<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/NCT03012087</url>
  </required_header>
  <id_info>
    <org_study_id>MyHealthyChoices</org_study_id>
    <nct_id>NCT03012087</nct_id>
  </id_info>
  <brief_title>Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers</brief_title>
  <official_title>Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to pilot test a web-based, patient-centered educational program that&#xD;
      encourages the patient to have an informed discussion about pain medication options with&#xD;
      their emergency department (ED) provider.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multi-site, randomized trial will evaluate an m-health program designed to aid the&#xD;
      patient in making an informed decision about their pain treatment. Patients reporting to the&#xD;
      ED with an injury-related chief complaint who agree to participate are randomized to receive&#xD;
      the intervention program, My Healthy Choices, or an attention-matched control. My Healthy&#xD;
      Choices pairs tailored education with a patient decision aid to describe what opioid and&#xD;
      non-opioid pain medications are, assess the patient's risk factors for opioid-related adverse&#xD;
      effects, and produce a tailored report that patients are encouraged to share with their&#xD;
      doctor. Data are collected through surveys at three time points during the ED encounter&#xD;
      (baseline, immediately after the intervention, and just before discharge), and at a 6-week&#xD;
      follow-up survey. The primary outcomes are whether the patient prefers an opioid pain&#xD;
      reliever (OPR) and whether the patient takes an OPR. The investigators hope this program will&#xD;
      facilitate patient-provider communication, as well as reduce the number of prescriptions&#xD;
      written for OPRs and thus the number of patients exposed to prescription opioids and the&#xD;
      associated risks of addiction and overdose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Self-Reported Preference for Opioid Pain Reliever</measure>
    <time_frame>Baseline and Immediate Post-test</time_frame>
    <description>Assessed via questionnaire on a scale of 0-10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain Medications</measure>
    <time_frame>Baseline and 6 weeks</time_frame>
    <description>Assessed with a 25-item questionnaire. Knowledge items will be scored correct or incorrect and summed to generate a total knowledge score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Reported Prescription Drug Storage and Disposal Behaviors</measure>
    <time_frame>6 weeks</time_frame>
    <description>Assessed via 5 items on a questionnaire. Behaviors will be scored correct or incorrect and tabulated across study groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Prescription Drug Abuse</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MyHealthyChoices</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Health Risk Assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MyHealthyChoices</intervention_name>
    <description>My Healthy Choices explains what opioid pain medications are, assesses and explains the patient's risk factors related to taking opioids, assesses patient preferences about pain medications, and produces a tailored patient report based on the answers. The patient is encouraged to show the report to the treating ED clinician so they can discuss medication options for treating the patient's pain. Following discharge from the ED, intervention group participants discharged with a prescription pain reliever receive messages about safe medication use, storage, and disposal and access to an educational web portal that contains more information on prescription pain medications and safety.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health Risk Assessment</intervention_name>
    <description>The WellSource health risk assessment content focuses on general health promotion, and the participant's overall health and wellness. A summary report based on the participants' answers is sent to their email address.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ED visit for an injury- or pain-related chief complaint&#xD;
&#xD;
          2. 18 years of age or older&#xD;
&#xD;
          3. speak English&#xD;
&#xD;
          4. has a smart phone or email address that is used on a regular basis&#xD;
&#xD;
          5. no previous medical care for the current complaint&#xD;
&#xD;
          6. triage pain score between 7-10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to pain medications&#xD;
&#xD;
          -  have used a prescription pain medication for more than two days in the past month&#xD;
&#xD;
          -  report renal problems or a history of dialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea C Gielen, ScD ScM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital Emergency Department</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Emergency Department</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03012087
org study id: MyHealthyChoices
nct id: NCT03012087
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to pilot test a web-based, patient-centered educational program that
      encourages the patient to have an informed discussion about pain medication options with
      their emergency department (ED) provider.
This multi-site, randomized trial will evaluate an m-health program designed to aid the
      patient in making an informed decision about their pain treatment. Patients reporting to the
      ED with an injury-related chief complaint who agree to participate are randomized to receive
      the intervention program, My Healthy Choices, or an attention-matched control. My Healthy
      Choices pairs tailored education with a patient decision aid to describe what opioid and
      non-opioid pain medications are, assess the patient's risk factors for opioid-related adverse
      effects, and produce a tailored report that patients are encouraged to share with their
      doctor. Data are collected through surveys at three time points during the ED encounter
      (baseline, immediately after the intervention, and just before discharge), and at a 6-week
      follow-up survey. The primary outcomes are whether the patient prefers an opioid pain
      reliever (OPR) and whether the patient takes an OPR. The investigators hope this program will
      facilitate patient-provider communication, as well as reduce the number of prescriptions
      written for OPRs and thus the number of patients exposed to prescription opioids and the
      associated risks of addiction and overdose.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Self-Reported Preference for Opioid Pain Reliever
time frame: Baseline and Immediate Post-test
description: Assessed via questionnaire on a scale of 0-10.
measure: Change in Knowledge about Prescription Pain Medication Side Effects and Safe Practices for Taking, Storing and Disposing Prescription Pain Medications
time frame: Baseline and 6 weeks
description: Assessed with a 25-item questionnaire. Knowledge items will be scored correct or incorrect and summed to generate a total knowledge score.
measure: Self-Reported Prescription Drug Storage and Disposal Behaviors
time frame: 6 weeks
description: Assessed via 5 items on a questionnaire. Behaviors will be scored correct or incorrect and tabulated across study groups.
arm group label: Intervention Group
arm group type: Experimental
description: MyHealthyChoices
arm group label: Control Group
arm group type: Placebo Comparator
description: Health Risk Assessment
intervention type: Behavioral
intervention name: MyHealthyChoices
description: My Healthy Choices explains what opioid pain medications are, assesses and explains the patient's risk factors related to taking opioids, assesses patient preferences about pain medications, and produces a tailored patient report based on the answers. The patient is encouraged to show the report to the treating ED clinician so they can discuss medication options for treating the patient's pain. Following discharge from the ED, intervention group participants discharged with a prescription pain reliever receive messages about safe medication use, storage, and disposal and access to an educational web portal that contains more information on prescription pain medications and safety.
arm group label: Intervention Group
intervention type: Other
intervention name: Health Risk Assessment
description: The WellSource health risk assessment content focuses on general health promotion, and the participant's overall health and wellness. A summary report based on the participants' answers is sent to their email address.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea C Gielen, ScD ScM
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: No