<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/NCT03805386</url>
  </required_header>
  <id_info>
    <org_study_id>18-004216</org_study_id>
    <nct_id>NCT03805386</nct_id>
  </id_info>
  <brief_title>Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery</brief_title>
  <official_title>Patient-Directed Postoperative Opioid Prescribing for Gynecologic Surgery</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      We would like to evaluate and optimize opioid prescribing after minimally invasive&#xD;
      hysterectomy. Currently, our standard prescribing is 150 oral morphine equivalents. However,&#xD;
      recent studies show that half of the opioids prescribed are not used. We would like to&#xD;
      include the patient in the decision making of the opioid prescribing.&#xD;
&#xD;
      We have designed a randomized controlled trial to prescribe standard (150 oral morphine&#xD;
      equivalents) or patient directed (less than or equal to 150 oral morphine equivalents) for&#xD;
      pain control.&#xD;
&#xD;
      We hypothesize that with patient input, there will be a higher utilization of the opioids&#xD;
      prescribed. Also, we anticipate a lower number of opioids used overall.&#xD;
&#xD;
      This study will help us optimize opioid prescribe and evaluate whether patient input can help&#xD;
      in this important measure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is an emphasis in patient centered care in medicine and part of this effort has&#xD;
      evaluated the success of shared decision making in the care of the patient. Currently, there&#xD;
      is strong research and clinical emphasis trying to determine how, as surgeons, we can assist&#xD;
      in minimizing the misuse of opioid medications. Several studies have shown significant&#xD;
      over-prescribing and under-utilizing of the pain medications that are prescribed to patients&#xD;
      after surgery. One such study by As-Sanie et al showed that about half of medications were&#xD;
      utilized for pain after surgery, with typically 200 oral morphine equivalents prescribed.&#xD;
&#xD;
      A recent prospective cohort study by Prabhu et al showed that shared decision making in the&#xD;
      prescription of narcotic pain medications after cesarean section decreased opioid use without&#xD;
      impacting patient satisfaction.&#xD;
&#xD;
      We propose a randomized controlled trial evaluating the impact of shared decision making in&#xD;
      the prescribing of pain medications after minimally invasive gynecologic surgery. For adult&#xD;
      female patients who are undergoing minimally invasive hysterectomy, we will randomize them to&#xD;
      either standard care or patient directed treatment. Our standard arm will receive 150 oral&#xD;
      morphine equivalents, or 30 tablets of oxycodone, whereas our patient directed arm will&#xD;
      receive a prescription with as many pills is determined after discussion with the patient.&#xD;
&#xD;
      We hope to contribute to identifying the optimized opioid prescription for post surgical&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">April 15, 2020</completion_date>
  <primary_completion_date type="Actual">April 15, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure># of Opioid Pills Consumed</measure>
    <time_frame>6 weeks postop</time_frame>
    <description>Percent utilization of opioids consumed (consumed/prescribed)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid Pills Prescribed</measure>
    <time_frame>preoperative visit</time_frame>
    <description>Number of opioids prescribed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>6 weeks post-operative</time_frame>
    <description>Patients were asked if they were satisfied with the # of oxycodone pills prescribed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Gynecology</condition>
  <condition>Surgery</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient Directed Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject directed arm will be prescribed the number of opioids that the patient decides to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Physician directed opioid prescribing</intervention_name>
    <description>Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Patient directed opioid prescribing</intervention_name>
    <description>Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.</description>
    <arm_group_label>Patient Directed Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Female patients &gt;18 years old&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Planned minimally invasive hysterectomy with the Department of Gynecology o&#xD;
             Concomitant minimally invasive surgeries performed by Gynecology will be allowed&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Combined surgical cases with other surgical departments&#xD;
&#xD;
          -  Planned laparotomy&#xD;
&#xD;
          -  Surgery planned to last &gt;4 hours&#xD;
&#xD;
          -  Postoperative hospitalization planned for &gt;7 days&#xD;
&#xD;
          -  Planned use of oral opioids other than oxycodone postoperatively&#xD;
&#xD;
          -  Pre-existing chronic pain conditions including: chronic pelvic pain, migraines,&#xD;
             temporomandibular joint dysfunction syndrome, fibromyalgia, and interstitial cystitis&#xD;
&#xD;
          -  Preoperative diagnosis of pelvic pain&#xD;
&#xD;
          -  Chronic preoperative opioid use&#xD;
&#xD;
          -  History of or current diagnosis of narcotic or alcohol dependence&#xD;
&#xD;
             o Screening question asked at preoperative appointment: Have you or are you currently&#xD;
             dependent on narcotic medications or alcohol?&#xD;
&#xD;
          -  Desire for more opioids than standard therapy&#xD;
&#xD;
          -  Postoperative decision of surgeon to prescribed more than standard therapy&#xD;
&#xD;
          -  Allergy or contraindication to taking opioids, ibuprofen, or acetaminophen&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johnny Yi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 12, 2019</study_first_submitted>
  <study_first_submitted_qc>January 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <results_first_submitted>January 29, 2021</results_first_submitted>
  <results_first_submitted_qc>January 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2021</results_first_posted>
  <last_update_submitted>January 29, 2021</last_update_submitted>
  <last_update_submitted_qc>January 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Johnny Yi</investigator_full_name>
    <investigator_title>Prinicpal Investigator</investigator_title>
  </responsible_party>
  <keyword>patient directed postoperative opioid prescribing</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 29, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03805386/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Ambulatory Gynecologic Surgery Clinic</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard of Care</title>
          <description>Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.&#xD;
Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.</description>
        </group>
        <group group_id="P2">
          <title>Patient Directed Care</title>
          <description>Subject directed arm will be prescribed the number of opioids that the patient decides based on shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.&#xD;
Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard of Care</title>
          <description>Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.&#xD;
Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.</description>
        </group>
        <group group_id="B2">
          <title>Patient Directed Care</title>
          <description>Subject directed arm will be prescribed the number of opioids that the patient decides based on a shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.&#xD;
Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="32"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="65"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.5" lower_limit="50" upper_limit="66.5"/>
                    <measurement group_id="B2" value="52" lower_limit="46" upper_limit="64"/>
                    <measurement group_id="B3" value="55" lower_limit="47" upper_limit="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Did not ask</measurement>
                    <measurement group_id="B2" value="NA">did not ask</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">did not ask</measurement>
                    <measurement group_id="B2" value="NA">did not ask</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.3" lower_limit="24" upper_limit="33.1"/>
                    <measurement group_id="B2" value="28.3" lower_limit="24.5" upper_limit="33.1"/>
                    <measurement group_id="B3" value="26.9" lower_limit="24" upper_limit="33.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title># of Opioid Pills Consumed</title>
        <description>Percent utilization of opioids consumed (consumed/prescribed)</description>
        <time_frame>6 weeks postop</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.&#xD;
Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.</description>
          </group>
          <group group_id="O2">
            <title>Patient Directed Care</title>
            <description>Subject directed arm will be prescribed the number of opioids that the patient decides to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.&#xD;
Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title># of Opioid Pills Consumed</title>
          <description>Percent utilization of opioids consumed (consumed/prescribed)</description>
          <units>% oxycodone used</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7" spread="0.91"/>
                    <measurement group_id="O2" value="38.4" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Pills Prescribed</title>
        <description>Number of opioids prescribed</description>
        <time_frame>preoperative visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title># Pills Prescribed Standard</title>
            <description>The number of 5mg oxycodone pills prescribed to patients at the preoperative visit.</description>
          </group>
          <group group_id="O2">
            <title># Pills Prescribed Patient Directed</title>
            <description># of 5mg oxycodone pills prescribed based on shared decision making.</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Pills Prescribed</title>
          <description>Number of opioids prescribed</description>
          <units>pills</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="30" upper_limit="30"/>
                    <measurement group_id="O2" value="15" lower_limit="12" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patients were asked if they were satisfied with the # of oxycodone pills prescribed.</description>
        <time_frame>6 weeks post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.&#xD;
Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.</description>
          </group>
          <group group_id="O2">
            <title>Patient Directed Care</title>
            <description>Subject directed arm will be prescribed the number of opioids that the patient decides based on shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.&#xD;
Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patients were asked if they were satisfied with the # of oxycodone pills prescribed.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Patients were followed up to 6 weeks postoperative visit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Standard of Care</title>
          <description>Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.&#xD;
Physician directed opioid prescribing: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.</description>
        </group>
        <group group_id="E2">
          <title>Patient Directed Care</title>
          <description>Subject directed arm will be prescribed the number of opioids that the patient decides based on shared decision making model to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.&#xD;
Patient directed opioid prescribing: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Principal Investigator, Dr Johnny Yi</name_or_title>
      <organization>Mayo Clinic Arizona</organization>
      <phone>14803420612</phone>
      <email>yi.johnny@mayo.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03805386
org study id: 18-004216
nct id: NCT03805386
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
We would like to evaluate and optimize opioid prescribing after minimally invasive
      hysterectomy. Currently, our standard prescribing is 150 oral morphine equivalents. However,
      recent studies show that half of the opioids prescribed are not used. We would like to
      include the patient in the decision making of the opioid prescribing.

      We have designed a randomized controlled trial to prescribe standard (150 oral morphine
      equivalents) or patient directed (less than or equal to 150 oral morphine equivalents) for
      pain control.

      We hypothesize that with patient input, there will be a higher utilization of the opioids
      prescribed. Also, we anticipate a lower number of opioids used overall.

      This study will help us optimize opioid prescribe and evaluate whether patient input can help
      in this important measure.
There is an emphasis in patient centered care in medicine and part of this effort has
      evaluated the success of shared decision making in the care of the patient. Currently, there
      is strong research and clinical emphasis trying to determine how, as surgeons, we can assist
      in minimizing the misuse of opioid medications. Several studies have shown significant
      over-prescribing and under-utilizing of the pain medications that are prescribed to patients
      after surgery. One such study by As-Sanie et al showed that about half of medications were
      utilized for pain after surgery, with typically 200 oral morphine equivalents prescribed.

      A recent prospective cohort study by Prabhu et al showed that shared decision making in the
      prescription of narcotic pain medications after cesarean section decreased opioid use without
      impacting patient satisfaction.

      We propose a randomized controlled trial evaluating the impact of shared decision making in
      the prescribing of pain medications after minimally invasive gynecologic surgery. For adult
      female patients who are undergoing minimally invasive hysterectomy, we will randomize them to
      either standard care or patient directed treatment. Our standard arm will receive 150 oral
      morphine equivalents, or 30 tablets of oxycodone, whereas our patient directed arm will
      receive a prescription with as many pills is determined after discussion with the patient.

      We hope to contribute to identifying the optimized opioid prescription for post surgical
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: # of Opioid Pills Consumed
time frame: 6 weeks postop
description: Percent utilization of opioids consumed (consumed/prescribed)
measure: Opioid Pills Prescribed
time frame: preoperative visit
description: Number of opioids prescribed
measure: Patient Satisfaction
time frame: 6 weeks post-operative
description: Patients were asked if they were satisfied with the # of oxycodone pills prescribed.
arm group label: Standard of Care
arm group type: Active Comparator
description: Subjects will be prescribed the standard amount of opioids that are typically prescribed by our practice after surgery. Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.
arm group label: Patient Directed Care
arm group type: Experimental
description: Subject directed arm will be prescribed the number of opioids that the patient decides to be appropriate after discussion with the surgeon. This can be as low as 0 pills and as much as 30 pills as described in the standard care.
intervention type: Drug
intervention name: Physician directed opioid prescribing
description: Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.
arm group label: Standard of Care
intervention type: Drug
intervention name: Patient directed opioid prescribing
description: Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.
arm group label: Patient Directed Care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johnny Yi
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Johnny Yi
investigator title: Prinicpal Investigator
mesh term: Analgesics, Opioid
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 