MHealth Incentivized Adherence Plus Patient Navigation (MIAPP)

University of Washington

Status: Enrolling

Conditions: Medication Adherence; Opioid Use Disorder; Methamphetamine-dependence; Polysubstance Drug Use (Indiscriminate Drug Use)

Treatments: Behavioral: Patient Navigation and mHealth (PN+mHealth)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06027814

1R34DA057609-01 (U.S. NIH Grant/Contract)

STUDY00016329

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Treatment-as-usual (TAU)

No Intervention group

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.

PN+mHealth

Experimental group

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.

Treatment:

Behavioral: Patient Navigation and mHealth (PN+mHealth)