure>
    <time_frame>baseline and 90 days</time_frame>
    <description>Survey on wound care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in UDT survey results from baseline at 30 days</measure>
    <time_frame>baseline and 30 days</time_frame>
    <description>Survey on urinary drug testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in UDT survey results from baseline at 60 days</measure>
    <time_frame>baseline and 60 days</time_frame>
    <description>Survey on urinary drug testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in UDT survey results from baseline at 90 days</measure>
    <time_frame>baseline and 90 days</time_frame>
    <description>Survey on urinary drug testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain survey results from 30 days at 60 days</measure>
    <time_frame>30 days and 60 days</time_frame>
    <description>Survey on pain management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain survey results from 30 days at 90 days</measure>
    <time_frame>30 days and 90 days</time_frame>
    <description>Survey on pain management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain survey results from 60 days at 90 days</measure>
    <time_frame>60 days and 90 days</time_frame>
    <description>Survey on pain management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>at baseline</time_frame>
    <description>if applicable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scar care survey results from 30 days at 60 days</measure>
    <time_frame>30 days and 60 days</time_frame>
    <description>Survey on scar care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scar care survey results from 30 days at 90 days</measure>
    <time_frame>30 days and 90 days</time_frame>
    <description>Survey on scar care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in scar care survey results from 60 days at 90 days</measure>
    <time_frame>60 days and 90 days</time_frame>
    <description>Survey on scar care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in wound care survey results from 30 days at 60 days</measure>
    <time_frame>30 days and 60 days</time_frame>
    <description>Survey on wound care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in wound care survey results from 30 days at 90 days</measure>
    <time_frame>30 days and 90 days</time_frame>
    <description>Survey on wound care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in UDT survey results from 60 days at 90 days</measure>
    <time_frame>60 days and 90 days</time_frame>
    <description>Survey on urinary drug testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in UDT survey results from 30 days at 60 days</measure>
    <time_frame>30 days and 60 days</time_frame>
    <description>Survey on urinary drug testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in UDT survey results from 30 days at 90 days</measure>
    <time_frame>30 days and 90 days</time_frame>
    <description>Survey on urinary drug testing</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Pain</condition>
  <condition>Scars</condition>
  <condition>Wounds</condition>
  <condition>Urinary Drug Testing</condition>
  <arm_group>
    <arm_group_label>Pain management</arm_group_label>
    <description>patients undergoing transdermal treatment for pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Scar care</arm_group_label>
    <description>patients undergoing transdermal treatment for scars</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wound care</arm_group_label>
    <description>patients undergoing transdermal treatment for wounds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UDT</arm_group_label>
    <description>patients receiving urinary drug tests</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are given a prescription for topical compound for pain, scar care, or wound&#xD;
        care, and agree to complete the surveys&#xD;
&#xD;
        or&#xD;
&#xD;
        Patients who are given a UDT and agree to complete the surveys.&#xD;
&#xD;
        Patients will be recruited into the study if their providers prescribe a topical cream for&#xD;
        pain, scar care or wound care or if the provider performs a UDT prior to treatment or&#xD;
        surgery. The providers will follow their office procedure for UDT. If they perform a UDT&#xD;
        and the patient agrees to participate in the survey study, they will have the patient&#xD;
        complete the surveys.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prescribed a topical cream for pain, scar care, or wound OR Provider preforms urinary&#xD;
             drug test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with legally authorized representatives&#xD;
&#xD;
          -  Minors&#xD;
&#xD;
          -  Prisoners&#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_contact>
    <last_name>Christina R Cook, PhD</last_name>
    <phone>615-712-9574</phone>
    <email>ccook@blueprintpathways.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Risa Tyo, PharmD</last_name>
    <phone>615-712-9574</phone>
    <email>rtyo@datumcro.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Blueprint Pathways</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina R Cook, PhD</last_name>
      <phone>615-712-9574</phone>
      <email>ccook@blueprintpathways.com</email>
    </contact>
    <contact_backup>
      <last_name>Risa Tyo, PharmD</last_name>
      <phone>615-712-9574</phone>
      <email>rtyo@datumcro.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.blueprintpathways.com</url>
    <description>Blueprint Pathways</description>
  </link>
  <link>
    <url>http://www.rahmfoundation.org/</url>
    <description>The Rahm Foundation</description>
  </link>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>January 27, 2015</last_update_submitted>
  <last_update_submitted_qc>January 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain management</keyword>
  <keyword>Scar care</keyword>
  <keyword>Wound care</keyword>
  <keyword>UDT</keyword>
  <keyword>Urinary drug testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02195063
org study id: RAHM 1001
nct id: NCT02195063
lead sponsor: 
collaborator: 
has dmc: No
This is a survey study that will be given to patients who have been prescribed a topical
      compound for pain management, wound care or scar care or to patients who have been requested
      to do a urinary drug test (UDT) by their provider.

      The initial survey for pain management, wound care, scar care or UDT will be given to the
      patient by their providers during their office visit.
We have designed a survey study that will be given to patients who have been prescribed a
      topical compound for pain management, wound care or scar care or to patients who have been
      requested to do a urinary drug test (UDT) by their provider.

      The initial survey for pain management, wound care, scar care or UDT will be given to the
      patient by their providers during their office visit.

      Follow-up surveys will be given at 30, 60, and 90 days. These surveys will be collected by
      e-mail or follow-up calls from Datum Research, LLC, contract research organization.

      Data collection for this study will be derived through the 4 patient surveys (initial, 30
      day, 60 day, and 90 day) and the prescription written by the provider.

      The survey study will enroll patients until December 31, 2014, or until sufficient numbers
      have been achieved.

      Rahm Foundation will continue the study until:

        -  Sufficient information has accumulated to meet the scientific objectives of the Study
           (i.e. numeric targets or effect size)

        -  The feasibility of collecting sufficient information diminishes to unacceptable levels,
           poor enrollment, loss to follow-up and/or

        -  Other methods of gathering appropriate information become achievable or are deemed
           preferable.

      Datum Research will need to have access to the prescription to see what compound was
      prescribed.
observational model: Case-Only
time perspective: Prospective
measure: Change in pain survey results from baseline at 30 days
time frame: baseline and 30 days
description: Survey on pain management
measure: Change in pain survey results from baseline at 60 days
time frame: baseline and 60 days
description: Survey on pain management
measure: Change in pain survey results from baseline at 90 days
time frame: baseline and 90 days
description: Survey on pain management
measure: Change in scar care survey results from baseline at 30 days
time frame: baseline and 30 days
description: Survey on scar care
measure: Change in scar care survey results from baseline at 60 days
time frame: baseline and 60 days
description: Survey on scar care
measure: Change in scar care survey results from baseline at 90 days
time frame: baseline and 90 days
description: Survey on scar care
measure: Change in wound care survey results from baseline at 30 days
time frame: baseline and 30 days
description: Survey on wound care
measure: Change in wound care survey results from baseline at 60 days
time frame: baseline and 60 days
description: Survey on wound care
measure: Change in wound care survey results from baseline at 90 days
time frame: baseline and 90 days
description: Survey on wound care
measure: Change in UDT survey results from baseline at 30 days
time frame: baseline and 30 days
description: Survey on urinary drug testing
measure: Change in UDT survey results from baseline at 60 days
time frame: baseline and 60 days
description: Survey on urinary drug testing
measure: Change in UDT survey results from baseline at 90 days
time frame: baseline and 90 days
description: Survey on urinary drug testing
measure: Change in pain survey results from 30 days at 60 days
time frame: 30 days and 60 days
description: Survey on pain management
measure: Change in pain survey results from 30 days at 90 days
time frame: 30 days and 90 days
description: Survey on pain management
measure: Change in pain survey results from 60 days at 90 days
time frame: 60 days and 90 days
description: Survey on pain management
measure: Length of hospital stay
time frame: at baseline
description: if applicable
measure: Change in scar care survey results from 30 days at 60 days
time frame: 30 days and 60 days
description: Survey on scar care
measure: Change in scar care survey results from 30 days at 90 days
time frame: 30 days and 90 days
description: Survey on scar care
measure: Change in scar care survey results from 60 days at 90 days
time frame: 60 days and 90 days
description: Survey on scar care
measure: Change in wound care survey results from 30 days at 60 days
time frame: 30 days and 60 days
description: Survey on wound care
measure: Change in wound care survey results from 30 days at 90 days
time frame: 30 days and 90 days
description: Survey on wound care
measure: Change in UDT survey results from 60 days at 90 days
time frame: 60 days and 90 days
description: Survey on urinary drug testing
measure: Change in UDT survey results from 30 days at 60 days
time frame: 30 days and 60 days
description: Survey on urinary drug testing
measure: Change in UDT survey results from 30 days at 90 days
time frame: 30 days and 90 days
description: Survey on urinary drug testing
arm group label: Pain management
description: patients undergoing transdermal treatment for pain
arm group label: Scar care
description: patients undergoing transdermal treatment for scars
arm group label: Wound care
description: patients undergoing transdermal treatment for wounds
arm group label: UDT
description: patients receiving urinary drug tests
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christina R Cook, PhD
phone: 615-712-9574
email: ccook@blueprintpathways.com
last name: Risa Tyo, PharmD
phone: 615-712-9574
email: rtyo@datumcro.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
url: http://www.blueprintpathways.com
description: Blueprint Pathways
url: http://www.rahmfoundation.org/
description: The Rahm Foundation
responsible party type: Sponsor
mesh term: Wounds and Injuries