<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/NCT03287622</url>
  </required_header>
  <id_info>
    <org_study_id>00127009</org_study_id>
    <secondary_id>1R01DA044245-01A1</secondary_id>
    <nct_id>NCT03287622</nct_id>
  </id_info>
  <brief_title>Evaluation of an Interactive Opioid Risk Education Program (STOMP) for Parents</brief_title>
  <acronym>STOMP</acronym>
  <official_title>Scenario-tailored Opioid Messaging Program (STOMP): An Interactive Intervention to Prevent Opioid-related Adverse Drug Events in Children and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Millions of children and adolescents are prescribed opioid pain relievers each year, placing&#xD;
      them at risk for serious adverse events and misuse in the home setting. Parents who manage&#xD;
      these medicines, therefore, need to recognize opioid-related risks and make decisions that&#xD;
      will both reduce these risks yet ensure effective pain relief for their children. The&#xD;
      proposed research will evaluate new strategies to help parents learn about opioid risks, make&#xD;
      safe and effective analgesic decisions, and develop and demonstrate safe drug management&#xD;
      behaviors. 840 parents and their children who are undergoing an elective surgical procedure&#xD;
      will be recruited. Parents will be randomized to receive the new educational and practical&#xD;
      behavioral strategy or routine information. Parents' knowledge and perceptions will be&#xD;
      evaluated at baseline and at critical times after surgery. Parents' opioid handling and&#xD;
      administration will also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overarching goal of this research is to improve opioid analgesic safety and efficacy by&#xD;
      optimizing opioid risk recognition, informed analgesic decision-making, and drug&#xD;
      storage/disposal behaviors among parents of youth who are prescribed these agents for home&#xD;
      use. The study aims are to determine whether the Scenario-Tailored Opioid Messaging Program&#xD;
      (STOMP) will: 1) Improve parents' opioid risk understanding and their analgesic&#xD;
      decision-making; 2) Enhance parents' analgesic self-efficacy, analgesic use, storage&#xD;
      behaviors and their children's pain outcomes, and 3) To demonstrate that the STOMP plus&#xD;
      provision of a simple method to get rid of left-over opioids will effectively nudge parents&#xD;
      to safely dispose of left-over opioid analgesics. Parents whose children are prescribed&#xD;
      opioids for acute, short-lived pain after surgery will be randomly assigned to receive our&#xD;
      interventions or a routine provider informational interaction at the time of opioid&#xD;
      prescribing. Parents will be surveyed about their opioid familiarity, knowledge, risk&#xD;
      perceptions and common analgesic decision-making at baseline and after hospital discharge.&#xD;
      Parents will also record their child's pain medication use and symptoms after discharge. Data&#xD;
      will be analyzed to determine whether the STOMP educational intervention with or without the&#xD;
      behavioral nudge intervention will enhance parents' risk perceptions, their decision-making&#xD;
      skills and their opioid handling behaviors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Four-armed, randomized, control, factorial design</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Group assignment will be coded for parents and data collectors. Parents will be blinded to whether the information they receive is the Intervention vs. Control.&#xD;
Group assignment will coded on data entry and unblinded after analyses.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid-related Risk Knowledge</measure>
    <time_frame>Day 3 follow-up assessment</time_frame>
    <description>Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Opioid Risk Perception</measure>
    <time_frame>Mean difference in score from baseline to follow-up assessments (Days 3 &amp; 14)</time_frame>
    <description>Change in parent's perceived risk of keeping/sharing opioids (misuse) (Risk perceptions measured on scale from -4 to +4 where higher number reflects higher perception of riskiness; the outcome is measured as change in risk perception - positive change indicates that risk perception became greater)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid Disposal Behavior</measure>
    <time_frame>Day 14 (or after course completion)</time_frame>
    <description>Number of parents (and percentage) who disposed of left-over opioids after use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Interference (PROMIS)</measure>
    <time_frame>Day 14</time_frame>
    <description>The Parents PROMIS Pain Interference measure was used to capture pain interference with functioning (score range 0-30 with higher number indicating worse pain interference)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic Self-Efficacy</measure>
    <time_frame>Efficacy scores Day 14</time_frame>
    <description>Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic Use / Adherence</measure>
    <time_frame>Day 14</time_frame>
    <description>Total number of opioid doses administered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic Decision Competency</measure>
    <time_frame>Day 3</time_frame>
    <description>Number of participants who made the scenario-based decision to administer opioid to excessively sedated child</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">712</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Medication Adherence</condition>
  <condition>Opioid Use</condition>
  <condition>Knowledge, Attitudes, Practice</condition>
  <condition>Risk Reduction Behavior</condition>
  <arm_group>
    <arm_group_label>Education Intervention + Nudge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care + Nudge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive routine, standard of care information AND the behavioral Nudge intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational Intervention no Nudge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care no Nudge</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive only standard of care information and NO behavioral nudge intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.</description>
    <arm_group_label>Education Intervention + Nudge</arm_group_label>
    <arm_group_label>Educational Intervention no Nudge</arm_group_label>
    <other_name>STOMP Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nudge</intervention_name>
    <description>Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids</description>
    <arm_group_label>Education Intervention + Nudge</arm_group_label>
    <arm_group_label>Standard of Care + Nudge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent (&gt;=21yr) and child (5-17 yr) (dyad) who lives in the home and is prescribed an&#xD;
             opioid for postoperative pain management&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child is undergoing a non-elective procedure&#xD;
&#xD;
          -  Child cannot self-report pain levels (i.e., is cognitively impaired)&#xD;
&#xD;
          -  Child has a hematologic/oncologic condition&#xD;
&#xD;
          -  Child has a kidney or liver conditions that precludes the usual analgesic prescription&#xD;
             pattern (opioid plus a non-opioid)&#xD;
&#xD;
          -  Child has been taking opioids for prolonged pain pre-operatively (&gt;2 weeks)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Terri Voepel-Lewis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan, C.S. Mott Children's Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <results_first_submitted>September 29, 2020</results_first_submitted>
  <results_first_submitted_qc>October 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 19, 2020</results_first_posted>
  <last_update_submitted>October 28, 2020</last_update_submitted>
  <last_update_submitted_qc>October 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Terri Voepel-Lewis</investigator_full_name>
    <investigator_title>Associate Research Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 22, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03287622/ICF_000.pdf</document_url>
    </provided_document>
    <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 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03287622/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Education Intervention</title>
          <description>This group will receive the scenario-tailored STOMP educational feedback.&#xD;
Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>This group will receive routine, standard of care information</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="356"/>
                <participants group_id="P2" count="356"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Sub-randomized to Nudge/NoNudge</title>
              <participants_list>
                <participants group_id="P1" count="253"/>
                <participants group_id="P2" count="266"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="298"/>
                <participants group_id="P2" count="308"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No prescripion after surgery</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>prolonged Length of stay</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>surgery related</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>298 subjects (84%) completed surveys required for analysis in the INTERVENTION GROUP.&#xD;
308 subjects (87%) completed surveys required for analysis in the STANDARD OF CARE GROUP</population>
      <group_list>
        <group group_id="B1">
          <title>Education Intervention</title>
          <description>This group will receive the scenario-tailored STOMP educational feedback.&#xD;
Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>This group will receive routine, standard of care information.</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="298"/>
            <count group_id="B2" value="308"/>
            <count group_id="B3" value="606"/>
          </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="298"/>
                    <measurement group_id="B2" value="308"/>
                    <measurement group_id="B3" value="606"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="252"/>
                    <measurement group_id="B2" value="241"/>
                    <measurement group_id="B3" value="493"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="289"/>
                    <measurement group_id="B2" value="298"/>
                    <measurement group_id="B3" value="587"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>
          <population>298 subjects completed surveys required for analysis in the INTERVENTION GROUP. 308 subjects completed surveys required for analysis in the STANDARD OF CARE GROUP</population>
          <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="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="262"/>
                    <measurement group_id="B2" value="267"/>
                    <measurement group_id="B3" value="529"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education Level</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Some HS or HS complete</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some College</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Assoc. Degree or Trade School</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Year College Graduate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Graduate School</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Opioid-related Risk Knowledge</title>
        <description>Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)</description>
        <time_frame>Day 3 follow-up assessment</time_frame>
        <population>These parents completed at least one follow-up assessment for risk awareness</population>
        <group_list>
          <group group_id="O1">
            <title>Education Intervention</title>
            <description>This group received the scenario-tailored STOMP educational feedback.&#xD;
Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Education</title>
            <description>This group received routine, standard of care information.</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid-related Risk Knowledge</title>
          <description>Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)</description>
          <population>These parents completed at least one follow-up assessment for risk awareness</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="296"/>
                <count group_id="O2" value="308"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="287"/>
                    <measurement group_id="O2" value="289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Opioid Risk Perception</title>
        <description>Change in parent's perceived risk of keeping/sharing opioids (misuse) (Risk perceptions measured on scale from -4 to +4 where higher number reflects higher perception of riskiness; the outcome is measured as change in risk perception - positive change indicates that risk perception became greater)</description>
        <time_frame>Mean difference in score from baseline to follow-up assessments (Days 3 &amp; 14)</time_frame>
        <population>296 in the Interventional Group completed at least one follow-up assessment and 281 in the Standard of Care group did so.</population>
        <group_list>
          <group group_id="O1">
            <title>Education Intervention</title>
            <description>This group received the scenario-tailored STOMP educational feedback.&#xD;
Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>This group received routine, standard of care information</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Risk Perception</title>
          <description>Change in parent's perceived risk of keeping/sharing opioids (misuse) (Risk perceptions measured on scale from -4 to +4 where higher number reflects higher perception of riskiness; the outcome is measured as change in risk perception - positive change indicates that risk perception became greater)</description>
          <population>296 in the Interventional Group completed at least one follow-up assessment and 281 in the Standard of Care group did so.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="296"/>
                <count group_id="O2" value="281"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean difference in perceived riskiness of keeping/sharing opioids day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" lower_limit="0.07" upper_limit="0.63"/>
                    <measurement group_id="O2" value="0.12" lower_limit="-0.06" upper_limit="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in perceived riskiness keeping/sharing day 14</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" lower_limit="0.07" upper_limit="0.50"/>
                    <measurement group_id="O2" value="0.14" lower_limit="-0.06" upper_limit="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Disposal Behavior</title>
        <description>Number of parents (and percentage) who disposed of left-over opioids after use</description>
        <time_frame>Day 14 (or after course completion)</time_frame>
        <population>This subgroup analysis included parents that were randomized to four groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Nudge + Educational Intervention</title>
            <description>This group received BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention&#xD;
Nudge: Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids</description>
          </group>
          <group group_id="O2">
            <title>Nudge + Standard of Care</title>
            <description>This group received routine, standard of care information AND the behavioral Nudge intervention&#xD;
Nudge: Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids</description>
          </group>
          <group group_id="O3">
            <title>Educational Intervention Only (No Nudge)</title>
            <description>This group received scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention.&#xD;
Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.</description>
          </group>
          <group group_id="O4">
            <title>Standard of Care Only (No Nudge)</title>
            <description>This group received only standard of care information and NO behavioral nudge intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Disposal Behavior</title>
          <description>Number of parents (and percentage) who disposed of left-over opioids after use</description>
          <population>This subgroup analysis included parents that were randomized to four groups.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="131"/>
                <count group_id="O3" value="129"/>
                <count group_id="O4" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="40"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Interference (PROMIS)</title>
        <description>The Parents PROMIS Pain Interference measure was used to capture pain interference with functioning (score range 0-30 with higher number indicating worse pain interference)</description>
        <time_frame>Day 14</time_frame>
        <population>These are the parents that recorded a value in the follow-up diary/survey</population>
        <group_list>
          <group group_id="O1">
            <title>Education Intervention</title>
            <description>This group received the scenario-tailored STOMP educational feedback.&#xD;
Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>This group will receive routine, standard of care information</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Interference (PROMIS)</title>
          <description>The Parents PROMIS Pain Interference measure was used to capture pain interference with functioning (score range 0-30 with higher number indicating worse pain interference)</description>
          <population>These are the parents that recorded a value in the follow-up diary/survey</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="271"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.63" spread="8.39"/>
                    <measurement group_id="O2" value="8.06" spread="8.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analgesic Self-Efficacy</title>
        <description>Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy)</description>
        <time_frame>Efficacy scores Day 14</time_frame>
        <population>Completion of at least one follow-up efficacy assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Education Intervention</title>
            <description>This group received the scenario-tailored STOMP educational feedback.&#xD;
Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>This group received routine, standard of care information</description>
          </group>
        </group_list>
        <measure>
          <title>Analgesic Self-Efficacy</title>
          <description>Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy)</description>
          <population>Completion of at least one follow-up efficacy assessment</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="308"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.5" spread="3.22"/>
                    <measurement group_id="O2" value="32.2" spread="3.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analgesic Use / Adherence</title>
        <description>Total number of opioid doses administered</description>
        <time_frame>Day 14</time_frame>
        <population>These parents completed follow-up data regarding doses administered at home (completed diary or survey)</population>
        <group_list>
          <group group_id="O1">
            <title>Education Intervention</title>
            <description>This group received the scenario-tailored STOMP educational feedback.&#xD;
Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>This group received routine, standard of care information</description>
          </group>
        </group_list>
        <measure>
          <title>Analgesic Use / Adherence</title>
          <description>Total number of opioid doses administered</description>
          <population>These parents completed follow-up data regarding doses administered at home (completed diary or survey)</population>
          <units>Doses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
                <count group_id="O2" value="271"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="10.3"/>
                    <measurement group_id="O2" value="7.9" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analgesic Decision Competency</title>
        <description>Number of participants who made the scenario-based decision to administer opioid to excessively sedated child</description>
        <time_frame>Day 3</time_frame>
        <population>Parents who completed at scenario decisions in Day 3 follow-up survey</population>
        <group_list>
          <group group_id="O1">
            <title>Education Intervention</title>
            <description>This group received the scenario-tailored STOMP educational feedback.&#xD;
Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Only</title>
            <description>This group received routine, standard of care information</description>
          </group>
        </group_list>
        <measure>
          <title>Analgesic Decision Competency</title>
          <description>Number of participants who made the scenario-based decision to administer opioid to excessively sedated child</description>
          <population>Parents who completed at scenario decisions in Day 3 follow-up survey</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="308"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events within 30 days of enrollment were recorded.</time_frame>
      <desc>All adverse effects were recorded according to the definition from clinicaltrials.gov. Of particular interest for this study were all analgesic-related side effects and parent calls and any return to the hospital. Clinic notes (30 days) were reviewed for surgical and analgesic-related calls or return visits to the clinic or hospital.</desc>
      <group_list>
        <group group_id="E1">
          <title>Education Intervention</title>
          <description>This group received the scenario-tailored STOMP educational feedback.&#xD;
Educational Intervention: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>This group received routine, standard of care information</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="298"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="308"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="298"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="308"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <description>deep vein thrombosis after ortho surgery; treated with anticoagulation therapy</description>
                <counts group_id="E1" events="298" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="308"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse Drug Reaction</sub_title>
                <description>Child had reaction to a medication used for underlying condition (present preoperatively)</description>
                <counts group_id="E1" events="298" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="308"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <description>dehydration due to poor fluid intake at home</description>
                <counts group_id="E1" events="298" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="308" subjects_affected="1" subjects_at_risk="308"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Postoperative hemorrhage</sub_title>
                <description>Bleeding due to otorhinolaryngology procedure (postoperative bleeding)</description>
                <counts group_id="E1" events="298" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="308" subjects_affected="1" subjects_at_risk="308"/>
              </event>
              <event>
                <sub_title>Suspected postoperative infection</sub_title>
                <description>Fever, elevated white blood cell count; treated for postoperative infection</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="308" subjects_affected="1" subjects_at_risk="308"/>
              </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="298"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="308"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Terri Voepel-Lewis</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734-646-6803</phone>
      <email>terriv@umich.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/NCT03287622
org study id: 00127009
secondary id: 1R01DA044245-01A1
nct id: NCT03287622
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Millions of children and adolescents are prescribed opioid pain relievers each year, placing
      them at risk for serious adverse events and misuse in the home setting. Parents who manage
      these medicines, therefore, need to recognize opioid-related risks and make decisions that
      will both reduce these risks yet ensure effective pain relief for their children. The
      proposed research will evaluate new strategies to help parents learn about opioid risks, make
      safe and effective analgesic decisions, and develop and demonstrate safe drug management
      behaviors. 840 parents and their children who are undergoing an elective surgical procedure
      will be recruited. Parents will be randomized to receive the new educational and practical
      behavioral strategy or routine information. Parents' knowledge and perceptions will be
      evaluated at baseline and at critical times after surgery. Parents' opioid handling and
      administration will also be assessed.
The overarching goal of this research is to improve opioid analgesic safety and efficacy by
      optimizing opioid risk recognition, informed analgesic decision-making, and drug
      storage/disposal behaviors among parents of youth who are prescribed these agents for home
      use. The study aims are to determine whether the Scenario-Tailored Opioid Messaging Program
      (STOMP) will: 1) Improve parents' opioid risk understanding and their analgesic
      decision-making; 2) Enhance parents' analgesic self-efficacy, analgesic use, storage
      behaviors and their children's pain outcomes, and 3) To demonstrate that the STOMP plus
      provision of a simple method to get rid of left-over opioids will effectively nudge parents
      to safely dispose of left-over opioid analgesics. Parents whose children are prescribed
      opioids for acute, short-lived pain after surgery will be randomly assigned to receive our
      interventions or a routine provider informational interaction at the time of opioid
      prescribing. Parents will be surveyed about their opioid familiarity, knowledge, risk
      perceptions and common analgesic decision-making at baseline and after hospital discharge.
      Parents will also record their child's pain medication use and symptoms after discharge. Data
      will be analyzed to determine whether the STOMP educational intervention with or without the
      behavioral nudge intervention will enhance parents' risk perceptions, their decision-making
      skills and their opioid handling behaviors.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Four-armed, randomized, control, factorial design
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Group assignment will be coded for parents and data collectors. Parents will be blinded to whether the information they receive is the Intervention vs. Control.
Group assignment will coded on data entry and unblinded after analyses.
measure: Opioid-related Risk Knowledge
time frame: Day 3 follow-up assessment
description: Number of parent participants who became aware (binary) of serious opioid-related adverse effect (over sedation)
measure: Opioid Risk Perception
time frame: Mean difference in score from baseline to follow-up assessments (Days 3 & 14)
description: Change in parent's perceived risk of keeping/sharing opioids (misuse) (Risk perceptions measured on scale from -4 to +4 where higher number reflects higher perception of riskiness; the outcome is measured as change in risk perception - positive change indicates that risk perception became greater)
measure: Opioid Disposal Behavior
time frame: Day 14 (or after course completion)
description: Number of parents (and percentage) who disposed of left-over opioids after use
measure: Pain Interference (PROMIS)
time frame: Day 14
description: The Parents PROMIS Pain Interference measure was used to capture pain interference with functioning (score range 0-30 with higher number indicating worse pain interference)
measure: Analgesic Self-Efficacy
time frame: Efficacy scores Day 14
description: Survey measures how confident the parent is in managing pain and opioid-related adverse events (score range 0-35; higher = more efficacy)
measure: Analgesic Use / Adherence
time frame: Day 14
description: Total number of opioid doses administered
measure: Analgesic Decision Competency
time frame: Day 3
description: Number of participants who made the scenario-based decision to administer opioid to excessively sedated child
arm group label: Education Intervention + Nudge
arm group type: Experimental
description: This group will receive BOTH the scenario-tailored STOMP educational feedback AND the behavioral Nudge intervention
arm group label: Standard of Care + Nudge
arm group type: Experimental
description: This group will receive routine, standard of care information AND the behavioral Nudge intervention
arm group label: Educational Intervention no Nudge
arm group type: Experimental
description: This group will receive scenario-tailored opioid message (STOMP) feedback and NO behavioral nudge intervention.
arm group label: Standard of Care no Nudge
arm group type: No Intervention
description: This group will receive only standard of care information and NO behavioral nudge intervention.
intervention type: Behavioral
intervention name: Educational Intervention
description: This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
arm group label: Education Intervention + Nudge
arm group label: Educational Intervention no Nudge
other name: STOMP Intervention
intervention type: Behavioral
intervention name: Nudge
description: Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids
arm group label: Education Intervention + Nudge
arm group label: Standard of Care + Nudge
criteria: 
gender: All
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: No
last name: Terri Voepel-Lewis, PhD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Terri Voepel-Lewis
investigator title: Associate Research Scientist
mesh term: Pain, Postoperative
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 