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MHealth Incentivized Adherence Plus Patient Navigation (MIAPP)

Primary Purpose

Opioid Use Disorder, Medication Adherence, Polysubstance Drug Use (Indiscriminate Drug Use)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient Navigation and mHealth (PN+mHealth)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult greater than or equal to 18 years of age Admitted to Harborview Medical Center (HMC) on any inpatient service Initiated on buprenorphine for OUD while in the hospital or at the time of discharge and planning to continue outpatient Used methamphetamine within the past 30 days (any route of administration or frequency) Willing to be randomized to video-DOT Willing and able to use a smartphone (study can provide) and work with patient navigator Discharge setting does not preclude the use of video-DOT (i.e., nursing home, inpatient psychiatry, etc.) Exclusion Criteria: Unable or unwilling to use smartphone (phones to be provided when needed) Cognitive impairment (acute or chronic) resulting in inability to provide informed consent Currently incarcerated and will discharge to jail or prison Plans to discontinue buprenorphine in the near future (<3 months) Lives far away such that cannot keep study visit at 30 days post-discharge Not English speaking Behavioral risk per discretion of research staff

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Treatment-as-usual (TAU)

    PN+mHealth

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Patient linkage to an outpatient program that provides medication for opioid use disorder
    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.

    Secondary Outcome Measures

    Retention on medication for opioid use disorder
    This will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone).
    Hospital readmission
    The number of hospital admissions will be extracted from statewide Medicaid claims data.
    Emergency department visits
    The number of emergency department visits will be extracted from statewide Medicaid claims data.
    Past 30-day opioid use
    The number of days using illicit opioids in the past 30 days per self-report as collected through the modified Addiction Severity Index.
    Past 30-day methamphetamine use
    The number of days using methamphetamine in the past 30 days per self-report as collected through the modified Addiction Severity Index.

    Full Information

    First Posted
    August 30, 2023
    Last Updated
    August 30, 2023
    Sponsor
    University of Washington
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06027814
    Brief Title
    MHealth Incentivized Adherence Plus Patient Navigation
    Acronym
    MIAPP
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    September 22, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Opioid Use Disorder, Medication Adherence, Polysubstance Drug Use (Indiscriminate Drug Use), Methamphetamine-dependence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment-as-usual (TAU)
    Arm Type
    No Intervention
    Arm 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 Title
    PN+mHealth
    Arm Type
    Experimental
    Arm 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(s)
    Patient Navigation and mHealth (PN+mHealth)
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Patient linkage to an outpatient program that provides medication for opioid use disorder
    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.
    Time Frame
    30 days post-discharge from hospital
    Secondary Outcome Measure Information:
    Title
    Retention on medication for opioid use disorder
    Description
    This will be measured as the number of days with medication coverage. (buprenorphine, naltrexone, or methadone).
    Time Frame
    90 days post-discharge from hospital
    Title
    Hospital readmission
    Description
    The number of hospital admissions will be extracted from statewide Medicaid claims data.
    Time Frame
    90 days post-discharge from hospital
    Title
    Emergency department visits
    Description
    The number of emergency department visits will be extracted from statewide Medicaid claims data.
    Time Frame
    90 days post-discharge from hospital
    Title
    Past 30-day opioid use
    Description
    The number of days using illicit opioids in the past 30 days per self-report as collected through the modified Addiction Severity Index.
    Time Frame
    30 days post-discharge
    Title
    Past 30-day methamphetamine use
    Description
    The number of days using methamphetamine in the past 30 days per self-report as collected through the modified Addiction Severity Index.
    Time Frame
    30 days post-discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult greater than or equal to 18 years of age Admitted to Harborview Medical Center (HMC) on any inpatient service Initiated on buprenorphine for OUD while in the hospital or at the time of discharge and planning to continue outpatient Used methamphetamine within the past 30 days (any route of administration or frequency) Willing to be randomized to video-DOT Willing and able to use a smartphone (study can provide) and work with patient navigator Discharge setting does not preclude the use of video-DOT (i.e., nursing home, inpatient psychiatry, etc.) Exclusion Criteria: Unable or unwilling to use smartphone (phones to be provided when needed) Cognitive impairment (acute or chronic) resulting in inability to provide informed consent Currently incarcerated and will discharge to jail or prison Plans to discontinue buprenorphine in the near future (<3 months) Lives far away such that cannot keep study visit at 30 days post-discharge Not English speaking Behavioral risk per discretion of research staff
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Research Study Coordinator
    Phone
    206-744-1838
    Email
    miappstudy@uw.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Judith I Tsui, MD, MPH
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    MHealth Incentivized Adherence Plus Patient Navigation

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