Clinical trial NCT06027814: MHealth Incentivized Adherence Plus Patient Navigation
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Medication Adherence
Polysubstance Drug Use (Indiscriminate Drug Use)
Methamphetamine-dependence
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-09-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to treatment group. Group assignment will occur through computerized (REDCap) randomization procedures. The investigators 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

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. The investigators 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. The investigators 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.


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

Primary outcomes:
measure: Patient linkage to an outpatient program that provides medication for opioid use disorder
timeFrame: 30 days post-discharge from hospital
Secondary outcomes:
measure: Retention on medication for opioid use disorder
timeFrame: 90 days post-discharge from hospital
measure: Hospital readmission
timeFrame: 90 days post-discharge from hospital
measure: Emergency department visits
timeFrame: 90 days post-discharge from hospital
measure: Past 30-day opioid use
timeFrame: 30 days post-discharge
measure: Past 30-day methamphetamine use
timeFrame: 30 days post-discharge
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Judith I Tsui, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: