xml: <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/NCT06027814</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00016329</org_study_id>
      <secondary_id>1R34DA057609-01</secondary_id>
      <nct_id>NCT06027814</nct_id>
    </id_info>
    <brief_title>MHealth Incentivized Adherence Plus Patient Navigation</brief_title>
    <acronym>MIAPP</acronym>
    <official_title>Patient Navigator Plus Remote mHealth Adherence Support With Incentives to Improve Linkage and Retention Among Hospitalized Patients With Opioid and Methamphetamine Use Who Initiate Buprenorphine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</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 Washington</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>
        Polysubstance use involving opioids and methamphetamine is emerging as a new public health&#xD;
        crisis. Patients with opioids and methamphetamine use often experience serious medical&#xD;
        complications requiring hospitalization, which provides an opportunity to offer addiction&#xD;
        treatment. Yet linkage to outpatient treatment post-discharge is suboptimal and&#xD;
        methamphetamine exacerbates outcomes. We propose to pilot test &quot;MHealth Incentivized&#xD;
        Adherence Plus Patient Navigation&quot; (MIAPP) to promote treatment linkage and retention for&#xD;
        patients with opioid use disorder (OUD) and methamphetamine use who initiate buprenorphine in&#xD;
        the hospital. Our Aim is to perform a two-arm, pilot randomized clinical trial (n=40)&#xD;
        comparing MIAPP + treatment-as-usual (TAU) versus TAU alone on outpatient medication for&#xD;
        opioid use disorder (MOUD) linkage within 30 days (primary) and 90-day retention on&#xD;
        medications (secondary) among hospitalized patients with OUD and methamphetamine use.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 22, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2024</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>
      <intervention_model_description>Participants will be randomized to treatment group. Group assignment will occur through computerized (REDCap) randomization procedures. We will stratify randomization by whether the patient has buprenorphine treatment in the past year. Randomization lists will be prepared within each stratum using random block sizes of 4 to ensure balanced groups throughout the enrollment period. Participants will be informed of their assignment by research staff after completion of informed consent and the baseline survey.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient linkage to an outpatient program that provides medication for opioid use disorder</measure>
      <time_frame>30 days post-discharge from hospital</time_frame>
      <description>Defined as documentation of an outpatient clinical encounter (either in-person or via telemedicine) where a medication for OUD (either buprenorphine, naltrexone, or methadone) was provided or prescribed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Retention on medication for opioid use disorder</measure>
      <time_frame>90 days post-discharge from hospital</time_frame>
      <description>This will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital readmission</measure>
      <time_frame>90 days post-discharge from hospital</time_frame>
      <description>The number of hospital admissions will be extracted from statewide Medicaid claims data.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emergency department visits</measure>
      <time_frame>90 days post-discharge from hospital</time_frame>
      <description>The number of emergency department visits will be extracted from statewide Medicaid claims data.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Past 30-day opioid use</measure>
      <time_frame>30 days post-discharge</time_frame>
      <description>The number of days using illicit opioids in the past 30 days per self-report as collected through the modified Addiction Severity Index.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Past 30-day methamphetamine use</measure>
      <time_frame>30 days post-discharge</time_frame>
      <description>The number of days using methamphetamine in the past 30 days per self-report as collected through the modified Addiction Severity Index.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Opioid Use Disorder</condition>
    <condition>Medication Adherence</condition>
    <condition>Polysubstance Drug Use (Indiscriminate Drug Use)</condition>
    <condition>Methamphetamine-dependence</condition>
    <arm_group>
      <arm_group_label>Treatment-as-usual (TAU)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>TAU will be usual care that the Addiction Consult Service provides. It is comprised of a multidisciplinary team of professionals, including addiction medicine and addiction psychiatry physicians, nurses specializing in the treatment of OUD, substance use disorder counselors, peer recovery supports, and program coordinators.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PN+mHealth</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention is patient navigation and mHealth in addition to treatment-as-usual. The intervention consists of a patient navigator (PN) with the mHealth adherence application facilitating telehealth visits, two-way chats, video-DOT, and delivery of financial incentives via smartphone for adherence and linkage to outpatient treatment within 30 days. Participants will be asked to upload medication adherence videos once a day over the 30 days post discharge from the hospital. Patients will be instructed to continue to take their medication as prescribed in any circumstance where they are unable to upload the video for any reason.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Patient Navigation and mHealth (PN+mHealth)</intervention_name>
      <description>Intervention consists of patient navigation with the mHealth adherence application facilitating telehealth visits, two-way chats, video-DOT, and delivery of financial incentives via smartphone.</description>
      <arm_group_label>PN+mHealth</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult greater than or equal to 18 years of age&#xD;
  &#xD;
            -  Admitted to Harborview Medical Center (HMC) on any inpatient service&#xD;
  &#xD;
            -  Initiated on buprenorphine for OUD while in the hospital or at the time of discharge&#xD;
               and planning to continue outpatient&#xD;
  &#xD;
            -  Used methamphetamine within the past 30 days (any route of administration or&#xD;
               frequency)&#xD;
  &#xD;
            -  Willing to be randomized to video-DOT&#xD;
  &#xD;
            -  Willing and able to use a smartphone (study can provide) and work with patient&#xD;
               navigator&#xD;
  &#xD;
            -  Discharge setting does not preclude the use of video-DOT (i.e., nursing home,&#xD;
               inpatient psychiatry, etc.)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable or unwilling to use smartphone (phones to be provided when needed)&#xD;
  &#xD;
            -  Cognitive impairment (acute or chronic) resulting in inability to provide informed&#xD;
               consent&#xD;
  &#xD;
            -  Currently incarcerated and will discharge to jail or prison&#xD;
  &#xD;
            -  Plans to discontinue buprenorphine in the near future (&lt;3 months)&#xD;
  &#xD;
            -  Lives far away such that cannot keep study visit at 30 days post-discharge&#xD;
  &#xD;
            -  Not English speaking&#xD;
  &#xD;
            -  Behavioral risk per discretion of research staff&#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>Judith I Tsui, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Research Study Coordinator</last_name>
      <phone>206-744-1838</phone>
      <email>miappstudy@uw.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Judith I. Tsui</investigator_full_name>
      <investigator_title>Professor, School of Medicine, General Internal Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Opioid-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>
  
  
text: 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/NCT06027814
  org study id: STUDY00016329
  secondary id: 1R34DA057609-01
  nct id: NCT06027814
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Polysubstance use involving opioids and methamphetamine is emerging as a new public health
        crisis. Patients with opioids and methamphetamine use often experience serious medical
        complications requiring hospitalization, which provides an opportunity to offer addiction
        treatment. Yet linkage to outpatient treatment post-discharge is suboptimal and
        methamphetamine exacerbates outcomes. We propose to pilot test "MHealth Incentivized
        Adherence Plus Patient Navigation" (MIAPP) to promote treatment linkage and retention for
        patients with opioid use disorder (OUD) and methamphetamine use who initiate buprenorphine in
        the hospital. Our Aim is to perform a two-arm, pilot randomized clinical trial (n=40)
        comparing MIAPP + treatment-as-usual (TAU) versus TAU alone on outpatient medication for
        opioid use disorder (MOUD) linkage within 30 days (primary) and 90-day retention on
        medications (secondary) among hospitalized patients with OUD and methamphetamine use.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomized to treatment group. Group assignment will occur through computerized (REDCap) randomization procedures. We will stratify randomization by whether the patient has buprenorphine treatment in the past year. Randomization lists will be prepared within each stratum using random block sizes of 4 to ensure balanced groups throughout the enrollment period. Participants will be informed of their assignment by research staff after completion of informed consent and the baseline survey.
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Patient linkage to an outpatient program that provides medication for opioid use disorder
  time frame: 30 days post-discharge from hospital
  description: Defined as documentation of an outpatient clinical encounter (either in-person or via telemedicine) where a medication for OUD (either buprenorphine, naltrexone, or methadone) was provided or prescribed.
  measure: Retention on medication for opioid use disorder
  time frame: 90 days post-discharge from hospital
  description: This will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone).
  measure: Hospital readmission
  time frame: 90 days post-discharge from hospital
  description: The number of hospital admissions will be extracted from statewide Medicaid claims data.
  measure: Emergency department visits
  time frame: 90 days post-discharge from hospital
  description: The number of emergency department visits will be extracted from statewide Medicaid claims data.
  measure: Past 30-day opioid use
  time frame: 30 days post-discharge
  description: The number of days using illicit opioids in the past 30 days per self-report as collected through the modified Addiction Severity Index.
  measure: Past 30-day methamphetamine use
  time frame: 30 days post-discharge
  description: The number of days using methamphetamine in the past 30 days per self-report as collected through the modified Addiction Severity Index.
  arm group label: Treatment-as-usual (TAU)
  arm group type: No Intervention
  description: TAU will be usual care that the Addiction Consult Service provides. It is comprised of a multidisciplinary team of professionals, including addiction medicine and addiction psychiatry physicians, nurses specializing in the treatment of OUD, substance use disorder counselors, peer recovery supports, and program coordinators.
  arm group label: PN+mHealth
  arm group type: Experimental
  description: The intervention is patient navigation and mHealth in addition to treatment-as-usual. The intervention consists of a patient navigator (PN) with the mHealth adherence application facilitating telehealth visits, two-way chats, video-DOT, and delivery of financial incentives via smartphone for adherence and linkage to outpatient treatment within 30 days. Participants will be asked to upload medication adherence videos once a day over the 30 days post discharge from the hospital. Patients will be instructed to continue to take their medication as prescribed in any circumstance where they are unable to upload the video for any reason.
  intervention type: Behavioral
  intervention name: Patient Navigation and mHealth (PN+mHealth)
  description: Intervention consists of patient navigation with the mHealth adherence application facilitating telehealth visits, two-way chats, video-DOT, and delivery of financial incentives via smartphone.
  arm group label: PN+mHealth
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Judith I Tsui, MD, MPH
  role: Principal Investigator
  affiliation: University of Washington
  last name: Research Study Coordinator
  phone: 206-744-1838
  email: miappstudy@uw.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Judith I. Tsui
  investigator title: Professor, School of Medicine, General Internal Medicine
  mesh term: Opioid-Related Disorders
  sharing ipd: No